U.S. patent application number 15/166932 was filed with the patent office on 2016-09-22 for patient-specific surgical guidance tool and method of use.
The applicant listed for this patent is Queen's University at Kingston. Invention is credited to Manuela Kunz, John F. Rudan.
Application Number | 20160270855 15/166932 |
Document ID | / |
Family ID | 51896308 |
Filed Date | 2016-09-22 |
United States Patent
Application |
20160270855 |
Kind Code |
A1 |
Kunz; Manuela ; et
al. |
September 22, 2016 |
Patient-Specific Surgical Guidance Tool and Method of Use
Abstract
Presented is a preoperatively designed guidance tool for
intraoperative use during bone or joint surgery wherein the
guidance tool is specific to the anatomy of the patient being
treated. The guidance tool comprises a body portion, a mating
surface provided on the body portion for positioning the guidance
tool on a corresponding registration surface of a patient's
anatomy. The guidance tool further comprises at least one guide
mechanism provided on the body portion for guiding a medical
instrument at one or more preoperatively defined trajectories
relative to a patient's anatomy. In the event of misalignment, the
at least one guide mechanism is adjustable to alter the one or more
preoperatively defined trajectories if necessary during
intraoperative use. Also presented is a preoperative process for
designing the guidance tool.
Inventors: |
Kunz; Manuela; (Kingston,
CA) ; Rudan; John F.; (Kingston, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Queen's University at Kingston |
Kingston |
CA |
US |
|
|
Family ID: |
51896308 |
Appl. No.: |
15/166932 |
Filed: |
May 27, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13893484 |
May 14, 2013 |
9351744 |
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15166932 |
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12120547 |
May 14, 2008 |
8444651 |
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13893484 |
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60917713 |
May 14, 2007 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/1764 20130101;
A61B 2034/108 20160201; A61B 2090/061 20160201; A61B 17/1703
20130101; A61B 17/1778 20161101; A61B 17/1775 20161101; A61B 17/15
20130101; A61B 2034/107 20160201; A61B 17/1721 20130101; A61B
17/1782 20161101; A61B 34/10 20160201; A61B 17/175 20130101; A61B
2017/568 20130101; A61B 2034/104 20160201; A61B 90/06 20160201;
A61B 2090/067 20160201; A61B 17/1742 20130101 |
International
Class: |
A61B 34/10 20060101
A61B034/10; A61B 90/00 20060101 A61B090/00; A61B 17/17 20060101
A61B017/17 |
Claims
1. A preoperatively designed guidance tool for intraoperative use
during bone or joint surgery wherein said guidance tool is specific
to the anatomy of the patient being treated, said guidance tool
comprising: a body portion; a mating surface provided on said body
portion, said mating surface for positioning said guidance tool on
a corresponding registration surface of a patient's anatomy; and at
least one guide mechanism provided on said body portion, said at
least one guide mechanism for guiding at least one medical
instrument at one or more preoperatively defined trajectories
relative to a patient's anatomy; wherein said at least one guide
mechanism is adjustable to alter the one or more preoperatively
defined trajectories if necessary during intraoperative use.
2. The guidance tool of claim 1, wherein said body portion
comprises a guide component, and a registration component, each of
said at least one guide mechanism and said mating surface being
provided on at least one of said guide component and said
registration component.
3. The guidance tool of claim 2, wherein said body portion further
comprises a stability component.
4. The guidance tool of claim 1, wherein said mating surface
comprises a profile that is complementary to characteristic
anatomical landmarks found on said registration surface of a
patient's anatomy.
5. The guidance tool of claim 1, further comprising a removable
verification tool for mechanically verifying the correct position
of the guidance tool on the patient's anatomy, having regard to
preoperatively selected anatomical landmarks.
6. The guidance tool of claim 5, wherein said verification tool is
configured for insertion into said guide mechanism.
7. The guidance tool of claim 5, wherein said verification tool
comprises at least one graduated section to determine misalignment
of the guidance tool relative to said one or more preoperatively
defined trajectories.
8. The guidance tool of claim 7, wherein said verification tool
comprises two graduated sections for providing misalignment values
relative to the patient's anatomy, a first graduated section
providing misalignment values in a longitudinal direction, and a
second graduated section providing misalignment values in a radial
direction.
9. The guidance tool of claim 5, further comprising locking keys
provided on said body portion for aligning said verification tool
in a preoperatively defined position for comparison with previously
selected anatomical landmarks.
10. The guidance tool of claim 1, wherein said guide mechanism
comprises a guide channel and corresponding instrument sleeve for
placement within said guide channel, said instrument sleeve for
guiding said medical instrument at said one or more preoperatively
defined trajectories relative to a patient's anatomy.
11. The guidance tool of claim 10, wherein said guide mechanism
comprises a realignment sleeve for use in place of said instrument
sleeve, said realignment sleeve providing a realignment of the
instrument trajectory where the established trajectory requires
adjustment.
12. A preoperative process for designing at least one guidance tool
for intraoperative use during bone or joint surgery wherein said at
least one guidance tool is specific to the anatomy of the patient
being treated, said process comprising creating a 3-D surface model
of the patient's anatomy; using the 3-D surface model of the
patient's anatomy to preoperatively determine a trajectory of at
least one medical instrument during bone or joint manipulation;
designing at least one guidance tool for registering against the
patient's anatomy, said at least one guidance tool providing a
guide mechanism and a mating surface, said guide mechanism for
guiding said at least one medical instrument during said bone or
joint manipulation at one or more preoperatively defined trajectory
relative to a patient's anatomy, said mating surface providing
positional registration of said at least one guidance tool on the
patient's anatomy; and preoperatively assessing the fit, size and
design of the at least one guidance tool on the patient anatomy
using the 3-D surface model of the patient's anatomy, and adjusting
the design of the at least one guidance tool as necessary to
achieve a correct fit.
13. The preoperative process of claim 12, wherein said 3-D surface
model of the patient's anatomy is created by one or more of CT,
MRI, X-ray, and ultrasound.
14. The preoperative process of claim 12, wherein said assessment
of fit involves a quantitative figure of merit determination based
on an examination of characteristic landmarks on said mating
surface relative to said patient's anatomy.
15. The preoperative process of claim 12, further comprising the
identification of at least one characteristic anatomical landmark
to be used in connection with a removable verification tool for
mechanically verifying correct position of the at least one
guidance tool on the patient's anatomy, said verification tool
being configured for attachment to the at least one guidance
tool.
16. A method of facilitating bone or joint surgery using a
preoperatively designed patient-specific guidance tool, said method
comprising the steps of: placing the guidance tool directly upon
the patient's anatomy for which it has been designed, said guidance
tool providing a mating surface and a guide mechanism, said guide
mechanism for guiding at least one medical instrument during bone
or joint manipulation at one ore more preoperatively defined
trajectory relative to a patient's anatomy, said mating surface
providing positional registration of said guidance tool on said
patient's anatomy; assessing the position of the guidance tool upon
the patient's anatomy; assessing the preoperatively defined one or
more trajectory governed by the guide mechanism of the guidance
tool; determining whether adjustments to the guide mechanism are
necessary for achieving an optimal trajectory of said at least one
medical instrument; and adjusting, if necessary, the guide
mechanism of said guidance tool to achieve one or more alternate
trajectory for said at least one medical instrument.
17. The method according to claim 16, wherein a verification tool,
fitted to said guide mechanism of the guidance tool, is used to
assess the position and orientation of the guidance tool having
regard to the preoperatively defined trajectory.
18. The guidance tool of claim 17, wherein said verification tool
comprises at least one graduated section to determine misalignment
of the guidance tool relative to said one or more preoperatively
defined trajectories.
19. The guidance tool of claim 18, wherein said verification tool
comprises two graduated sections for providing misalignment values
relative to the patient's anatomy, a first graduated section
providing misalignment values in a longitudinal direction, and a
second graduated section providing misalignment values in a radial
direction.
20. The method according to claim 17, wherein said guide mechanism
comprises a guide channel and an instrument sleeve, and wherein a
correction to realign said trajectory is provided by a realignment
sleeve used in place of said instrument sleeve to achieve the
corrected trajectory.
Description
RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Patent Application No. 60/917,713 filed on May 14, 2007 which is
incorporated herein by reference.
FIELD
[0002] The present invention pertains to a patient-specific
alignment and guidance tool for a surgical procedure, and software
associated with designing such a tool. The present invention also
pertains to a pre-operative process using the software for
designing the patient-specific alignment and guidance tool. The
present invention also pertains to an intraoperative process
wherein the patient-specific alignment and guidance tool is used
during a surgical procedure.
BACKGROUND
[0003] Bone and joint surgical procedures are well known in the
art. To improve on conventional surgical techniques, imaging
technologies and computers are increasingly being adopted and
implemented by surgeons. The primary drive in developing such
technology is to reduce the overall invasiveness of the procedure,
while maintaining or increasing the overall accuracy.
[0004] Computer assisted surgery (CAS) is now quite common for a
range of surgical procedures. Surgeons are able to use computer
tracking technology to visually map a patient's anatomy both before
and during the surgical procedure. CAS also provides increased
precision in targeting a particular site for correction. These
techniques are also very useful for determining the optimal size
and location of prosthetic implants.
[0005] Publications in the area of CAS have shown increased
accuracy and/or precision during the intraoperative procedure;
however, these systems add not only higher costs to the surgery,
but also increased surgical time. The necessary technical equipment
related to conventional computer-assisted systems makes additional
surgeon and operating room (OR) team training necessary.
Additionally, not all hospitals have access to CAS techniques.
Furthermore, the accuracy benefits of CAS are not necessarily
reflected in the patient outcomes, as there is significant
variability amongst surgeons in their ability to perform precise
surgical operations.
[0006] Also known in the art is the use of templates for surgical
procedures. Templates may be prepared using medical imaging
techniques and they can enhance the accuracy of the procedure in
the operating room. However, a drawback of such templates is that
the alignment provided cannot be verified or adjusted
intraoperatively.
[0007] In view of the foregoing disadvantages, it would be
beneficial to implement a procedure that combines the accuracy
benefits of CAS with the precision, repeatability, low cost and
ease of use benefits associated with surgical alignment tools.
