U.S. patent application number 15/709085 was filed with the patent office on 2018-01-11 for method of estimating soft tissue balance for knee arthroplasty.
The applicant listed for this patent is ZIMMER, INC.. Invention is credited to Jia LI.
Application Number | 20180008433 15/709085 |
Document ID | / |
Family ID | 48173191 |
Filed Date | 2018-01-11 |
United States Patent
Application |
20180008433 |
Kind Code |
A1 |
LI; Jia |
January 11, 2018 |
METHOD OF ESTIMATING SOFT TISSUE BALANCE FOR KNEE ARTHROPLASTY
Abstract
A method is provided for evaluating the tension or laxity of the
soft tissue surrounding a patient's knee joint. Based on this
evaluation, a surgeon may determine a desired resection depth for a
knee arthroplasty procedure that will achieve an appropriate
spacing between adjacent, articulating components of the knee
joint.
Inventors: |
LI; Jia; (Warsaw,
IN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
ZIMMER, INC. |
Warsaw |
IN |
US |
|
|
Family ID: |
48173191 |
Appl. No.: |
15/709085 |
Filed: |
September 19, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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13283879 |
Oct 28, 2011 |
9788975 |
|
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15709085 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/1071 20130101;
A61B 5/1075 20130101; A61F 2/4657 20130101; A61F 2002/4666
20130101; A61B 2034/105 20160201; B33Y 80/00 20141201; A61B 17/155
20130101; A61B 2034/108 20160201; A61B 17/157 20130101; A61B 34/10
20160201 |
International
Class: |
A61F 2/46 20060101
A61F002/46; A61B 5/107 20060101 A61B005/107 |
Claims
1. A method of performing an arthroplasty procedure on a patient's
knee joint, the knee joint including a femur and a tibia, the
method comprising: obtaining preoperatively a three-dimensional
model of the patient's knee joint, the three-dimensional model
based on at least one of a MRI, CT and X-ray image of the patient's
knee joint; determining preoperatively an initial resection depth
for a femoral prosthesis; capturing the rotation of the patient's
femur relative to the tibia in response to a directed force applied
to the patient's knee joint; adjusting the initial resection depth
based on the captured rotation to determine an actual resection
depth; and resecting the patient's femur according to the actual
resection depth.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] The present application is a continuation application of
U.S. patent application Ser. No. 13/283,879 filed on Oct. 28, 2011,
incorporated herewith by reference.
FIELD OF THE DISCLOSURE
[0002] The present disclosure relates to knee arthroplasty
procedures. More particularly, the present disclosure relates to a
method for evaluating soft tissue during knee arthroplasty
procedures.
BACKGROUND OF THE DISCLOSURE
[0003] In a natural knee joint, the distal end of the femur
articulates against the proximal end of the tibia. If the natural
knee joint becomes diseased or damaged, a knee arthroplasty
procedure may be performed to repair the distal end of the femur
and/or the proximal end of the tibia. The knee arthroplasty
procedure involves resecting the distal end of the femur and/or the
proximal end of the tibia and replacing the resected bones with
prosthetic components that are designed to replicate articulation
of the natural knee joint.
SUMMARY
[0004] The present disclosure provides a method for evaluating the
tension or laxity of the soft tissue surrounding a patient's knee
joint. Based on this evaluation, a surgeon may determine a desired
resection depth for a knee arthroplasty procedure that will achieve
an appropriate spacing between adjacent, articulating components of
the knee joint.
[0005] According to an embodiment of the present disclosure, a
method is provided for performing an arthroplasty procedure on a
patient's knee joint. The knee joint includes a femur, a tibia, and
soft tissue. The method includes the steps of: comparing a first
image of the knee joint in an unloaded state and a second image of
the knee joint in a loaded state; evaluating at least one movement
of the knee joint between the first and second images to evaluate
laxity of the knee joint; and resecting at least one of the femur
and the tibia to a desired resection depth based on the at least
one movement evaluated during the evaluating step.
[0006] According to another embodiment of the present disclosure, a
method is provided for performing an arthroplasty procedure on a
patient's knee joint. The knee joint includes a femur, a tibia, and
soft tissue. The method includes the steps of: measuring at least
one movement of the knee joint between an unloaded state and a
loaded state; and resecting at least one of the femur and the tibia
to a desired resection depth based on the at least one movement
measured during the measuring step.
