Global spinal alignment method
11410767 · 2022-08-09
Assignee
Inventors
- Eliyahu Zehavi (Haifa, IL)
- Yossi Bar (Haifa, IL)
- Shlomit Steinberg (Tel Aviv, IL)
- Leonid Kleyman (Atzmon, IL)
- Isador Lieberman (Plano, TX, US)
Cpc classification
A61B6/5235
HUMAN NECESSITIES
G16H20/40
PHYSICS
G16H50/20
PHYSICS
A61B6/5217
HUMAN NECESSITIES
A61B2034/104
HUMAN NECESSITIES
A61B2034/105
HUMAN NECESSITIES
International classification
G16H20/40
PHYSICS
A61B6/00
HUMAN NECESSITIES
A61B34/10
HUMAN NECESSITIES
Abstract
A method of planning the correction of spinal deformations of a subject, by performing segmentation on a three dimensional image of the subject's spine in its erect neutral position, such that the positions and orientations of the vertebrae in a region of interest are characterized. Parameters relating to the alignment and position of the vertebrae are derived from the segmentation, followed by determining whether the parameters fall within an acceptable range desired for the spine of the subject. If not within the acceptable range, an alignment optimization is performed on the vertebrae to bring the parameters within the acceptable range, to reduce the spinal deformations of the subject's spine. The alignment optimization is performed by taking into consideration limitations arising from the dynamic range of motion of the vertebrae as determined by analyzing images of the subject's spine, while the subject is in positions of maximum bending.
Claims
1. A method of planning a correction of spinal deformations, the method comprising: performing segmentation of at least one three-dimensional image of a subject's spine in its erect neutral position, such that positions and orientations of at least some vertebrae in a region of interest of the spine are characterized; calculating spinal parameters from the segmentation that relate to an alignment and position of at least one vertebra in the region of interest; determining a dynamic range of motion of the at least one vertebra by analyzing at least one two-dimensional or three-dimensional image of the subject's spine in a position of bending of the subject; identifying an alignment change of the at least one vertebra that will bring the spinal parameters within a predetermined acceptable range; comparing the identified alignment change to the dynamic range of motion; and when the identified alignment change exceeds the dynamic range of motion of the at least one vertebra, determining a surgical procedure to increase the dynamic range of motion of the at least one vertebra.
2. The method of claim 1, wherein the at least one vertebra comprises every vertebra in the region of interest.
3. The method of claim 1, wherein the surgical procedure comprises at least one of an anatomical release procedure and an osteotomy procedure.
4. The method of claim 1, wherein the surgical procedure comprises a fusion of adjacent vertebrae to provide support for the at least one vertebra, and the method further comprises: determining at least one level for the fusion; and generating a rod shape at the at least one level.
5. The method of claim 4, further comprising generating instructions for a rod bending apparatus for shaping a rod according to the rod shape.
6. The method of claim 4, further comprising determining an orientation for one or more screws, each of the one or more screws configured to receive a rod for fixing the rod in place.
7. The method of claim 1, wherein the dynamic range of motion of the at least one vertebra is less than a dynamic range of motion of any other vertebrae in the region of interest.
8. The method of claim 1, wherein the spinal parameters relate to at least some mutual angles, projections and linear positions generated by vertebrae in the region of interest.
9. The method of claim 1, wherein the at least one vertebra is a spinal segment comprising a number of adjoining vertebrae.
10. A method of planning to correct a spinal deformation, method comprising: obtaining images of a spine of a subject in the spine's erect neutral position; obtaining additional images of the spine in positions of full bending achieved by the subject; obtaining at least one parameter quantizing a limit of at least one of translational and orientational motion of at least one vertebra of the spine in the positions of full bending; determining an adjustment of a virtual orientation and position of the at least one vertebra in the images of the spine in the erect neutral position to reduce the spinal deformation; and when the determined adjustment requires a translational or orientational motion of the at least one vertebra that would exceed the at least one parameter, recommending a surgical procedure to adjust at least one parameter.