SUMMARY
[0008] According to one aspect, provided is a guidance tool for
intraoperative use during bone or joint surgery wherein said
guidance tool is specific to the anatomy of the patient being
treated, said guidance tool comprising a guide component for
guiding a medical instrument at one or more predetermined
trajectories relative to a patient's anatomy, and a registration
component attached to said guide component for positioning said
guidance tool on a patient's anatomy, wherein said guide component
can be adjusted to alter the one or more predetermined trajectories
if necessary during intraoperative use.
[0009] In one embodiment, the guidance tool further comprises a
verification component for mechanically verifying correct position
of the guidance tool on the patient's anatomy.
[0010] According to a further aspect, provided is a preoperative
process for designing a guidance tool for intraoperative use during
bone or joint surgery wherein said guidance tool is specific to the
anatomy of the patient being treated, said process comprising
creating a 3-D surface model of the patient's anatomy, using the
3-D surface model of the patient's anatomy to preoperatively
determine a trajectory for pin placement, designing a virtual
guidance tool for registering against the patient's anatomy, said
virtual guidance tool providing a guide component for guiding pin
placement at the predetermined trajectory relative to the patient's
anatomy, and a registration component attached to said guide
component for positioning said guidance tool on the patient's
anatomy, preoperatively assessing the fit, size and/or design of
the guidance tool on the patient anatomy using the 3-D surface
model of the patient's anatomy, and adjusting the design of the
guidance tool as necessary to achieve a correct fit.
[0011] According to another aspect, provided is a method of
facilitating bone or joint surgery using a preoperatively designed
patient-specific guidance tool, said method comprising the steps of
placing the guidance tool directly upon the patient's anatomy for
which it has been designed, said guidance tool providing a guide
component establishing a predetermined trajectory for pin
placement, assessing the predetermined trajectory governed by the
guide component of the guidance tool, determining whether
adjustments to the guide component are necessary for achieving an
optimal placement of said pin, and adjusting, if necessary, the
guide component of said guidance tool to achieve an alternate
trajectory for optimal placement of said pin.
[0012] According to a further aspect, provided is a method of
verifying correct placement of a preoperatively designed
patient-specific guidance tool, comprising intraoperatively placing
the guidance tool directly upon the patient's anatomy for which it
has been designed, the guidance tool having a guide component
establishing a predetermined trajectory for pin placement and a
verification component for mechanically verifying correct position
of the guidance tool on the patient's anatomy, and using the
verification component to mechanically verify correct position of
the guidance tool on the patient's anatomy.
[0013] According to an aspect, provided is a preoperatively
designed guidance tool for intraoperative use during bone or joint
surgery wherein said guidance tool is specific to the anatomy of
the patient being treated, said guidance tool comprising:
[0014] a body portion;
[0015] a mating surface provided on said body portion, said mating
surface for positioning said guidance tool on a corresponding
registration surface of a patient's anatomy; and
[0016] at least one guide mechanism provided on said body portion,
said at least one guide mechanism for guiding at least one medical
instrument at one or more preoperatively defined trajectories
relative to a patient's anatomy;
[0017] wherein said at least one guide mechanism is adjustable to
alter the one or more preoperatively defined trajectories if
necessary during intraoperative use.
[0018] In some embodiments, said body portion comprises a guide
component, and a registration component, each of said at least one
guide mechanism and said mating surface being provided on at least
one of said guide component and said registration component.
[0019] In some embodiments, said body portion further comprises a
stability component.
[0020] In some embodiments, said mating surface on said body
portion is discontinuous having regard to the patient's
anatomy.
[0021] In some embodiments, said mating surface comprises a profile
that is complementary to characteristic anatomical landmarks found
on said registration surface of a patient's anatomy.
[0022] In some embodiments, the guide tool further comprises a
removable verification tool for mechanically verifying the correct
position of the guidance tool on the patient's anatomy, having
regard to preoperatively selected anatomical landmarks.
[0023] In some embodiments, said verification tool is configured
for insertion into said guide mechanism.
[0024] In some embodiments, said verification tool comprises at
least one graduated section to determine misalignment of the
guidance tool relative to said one or more preoperatively defined
trajectories.
[0025] In some embodiments, said verification tool comprises two
graduated section for providing misalignment values relative to the
patient's anatomy, a first graduated section providing misalignment
values in a longitudinal direction, and a second graduated section
providing misalignment values in a radial direction.
[0026] In some embodiments, said at least one graduated section is
a sliding ruler is provided with graduations for measuring said
misalignment.
[0027] In some embodiments, the guidance tool further comprises
locking keys provided on said body portion for aligning said
verification tool in a preoperatively defined position for
comparison with previously selected anatomical landmarks.
[0028] In some embodiments, said guide mechanism comprises a guide
channel and corresponding instrument sleeve for placement within
said guide channel, said instrument sleeve for guiding said medical
instrument at said one or more preoperatively defined trajectories
relative to a patient's anatomy.
[0029] In some embodiments, said guide mechanism comprises a
realignment sleeve for use in place of said instrument sleeve, said
realignment sleeve providing a realignment of the instrument
trajectory where the established trajectory requires
adjustment.
[0030] In some embodiments, said realignment sleeve is configured
with a translational offset relative to the central axis of the
sleeve.
[0031] In some embodiments, said realignment sleeve is configured
with an angled offset relative to the central axis of the
sleeve.
[0032] In some embodiments, said realignment sleeve is configured
with a combined translational offset and angled offset relative to
the central axis of the sleeve.
[0033] In some embodiments, the translational offsets are from
about 0 to about 5 mm from the central axis.
[0034] In some embodiments, the translational offsets are provided
in increments ranging from about 0.01 mm to about 1 mm.
[0035] In some embodiments, the angled offset is from about 0 to
about 5.degree. relative to the central axis.
[0036] In some embodiments, the angled offsets are provided in
increments ranging from about 0.05.degree. to about 1.degree..
[0037] According to another aspect, provided is a preoperative
process for designing at least one guidance tool for intraoperative
use during bone or joint surgery wherein said at least one guidance
tool is specific to the anatomy of the patient being treated, said
process comprising
[0038] creating a 3-D surface model of the patient's anatomy;
[0039] using the 3-D surface model of the patient's anatomy to
preoperatively determine a trajectory of at least one medical
instrument during bone or joint manipulation;
[0040] designing at least one guidance tool for registering against
the patient's anatomy, said at least one guidance tool providing a
guide mechanism and a mating surface, said guide mechanism for
guiding said at least one medical instrument during said bone or
joint manipulation at the preoperatively defined trajectory
relative to a patient's anatomy, said mating surface providing
positional registration of said at least one guidance tool on the
patient's anatomy; and
[0041] preoperatively assessing the fit, size and design of the at
least one guidance tool on the patient anatomy using the 3-D
surface model of the patient's anatomy, and adjusting the design of
the at least one guidance tool as necessary to achieve a correct
fit.
[0042] In some embodiments, said 3-D surface model of the patient's
anatomy is created by one or more of CT, MRI, X-ray, and
ultrasound.
[0043] In some embodiments, said assessment of fit involves a
quantitative figure of merit determination based on an examination
of characteristic landmarks on said mating surface relative to said
patient's anatomy.
[0044] In some embodiments, the preoperative process further
comprises the identification of at least one characteristic
anatomical landmark to be used in connection with a removable
verification tool for mechanically verifying correct position of
the at least one guidance tool on the patient's anatomy, said
verification tool being configured for attachment to the at least
one guidance tool.
[0045] In some embodiments, multiple guidance tools are designed
for intraoperative use for a particular procedure.
[0046] According to a further aspect, provided is a method of
facilitating bone or joint surgery using a preoperatively designed
patient-specific guidance tool, said method comprising the steps
of:
[0047] placing the guidance tool directly upon the patient's
anatomy for which it has been designed, said guidance tool
providing a mating surface and a guide mechanism, said guide
mechanism for guiding at least one medical instrument during bone
or joint manipulation at a preoperatively defined trajectory
relative to a patient's anatomy, said mating surface providing
positional registration of said guidance tool on said patient's
anatomy;
[0048] assessing the position of the guidance tool upon the
patient's anatomy;
[0049] assessing the preoperatively defined trajectory governed by
the guide mechanism of the guidance tool;
[0050] determining whether adjustments to the guide mechanism are
necessary for achieving an optimal trajectory of said at least one
medical instrument; and
[0051] adjusting, if necessary, the guide mechanism of said
guidance tool to achieve an alternate trajectory for said at least
one medical instrument.
[0052] In some embodiments, a verification tool, fitted to said
guide mechanism of the guidance tool, is used to assess the
position and orientation of the guidance tool having regard to the
preoperatively defined trajectory.
[0053] In some embodiments, said verification tool comprises at
least one graduated section to determine misalignment of the
guidance tool relative to said one or more preoperatively defined
trajectories.
[0054] In some embodiments, said verification tool comprises two
graduated sections for providing misalignment values relative to
the patient's anatomy, a graduated section providing misalignment
values in a longitudinal direction, and a second graduated section
providing misalignment values in a radial direction.
[0055] In some embodiments, said at least one graduated section is
a sliding ruler provided with graduations for measuring said
misalignment.
[0056] In some embodiments, said guide mechanism comprises a guide
channel and an instrument sleeve, and wherein a correction to
realign said trajectory is provided by a realignment instrument
sleeve used in place of said instrument sleeve to achieve the
corrected trajectory.
[0057] In some embodiments, said guidance tool is retained in place
on the patient's anatomy manually by hand.
[0058] In some embodiments, said guidance tool is retained in place
on the patient's anatomy using suitable fasteners selected from the
group consisting of pins, screws, straps, clamps, zip-ties and
elastic fasteners.
[0059] In some embodiments, said verification tool is further used
to visualize and assess the preoperatively defined trajectory
governed by the guide mechanism, wherein said verification tool is
rotatable relative to said guidance tool.
[0060] According to a still further aspect, provided is a method of
realigning a trajectory in a preoperatively designed
patient-specific guidance tool, comprising:
[0061] intraoperatively placing the guidance tool directly upon the
patient's anatomy for which it has been designed, the guidance tool
having a guide mechanism establishing a preoperatively defined
trajectory for at least one medical instrument and a verification
tool for mechanically verifying correct position of the guidance
tool on the patient's anatomy; and
[0062] using the verification tool to mechanically verify correct
position of the guidance tool on the patient's anatomy.
[0063] In some embodiments, upon detection of a misalignment, said
verification tool is used to quantify the misalignment using at
least one graduated section provided on said verification tool.
