This invention relates to orthopedic knee replacement. More particularly, the invention relates to surgical jigs for guiding bone resectioning in knee replacement surgery, and to the manufacture of such jigs, such that each jig is patient-specific with custom specifications determined from MRI slices of a patient's tibio-femoral joint region.
Femoral and tibial surgical cutting jigs are used to guide bone resectioning in knee replacement surgery. Each jig contains both the various bone-jig contact surfaces and a cutting guide defining a cut plane. In order that the cut planes are correct when the respective jigs are installed during surgery, each jig must be custom manufactured to correspond to a patient's own femur and tibia. Magnetic resonance imaging (MRI) of a patient's tibio-femoral joint region is performed prior to surgery to define the parameters needed to manufacture patient-specific jigs.
Some arthroplasty jigs employ only planar contact surfaces (much like a vise) that do not offer a unique jig position and thus requires greater skill on the part of the surgeon to get the alignment right. Still other jigs are of the sparse contact type with multi-point contacts in the form of tips or pins. This type of jig also tends to allow more than one possible positioning of the jig against the joint, rather than only one fit.
Thus, one problem in parameterizing the surface features from the MRI scans and creating the jig, is that prior methods of point-to-point type bone-jig contact do not provide unique mechanical self-locking with respect to features in the tibio-femoral joint region. The jig has sufficient play over the end of the bone as to yield unacceptable levels of uncertainty in the cut plane. Instead, the jig should have one and only one mechanical self-locking position such that the bone cutting guide defines a single unique cut plane to guide the surgeon during bone resectioning.
In U.S. Pat. No. 8,323,268, Zajac describes patient-specific femoral and tibial cutting blocks that have bone-facing surfaces with customized negative contours. When the cutting blocks are used, the bone-facing surfaces receive a corresponding positive contour of a portion of a patient's femur or tibia to contact with a unique position or location on the bone. In particular, bone-facing surfaces may contact specified portions of anterior, distal and posterior sides of a femur and likewise with medial and proximal sides of a tibia.
In U.S. Pat. No. 8,617,175, Park describes femoral and tibial arthroplasty jigs with a mating surface on one side. The mating surfaces include a customized surface contour that is generally a negative of corresponding femoral and tibial target surfaces.
In U.S. Pat. No. 10,206,697, Metzger et al. describe a femoral alignment guide with a patient-specific 3D curved inner surface the mates with a corresponding femoral joint surface of the patient.
This invention provides patient-specific cutting jigs, whose mating mechanism consists of a set of multiple projecting fins that terminate in curvilinear contacts that mate with respective distal femur and proximal tibia joint surfaces to ensure accurate bone resections.
The cutting jigs FCJM and TCJM illustrated in
For example, the cutting jig mechanism FCJM is positioned in contact with the lateral/medial condyles (LC/MC) and the trochlear groove TG on the femur, and two or more FCJM positioning apertures (drill holes) are drilled through the FCJM and into a portion of cortical bone of the patient. This provides a cut plane guide for resection and removal of a lower portion of the patient's femur. After resection has occurred, the cut plane bar is removed and optionally might be reused in replacement of another patient's knee. A similar procedure is followed for replacement of a tibia using the tibial cutting jig mechanism TCJM. In the following, contact curvilinear curves are estimated for both femur and tibia components.
Accordingly, a cutting jig of the present invention comprises a unitary piece combining a bone cutting guide defining a cut plane and a set of curvilinear bone-jig contact surfaces (defined by curves CA1, CA2 and CA3 in
More particularly, the custom patient-specific parameters are obtained from a sequence of image slices, defining x-y image planes and a separation distance Δz between image slices. First, one forms at least one sequence of curves from projections of the image slices for one or more selected viewing angles φ relative to the respective x-y image planes. The curves follow medial and lateral condyles of ends of respective femur and tibia proximate to a region of the knee as identified in the image slices. Each curve is approximated as a polynomial in its x-y image plane, which is then projected by geometric transformation onto rotated planes that correspond to the selected viewing angles φ. Finally, the viewing angles φ are constrained to meet a non-intersection condition on the respective sequences of curves, leading to a selection of curves for jig formation. The curvilinear contact surfaces may be manufactured in accord with those curves projected onto rotated planes for the constrained viewing angles by extruding step structures in the form of fins in the direction of the rotated planes and that terminate in a stepped set of line segments that follow the projected curves.
This invention provides a method, and corresponding apparatus, for determining a small number (≥2) of contact curves located on a femur and tibia, for locating and orienting a cut plane appliance, commonly referred to as a surgical cutting jig, that can be used in a total knee replacement.