[0007] According to yet another embodiment of the present
disclosure, a method is provided for performing an arthroplasty
procedure on a patient's knee joint. The knee joint includes a
femur, a tibia, and soft tissue. The method includes the steps of:
capturing a first image of the knee joint in an unloaded state;
capturing a second image of the knee joint in a loaded state;
aligning at least one corresponding anatomic feature of the first
and second images; measuring at least one movement of the knee
joint between the first and second images to evaluate laxity of the
knee joint; and determining a desired resection depth of at least
one of the femur and the tibia based on the measuring step.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] The above-mentioned and other features and advantages of
this disclosure, and the manner of attaining them, will become more
apparent and the invention itself will be better understood by
reference to the following description of embodiments of the
invention taken in conjunction with the accompanying drawings,
wherein:
[0009] FIG. 1A is an anterior elevational view of a patient's knee
joint shown in a normal, aligned state, the knee joint including a
femur and a tibia;
[0010] FIG. 1B is another anterior elevational view of the
patient's knee joint shown in a varus state;
[0011] FIG. 1C is another anterior elevational view of the
patient's knee joint shown in a valgus state;
[0012] FIG. 2 is a flow chart of an exemplary method for performing
a knee arthroplasty procedure;
[0013] FIG. 3 is a plan view of a first image taken with the
patient's knee joint in an unloaded state;
[0014] FIG. 4 is a plan view of a second image taken with the
patient's knee joint in a loaded state;
[0015] FIG. 5 is a plan view of the second image overlying the
first image to align corresponding femoral regions of the first and
second images;
[0016] FIG. 6A is a plan view similar to FIG. 5 showing a first
measurement of tibial movement between the first and second
images;
[0017] FIG. 6B is a plan view similar to FIG. 5 showing a second
measurement of tibial movement between the first and second
images;
[0018] FIG. 6C is a plan view similar to FIG. 5 showing a third
measurement of tibial movement between the first and second
images;
[0019] FIG. 7 is a side elevational view of the patient's femur
shown with a cut guide for resecting the distal end of the
patient's femur;
[0020] FIG. 8 is a side elevational view of the patient's resected
femur shown with a corresponding femoral prosthesis; and
[0021] FIG. 9 is a side elevational view of the patient's
surgically repaired knee joint, also including a tibial prosthesis
that articulates with the femoral prosthesis.
[0022] Corresponding reference characters indicate corresponding
parts throughout the several views. The exemplifications set out
herein illustrate exemplary embodiments of the invention and such
exemplifications are not to be construed as limiting the scope of
the invention in any manner.
DETAILED DESCRIPTION
[0023] A patient's knee joint 10 is depicted in FIG. 1A. Knee joint
10 is formed between the patient's femur 12 and tibia 14.
Specifically, knee joint 10 is formed between distal end 22 of the
patient's femur 12 and proximal end 24 of the patient's tibia 14.
The patient's patella is not shown in FIG. 1A, but the patient's
fibula 16 is shown in FIG. 1A to distinguish lateral side 26 from
medial side 28 of knee joint 10.
[0024] As shown in FIG. 1A, femur 12 extends along anatomic axis A
and includes an intercondylar notch or recess 13. Tibia 14 extends
along anatomic axis B and includes a tibial eminence 15. During
normal articulation of knee joint 10, distal end 22 of the
patient's femur 12 rolls back and forth across proximal end 24 of
the patient's tibia 14, with a tibial eminence 15 extending
proximally from tibia 14 and into intercondylar recess 13 of femur
12.
[0025] The bones of knee joint 10 are surrounded by soft tissue to
support and stabilize knee joint 10. The soft tissue of knee joint
10 includes various ligaments (not shown) extending between femur
12 and tibia 14, such as the lateral collateral ligament (LCL),
which stabilizes lateral side 26 of knee joint 10, the medial
collateral ligament (MCL), which stabilizes medial side 28 of knee
joint 10, the anterior cruciate ligament (ACL), which limits
rotation and the forward movement of tibia 14, and the posterior
cruciate ligament (PCL), which limits backward movement of tibia
14. The soft tissue of knee joint 10 also includes various tendons
and muscles (not shown).
[0026] The alignment of the patient's knee joint 10, and more
specifically the alignment between anatomic axis A of the patient's
femur 12 and anatomic axis B of the patient's tibia 14, may vary.
Knee joint 10 is shown in a normal state in FIG. 1A, in a varus
state in FIG. 1B, and in a valgus state in FIG. 10.
[0027] In the normal state of FIG. 1A, anatomic axis A of femur 12
extends slightly laterally relative to anatomic axis B of tibia 14.