[0064] In some embodiments, upon detection of a misalignment, said
verification tool is used to quantify the misalignment using at
least two graduated sections provided on said verification
tool.
[0065] In some embodiments, at least one of a reference chart,
table or realignment calculator is used to determine a correct
realignment trajectory based on the registered misalignment, so as
to return to the preoperatively defined trajectory.
[0066] In some embodiments, said reference chart and/or table are
preoperatively generated based on preoperative planning having
regard to the geometry of the guidance tool and the patient's
specific anatomy.
[0067] In some embodiments, said guide mechanism is adjusted to
accord with the calculated realignment trajectory.
[0068] According to yet another aspect, provided is a method of
verifying correct placement of a preoperatively designed
patient-specific guidance tool, comprising:
[0069] intraoperatively placing the guidance tool directly upon the
patient's anatomy for which it has been designed, the guidance tool
having a guide mechanism establishing a preoperatively defined
trajectory for at least one medical instrument and a verification
tool for mechanically verifying correct position of the guidance
tool on the patient's anatomy; and
[0070] using the verification tool to mechanically verify correct
position of the guidance tool on the patient's anatomy.
BRIEF DESCRIPTION OF THE DRAWINGS
[0071] Embodiments will now be described, by way of example only,
with reference to the attached Figures, wherein:
[0072] FIG. 1 is a skeletal representation of a human hip
joint;
[0073] FIG. 2 is a skeletal representation of a human femur;
[0074] FIG. 3 is a 3-D computer iso-surface model representing bone
and/or soft tissue of the proximal femur and acetabulum;
[0075] FIGS. 4a and 4b show the establishment of a drilling
trajectory for the central pin;
[0076] FIG. 5 is a 3-D computer iso-surface model representing bone
and/or soft tissue of the proximal femur and acetabulum, wherein
the virtual femoral and acetabular components are fitted to the
virtual model;
[0077] FIG. 6 is a 3-D computer iso-surface model representing bone
and/or soft tissue of the proximal femur, wherein the guidance tool
is fitted to the virtual model;
[0078] FIGS. 7a to 7c are perspective views of the femur with the
guidance tool in position, wherein FIGS. 7b and 7c show a
verification tool used to verify correct positioning of the
guidance tool on the femur;
[0079] FIG. 7d is a perspective view of an embodiment of the
verification tool used with the guidance tool to verify correct
positioning of the guidance tool on the femur;
[0080] FIGS. 8a and 8b are perspective views of an embodiment of
the verification tool in which it is used as a visual aid in
verifying the planned trajectory;
[0081] FIGS. 9a to 9d show a 3-D computer iso-surface model
representing bone and/or soft tissue of the proximal femur, the
series of illustrations showing a determined pin trajectory, a
registration surface and a guidance tool comprising these
features;
[0082] FIG. 10 is a perspective view of the femur, shown
intraoperatively, with the guidance tool in position;
[0083] FIGS. 11a and 11b are perspective views of the femur with
the guidance tool in position, wherein the guidance tool is readied
for guiding the central pin into the femoral head;
[0084] FIG. 12a illustrates a misalignment of the drilling
trajectory.
[0085] FIGS. 12b and 12c are perspective views of alternate
drilling sleeves for use with the guidance tool wherein the guide
holes are offset from the central axis;
[0086] FIG. 13 is a perspective view of the femur with the guidance
tool in position, wherein the central pin is being inserted into
the drill sleeve for threaded insertion into the femoral head;
[0087] FIG. 14 is an schematic representation of how a guidance
tool can similarly be used in mosaicplasty;
[0088] FIGS. 15a and 15b provide an illustration of how a guidance
tool can be used in mosaicplasty of the knee;
[0089] FIG. 16 is an illustration of how a guidance tool can
similarly be used in distal radius osteotomy;
[0090] FIG. 17 is an illustration of how a guidance tool can
similarly be used in total knee arthroplasty;
[0091] FIG. 18 is an illustration of how a guidance tool can
similarly be used in total ankle arthroplasty;
[0092] FIG. 19a through 19c show an alternate guidance tool for
total ankle arthroplasty; and
[0093] FIG. 20 is a diagram representing the general steps in the
preoperative planning stage in which a patient-specific guidance
tool is created based on a patient's characteristic anatomy.
DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS
[0094] The following discussion presents an embodiment wherein the
patient specific guidance tool and associated methodology/procedure
for construction and implementation are presented largely within
the framework of hip resurfacing. One will appreciate, however that
the guidance tool and associated methodology/procedure may be
implemented in a range of bone and joint surgical applications. For
example, the following discussion may find application for use in,
but not limited to, ankle, knee and shoulder surgery, spine fusion,
craniomaxillofacial surgery, osteotomies, fracture treatment and
fixation, scoliosis, wrist surgery, and mosaicplasty. Thus, the
following description is intended as an exemplification of
illustrative embodiments, and is not intended to limit the
description to the particular embodiments illustrated.
[0095] Unlike prior art technologies that incorporate
intraoperative computer-assisted methods for pin-drilling guidance,
the embodiment discussed below provides an individualized,
patient-specific procedure that begins prior to surgery. The method
generally initiates with a pre-operative planning stage in which a
virtual 3-dimensional (3-D) iso-surface model of the patient's
specific anatomy is created. Specifically, the anatomy of the
patient undergoes preoperative medical imaging by one or more of
computed tomography (CT), magnetic resonance imaging (MRI),
ultrasound, X-ray, etc. With this data, a 3-D computer iso-surface
model representing bone and/or soft tissue of the patient's anatomy
is produced, upon which the location and/or trajectory for
drilling, cutting, reaming, resurfacing, and/or modifying of bone
and/or other tissue, for a central pin, guide pin or other surgical
implement, can be preoperatively determined. The specific patient
anatomy and the preoperatively determined trajectories are then
factored into the manufacture of a patient-specific guidance tool
to assist intraoperatively. The preoperative design phase
preferably includes a virtual assessment of quality of fit, and
further enables the design and manufacture of a verification tool
to verify position/orientation of the guidance tool relative to the
preoperatively determined trajectory and the patient's anatomy.
[0096] As mentioned above, the patient-specific guidance tool and
associated methodology/procedure for construction and
implementation (generally termed "patient-specific procedure") is
herein initially discussed within the framework of hip resurfacing.
Hip resurfacing is a relatively new procedure that is seen as an
attractive alternative to total hip replacement (THR) for younger,
more active patients. In hip resurfacing the femoral head is not
replaced, as is done in THR, but instead a femoral component is
implanted on the femoral head. The femoral component includes a
metallic hemisphere that effectively replaces the articular
cartilage covering the femoral head, and forms the bearing surface
of the femoral component, and one of the articulating surfaces of
the hip joint. The femoral component also includes a central pin
that is inserted into the femoral head/neck, which maintains the
correct position of the femoral component. The hemisphere
subsequently mates with an acetabular component that is positioned
in and provides a lining in the acetabulum of the pelvic bone, and
provides the other articulating surface of the hip joint.
[0097] The most common cause of early failure of a hip resurfacing
procedure is femoral neck fracture. While careful patient selection
can reduce the risk of neck fractures, a further significant
contributing factor is the orientation of the hemi-spherical
femoral component. A non-optimal orientation of the femoral
component can result in notching of femoral neck cortex, which
increases the risk of fracture. Also, excessive tilting of the
femoral component in varus may result in greater stresses within
the bone, which adds to the risk of neck fractures. The size of the
component may also play an important role in early clinical
success. The appropriate size of the femoral component should be
large enough to prevent impingement, but small enough to avoid
large bone resection of the acetabulum.
[0098] Referring now to FIG. 1, a skeletal representation of a hip
is indicated generally at reference numeral 10. The hip joint 20 is
a synovial joint comprised of the rounded head 22 of the femur 24
and the cup-like acetabulum 26 of the pelvis 28; the primary
function of this joint being to support the weight of the body in
both static and dynamic postures.
[0099] The femur 24 is shown in greater detail in FIG. 2. As shown,
the femur 24 is divisible into a body 30, and two extremities. The
upper extremity 32 comprises the head 22, a neck 36, a greater
trochanter 38 and a lesser trochanter 40; while the lower extremity
42 largely comprises a medial condyle 44 and a lateral condyle 46.
Between the two extremities is the body 30 (or shaft) which is
generally cylindrical in form.
[0100] Referring now to FIG. 3, hip resurfacing carried out in
accordance with the herein described patient-specific procedure
begins with a pre-operative planning stage in which the 3-D
iso-surface model of the patient's specific hip joint anatomy is
created. As shown, the 3-D iso-surface model 50 represents to a
high degree of accuracy the bone and/or soft tissue of the
patient's anatomy. Shown in FIG. 3 is a virtual representation of
the proximal femur 52 and the acetabulum 54.
[0101] Using the virtual 3-D iso-surface model 50, the drilling
trajectory for a central pin or guide pin is preoperatively
determined. As the central pin will form the reference or guide for
all subsequent procedures, it is desirable to establish and achieve
a precise central pin trajectory. To determine the trajectory, a
Virtual Surgical System (VSS) software package is used, developed
by iGo Technologies Inc. (Kingston, Canada). One will appreciate,
however, that other virtual surgical planning programs are
applicable and may be substituted.
[0102] As shown in FIG. 4a, using the VSS software and the
established 3-D iso-surface model 50 of the proximal femur 52, the
anatomical position/orientation of the neck-shaft axis 56 relative
to the femur 52 is registered. With this alignment information, the
position and orientation of the trajectory 58 for the central pin
is established. The femoral component 60, which comprises an
articulating or bearing surface 62 and the central pin is then
fitted to the femur 52 in the virtual space, as shown in FIGS. 4b
and 5. In addition, and quite advantageously, having regard to the
alignment information, the established trajectory 58 and the
established positioning/orientation of the femoral component, the
hip joint can be assessed for possible intraoperative
complications, such as notching of the femoral neck cortex during
reaming of the femoral head. Based on these assessments,
alterations to the positioning/orientation of the femoral component
can more safely and accurately be made preoperatively.
[0103] With the drilling trajectory 58 determined, the 3-D
iso-surface model 50 is then used to establish an accurate sizing
of the femoral and acetabular components, so as to ensure that the
femoral component does not infringe the femoral neck, and that
excessive resection of the acetabulum is not required. As shown in
FIG. 5, the 3-D iso-surface model 50 serves as a pre-operative
virtual space to fit the femoral component 60 and the acetabular
component 64 to the individual patient-specific anatomy.