11. The method of claim 10, wherein the surgical procedure comprises at least one of an anatomical release procedure and an osteotomy procedure.
12. The method of claim 10, wherein the surgical procedure comprises a fusion of at least two adjacent vertebrae to provide support for the at least one vertebra, and the method further comprises: determining at least one level for the fusion; and generating a rod shape at each level of the at least one level.
13. The method of claim 12, further comprising generating instructions for a rod bending apparatus for shaping a rod according to the rod shape.
14. The method of claim 12, further comprising determining an orientation of one or more screws, each of the one or more screws configured to receive a rod for fixing the rod in place.
15. The method of claim 10, wherein a dynamic range of motion of the at least one vertebra is less than a dynamic range of motion of any other vertebrae in a region of interest.
16. The method of claim 10, wherein the at least one parameter is the extent of at least one of axial, AP, or lateral rotation of the at least one vertebra.
17. A method of planning a correction of spinal deformations, the method comprising: performing segmentation of at least one image of a subject's spine in its erect neutral position; calculating spinal parameters from the segmentation that relate to an alignment and position of at least one vertebra of the spine; determining a dynamic range of motion of the at least one vertebra by analyzing at least one image of the subject's spine in a position of bending of the subject; identifying an alignment change of the at least one vertebra that will bring the spinal parameters within a predetermined range; comparing the identified alignment change to the dynamic range of motion; and when the identified alignment change exceeds the dynamic range of motion of the at least one vertebra, recommending performance of a surgical procedure on at least one identified vertebra of the spine, the at least one identified vertebra being different than the at least one vertebra.
18. The method of claim 17, wherein the at least one identified vertebra is remote from the at least one vertebra, and the surgical procedure is less invasive than an alternative surgical procedure on the at least one vertebra that would be required to bring the spinal parameters within the predetermined range.
19. The method of claim 17, wherein a dynamic range of motion of the at least one identified vertebra is greater than the dynamic range of motion of the at least one vertebra.
20. The method of claim 17, wherein the surgical procedure recommended to be performed on the at least one identified vertebra is selected to bring the spinal parameters within the predetermined range.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) The present invention will be understood and appreciated more fully from the following detailed description, taken in conjunction with the drawings in which:
(2)
(3)
(4)
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(6)
DETAILED DESCRIPTION
(7) Reference is now made to
(8) In step 20, a three dimensional image set of the subject's spine is obtained, such that the spinal structure can be examined in three dimensions, and over the whole of its length if so required by the correction of the spinal section(s) envisaged. The image set should be of the subject's spine in an erect position, known as the neutral position or the natural anatomic posture. The image set may either be obtained directly by an imaging system which can obtain three-dimensional images of the subject while standing, or alternatively, if the three-dimensional image set can only be obtained while the subject is lying down, such as for most CT imaging systems, then the prone or supine image sets have to be converted to a representation of the erect images, taking into account the changes which occur in the position of the vertebrae as the spine becomes upright and hence weight bearing.