For example, anatomic axis A of femur 12 may extend 5 degrees, 6
degrees, or 7 degrees laterally relative to anatomic axis B of
tibia 14. Although anatomic axis A and anatomic axis B of knee
joint 10 are not "aligned" (i.e., coaxial or parallel) in FIG. 1A,
femur 12 and tibia 14 of knee joint 10 may be described as being
"aligned" in FIG. 1A.
[0028] In the varus state of FIG. 1B, knee joint 10' appears to bow
laterally outward, because anatomic axis B' of tibia 14' has
rotated medially inward relative to anatomic axis A' of femur 12'.
To offset this medially inward rotation, tibia 14' may also shift
or translate laterally outward relative to femur 12'.
[0029] In the valgus state of FIG. 10, knee joint 10'' appears to
bow medially inward, because anatomic axis B'' of tibia 14'' has
rotated laterally outward relative to anatomic axis A'' of femur
12''. To offset this laterally outward rotation, tibia 14'' may
also shift or translate medially inward relative to femur 12''.
[0030] One variable that may affect the alignment of knee joint 10
is the relative laxity or tension of the soft tissue surrounding
knee joint 10. For example, knee joint 10 may be in the normal
state of FIG. 1A when the soft tissue on lateral side 26 of knee
joint 10 and the soft tissue on medial side 28 of knee joint 10 are
balanced. Knee joint 10' may be in the varus state of FIG. 1B when
the soft tissue on lateral side 26' of knee joint 10' is relatively
lax and the soft tissue on medial side 28' of knee joint 10' is
relatively tense. Knee joint 10'' may be in the valgus state of
FIG. 10 when the soft tissue on lateral side 26'' of knee joint
10'' is relatively tense and the soft tissue on medial side 28'' of
knee joint 10'' is relatively lax.
[0031] Another variable that may affect the alignment of knee joint
10 is the force applied to knee joint 10. For example, knee joint
10 may be in the normal state of FIG. 1A when the patient is lying
down in a supine position without subjecting knee joint 10 to a
load. Knee joint 10' may be in the varus state of FIG. 1B when
subjected to a laterally directed force. Knee joint 10'' may be in
the valgus state of FIG. 10 when subjected to a medially directed
force.
[0032] These variables may also work in combination to affect the
alignment of knee joint 10. For example, knee joint 10 may be in
the normal state of FIG. 1A when the patient is lying down in a
supine position without subjecting knee joint 10 to a load.
However, when the patient is standing in an upright position and
subjecting knee joint 10 to a load, the surrounding soft tissue may
move knee joint 10 into the varus state of FIG. 1B or the valgus
state of FIG. 10. The more lax the surrounding soft tissue, the
more knee joint 10 may move between the supine position and the
upright position. By contrast, the more tense the surrounding soft
tissue, the less knee joint 10 may move between the supine position
and the upright position. In certain cases, the surrounding soft
tissue may be so tight that the patient is unable to bend knee
joint 10, a condition known as flexion contracture.
[0033] If knee joint 10 becomes diseased or damaged, a knee
arthroplasty procedure may be performed to repair distal end 22 of
the patient's femur 12 and/or proximal end 24 of the patient's
tibia 14. The present disclosure provides a method 100 (FIG. 2) for
estimating the laxity or tension of knee joint 10 during such a
knee arthroplasty procedure. Method 100 is exemplified with
reference to FIGS. 3-9.
[0034] Beginning at step 102 of method 100 (FIG. 2), and as shown
in FIG. 3, a surgeon or another party generates data representative
of the patient's knee joint 10a in an unloaded state. This data may
include a visual representation or image of the patient's knee
joint 10a, which may be in the form of a two-dimensional image or a
three-dimensional model, for example. Thus, step 102 may involve
capturing at least one first image 30 of the patient's knee joint
10a in the unloaded state. To capture the unloaded knee joint 10a
in the first image 30, the patient may be instructed to lie down in
a supine position. The first image 30 may be captured using a
suitable imaging modality, such as X-ray, fluoroscopy, magnetic
resonance imaging (MRI), computed tomography (CT), or ultrasound,
for example.
[0035] According to an exemplary embodiment of the present
disclosure, the first image 30 is a digital, three-dimensional
model of the patient's knee joint 10a. The first image 30 may be
captured using a suitable three-dimensional imaging modality, such
as MRI or CT. As discussed above, it is also within the scope of
the present disclosure that the first image 30 is a two-dimensional
image.