With reference to
With reference to
The number of femur or tibia contact curves can be as small as 2-5, or can be larger if desired, depending upon the femur topography and the degree of stability desired. A Cartesian coordinate system (x, y, z) is established, with fixed z-axis oriented parallel to a unit length vector ū, which is perpendicular to a sequence of spaced apart xy-planes that are coincident with a sequence of planes defined by MRI planes. The MRI planes are spaced apart by a non-zero separation distance Δz=zn+1−zn, either constant or variably as illustrated in
A medial condyle MC and the corresponding lateral condyle LC of the distal femur (
Each of a sequence {P(zn)}n of z-axis projections (MRI images) onto one of the xy-planes (e.g., z=zn) is a curve that can be approximated (see
(x,y)=(xn,1,yn1),(xn,2,yn2),(xn,3,yn3)(n=1,2, . . . ,N;N≥2) (1)
As illustrated in
y=Qn(x)=an+bn(x−xn,1)−un0{(x−xn,1)2(x−xn,3)2}, (2-A)
(dy/dx)xn,1=(dy/dx)xn,2=(dy/dx)xn,3=0, (2-B)
Qn(xn,1)=an=y(xn,1), (3)
Qn(xn,2)=an+bn(xn,2−xn,1)=y(xn,3), (4)
bn=(y(xn,3)−y(xn,1))/(xn,3−xn,1), (5)
where the line segment y(x)=an+bn(x−xn,1) passes through the points, (xn,1, yn,1) and (xn,3, yn,3). Alternatively, the three consecutive y-extremum values may be a first y-minimum, an intermediate y-maximum, and a second y-minimum, and the polynomial approximation in Eq. (2-A) is replaced by an alternative expression,
y=Qn,alt(x)=an+bn(x−xn,1)+un0{(x−xn,1)2(x−xn,3)2}, (2-C)
an+bnxn,3=Q(xn,3), (2-D)
and Eqs. (3)-(5) are unchanged.
Returning to Eqs. (2-A) and (2-B), a minimum value for Qn(x) (xn,1<x<xn,3) is determined from
{(∂Qn(x))/∂x}=bn−4un,0{(x−xn,1)2(x−xn,3)2}≈0, (6)
xn,13=(xn,1+xn,3)/2, (7)
Eq. (6) is a cubic equation in the unknown, xn,min, with at least one determinable real root, x=xn,min. A suitable approximation for xn,min is
xn,min=xn,13+cnbn, (8)
cn=−1/{4un,0(xn,1−xn,3)2}, (9)
Qn(xmin)=an+bnxn,min−un,0(xn,min−xn,1)2(xn,min−xn,3)=Qn,min, (10)
where x=xn,min is a real solution of the cubic equation in Eq. (6), and Qn,min is a measured (minimum) value that determines the value of the parameter un,0.
A difference of two (not necessarily consecutive) approximation polynomials,
ΔQn2(x)=Qn1(x)Qn2,n1(x), (11)
is computed for each of a sequence of selected x-coordinate values, x=xp (independent of fixed indices n1 and n2) in a selected x-interval, xLB≤xUB. Ideally, the values ΔQn2,n1(x) satisfy
ΔQn2,n1(xp)>0(1≤n1<n2≤N), (12)
for each of the selected values, x=xp (p=1, . . . , P≥2), so that the two approximation polynomials, Qn1(xp) and Qn2(xp), do not intersect with each other. This condition of non-intersection is unlikely to occur for some value pairs (n1, n2) of the indices. Values, ΔQn2,n1>0, ΔQn2,n1(xp)=0 or ΔQn2,n1(xp)<0, with n fixed, as illustrated in
However, if the sequence of approximation polynomials ΔQn1,n2(xp) is viewed at a selected non-zero viewing angle φ (0<φ<π), as illustrated in
Viewing of a polynomial difference ΔQn2,n1(x) for two consecutive MRI slices at an angle φ is implemented by a geometric transformation from the original coordinate system (x, y, z) to a rotated coordinate system (x′, y′, z′),
Note that under this transformation the value of each of the selected x-coordinate values, x′p=xp, are unchanged. Under this transformation, the quantities of interest, (ΔQn2,n1(x), Δzn2,n1)=(Qn2(x)−Qn1(x), zn2−zn1) become transformed to
{Qn+1(x)−Qn(x)}′={Qn2(x)−Qn1(x)}·cos φ+{zn2−zn1)·sin φ=ΔQn2n1(x,φ), (14)
{zn21−zn1}′=−{(Qn+1(x)−Qn1(x)}·sin φ+{zn+1−zn}·cos φ=Δzn+1(φ), (15)
zn2−zn1=(n2−n1)·Δz, (16)
where Δz is a known and fixed distance between two consecutive slices. The non-intersection condition in Eq. (12) becomes
ΔQn2,n1(x,φ)=ΔQn2,n1(xp)·cos φ+Δzn+1·sin φ={(Qn2,n1(xp)}2+(Δzn2,n1)2}1/2·{sin{(φ+tan−1[(ΔQn2,n1(xp)/Δzn2,n1)]}>0. (17)
Equations (14) and (15) apply to any pair of slices, z=zn1 and z=zn2 (1≤n1<n2≤N). An arithmetic average value of the values ΔQn2,n1(xp)/{(n2−n1)Δz}.