(9) In step 21, segmentation is performed on the region of the spine of interest, which will often be the whole length of the spine though the present method may also be applied to limited segments of the spine. The position and orientation of each vertebra may be defined by use of feature extraction, though any other form of image processing which can provide that data is equally acceptable, such as image processing routines that are configured to recognize pedicles, endplates and the spinal canal. This may be conveniently performed by marking planes parallel to the end plates of the vertebral bodies, such as detected by the feature extraction techniques of the image processing procedure used. Segmentation of an exemplary scoliotic deformed spine is shown in the coronal views depicted in
(10) In step 22, the spinal alignment parameters, such as the sagittal parameters PI, PT, SS, LL, TK and SVA, and the coronal parameters, such as the Cobb angles, and parameters such as the well-known AVT-T, AVT-L, CD and RAD parameters, are calculated from the segmentation measurements, and a spinal alignment optimization is performed in both coronal and sagittal planes in order to achieve an optimally balanced spine having acceptable global balance parameters. One exemplary sagittal optimization procedure is outlined in
(11) The above-mentioned dynamic ranges of mobility of each of the vertebrae are most simply obtained by first generating, in step 23, a number of two-dimensional X-ray images of the subject bending to his/her maximum comfortable abilities in a number of predetermined directions. Although two-dimensional X-ray images of the simplest method of obtaining the images of the range of motion (ROM) of the subject, it is to be understood that any other method of obtaining such two-dimensional information can also be used, such as derivation from three-dimensional image sets of the person bending and flexing. Typically bending to left and right, as shown in step 24, is used in order to determine the extent of flexibility or motion of the vertebrae in the coronal view, using AP images, while maximum flexion and extension of the subject's spine is obtained in the sagittal view, using lateral images, as shown in step 25. Additional information may be obtained by generating 2-D X-ray images of the subject twisting his/her spine to the maximum comfortable extent. Including the erect X-ray image, a total of up to six 2-dimensional X-ray images may be used to define the dynamic limits of mobility of each of the subject's vertebra. In cases in which, instead of each individual vertebra, complete spinal segments are used for performing the methods of this disclosure, the data obtained will be for those spinal segments. In the description which follows, the case of the alignment analysis of individual vertebrae will be followed.
(12) The dynamic range of each vertebra can be calculated by one of two methods:
(13) (i) In step 26, the axial rotation of each vertebra is determined by analysis of the 2-D images, such as by the methods to be shown in
(ii) Alternatively in step 27, the dynamic range is calculated by performing a registration or spatial correlation between the shape of each vertebra in the 2-D X-ray images, and the corresponding vertebrae in the CT images as determined by the closest matching resulting from projecting of the vertebral shape from the X-ray image onto a selected viewing plane of the CT images. By this means, the bending limitation of any vertebra obtained from a 2-D X-ray image, can be impressed on a fully 3-dimensional representation of the vertebra. Thus, by registering the 2 dimensional X-ray images to the CT image set, a three-dimensional model of each vertebra can be generated, including the three-dimensional range of motion which the subject can achieve.
(14) Either of these methods of determining the dynamic range of the vertebrae is then used as inputs in step 22, in determining the optimally aligned spine curvature, taking into account any limitations imposed by the dynamic range of specific vertebrae. These dynamic range-of-motion limitations can be applied either at the micro-level or at a more macro-level. In the former case, in the optimization process, every vertebra can have changes to its orientation and position as restrained by the allowable rotation, limited by the data obtained in the preplanning 2-D X-ray bending images. At a more macro level, the division of realignment of the vertebra may also be governed by predetermined decisions as to overall realignment of sections of the spine, such that if it transpires that a certain vertebra is more severely limited than, for instance, its immediate neighbors, the method can decide to redistribute the total required realignment over a number of vertebrae, such that the more limited motion vertebra is realigned or reoriented less than optimally, and the missing correction level is spread out over neighboring vertebrae, thus achieving the required realignment optimization, yet without the need for surgical intervention on the vertebra with the problematic motion range.
(15) Furthermore, the division of realignment of the vertebra may also be governed by predetermined anatomical decisions, based on the known biomechanical properties of groups of vertebrae. Thus, for example, if a certain level of realignment is indicated over a certain segment of the spine by the optimization procedure, and it is known anatomically that certain vertebrae in that section are more mobile than others, the division of the realignment can be performed taking that anatomical knowledge into account. For example, for a specifically indicated realignment of the lower section of the spine, it may be advisable to divide the total realignment such that one third falls between L1 and L4, and two thirds between L4 and S1, or other defined divisions. In general the manipulation on the CT scan imitates the natural movement of each vertebra separately and relative to the other vertebrae. Thus, the rotation is angular, around the joint, and the distance between every adjacent pair of vertebrae is constant.