[0036] The first image 30 may be generated and processed using a
suitable computer having, for example, image processing software
and/or computer-aided design (CAD) software installed thereon. The
computer may be programmed to digitally process, evaluate, and
combine multiple images of the patient's knee joint 10a. For
example, the computer may be programmed to combine a plurality of
two-dimensional X-ray images to generate the digital,
three-dimensional model. The computer may also be programmed to
digitally segment, or differentiate, desired anatomic structures
(e.g., bone tissue) from undesired structures (e.g., surrounding
soft tissue) to create the first image 30. For example, the
computer may be programmed to assign a grey value to each pixel of
the image, set a threshold grey value, and segment desired pixels
from undesired pixels based on the threshold grey value, as
discussed in U.S. Pat. No. 5,768,134 to Swaelens et al., the
disclosure of which is expressly incorporated herein by
reference.
[0037] Using the first image 30, the surgeon may evaluate and
identify certain features of femur 12a and tibia 14a. For example,
the surgeon may use the first image 30 to evaluate the surface
contour, size, and bone quality of femur 12a and tibia 14a. Also,
the surgeon may use the first image 30 to identify features such as
anatomic axis Aa of femur 12a, intercondylar recess 13a of femur
12a, anatomic axis Ba of tibia 14a, and eminence 15a of tibia
14a.
[0038] Continuing to step 104 of method 100 (FIG. 2), and as shown
in FIG. 4, the surgeon or another party generates data
representative of the patient's knee joint 10b in a loaded state.
This data may include a visual representation or image of the
patient's knee joint 10b, which may be in the form of a
two-dimensional image or a three-dimensional model, for example.
Thus, step 104 may involve capturing at least one second image 40
of the patient's knee joint 10b in the loaded state. To capture the
loaded knee joint 10b in the second image 40, the patient may be
instructed to stand in an upright position, subjecting the loaded
knee joint 10b of FIG. 4 to more force than the unloaded knee joint
10a of FIG. 3. For simplicity and efficiency, the second image 40
may be captured using a suitable two-dimensional imaging modality,
such as X-ray. It is also within the scope of the present
disclosure that the second image 40 may be captured using a
three-dimensional imaging modality.
[0039] Using the second image 40, the surgeon may evaluate and
identify certain features of femur 12b and tibia 14b. For example,
the surgeon may use the second image 40 to identify features such
as anatomic axis Ab of femur 12b, intercondylar recess 13b of femur
12b, anatomic axis Bb of tibia 14b, and eminence 15b of tibia
14b.
[0040] The first and second images 30, 40 shown and described
herein are anterior views of the patient's knee joint 10a, 10b,
respectively. It is also within the scope of the present disclosure
to capture other views of the patient's knee joint 10a, 10b,
including lateral, medial, and/or posterior views.
[0041] The unloaded knee joint 10a is shown in of FIG. 3 in a
substantially normal or "aligned" state. Compared to the unloaded
knee joint 10a of FIG. 3, the loaded knee joint 10b of FIG. 4 has
transitioned into a more varus state. It is also within the scope
of the present disclosure that another patient's knee joint may
transition into a more valgus state when loaded (See FIG. 1C).
[0042] In step 106 of method 100 (FIG. 2), and as shown in FIG. 5,
corresponding regions of the first and second images 30, 40 are
aligned. According to an exemplary embodiment of the present
disclosure, the aligning step 106 of method 100 is performed using
a suitable computer, which may be the same computer discussed above
with respect to the capturing step 102. The computer may
automatically align corresponding regions of the first and second
images 30, 40 by performing best-fit calculations, for example.
Alternatively, the computer may respond to manual instructions from
the surgeon or another party to digitally align corresponding
regions of the first and second images 30, 40. Rather than aligning
the first and second images 30, 40 using the computer, it is also
within the scope of the present disclosure that the surgeon or
another party may align tangible, transparent versions of the first
and second images 30, 40, for example.
[0043] The aligning step 106 may involve combining, mapping, or
overlapping corresponding regions of the first and second images
30, 40, such as by overlaying the second image 40 onto the first
image 30, or vice versa. As discussed above, at least one of the
first and second images 30, 40 may be transparent to facilitate
this overlaying step. In the illustrated embodiment of FIG. 5, for
example, the second image 40 overlays the first image 30 to align
corresponding regions of the femurs 12a, 12b, such as the
corresponding anatomic axes Aa, Ab, the corresponding curved distal
ends 22a, 22b (e.g., the corresponding intercondylar recesses 13a,
13b of the curved distal ends 22a, 22b), the corresponding elongate
shafts, and/or other corresponding regions of the femurs 12a, 12b.
If one or both of the first and second images 30, 40 are
three-dimensional models, the first and second images 30, 40 may be
aligned by generating and then aligning two-dimensional, planar
projections of the three-dimensional models. The computer may
generate such projections by performing linear algebraic
calculations, for example.