For a fixed slice pair (n2,n1), Eq. (12) should be satisfied for each selected x-value, x=xp in the selected sequence {xp}. Each selected coordinate value, x=xp, may require a different range of the viewing angles φ so that φ becomes dependent upon the index n and upon the coordinate value, x=xp: φ=φ(n2;n1;xp). The coordinate difference, Δzn2n1 is always positive and constant so that the signum of the ratio
R=R(n2;n1;xp)=ΔQn2,n1(xp)/(NΔz), (18-1)
is the signum of the numerator ΔQn2,n1(xp). For definiteness, where ΔQn2,n1(xp)<0, write
R=−|R(n2;n1;xp)|=−|(ΔQn2,n1(xp))/NΔz|(R<0), (18-2)
R=|R(n2;n1;xp)|=|(ΔQn2,n1(xp))/NΔz|(R>0). (18-3)
From a consideration of the different circumstances, one verifies that the angle φ that satisfies the non-intersection condition in Eq. (12) is constrained as follows:
ΔQn+1(xp)>0:−tan−1(R)<φ<π−tan−1(R)(R>0), (19-1)
ΔQn+1(xp)>0:0<φ<π(R=0), (19-2)
ΔQn+1(xp)>0:−{π+tan−1(|R|)}<φ<tan−1(|R|)(R<0) (19-3)
The φ-ranges for each of the three φ-constraints in Eqs. (19-1)-(19-3) overlap and are illustrated graphically in
ρp+={φ|−tan−1(R)<φ<π−tan−1(R)}(R>0) (20-1)
ρp0={φ|0<φ<π}(R=0) (20-2)
ρp−={φ|−{π+tan−1(R)<φ<tan−1(R)}(R<0) (20-3)
And each of these three φ-ranges sets is summed over all x-coordinate values, x=xp, that satisfy the corresponding φ-constraint set forth in the φ-constraint sets, Eq. (20-1), (20-2) and (20-3). The dotted curvilinear segments in
Each of the sets, ρp+, ρp0 and ρp−, of φ-values corresponds to a mutually exclusive set of x-coordinate values, x=xp, and to a fixed choice of index n; and one or more of the corresponding x-coordinate sets may be empty. For a fixed slice index value n, a three-way intersection of permitted ranges of the angle φ,
ρp(n)=ρp+∩ρp0∩ρp−(ρp0 non-empty) (21-1)
or ρp(n)=ρp+∩ρp−(ρp0 empty) (21-2)
of the three φ-constraint sets defines the permissible range for the viewing angle φ that satisfies the non-intersection condition Eq. (12) for fixed slice indices, n2 and n1. Note that the intersection condition ρp(n) must be determined separately for each pair of consecutive MRI slices (z=zn2 and z=zn1) of interest. The set intersection ρp(n) can also be characterized as
ρp(n)={∅|max{tan−1(R)}<φ<π−max{tan−1(R)}}, (22)
where the first max{tan−1(R)} term in Eq. (20-1) and the second max{tan−1(R)} term in Eq. (20-3) correspond to ρp− and ρp+, respectively.
Where one seeks to satisfy the non-intersection condition in Eq. (12) for a consecutive sequence of slice indices, n=n1, n1+1, n1+2, . . . , n2 (n2>n1), one estimates a further intersection of permitted angles
ρp(total)=ρp(n=n1)∩ρp(n=n1+1)∩ρp(n=n1+2) . . . ∩ρp(n=n2) (23)
of the corresponding φ-constraint sets. The selected viewing angle β can be chosen within the ranges defined by Eq. (21-1) or (alternatively) Eq. (21-2).
This condition is illustrated in
Although the selected segmented lines are optimal to mate the jig on the anatomical surface, there is uncertainty on the anatomical surface due to the random characteristics of joint arthritis.
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