[0104] Continuing with the preoperative planning stage, the 3-D
iso-surface model and the established drilling trajectory
information are used to design a patient-specific guidance tool 66
for accurately achieving the planned drilling trajectory for the
central pin of the femoral component. A virtual representation of
the patient-specific guidance tool 66 relative to the
patient-specific 3-D iso-surface model 50 is shown in FIG. 6. In
general, the guidance tool comprises at least one guide component
that serves as a drill guide, at least one registration component
for providing a mating surface relative to the patient's anatomy,
and optionally, at least one stability component for adding
stability to the tool when placed upon the patient's anatomy.
[0105] As used herein, the term "mating surface" refers to a 3-D
surface which is complementary to and mates with the 3-D surface
(registration surface) of a selected portion of a patient's
anatomy. A guidance tool as described herein includes at least one
mating surface.
[0106] As used herein, the term "registration surface" refers to
the 3-D surface of a selected portion of a patient's anatomy.
[0107] In the embodiment shown in FIG. 6, the guidance tool 66
comprises a body portion 68 that is placed directly upon the
patient's anatomy. Although the body portion 68 of the guidance
tool 66 can assume a wide range of configurations, depending on the
implementation, the body portion 68 as shown in FIG. 6 can be
described by way of three components. First, provided is a guide
component 70 for establishing the planned central pin trajectory
58. The guide component 70 is provided with a guide mechanism 72
comprising a guide channel 74 for later receipt of a removable
instrument (e.g. drill) sleeve following correct and verified
positioning of the guidance tool on the patient's anatomy. Second,
provided is a registration component 76 spanning the femoral neck,
the registration component 76 comprising a mating surface 78 (more
clearly shown in FIG. 7) for accurate registration on the patient's
anatomy. Third, optionally provided is a stability component 80 for
additional stability during use. The body portion 68 of the
guidance tool, in particular the guide component 70 may optionally
include one or more locking keys 82 for use with a verification
tool, as discussed below.
[0108] As mentioned above, the guidance tool 66 may take on any
number of configurations, depending on the implementation. As such,
in alternate configurations, the guidance tool 66 may be comprised
of a combination of the above noted components. For example, while
the guide component 70 is configured to serve as a drill guide, it
may also be provided with a mating surface 78 for additional
registration on the patient's anatomy. Additionally, the
registration component 76, while comprising the mating surface 78
for registration on a patient's anatomy, may also comprise one or
more guide channels 74 for receiving drill sleeves. As will be
appreciated, the patient-specific guidance tool 66 is designed for
intraoperative use, whereby the guidance tool 66 is fitted to the
patient's anatomy. As indicated earlier, while the present
embodiment is being presented within the framework of
hip-resurfacing, the guidance tool and associated
methodology/procedure for construction and implementation may be
suitably applied to a range of surgical procedures, such as, but
not limited to ankle, knee and shoulder surgery, spine fusion,
craniomaxillofacial surgery, osteotomies, fracture treatment and
fixation, scoliosis, wrist surgery, and mosaicplasty. In addition,
for any one surgical procedure, particularly those during which
multiple manipulations are necessary, it may be preferable to
create and use a plurality of guidance tools. For example, a first
guidance tool may facilitate a set of drilling trajectories, while
a subsequently used second guidance tool may facilitate shaping.
Using a plurality of tools will assist in keeping the size of the
tool to a minimum, and should also serve to avoid an unnecessarily
complicated design.
[0109] In certain circumstances, the registration component 70 of
the guidance tool 66 may comprise a discontinuous mating surface
78, particularly if a portion of the imaging data is not suitable
for rendering the surface detail of the patient's anatomy. In other
instances, the registration surface 84 (see FIG. 6) of the
patient's anatomy may not be suitable for incorporation into the
registration component 76 of the guidance tool 66. In a guidance
tool 66 comprising such a discontinuous mating surface 78, certain
sections of the mating surface 78 may be voided in a manner that
prevents interference with the patient's anatomy. For example, the
discontinuous portions may be sufficiently recessed to clear the
patient's anatomy.
[0110] In designing the patient specific guidance tool 66, a wide
range of factors may be considered, so as to ensure the development
of a specific customized product. For example, the guidance tool
may be designed having regard to a chosen or preferred surgical
approach or technique. For example, as one skilled in the art will
appreciate, in hip resurfacing, the anterior-lateral approach is
generally preferred to preserve a better blood supply to the
femoral head, while the posterior approach serves to retain the
capsular. The choice of anterior-lateral vs. posterior approach
will have an overall impact upon the final design of the tool.
Customization of the guidance tool based on a single chosen
surgical approach has the advantage of simplifying the final
design, as multiple surgical approaches need not be engineered into
a single tool. As such, the patient-specific guidance tool need not
be unnecessarily large, and can therefore be appropriately sized to
reduce the invasiveness of the surgical procedure.
[0111] The guidance tool 66 is designed having regard to the
specific registration surface 84 of the patient's anatomy, namely
characteristic anatomical landmarks, bony structures and/or soft
tissue (e.g., tendons, ligaments, etc.). For clarity, anatomical
landmarks, bony structures and soft tissue are herein collectively
termed "characteristic landmarks". The characteristic landmarks of
the registration surface 84 are used in designing the mating
surface 78 of the guidance tool 66, so as to register it in a
specific position/orientation necessary to attain the desired
drilling trajectory 58 determined during the pre-operative planning
stage. The chosen surgical approach (e.g., anterior-lateral vs.
posterior) may also have a bearing here, as certain characteristic
landmarks may be exposed depending on the selected approach. As
will be discussed below, the characteristic landmarks may also be
used intraoperatively to verify the position of the guidance tool
66 when affixed to the anatomy. Any combination of characteristic
landmarks (anatomical landmarks, bony structures, soft tissue,
etc.) may be used for registering and/or verifying correct
positioning of the tool on the patient's anatomy. This information
is taken into consideration during the design of the guidance
tool.
[0112] To verify the position/orientation of the guidance tool 66
on the patient's anatomy, and to verify that the correct
preoperatively define trajectory is attained, the guidance tool 66
may be provided with a removable mechanical verification tool 86,
as shown in FIGS. 7b through 7d. With the guidance tool 66 placed
onto the patient's anatomy as shown in FIG. 7a, the verification
tool 86 is configured to be removably attached to the guidance tool
66 by inserting the registration pin 88 of the verification tool 86
into the guide channel 74 of the guide component 70, as shown in
FIG. 7b. The pointer 90 of the verification tool 86 can then be
used, as shown in FIG. 7c, to locate one or more characteristic
landmarks 92 that were preoperatively identified, so as to
determine whether or not a proper positioning of the guidance tool
has been established. To ensure accurate radial placement of the
verification tool 86 relative to the longitudinal axis of the
planned central pin trajectory 58, one or more locking keys 82 are
provided on the guide component 70 to lock the verification tool in
one or more predefined orientations. As shown in FIG. 7d, the
verification tool 86 is provided with a recess 94 on the stem 96
for cooperating with the locking key 82 of the guide component 70,
thereby locking the verification tool 86 in a fixed position. As
will be appreciated, while a single characteristic landmark 92 may
be used for position verification, the procedure may use a
plurality of characteristic landmarks. As such, the guide component
70 may be configured with multiple locking keys 82, each
corresponding to a particular landmark.
[0113] The verification tool 86 is used to indicate whether or not
the guidance tool 66 is correctly positioned on the patient's
anatomy, and whether or not the guidance tool establishes the
preoperatively defined trajectory 58. In the event of a
misalignment, the user is able to quantifiably gauge the extent of
misalignment using one or more graduated sections provided on the
verification tool 86. The graduated sections may include a scale
such as a vernier or linear scale so as to allow measurement of the
position of the guidance tool. For example, a graduated section may
include a sliding ruler. In the embodiment shown in FIG. 7d,
measurements along the longitudinal axis (x) of the planned central
pin trajectory 58 are provided by a first sliding ruler 98, while
radial measurements (y) are provided by a second sliding ruler 100
provided on the pointer 90. Graduations 102 (e.g., mm) are provided
on each ruler so as to provide a numerical indication of how much
and in which direction the guide is misplaced from the planned
fitting position. The verification tool may provide further
indicators to characterize the nature of the misalignment. For
example, it may be useful to obtain an angular misalignment value,
that is the angle between the anatomical landmark and the
preoperatively defined position of the verification tool. As such,
a protractor-like scaling on the verification tool and/or guidance
tool would be provided to facilitate this type of measurement.
[0114] Misalignments of the guidance tool may arise due to a
variety of reasons. For example, they may arise due to an error
during the preoperative planning stage. Misalignments may also
arise due to physiological changes in the patient, for example the
formation of osteophytes on the registration surface. To realign
the guidance tool, removal of the osteophytes may be all that is
required. In other instances, the misalignment may require the use
of a realignment sleeve, as discussed in greater detail below. To
assist the use in determining the necessary course of action to
realign the guidance tool, the user of the guidance tool 66 is
preferably provided with a reference chart, table or realignment
calculator. The reference chart, table or realignment calculator
allows the user to determine an appropriate realignment trajectory
based on the characteristics of the misalignment obtained from the
verification tool, such that the preoperatively defined trajectory
can be attained.
[0115] The following demonstrates an exemplary use of the
verification tool. For each anatomical landmark l; chosen, a pair
of values (x,y) is preoperatively determined, which describe the
target location for the pointer of the verification tool.
Intraoperatively during the verification of the guidance tool
position, the verification tool is inserted into the guide channel
and the values (x_m, y_m) are measured for the preoperatively
determined anatomical landmark l.sub.i. If the guidance tool is
correctly placed in the preoperative defined position for all
landmarks the measured values (x_m, y_m) would be identical to the
preoperative determined values (x,y).
[0116] In case of misalignment, for one or more landmarks l.sub.i a
deviation between intraoperative measured values and preoperative
determined target values will occur. The characteristics of the
misalignment, namely the direction and amount of misalignment of
the landmarks can be used to identify a) position of
registration-error, of b) plan of correction possibility
(realignment). Based on this information the user can attempt an
initial correction by, for example, removing osteophyte. If
correction is not possible, the reference chart, table or
realignment calculator is provided to navigate the user to the
appropriate correction/realignment possibility.