[0044] Various techniques may be used to ensure that the first and
second images 30, 40 are similar in scale during the aligning step
106. In one embodiment, the surgeon may apply magnification markers
to the patient's bones when capturing the first and second images
30, 40. Then, the surgeon may reference the magnification markers
to scale the first and second images 30, 40. In another embodiment,
the surgeon may ensure that corresponding anatomic features
captured in the first and second images 30, 40 are scaled to the
same dimension. For example, the surgeon may ensure that the bones
captured in the first and second images 30, 40 have the same
overall width, the same overall length, the same epicondylar axis
length, the same anatomic axis length, and/or other similar
dimensions.
[0045] During the aligning step 106, it is within the scope of the
present disclosure that the femurs 12a, 12b and the tibias 14a, 14b
of the first and second images 30, 40 may not be perfectly aligned
due to joint rotation between the unloaded, supine position and the
loaded, standing position. Such rotation may be one factor in
determining the laxity or tension of the patient's knee joint
10.
[0046] Next, during step 108 of method 100 (FIG. 2), the surgeon or
another party evaluates differences between the aligned first and
second images 30, 40. If the femurs 12a, 12b of the first and
second images 30, 40 are aligned during step 106, for example,
differences between the tibias 14a, 14b of the first and second
images 30, 40 may be evaluated during step 108. Because the first
image 30 captures the unloaded knee joint 10a with the patient
lying down in a supine position and the second image 40 captures
the loaded knee joint 10b with the patient standing upright, the
evaluating step 108 allows the surgeon to evaluate the patient's
loaded, standing knee joint 10b versus the patient's unloaded,
supine knee joint 10a.
[0047] It is also within the scope of the present disclosure to
align corresponding regions of the tibias 14a, 14b of the first and
second images 30, 40 during the aligning step 106. In this case,
differences between the femurs 12a, 12b of the first and second
images 30, 40 would be evaluated during step 108.
[0048] It is further within the scope of the present disclosure to
divide one of the images, such as the second image 40, into
segments--one segment including the femur 12b and the other segment
including the tibia 14b. Then, during the aligning step 106, the
surgeon or another party would align both the femurs 12a, 12b and
the tibias 14a, 14b of the first and second images 30, 40. In this
case, differences between the divided segments of the second image
40 would be evaluated during step 108.
[0049] As shown in FIG. 6A, the evaluating step 108 may involve
measuring an angle .alpha. between the tibial anatomic axis Ba of
the first image 30 and the tibial anatomic axis Bb of the second
image 40. In this embodiment, angle .alpha. represents the degree
of rotation between the patient's unloaded, supine knee joint 10a
and the patient's loaded, standing knee joint 10b. In the
illustrated embodiment of FIG. 6A, for example, the patient's knee
joint becomes more varus when loaded, because anatomic axis Bb of
tibia 14b has rotated medially inward by angle .alpha. relative to
anatomic axis Ab of femur 12b. Angle .alpha. may be more easily
measured when the first and second images 30, 40 depict the entire
length of tibias 14a, 14b, respectively.
[0050] As shown in FIG. 6B, the evaluating step 108 may also
involve measuring an angle .beta. between tibial plateau Pa of the
first image 30 and tibial plateau Pb of the second image 40. Like
angle .alpha. described above, angle .beta. represents the degree
of rotation between the patient's unloaded, supine knee joint 10a
and the patient's loaded, standing knee joint 10b. Angle .alpha.
may be the same as angle R.
[0051] As shown in FIG. 6C, the evaluating step 108 may also
involve measuring a medial-lateral distance .DELTA..sub.1 between
the tibial eminence 15a of the first image 30 and the tibial
eminence 15b of the second image 40. In this embodiment, distance
.DELTA..sub.1 represents a shift or translation between the
patient's unloaded, supine knee joint 10a and the patient's loaded,
standing knee joint 10b. In the illustrated embodiment of FIG. 6C,
for example, the patient's knee joint becomes more varus when
loaded, and in response, tibia 14b has shifted or translated
laterally outward by distance .DELTA..sub.1 relative to femur 12b.
In FIG. 6C, distance .DELTA..sub.1 is measured by comparing
corresponding medial aspects or landmarks of tibial eminences 15a,
15b, but it is also within the scope of the present disclosure that
distance .DELTA..sub.1 may be measured by comparing corresponding
central aspects or landmarks or corresponding lateral aspects or
landmarks of tibial eminences 15a, 15b, for example.