(16) The result of these steps enables the generation of a 3 dimensional image set for presenting to the surgeon, in which the range of motion of each vertebrae is indicated, such that the surgeon can decide for each vertebra, whether correction of the global spinal alignment can be performed at that vertebra or not. A method of improvement of global motion is therefore performed by considering each vertebrae and siding act which points to attempt to improve the subject's overall motion. In other words in vertebra or regions where the range of motion is limited, or even nonexistent, the surgeon may decide to ignore that vertebra or region, regarding it as being completely immobile, when planning the complete spinal alignment, or the surgeon can decide to provide motion at that level by means of surgical correction, such as osteometric resection or posterior release. In regions where a full range of motion is available, the surgeon knows that that full range may be used in planning the complete spinal alignment, and that no surgical intervention is required at that spinal level. The “full range of motion” may be determined either by using a database of the biomechanical motion parameters of each vertebra of the spine in a spinally healthy population, or by using the subject's own overall total motion, and defining the range of motion of individual vertebrae or segments of the spine of the subject, in comparison with the subject's total motion range. Conversely, if the surgeon wishes to generate a spinal alignment plan which would involve relative motion of a specific vertebral pair beyond the capabilities of the range of motion of that vertebral pair, a warning will be given to the surgeon either that that alignment plan is invalid, or if it is to be used, that surgical correction will be needed at that specific vertebral pair. In further implementations of the methods of this disclosure, the decisions regarding which vertebra need surgical correction, which need motion limitation such as by the application of fusion rods, and which can utilize their natural flexibility, in planning the global spinal alignment, can be automated using the computer control to perform the iterative adjustments needed to achieve the optimum result within the limitations of the range of motions of each vertebral level.
(17) The outcome of this procedure is a complete spinal alignment plan, having a value for the SVA parameter in the sagittal plane, or of another parameter similarly used such as the CD and RAD in the coronal plane, within the limits employed to define a spine alignment providing adequate global balancing of the subject. Each vertebra of this optimized alignment can then be inspected in step 28 to check whether the vertebral orientation and positioning proposed by the optimization procedure is possible within the dynamic range of the subject, as determined in steps 23 to 27. If any of the vertebrae show that the reorientation or motion required to achieve the predicted position, as generally determined by the required rotation of the vertebra, is indeed beyond the abilities of its dynamic range, then two possibilities exist. The method can suggest either an osteotomy procedure on that particular vertebra, or an anatomical release procedure, as shown in step 29. Common surgical correction techniques used in this step include pedicle subtraction osteotomy (PSO), Smith-Peterson osteotomy (PSO) and vertebral column resection (VCR) techniques.
(18) An alternative process can be envisaged in which the dynamic range limitations of each vertebrae as determined by the 2-D X-ray images, are not taken into account initially during the optimization procedure shown in
(19) The final step of the process in step 30 is then the output of the complete optimization plan, which can include surgical proposals, and/or screw positions and fusion rod shapes.
(20) Reference is now made to
(21) Now that the individual vertebrae have been identified, it is necessary to define their orientation and position, in order to be able to characterize the entire vertebral structure of the spine, as imaged in the CT data set. Only when such a characterization has been achieved is it possible to attempt to optimize the alignment of the spine, whether in the coronal direction where a straight line alignment is generally sought after, or whether in the sagittal direction, where a number of sagittal alignment parameters optimized, as will be shown hereinbelow in the exemplary algorithm of
(22) In
(23) In
(24) In
(25) Once these axes have been defined for each vertebra, it is possible to define the position and orientation of each vertebra, and hence any translation and rotation motions of a vertebra generated in accordance with an optimization program can be performed on vertebrae having known positions and orientations in three dimensions. As formalized in the article entitled “Biomechanics of Spinal Deformities” by R. P. Schlenk et al, published in Neurosurg. Focus, Vol. 14(1), 2003, the six fundamental segmental movements or types of deformation of the spine along or around the Instantaneous Axis of Rotation (IAR) are: (1) rotation or translation around the long axis (A); 2) rotation or translation around the coronal axis (B); 3) rotation or translation around the sagittal axis (C); 4) translation along the long axis (A); 5) translation along the coronal axis (B); and 6) translation along the sagittal axis of the spine (C).