[0117] The following example demonstrates the use of such a
reference chart, table or realignment calculator using values
obtained from the verification tool. For this exemplary
implementation, two anatomical landmarks l.sub.1 and l.sub.2 were
chosen. The preoperative defined (x,y) values for these landmarks
are listed in Table 1.
TABLE-US-00001 TABLE 1 Preoperatively determined landmark
coordinates x y l.sub.1 92 mm 21 mm l.sub.2 57 mm 29 mm
[0118] With the verification tool, the preoperatively determined
anatomical landmarks are used to identify a misalignment. The
direction and amount of the misalignment is determined.
Example 1
[0119] A set of exemplary intraoperative measured (x_m, y_m) values
for both landmarks are presented in Table 2.
TABLE-US-00002 [0119] TABLE 2 Intraoperatively measured landmark
coordinates x_m y_m l.sub.1 92 mm 23 mm l.sub.2 57 mm 31 mm
[0120] In this case, the deviation between the intraoperatively
measured y_m values and the preoperatively defined y values
indicate a misalignment in the direction of the frontal plane. The
amount of deviation, defined as
[0120] a=y_m-y [0121] is used to identify the amount and type of
displacement. With respect to landmarks l.sub.1 and l.sub.2, the
corresponding a.sub.1 and a.sub.2 values are calculated as
follows:
[0121] a.sub.1=y_m.sub.1-y.sub.1=23-21=2
a.sub.2=y_m.sub.1-y.sub.1=31-29=2. [0122] From this analysis, a
translational misalignment is identified. Having regard to the
reference table (Table 3), the suggested realignment is the use of
a 2 mm translational offset in the inferior direction.
TABLE-US-00003 [0122] TABLE 3 Translational offsets for corrections
in Frontal Plane a A a 1 -0.5 < a < 0.5 0.5 <= a < 1.5
-1.5 < a =< -0.5 . . . 2 -0.5 < a < 0.5 0.5 <= a
< 1.5 -1.5 < a <= 0.5 No offset 1 mm offset 1 mm offset
superior inferior
[0123] Where, a=y_m-y [0124] x,y=preoperative defined values [0125]
x_m, y_m=intraoperative measured values
Example 2
[0125] [0126] A second set of exemplary intraoperative measured
(x_m, y_m) values for both landmarks are presented in Table 4.
TABLE-US-00004 [0126] TABLE 4 Intraoperatively measured landmark
coordinates x_m y_m l.sub.1 92 mm 21 mm l.sub.2 57 mm 31 mm
[0127] In this example the deviation between the amount of
displacement between landmarks l.sub.1 and l.sub.2 identifies an
angular displacement. With respect to landmarks l.sub.1 and
l.sub.2, the corresponding a.sub.1 and a.sub.2 values are
calculated as follows:
[0127] a.sub.1=y_m.sub.1-y.sub.1=21-21=0
a.sub.2=y_m.sub.2-y.sub.2=31-29=2 [0128] The difference (d) between
a.sub.2 and a.sub.1 is determined as
[0128] d=a.sub.2-a.sub.1. [0129] Accordingly, the difference is
determined as follows:
[0129] d=a.sub.2-a.sub.1=2-0=2 [0130] This angular displacement
represents a 3.degree. hyper-extension misplacement of the guide,
requiring the use of realignment sleeve having a 3.degree. flexion
offset, as specified in the reference table provided in Table
5.
TABLE-US-00005 [0130] TABLE 5 Angular offsets for correction in
Frontal Plane d d d d -0.5 < d <= 0.0 0.0 < d <= 1.0
1.0 < d <= 1.5 1.5 < d <= 2.5 No offset 1.degree.
offset 2.degree. offset 3.degree. offset flexion flexion flexion
-1.0 =< d < 0.0 -1.5 <= d < -1.0 . . . 1.degree. offset
. . . extension
[0131] Where, a=y_m-y, d=a.sub.2-a.sub.1 [0132] x,y=preoperative
defined values [0133] x_m, y_m=intraoperative measured values
[0134] Based on the preoperative planning of the guidance tool 66,
and the selection of the anatomical landmarks 92 for use with the
verification tool 86, the aforementioned reference chart or table
can be preoperatively calculated, such that cross-reference of
these misalignment values provides the realignment necessary to
achieve the preoperatively defined trajectory 58. In a preferred
embodiment, the realignment determination is provided by way of the
realignment calculator, provided for example on a computer
accessible within the operative environment.
[0135] The realignment is provided by way of a realignment sleeve,
as will be discussed in greater detail below. With this approach to
correct misalignments, the user is not left with having to
approximate the correction, but rather is provided with a directed
calculated correction based on a specific measurements made with
the verification tool.
[0136] Since the first sliding ruler 98 is generally configured to
be parallel to the longitudinal axis of the central pin, the
verification tool 86 may also be used as a visual sighting aid to
verify the chosen drilling trajectory 58 and planned axis
alignment, as shown in FIGS. 8a and 8b. By disengaging the
verification tool 86 from the locking keys 82 and rotating the
verification tool 86 about the guidance tool 66, the user is able
to visualise the trajectory 58 of the central pin with reference to
the plane defined by the first sliding ruler 98, or alternatively a
pin or guidewire inserted in place of the ruler. In some
embodiments, the verification tool 86 may be configured to receive
a separate pin or guide wire, also positioned parallel to the
trajectory defined by the guidance tool. If it appears that a
trajectory correction is necessary, suitable adjustments can be
made as described in greater detail below.
[0137] The verification tool 86 may also be used intraoperatively
to confirm that the selected femoral component size is appropriate
by measuring the radial distance between the planned central pin
trajectory 58 and the surface of the femoral neck. Alternatively,
or in addition, this process can also be used to confirm that the
planned trajectory is substantially centered within the femoral
neck.
[0138] The verification tool 86 as presented above is removable,
thus allowing it to be reused. Alternatively, the verification tool
86 may be incorporated as a permanently fixed, integral component
of the guidance tool 66. As such, there would be no need for the
verification tool locking keys as described above. In such a case,
the verification tool could be machined to use the sliding rulers
as discussed above, or constructed as a single purpose
non-adjustable pointer for identifying a chosen characteristic
landmark.
[0139] In the case of a removable verification tool 86, the tool
may find further application once detached from the guidance tool.
For example, the verification tool may be used to provide two or
more references points that are preoperatively determined to line
up with certain anatomical landmarks, or to provide a gauge for
assessing fit. The verification tool, particularly where the tool
is adjustable, can be set to a predefined setting that will enable
verification that a particular point, for example on a prosthesis
is correctly positioned at a preoperatively defined location
relative to a preoperatively selected anatomical landmark. The
verification tool may find further applications in which a
measuring device or gauge is useful in the operative
environment.
[0140] In instances where a plurality of guidance tools are used
for a particular procedure, a separate verification tool may be
configured for each guidance tool used. Alternatively, the
verification tool may be used with the first guidance tool, with
the positioning of subsequent guidance tools being verified
relative to a common reference point as determined by the first
guidance tool. For example, upon placement of the first guidance
tool, the bone or cartilage may be marked using at least one
reference point. During placement of each subsequent guidance tool,
to ensure proper alignment, each subsequent guidance tool is
verified against this at least one reference point.
[0141] The general steps involved in pre-operative planning of the
patient-specific procedure for hip resurfacing are represented in
FIGS. 9a through 9d. As shown in FIG. 9a, based on medical imaging
incorporating the patient's characteristic anatomical landmarks,
the virtual 3-D iso-surface model 50 of the patient's anatomy is
first created. The anatomical orientation/coordinates of the model
are determined, the shaft/neck axis is registered, and the position
and orientation of the femoral component is determined. FIG. 9a
illustrates the planned trajectory 58 of the central pin, based on
the established shaft/neck axis. In FIG. 9b, a selected portion of
the patient's anatomy is analyzed to determine characteristic
landmarks defining the registration surface 84, as well as tool
positioning verification anatomical landmarks. As shown in FIG. 9c,
an extracted surface image 104 of the registration surface 84 is
created. At this point in the process, the trajectory 58 of the
central pin and the characteristics of the mating surface 78 have
each been separately established. In FIG. 9d, the trajectory 58 of
the central pin and the characteristics of the mating surface 78
are combined into a single virtual guidance tool 66, wherein the
planned trajectory 58 is governed by the guide component 70. As
such, when used intraoperatively, the mating surface 78 of the tool
66 is positioned on and registered with the patient's anatomy, as
represented in FIG. 10, thus providing the planned trajectory 58
for the central pin.
[0142] The aforementioned task of designing the patient-specific
guidance tool during the preoperative planning stage is computer
assisted using a custom software program. The software program is
configured to design a specific and customized guidance tool by
taking into consideration the various factors discussed above. In
particular, the software program provides an interface enabling the
user to analyze and identify the location of characteristic
landmarks on the patient's anatomy, and design the guidance tool
such that it positionally registers on the patient's anatomy in a
predefined orientation. In addition, the software program helps the
user avoid structures not suitable for registration of the guidance
tool. For example, certain soft and/or unstable bony structures
such as osteophytes are dismissed as viable registration
points.
[0143] The creation of the patient-specific guidance tool using the
aforementioned software is generally a two step process. In the
first step, the software enables the user to plan the size, shape,
position, and orientation of the guidance tool based on the
patient's anatomy as determined in the initial medical imaging. In
the second step, a 3-D representation of the guidance tool is
calculated comprising the various characteristics specific to the
patient's unique anatomy. The calculated 3-D representation is then
saved in a 3-D model format, such as a stereolithographic format
(e.g., standard tessellation language (STL-format)).
[0144] The first step of patient-specific guidance tool planning is
accomplished using available software packages such as Qt
(Trolltech ASA, Oslo, Norway; www.trolltech.com) and Coin3D
(Systems in Motion AS, Oslo, Norway; www.coin3d.org). Qt allows
high-performance cross-platform GUI (graphical user interface)
development, while Coin3D is a high-level 3D graphics toolkit for
developing cross-platform real-time 3D visualization software. It
will be appreciated, however, that one skilled in the art could
implement other suitable software programs in place of those
mentioned above.