[0052] Referring still to FIG. 6C, the evaluating step 108 may
further involve measuring a superior-inferior distance
.DELTA..sub.2 between the tibial eminence 15a of the first image 30
and the tibial eminence 15b of the second image 40. In this
embodiment, distance .DELTA..sub.2 represents a shift or
translation between the patient's unloaded, supine knee joint 10a
and the patient's loaded, standing knee joint 10b. In the
illustrated embodiment of FIG. 6C, for example, tibia 14b has
shifted or translated inferiorly by distance .DELTA..sub.2 relative
to femur 12b. In FIG. 6C, distance .DELTA..sub.2 is measured by
comparing corresponding medial aspects or landmarks of tibial
eminences 15a, 15b, but like distance .DELTA..sub.1 discussed
above, may be measured by comparing corresponding central aspects
or landmarks or corresponding lateral aspects or landmarks of
tibial eminences 15a, 15b, for example.
[0053] One skilled in the art may identify other variables similar
to angle .alpha.(FIG. 6A), angle .beta. (FIG. 6B), and distances
.DELTA..sub.1 and .DELTA..sub.2 (FIG. 6C) that may be used to
evaluate differences between the first and second images 30, 40,
including rotation variables. Such variables may be used in
addition to or instead of angle .alpha., angle .beta., and
distances .DELTA..sub.1 and .DELTA..sub.2 described herein.
[0054] Based on the evaluating step 108, the surgeon or another
party determines the laxity or tension of the patient's knee joint
10 during step 110 of method 100 (FIG. 2). The more lax the
surrounding soft tissue, the more knee joint 10 tends to move when
loaded. Therefore, a relatively large angle .alpha. (FIG. 6A), a
relatively large angle .beta. (FIG. 6B), a relatively large
distance .DELTA..sub.1 (FIG. 6C), and/or a relatively large
distance .DELTA..sub.2 (FIG. 6C) measured during step 108 may
suggest that the patient's knee joint 10 is surrounded by lax soft
tissue. By contrast, the more tense the surrounding soft tissue,
the less knee joint 10 tends to move when loaded. Therefore, a
relatively small angle .alpha. (FIG. 6A), a relatively small angle
.beta. (FIG. 6B), a relatively large distance .DELTA..sub.1 (FIG.
6C), and/or a relatively small distance .DELTA..sub.2 (FIG. 6C)
measured during step 108 may suggest that the patient's knee joint
10 is surrounded by tense soft tissue.
[0055] Based on the determining step 110, the surgeon or another
party plans and surgically performs the knee arthroplasty procedure
during step 112 of method 100 (FIG. 2). The knee arthroplasty
procedure may involve resecting distal end 22 of the patient's
femur 12 and/or proximal end 24 of the patient's tibia 14 and
replacing the resected bones with prosthetic implants.
[0056] In FIG. 7, a cut guide 50 is shown for resecting distal end
22 of the patient's femur 12. Cut guide 50 includes at least one
cut slot, illustratively cut slots 51a-51e, for guiding a cutting
tool into the patient's femur 12 along corresponding cut planes
52a-52e to produce corresponding resected surfaces 53a-53e (FIG.
8). The cutting tool may include a saw blade or a mill, for
example. Cut guide 50 further includes at least one abutting
surface, illustratively abutting surfaces 54a, 54b of legs 56a,
56b, that abut the patient's femur 12. Cut guide 50 may be
temporarily secured to the patient's femur 12 using mechanical
fasteners or adhesive, for example.
[0057] According to an exemplary embodiment of the present
disclosure, cut guide 50 is a patient-specific instrument, with the
abutting surfaces 54a, 54b being shaped as substantially a negative
of the particular patient's femur 12 so that cut guide 50 conforms
to the particular patient's femur 12 and is perfectly contoured to
fit against the particular patient's femur 12. Although the
illustrative abutting surfaces 54a, 54b are located on spaced-apart
legs 56a, 56b that contact discrete points on the distal end 22 of
the patient's femur 12, it is also within the scope of the present
disclosure that the abutting surfaces 54a, 54b may form a
substantially continuous and concave surface that spans anteriorly
and posteriorly to wrap around and contact at least a portion of
distal end 22 of the patient's femur 12. In this manner, the
continuous abutting surfaces would have more surface contact with
the patient's femur 12 than the discrete abutting surfaces 54a, 54b
shown in FIG. 7.