(26) Once the axis of each vertebra has been obtained, the segmentation data is used in order to derive parameters that relate to the alignment and position of the vertebrae in the region of interest, relative to the entire spinal alignment plan.
(27) Typically, the spinal parameters are obtained such as the parameters LL, TK, PI, PT, SVA for the sagittal alignment direction, based on the geometry (mainly angles) of the vertebral alignments.
(28) Starting from the inferior segment (Pelvic Tilt measurement) and up to the SVA (Cervical measurement) each parametric value is obtained by geometrically measuring the angles between the two lines that create the measurement, as described in
(29) If the value is not within the “normal range” that is predefined according to atlases based on big data obtained from a large population of healthy subject, relative to patient age, gender and ethnicity, the parameter is increased or decreased by tilting the image around the pivot point, manipulating the CT scan by moving each pixel to create the desired movement. All image tilt motions are performed about the instantaneous Axis of Rotation (JAR) 31, 32, as shown in
(30) Rotation of vertebra by vertebra continues using an iterative algorithm, to be described in
(31) Reference is now made to
(32) In the example flow algorithm shown in
PI=PT+SS
PT<25°
|LL−PI|<10°
30<LL<80°
20<TK<40°
−10°<SVA<50 mm,
0°<Cobb<10°
(33) In step 51, the value of PT is determined, and if found to be greater than 25°, the sacral slope SS is increased by a predetermined angle, typically 1°, though if the value of PT is significantly greater than 25°, a larger initial incremental angle could be used. The PT is again measured, and this iteration is repeated until the value of PT becomes less than 25°.
(34) Once the value of PT is less than 25°, in step 52, the absolute value of LL−PI is measured and if not less than 10°, the value of LL is increased or decreased in order to attempt to bring the absolute value of LL−PI to less than 10°. In other words, this step of the optimization is intended to ensure that the difference between the LL angle and the PI angle is kept to less than 10°, regardless as to whether LL or PI is the bigger angle. In order to ensure this, the value of LL is increased or decreased depending on whether the actual value of LL−PI is positive or negative. If LL is the dominant angle, and LL is more than 10° larger than PI, then LL is decreased incrementally. Conversely, if PI is the dominant angle, and PI is more than 10° larger than LL, then LL must be increased incrementally.
(35) Once the absolute value of LL−PI is less than 10°, in step 53, TK is measured, and it is determined whether TK falls between 20° and 40°. If not, the value of TK is increased or decreased in order to bring TK within the desired range.
(36) Once TK falls within the desired range, in step 54 the value of SVA is measured. If the value of SVA is greater than 50 mm. or smaller than −10 mm., the angle TK is increased or decreased in order to bring SVA to within the range of −10 mm. to 50 mm., i.e. that the C7 plumb line falls anterior to the posterior-superior corner of the S1 endplate. If SVA is greater than 50 mm., TK is decreased. If SVA is still greater than 50 mm, then LL is increased up to 80°, while still ensuring that |LL−PI| is less than 10°. If SVA is found to be less than −10 mm., TK is increased in order to attempt to bring SVA to within the normal range. If SVA still cannot be brought positive, then LL is decreased down to a level of 30°, while still ensuring that |LL−PI| is less than 10°. Since the value of LL will have changed with change in TK, after any of these steps, the value of |LL−PI| is again measured to ensure that that criterion is still upheld.
(37) Once the value of SVA has been brought to be within the range of −10 mm. to 50 mm, the sagittal alignment procedure is considered to have been optimized at step 55, and the position and orientation of each of the vertebrae constitutes the optimized spine, which the physician implements in the main optimization algorithm shown in
(38) It is appreciated by persons skilled in the art that the present invention is not limited by what has been particularly shown and described hereinabove. Rather the scope of the present invention includes both combinations and subcombinations of various features described hereinabove as well as variations and modifications thereto which would occur to a person of skill in the art upon reading the above description and which are not in the prior art.