[0145] Software suited for the first step of patient-specific
guidance tool planning preferably offers the following functions:
a) establishment and loading of the 3-D surface model of a
patient's anatomy; b) establishment and loading of surgical
planning; c) planning of locking keys; and d) designing of
patient-specific guidance tool.
[0146] The following paragraphs describe an example of
patient-specific guidance tool planning as applied to hip
resurfacing. Variations of this procedure will be apparent to one
skilled in the art.
[0147] Based on preoperative medical imaging, the 3-D surface model
of a patient's anatomy is loaded and displayed to the user. Next,
the determined trajectory of the central pin is loaded and
displayed as a cylinder. The guidance tool is then designed, in
this case as three different parts. First, the registration
component is oriented along the femoral neck and contains the
mating surface which mates the registration surface of the
patient's anatomy. Second, the stability component is oriented
around the lateral femoral neck, and contains a mating surface that
registers with at least a portion of the anterio-lateral or
posterior-lateral neck. Third, the guide component provides the
guide channel for the drill sleeves.
[0148] During patient-specific guidance tool planning, the user
chooses the size, position and orientation of the registration
component. To facilitate the design process, a rectangular prism or
cube representing the registration component is displayed, allowing
the user to modify width, height and length, as deemed necessary to
achieve a proper sizing and fit. The user can further define the
final position by altering the position and rotation of the
rectangular prism or cube around the central pin axis.
[0149] For planning of the stability component a virtual
ring-segment is displayed, which is attached on the lateral side of
the registration component. The user can modify the radius, angle,
width and height of this ring segment and change its position and
orientation, so as to achieve a proper sizing and fit.
[0150] For planning of the guide component a virtual cube is
displayed, which is attached on the medial side of the registration
component. Similar to the previous two components, the user can
modify width, depth, and height of this cube, so as to optimize the
sizing and fit.
[0151] At this stage, the planning must also consider the
verification tool and the associated locking keys. It is during
this planning that the user selects one or more anatomical
landmarks on the femoral model that will align with the
verification tool. As described above, the alignment of the
verification tool is governed by the locking keys. As such, based
on the location of the anatomical landmarks, and the
configuration/size of the verification tool, the positioning of the
locking keys on the guide component is established.
[0152] In the second step wherein a 3-D representation of the
guidance tool is calculated, the mating surfaces for the
registration component and stability component of the guidance tool
are calculated. In one exemplary methodology, the registration
component and stability component are represented each as a set of
6 planes, which are defined by a bounding box. To determine the
registration surface of the patient's anatomy, the surface
representation of the bone is intersected with all six planes. For
all resulting triangles the normal vectors are inverted and the
mating surface is saved in a triangulated format.
[0153] For the final calculation of the registration and stability
components, both virtual representations (cube and ring-segment)
are saved as volumetric objects (sets of tetrahedrons). An
algorithm is then used to intersect each volumetric object along
the calculated mating surface. During this calculation the distance
of each tetrahedron with respect to the mating surface is
determined. Tetrahedrons which are intersected by the surface are
split in two sets of tetrahedrons, corresponding to those below and
above the surface. Finally all tetrahedrons above the surface are
combined into one volumetric object and this object is converted
into a surface model. The result is the surface representation of
the registration and stability components of the guidance tool,
which contains the mating surface complementary to the registration
surface of the patient's specific anatomy.
[0154] For determination of the guide component, in particular the
guide channel, the surface of a cylinder is modeled, which is
oriented along the determined pin trajectory. The outer shell of
the guide component and the locking keys are modeled as a
rectangular prisms or cubes. The guidance tool is determined by
combining these models.
[0155] The mating surfaces which are integrated into the guidance
tool allow intraoperative registration of the tool to the
characteristic landmarks of the registration surface of the
patient. The anatomical registration surfaces must provide
sufficient features to allow a precise fit of the tool to the
anatomy. Location and size of the mating surfaces are defined by
the shape, size, position and orientation of the guidance tool. To
avoid intraoperative problems during fitting of the guidance tool
to the anatomy, the mating surfaces can be evaluated for their
quality of fit during preoperative planning of the guidance
tool.
[0156] Quality of fit may be assessed by examining registration
features (i.e., characteristic landmarks) of the registration
surface and/or the mating surface. Various publications in the area
of registration during computer-assisted surgery provide methods to
evaluate registration features (Ma, B., Ellis, R. E. "A point
selection algorithm based on spatial-stiffness analysis of rigid
registration", Computer-Aided Surgery, 2005 July; 10(4): 209-223;
Simon, DA. "Fast and accurate shape-based registration", PhD
thesis, Carnegie Mellon University, Pittsburgh, Pa., December
1996). For clarity and by way of example only, the quality of fit
of a mating surface can be determined in the following way. Virtual
copies of the mating surface are created. To each of these copies a
different error-transformation is applied and a surface-based
registration algorithm is used to determine the transformation
between this modified mating surface and the corresponding
registration surface of the anatomy (Besl, P., McKay, N. "A method
for registration of 3-D shapes.", IEEE Trans. Pattern Anal. 1992,
14(2): 239-256). After the calculated transformation is applied to
the modified mating surface copy, the distance between this mating
surface and the original mating surface is calculated and saved as
an error value. A chosen mating surface has sufficient registration
features if the error values for all copies of the mating surface
are below a predefined threshold. The error value is used to
determine a figure of merit, which is indicative of quality of fit
of the guidance tool to the patient's anatomy.
[0157] The figure of merit may also be representative of the level
of invasiveness of the procedure. For example, the figure of merit
may represent an optimization of factors including tool fit and
level of invasiveness. For example, reducing tool size results in a
less invasive procedure but a smaller tool size may also reduce
quality of fit. As will be appreciated, the figure of merit is
provided by the software, whereas the manipulation of the size,
orientation, etc. is the designer's choice based on what the
designer is trying to achieve in designing the tool.
[0158] An advantage of the patient-specific procedure and resultant
guidance tool, which may be applied to any bone and joint surgical
procedure, is that the user may customize the tool, for example by
selecting a desired surgical approach (e.g., an anterior-lateral
approach versus a posterior approach) which best suits the users
ability and/or the needs of the patient.
[0159] Once the design is completed, the computer model data is
saved in a stereolithographic format (e.g., STL) suitable for
subsequent guidance tool manufacture. Alternatively, other formats
may be used as would be apparent to one skilled in the art.
[0160] In the present embodiment, the subsequent manufacturing of
the individual patient-specific guidance tool implements a rapid
prototyping machine, such as the Dimension SST 3-D printer provided
by Stratasys, Inc (Eden Prairie, Minn.). One will appreciate,
however, that other suitable rapid prototyping machines may be used
to manufacture the individual patient-specific guidance tool. In
such a process, rapid prototyping takes the design of the
patient-specific guidance tool and transforms it into virtual cross
sections, followed by the creation of each cross section in
physical space. The process continues through the various
cross-sections until the physical model is finished. While a
variety of metallic and non-metallic (e.g., polymers) materials may
be used in rapid prototyping methods to make the guidance tool, the
present embodiment is fabricated from acrylonitrile butadiene
styrene (ABS). Following manufacture, the guidance tool is readied
for use, which generally comprises sterilization and packaging
using known methodologies.
[0161] In another embodiment, the patient-specific guidance tool
may be manufactured intraoperatively in real time using computer
assisted tool generation.
[0162] In use during hip resurfacing, following conventional
surgical procedures known in the art, the femur is dislocated from
the acetabulum. The patient-specific guidance tool 66 is then
placed onto the desired part of the patient's anatomy as shown in
FIG. 11a, having regard to the positioning and fit of the mating
surface of the guidance tool relative to the corresponding
registration surface of the patient's anatomy. While the guidance
tool 66 may be fastened to the femur using suitable fasteners
(e.g., pins, screws, etc), the guidance tool may alternatively be
held in place manually by hand, or with suitable straps, clamps,
zip-ties or elastic fasteners (e.g., elastic bands). Once
registered to the bone, the verification tool 86 is used to verify
the correct positioning of the guidance tool. With correct
positioning verified, a drill sleeve 106 is inserted into the guide
channel 74, as shown in FIG. 11b. The sleeve 106 provides a guide
hole 108 for drilling and/or insertion of the central pin 110 at
the planned central pin trajectory 58. The sleeve 106 is preferably
a surgical grade metal, including but not limited to surgical grade
stainless steel and titanium.
[0163] During intraoperative use, as discussed above, it may be
necessary to alter the trajectory 58 of the central pin, either due
to a misaligned guidance tool as identified by the verification
tool, or due to decisions made in the operating room. An exemplary
misalignment 112 of 2.degree. from a preoperatively defined
trajectory 58 is shown in FIG. 12a. Should realignment or
alteration of the trajectory of the central pin be necessary,
realignment sleeves as shown in FIGS. 12b and 12c, can be used to
drill holes that are offset by a known amount or are in a different
orientation. For example, the realignment sleeve 114 shown in FIG.
12b has the guide hole 108 translationally offset from the central
axis 116 of the sleeve, while the realignment sleeve 114 shown in
FIG. 12c has an angled guide hole 108. Guide hole 108 translational
offsets may be anywhere from 0 to 5 mm from the central axis 116.
For example, the offsets are provided in 1 mm increments (e.g., 1
mm, 2 mm, 3 mm, 4 mm, 5 mm). Alternatively, the offsets are
provided in 0.5 mm increments (e.g., 0.5 mm, 1.0 mm, 1.5 mm, 2.0
mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm, 4.5 mm, 5.0 mm). Still further
alternatives with smaller increments may be provided such as 0.1 mm
increments, or 0.05 mm increments. Angled offsets from the central
axis 116 may be anywhere from 0 to 5.degree.. For example, the
angled offsets are provided in 1.degree. increments (e.g.
1.degree., 2.degree., 3.degree., 4.degree., 5.degree.).
Alternatively, the angled offsets are provided in 0.5.degree.
increments (e.g., 0.5.degree., 1.0.degree., 1.5.degree.,
2.0.degree., 2.5.degree., 3.0.degree., 3.5.degree., 4.0.degree.,
4.5.degree., 5.0.degree.). Still further alternatives with smaller
increments may be provided such as 0.1.degree. increments, or
0.05.degree. increments. Realignment sleeves 114 with combined
translational offsets and angled offsets may also be provided in
which the aforementioned dimensional characteristics would be
applicable. Further, the drill sleeves 106 (and realignment sleeves
114) may be configured with a stop or other suitable mechanism to
precisely control the depth of the pin placement. To ensure the
drill sleeve 106 (and realignment sleeves 114) remains in a fixed
position, the sleeves may be indexed relative to the guidance tool.