[0058] Cut guide 50 may be an entirely custom product that is
manufactured using a casting/molding process or a rapid
manufacturing process, such as 3-D printing, stereolithography,
selective laser sintering, fused deposition modeling, laminated
object manufacturing, or electron beam melting, for example. The
custom cut guide 50 may be designed using a three-dimensional model
of the patient's femur 12, which may include the above-described
first image 30 (FIG. 3) of the patient's femur 12. Specifically,
abutting surfaces 54a, 54b of the custom cut guide 50 may be
designed to fit perfectly against the three-dimensional model of
the patient's femur 12. In use, abutting surfaces 54a, 54b of the
custom cut guide 50 will fit perfectly against the patient's actual
femur 12. It is also within the scope of the present disclosure
that cut guide 50 may be a partially custom product. For example,
cut guide 50 may include a stock body with customizable, shapeable
legs 56a, 56b.
[0059] Based on the shape of cut guide 50 and the length of legs
56a, 56b, for example, the patient's femur 12 is resected at depth
D. In the illustrated embodiment of FIG. 7, the resection depth D
is measured with respect to cut slot 51e and extends from the
corresponding cut plane 52e to the distal-most end of the patient's
femur 12. For most patient's, the distal-most end of femur 12 will
lie on the medial femoral condyle (See, for example, the
distally-located condyle on the medial side 28 of femur 12 in FIG.
1A), but it is also within the scope of the present disclosure that
the distal-most end will lie on the lateral femoral condyle.
[0060] The resection depth D may be altered by customizing or
adjusting cut guide 50. In one embodiment, the resection depth D
may be altered by adjusting the length of legs 56a, 56b. For
example, a stock cut guide 50 may be supplied having relatively
long legs 56a, 56b, and then the stock cut guide 50 may be
customized to arrive at a desired resection depth D by shortening
and shaping legs 56a, 56b. In another embodiment, the resection
depth D may be altered by adjusting the location of cut slots
51a-51e in cut guide 50 or by selecting another cut guide having
different cut slot locations.
[0061] In FIG. 8, a corresponding femoral prosthesis 60 is shown
for replacing the resected distal end 22 of the patient's femur 12.
Femoral prosthesis 60 includes a bone-contacting surface 62 that is
contoured to fit against resected surfaces 53a-53e of the patient's
resected femur 12 and an opposing articulating surface 64 that is
contoured to articulate with the patient's adjacent tibia 14 (FIG.
1A) or an adjacent tibial prosthesis 70 (FIG. 9).
[0062] In FIG. 9, tibial prosthesis 70 is shown for replacing the
resected proximal end 24 of the patient's tibia 14. Tibial
prosthesis 70 includes tray 72 that attaches to the patient's
resected tibia 14 and a polymeric bearing layer 74 that is
contoured to articulate with the adjacent femoral prosthesis 60.
The polymeric bearing layer 74 may vary in thickness between about
10 mm and about 17 mm, for example.
[0063] If the resection depth D is too small, femoral prosthesis 60
would rest too shallow on the patient's femur 12 and too tight
against tibial prosthesis 70. In particular, knee joint 10 may
become tight when subjected to a load that forces femoral
prosthesis 60 and tibial prosthesis 70 together. In this case, the
freedom of movement between femoral prosthesis 60 and tibial
prosthesis 70 could be too small. Also, the tight spacing between
femoral prosthesis 60 and tibial prosthesis 70 may subject the
patient's femur 12 and/or tibia 14 to greater forces than desired.
To avoid this tight spacing, the surgeon may need to make
intraoperative modifications, such as re-cutting the patient's
femur 12, which increases the length of the surgical procedure.
[0064] If the resection depth D is too large, on the other hand,
femoral prosthesis 60 would rest too deep into the patient's femur
12 and too loose relative to tibial prosthesis 70. In particular,
knee joint 10 may become loose when not subjected to a load,
allowing femoral prosthesis 60 and tibial prosthesis 70 to spread
apart. In this case, the freedom of movement between femoral
prosthesis 60 and tibial prosthesis 70 could be greater than
desired. The loose spacing between femoral prosthesis 60 and tibial
prosthesis 70 may cause the patient's knee joint 10 to function
abnormally.
[0065] Method 100 of the present disclosure allows the surgeon to
determine an appropriate resection depth D during preoperative
planning, thereby reducing intraoperative modifications. In an
exemplary embodiment, the resection depth D chosen in accordance
with method 100 is a patient-specific solution that is based on the
laxity or tension of the particular patient's knee joint 10. From
one patient to the next, method 100 enables the surgeon to achieve
an appropriate freedom of movement between adjacent, articulating
components, even as the soft tissue balance varies between
patients.