For example, the drill sleeve 106 (and realignment sleeve 114) may
be provided with a keyed surface 118 that cooperates with a
receiving channel (not shown) on the guidance tool 66. The keyed
surface 118 ensures the placement of the drill sleeve 106, in
particular the realignment sleeve 114 in the preoperatively defined
anatomical direction of the femur to ensure the corrections are
performed in the desired direction (i.e., varus/valgus,
anterior/posterior, etc.).
[0164] To facilitate the above-noted correction, as discussed above
with reference to the verification tool, a reference chart, table
or realignment calculator may be provided to assist in choosing the
proper realignment sleeve to achieve the preoperatively defined
trajectory. The choice of the correct realignment sleeve is based
on the quantified misalignment as determined using the sliding
rulers of the verification tool. The misalignment values are
cross-referenced to the reference chart or table, or are inputted
into the realignment calculator, and an appropriate realignment
sleeve 114 is identified.
[0165] To further facilitate the above-described use, it may be
advantageous to provide the operating room personnel with a model
of the patient's anatomy. For example, the model may be provided as
a paper printout, a screen image on a monitor in the operating
room, or preferably a physical model. In certain circumstances,
during intraoperative use, the user may find that the guidance tool
is not fitting correctly to the patient's anatomy. For example, if
a period of time passes between the initial medical imaging and the
intraoperative procedure, the patient's anatomy could develop
osteophytes that affect the overall fit of the guidance tool.
Providing a model, in particular a physical model of the patient's
anatomy, could facilitate the troubleshooting process in the event
of guidance tool misalignment, if necessary.
[0166] To further enhance the adjustability of the guidance tool
66, the guide component 70 may be adjustable relative to the
registration component 76. For example, in some embodiments, the
guide component 70 may be detachable or configured to be loosened
from the registration component, whereby the guide component 70 can
be subsequently retightened in a slightly realigned position. The
capability of being realigned can be provided, for example, by way
of slotted or oversized holes through which suitable fasteners
would be used.
[0167] With the guidance tool 66 set in proper
position/orientation, and the correct drill sleeve 106 or
realignment sleeve 114 in place, the central pin 110 can be drilled
into the femoral head 22 using drilling methodologies known in the
art, as generally shown in FIG. 13.
[0168] Once the pin 110 is placed in the femur 24, the drill sleeve
106 (or realignment sleeve 114) is removed over the pin and the
tool 66 is removed from the bone. The hip resurfacing procedure
then continues according to instructions and/or training provided
by the implant manufacturer.
[0169] As previously indicated, for the purposes of discussion, the
patient-specific procedure and resultant guidance tool described
above is exemplified having regard to hip resurfacing. One skilled
in the art will appreciate that the above-noted patient-specific
procedure and resultant guidance tool may find application in other
surgical procedures, for example, knee, ankle and shoulder surgery,
spine fusion, craniomaxillofacial surgery, osteotomies, fracture
treatment and fixation, scoliosis, and wrist surgery.
[0170] FIG. 14 shows an embodiment in which the preoperative
procedure/methodology and resultant guidance tool is used in
mosaicplasty, a form of therapy designed to replace the articular
cartilage of the highly loaded surface of a joint that has been
damaged by trauma or arthritis. Damaged articular cartilage in
weight-bearing areas, for example the knee, is not only painful for
the patient, but also limits the range of motion (ROM) and
therefore has a great effect on the patient's quality of life.
Surgical treatment is often the only treatment option, as the
self-healing potential of articular cartilage is quite limited.
[0171] One treatment technique is the transplantation of multiple
autologous osteochondral plugs from a donor region into the damaged
region. For long term success of this procedure, the transplanted
plugs should reconstruct the curvature of the articular surface. As
such, many parameters including size, height, position, orientation
and rotation of the plugs, as well as number and pattern of the
plugs must be considered.
[0172] As generally represented in FIG. 14, mosaicplasty
traditionally involves two guidance tools 200, 202, the first 200
being used on the donor site 204 to extract cartilage material, the
second 202 being used on the receiver (damaged) site 206 to ensure
correct positioning of the extracted cartilage.
[0173] In the following exemplary embodiment of mosaicplasty of the
knee, as described above for hip resurfacing, the patient is
subjected to preoperative medical imaging by one or more of CT,
MRI, ultrasound, X-ray, etc. to reconstruct the knee's bony
anatomy, cartilage thickness, and an outline of the cartilage
defect. As shown in FIG. 15a, a virtual 3-D iso-surface model 208
of the knee is computed, containing a bone model 210 and a
transparent layer of cartilage 212. The damaged cartilage region
214 is next virtually restored by modifying the cartilage defects.
The modified model is then used as the template for preoperative
planning of mosaicplasty, using the aforementioned software. For
each plug, the user can modify radius, height, position and
orientation in the donor and receiving (damaged) areas. A graphical
user interface allows the user to plan and evaluate the quality of
fit of the final virtual guidance tool.
[0174] To transfer the final plan into intraoperative use, the
patient-specific, sterilizable, plastic guidance tool 216 is formed
using rapid prototype technology. As shown in FIG. 15b, the
guidance tool 216 includes a mating surface 218 complementary to
the articular registration surface 220 of the knee, enabling
correct positioning of the tool 216 on the knee, thereby ensuring a
precise transformation of the preoperative plan into the
intraoperative surgical field. For each plug, two instrument guides
may be incorporated in the guidance tool. For example, on the donor
side of the guidance tool, a donor guide 222 is positioned to
orient a plug cutting instrument with respect to the preoperative
planning. To ensure the planned height of the plug, it is
preferable to use a predefined height mark on the cutting
instrument for alignment with the top edge of the guide. In a
similar way, a guide 224 on the receiving (damaged) side of the
guidance tool 216 is provided to facilitate navigation of the tools
for preparation and transplantation of the plug into the damaged
area. Both guides 222, 224 are preferably designed with instrument
alignment marks to ensure that the rotation of the plug follows the
planned curvature of the articular surface.
[0175] In some circumstances, the damaged anatomy may cover a
sizable area. For example, it is not uncommon to have a cartilage
defect of 2.times.3 cm on the medial site of the knee. To repair
such a defect, a plurality of autologous osteochondral plugs are
generally required, the diameters of which range from 4 mm to 8
mm.
[0176] For such a procedure, to facilitate intraoperative
navigation, it may be advantageous to use three separately formed
patient-specific guidance tools. Each of the guidance tools serve
to guide the harvesting and insertion of 2-4 plugs. As previously
mentioned, in instances where multiple guidance tools are used, a
separate verification tool may be used for each guidance tool.
Alternatively, the first guidance tool may be configured for use
with a verification tool, while positioning of subsequent guidance
tools is verified using a set of reference points, common to each
of the guidance tools. For example, as shown in FIG. 15b, the
guidance tool 216 provides two reference points 226 that allow for
marking of the cartilage upon placement of the first guidance tool.
During subsequent steps, alignment of a second guidance tool (not
shown) to these reference marks 226 ensures that the second
guidance tool is aligned to the first guidance tool; the
positioning of the second guidance tool is verified. As each tool
is placed upon the anatomy, alignment with the reference points
ensures correct positioning of the guidance tool. With the guidance
tool facilitating navigation, the procedure itself may be conducted
using conventional cartilage repair systems, for example the COR
cartilage repair system (Depuy Mitek Inc., a Johnson and Johnson
company, Warsaw, USA).
[0177] The preoperative planning and guidance tool provides a
time-efficient, accurate, cost-effective and easy to use method of
articular cartilage reconstruction, particularly in instances
involving multiple autologous osteochondral plugs.
[0178] FIG. 16a through 16d provide an embodiment in which the
preoperative procedure/methodology and resultant guidance tool is
used in distal radius osteotomy. An osteotomy is a surgical
procedure to realign a bone in order to change the biomechanics of
a joint, especially to change the force transmission through a
joint. For distal radius osteotomy, a 3-D iso-surface model 300 of
the radius 302 is created (from CT-data, and/or other suitable
medical imaging) and the osteotomy is performed virtually (FIG.
16a). A model of the plate 304 is virtually placed on the proximal
and distal ends of the virtually corrected radius 302. The screw
positions and orientations of the plate are saved and transformed
onto the original radius (non-fractured). A patient-specific
guidance tool 306 is created (see FIG. 16b) in accordance with the
procedure/methodology described above, which provides guide
mechanism 308 for guided drilling of distal and proximal screw
holes. During the surgery, the distal end of the radius is
surgically exposed and the guidance tool 306 is positioned, as
shown in FIG. 16c. Following verification using a verification
tool, using drill sleeves (or realignment sleeves) inserted into
the guidance tool 306, the user drills the screw holes into the
radius 302, at the preoperatively planned trajectories 310 shown in
FIG. 16d. The procedure may further use a second guidance tool (not
shown) to facilitate the shaping of the distal surface using a
Forstner drill bit, or other suitable tool. The guidance tool 306
may be configured to facilitate both the position/location and
depth of milling in the shaping steps of the osteotomy. After the
shaping is complete, the guidance tool 306 is removed and the
surgeon performs the osteotomy in the conventional way. The plate,
for example a Synthes 3.5 mm locking compression plate 304, is
fixed using the preoperatively planned screw holes.
[0179] FIGS. 17a and 17b provide a further embodiment in which the
preoperative procedure/methodology and resultant guidance tool are
used in total knee arthroplasty. In total knee arthroplasty, a 3-D
iso-surface model 400 of the femur 402 and tibia 404 is created and
the femoral distal and tibial resection is planned. A
patient-specific guidance tool 406 for the femur 402 is created
(FIG. 17a), which contains guide mechanisms for guided placement of
two guidance pins 408. During the surgery the guidance tool 406 is
placed upon the patient's anatomy, positionally verified using a
verification tool and pins 408 are then placed into the femur 402.
After removing the guidance tool 406 the pins 408 are used to guide
a resection block with respect to the preoperative planning of the
resection plane. A similar guidance tool 410 is created for the
tibia 404 (FIG. 17b), which contains the guide mechanism for guided
placement of the pins 412. During surgery these guidance pins 412
allow placement of a resection block with respect to the planned
tibial resection plane. As required, the guide mechanisms are
adjusted in accordance with any correction required as indicated
using the verification tool.
[0180] FIG. 18 provides a further embodiment in which the
preoperative procedure/methodology and resultant guidance tool are
used in total ankle arthroplasty. Total ankle arthroplasty has, in
the past few years, become an accepted method in the treatment of
end-stage ankle arthritis. Studies analyzing the long-term outcome
of total ankle arthroplasty have shown that initial implant
alignment is a very important factor in avoiding intaoperative and
post-operative complications. The literature around total ankle
arthroplasty has shown a steep learning curve with adoption of this
procedure. In particular, obtaining correct alignment of the talar
component is problematic since the surgical exposure allows
visualization of only a small portion of the talus. This limited
view, among other problems, makes it difficult to intraoperatively
determine correct position of the initial surgical jig.
Highlighting the need for proper component alignment in lower limb
arthroplasty is the body of research showing that mal-alignment and
instability are the two most important causes of early (i.e., less
than five years) failure in total ankle arthroplasty.
[0181] In accordance with the preoperative procedure/methodology
described above for hip-resurfacing, the patient is first subjected
to preoperative planning in which a CT scan (or other suitable
medical imaging) is performed on the affected anatomy. As shown in
FIG. 18a, 3-D virtual model 500 is produced from the medical
imaging.
[0182] During pre-operative planning, the position, size and
orientation of the prosthesis components 502a, 502b are determined,
as shown in FIG. 18b. The virtual bone models 500 are then loaded,
anatomical axes are defined and virtual prosthesis components 502a,
502b are superimposed to the tibia and talus virtual models. At
this stage, the user is able to modify the position and orientation
of each virtual prosthesis model. The characteristics of the final
components are then saved.
[0183] Based on preoperative planning, the guidance tool 504 can
then be created using the rapid prototype technique, the guidance
tool 504 providing the mating surface 506 complementary to the
distal tibia and talus 508, which are accessible via the chosen
surgical approach.
[0184] Intraoperatively, the total ankle arthroplasty begins with a
conventional surgical approach. After the distal tibia and talus
508 are exposed, as shown in FIG. 18c, the guidance 506 tool is
fitted to the corresponding registration surface of the patient's
anatomy, drill sleeves are inserted, or adjusted with realignment
sleeves if necessary, and the guide pins 510 are drilled into
position. With the guidance tool removed, as shown in FIG. 18d, a
conventional planar tibia resection block 512 can be fitted to the
tibia 508. Resection can then be performed. Position of the cutting
guide may be confirmed fluoroscopically prior to cutting the
bone.
[0185] While exemplified largely within the framework of drilling
and pin placement, the preoperative process described above may
find application in the development of other guidance tools suited
for use with other medical instruments. Guidance tools may be
preoperatively planned and manufactured that are suitable for
guiding instruments intended for cutting, reaming and resurfacing.
Shown in FIG. 19a through 19c is an alternate procedure and
guidance tool 600 for Total Ankle Arthroplasty in which the guide
mechanism comprises a guidance block 602 used to guide a saw blade,
instead of setting guide pins as shown in FIG. 18c. In such a
procedure, the preoperative planning of the guidance tool 600 is
similar to that discussed above, except that the preoperatively
defined trajectory is identified as a plane upon which the saw is
to be directed. When being used intraoperatively, the guidance tool
600 is fitted to the patient's anatomy, and verified for accurate
placement. Once positionally verified, the guide mechanism is
fitted with an appropriate guide block 602 comprising a slot 604
for fitting a saw blade 606. The slot 604 is dimensioned to fit the
blade, and direct the blade along the preoperatively determined
trajectory plane. Should adjustments be necessary based on
measurements taken by the verification tool, alternate realignment
guide blocks 608 may be used, as shown in FIG. 19b (translational
offset) and 19c (angular offset).
[0186] While shown as a slot in a guide block, the guidance tool
may provide a bearing surface on one or more edges to guide a saw
blade or similar implement (e.g., a chisel). A guidance tool may
also comprise any combination of guide mechanisms to guide a range
of medical instruments. For example, a guidance tool may comprise
guide mechanisms for setting a plurality of pins, while also
providing a guide mechanism suited for receipt of a guide block
dimensioned to guide a saw blade.
[0187] The embodiment of the procedure described above enables the
intraoperative use of individualized patient-specific templates or
guidance tools to increase overall accuracy and success during bone
and joint surgery. As described, the patient-specific guidance tool
is created from a pre-operative survey of the anatomy of the
patient. The pre-operative steps of surveying and modeling the
anatomy provide a plan for central pin alignment based on precision
values used during intraoperative navigation. Furthermore the
preoperative planning provides a mathematical quality value for
registration (figure of merit), using the individual
patient-specific guidance tool. The value reflects the ability to
fit the guidance tool exactly to one position, specific to the
patient being treated. In addition, in the event a misalignment is
identified intraoperatively, offset drill sleeves can be used to
correct the noted misalignment, so as to achieve the preoperatively
defined pin trajectory. In fact, 3-D trajectory analysis on 25
hip-resurfacing procedures using the antero-lateral approach has
shown a high degree of trajectory accuracy. The average deviation
of the navigated valgus angle compared to the planned angle was
determined to be 1.46.degree. varus, with a standard deviation of
3.57.degree.. No complications such as femoral neck fracture,
sepsis, or inflections have been observed.
[0188] In summary the preoperative survey and modelling of the
patients anatomy and the subsequent planning and production of a
patient-specific guidance tool will allow clinics without a
"computer-assisted engineering team" in-house to achieve the
accuracy of computer-assisted surgery. As outlined in FIG. 20, the
general steps in the overall procedure are represented as follows:
[0189] a. a suitable medical image (e.g., CT scan) of the patient's
affected anatomy is obtained and a 3-D model is generated (700);
[0190] b. based on the 3-D model of the patient's anatomy,
preoperative planning is conducted to determine the correct
placement/trajectories of any manipulations (e.g. pin placement,
shaping, etc.) to the anatomy (710); [0191] c. based on the results
of preoperative planning, the design of the guidance tool is
calculated, taking into consideration factors such as, but not
limited to, the specific registration surface of the patient's
anatomy (720); [0192] d. the design of the guidance tool undergoes
inspection, verification and approval by the requesting user (730);
[0193] e. the design is converted into a usable physical form by
way of rapid prototype manufacture, and sent to the requesting user
(740); [0194] f. the guidance tool is sterilized and prepared for
use (either prior to or upon receipt by the user) (750); [0195] the
guidance tool is used intraoperatively (760).
[0196] The procedure described above has a number of notable
advantages over the prior art. First, the procedure combines the
accuracy benefits of CAS with the precision, repeatability, low
cost and ease of use benefits associated with surgical alignment
tools. By optimizing and customizing the guidance tool for the
specific patient being treated, the tool can be made smaller,
thereby reducing the size of the incision during surgery. The
procedure is easy to conduct and does not require expensive
disposables generally associated with intraoperative computer
assisted surgery methodologies. The procedure reduces
`line-of-sight` problems associated with opto-electronic computer
assisted surgery. That is, in an operating room configured for
conventional computer assisted surgery, there is generally a
certain amount of interference between the personnel present and
the equipment in place. For example, either the surgeons obstruct
the "line-of-sight" of the computer-assist equipment, or the
computer-assist equipment interferes with the "line-of-sight" of
the surgeons. The above noted procedure reduces such
"line-of-sight" problems as the quantity of cumbersome equipment in
the operating room is reduced. Moreover, no additional surgical
exposure is required. The guidance tool is customized, thereby
increasing the precision, and decreasing complications and
operating room time. The guidance tool is disposable, and inventory
management is optimized. The guidance tool also allows for
controlled translational and angular intraoperative adjustments for
pin placement.
[0197] As will be appreciated, for the various alternate applicable
procedures, specialized fasteners may be necessary as would be
evident to one skilled in the art. In no way are the techniques,
tools and methodologies meant to be limited to hip resurfacing, or
any of the exemplary embodiments.
[0198] It will be appreciated that, although embodiments have been
described and illustrated in detail, various modifications and
changes may be made. While several embodiments are described above,
some of the features described above can be modified, replaced or
even omitted. For example, the mating surface for registering the
guidance tool on the patient's anatomy may incorporate any number
of characteristic landmarks, from one to a plurality of such
features. Although the drilling sleeve is described as being a
surgical grade metal (e.g., surgical grade stainless steel,
titanium, etc.), other suitable materials such as surgically
compatible polymers may be used. Although the guidance tool is
manufactured from acrylonitrile butadiene styrene (ABS), other
suitable polymer materials and metals may be used. Although rapid
prototyping is used to create the guidance tool, other methods may
be used to form the necessary tool, such as CNC milling or molding
technologies. Although the central pin inserted into the femoral
head using the guidance tool is provided with a self-tapping
threaded configuration, other suitable pin-anchoring alternatives
may be employed, as would be evident to one skilled in the art.
Although the verification tool is shown with sliding rulers, the
verification tool could be configured with a geared calliper-like
or other mechanism. Although the guidance tool is generally shown
as a unitary structure, the guide block and the body section may be
manufactured separately and attached post-production. In addition,
it may be feasible to reuse the guide-block portion or the tool
while restricting the disposable portion to the customized body
section comprising the mating surface. Although the guide block is
described as having a locking key for each landmark, multiple
landmark locations may correspond to a single locking key, wherein
the landmarks lie on the same plane defined by the position of the
locking key. One or more locking keys may be intraoperatively
adjusted, and the amount of adjustment may be determined by
suitable markings or a scale such as a protractor-like scale on the
verification tool and/or the guidance tool. Alternatively, the
verification tool may be freed from the one or more locking keys
and its position adjusted, the amount of adjustment may be
determined by suitable markings or a scale such as a
protractor-like scale on the verification tool and/or the guidance
tool. Although the verification tool and drilling sleeve each
separately use the same channel during the described process, the
guidance tool, in particular the guide block, may be configured
with separate channels or receptacles for receiving each of these
components. Still further alternatives and modifications may occur
to those skilled in the art. All such alternatives and
modifications are believed to be within the scope of the invention
and are covered by the claims appended hereto.
[0199] The contents of all cited publications are incorporated
herein by reference in their entirety.
* * * * *
References