[0066] As the evaluating step 108 indicates more tension in the
surrounding soft tissue, the resection depth D increases by a
proportional amount. A tense knee joint 10 may be recognized during
step 108 as showing relatively little movement (e.g., a relatively
small angle .alpha. (FIG. 6A), a relatively small angle .beta.
(FIG. 6B), a relatively large distance .DELTA..sub.1 (FIG. 6C),
and/or a relatively small distance .DELTA..sub.2 (FIG. 6C)).
Because the resection depth D increases as the movement measured
during step 108 decreases, these variables are inversely
proportional. As a result of increasing the resection depth D, and
with reference to FIG. 9, femoral prosthesis 60 will be implanted
deeper into femur 12 and further away from the tightly-held tibial
prosthesis 70.
[0067] By contrast, as the evaluating step 108 indicates more
laxity in the surrounding soft tissue, the resection depth D
decreases by a proportional amount. A lax knee joint 10 may be
recognized during step 108 as showing relatively large movement
(e.g., a relatively large angle .alpha. (FIG. 6A), a relatively
large angle .beta. (FIG. 6B), a relatively large distance
.DELTA..sub.1 (FIG. 6C), and/or a relatively large distance
.DELTA..sub.2.DELTA..sub.2 (FIG. 6C)). Because the resection depth
D decreases as the movement measured during step 108 increases,
these variables are inversely proportional. As a result of
decreasing the resection depth D, and with reference to FIG. 9,
femoral prosthesis 60 will be implanted shallower into femur 12 and
closer to the loosely-held tibial prosthesis 70.
[0068] In one embodiment, the surgeon adjusts an initial resection
depth D by a desired amount. The initial resection depth D may be
pre-selected based on accepted surgical practices, the average
patient's needs, or the manufacturer's recommendations, for
example. If femoral prosthesis 60 corresponds to an initial or
planned resection depth D of about 20 millimeters (mm), for
example, the surgeon may choose to increase the actual resection
depth D above 20 mm (e.g., 21 mm, 22 mm, 23 mm, 24 mm, or more) to
accommodate a tense knee joint 10, or the surgeon may choose to
decrease the actual resection depth D below 20 mm (e.g., 19 mm, 18
mm, 17 mm, 16 mm, or less) to accommodate a lax knee joint 10.
[0069] In another embodiment, the surgeon selects resection depth D
from a look-up table, such as Table 1 below. The table may include
various angles .alpha. (FIG. 6A), angles .beta. (FIG. 6B),
distances .DELTA..sub.1 (FIG. 6C), and/or distances .DELTA..sub.2
(FIG. 6C) and corresponding resection depths D. The look-up table
may include known patient data from previous procedures.
TABLE-US-00001 TABLE 1 Measured Measured Resection Sample Angle
.beta. Distance .DELTA..sub.1 Depth SD Patient No. (.degree.) (mm)
(mm) 1 6.9 8 20 (planned) - 4 2 2.64 1.4 20 (planned) + 0 3 8.1 3.2
20 (planned) - 2 4 3.2 2.1 20 (planned) + 0 5 7.1 4 20 (planned) -
2
[0070] In yet another embodiment, the surgeon calculates resection
depth D as a function of angle .alpha. (FIG. 6A), angle .beta.
(FIG. 6B), and/or distance .DELTA. (FIG. 6C).
[0071] Although the resection depth D is described herein with
reference to the patient's femur 12, the same teachings may be
applied to the patient's tibia 14. For example, as shown in FIG. 9,
the more tense the surrounding soft tissue of knee joint 10, the
greater the resection depth D2 may be into tibia 14, and the more
lax the surrounding soft tissue of knee joint 10, the smaller the
resection depth D2 may be into tibia 14. The resection depth D2 of
tibia 14 may be adjusted instead of or in addition to the resection
depth D of femur 12.
[0072] The above-described method 100 (FIG. 2) provides information
to estimate the laxity or tension of knee joint 10. In addition to
using this information to determine an appropriate resection depth
D, as described above, the information may be used to generate a
natural, dynamic simulation of the patient's knee joint 10 moving
between flexion and extension, and vice versa, such as for surgical
planning purposes. Additionally, this information may be used to
predict flexion contractures.
[0073] While this invention has been described as having exemplary
designs, the present invention can be further modified within the
spirit and scope of this disclosure. This application is therefore
intended to cover any variations, uses, or adaptations of the
invention using its general principles. Further, this application
is intended to cover such departures from the present disclosure as
come within known or customary practice in the art to which this
invention pertains and which fall within the limits of the appended
claims.
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