Technique For Computer-assisted Planning of Placement of Fasteners in Vertebrae that are to be Stabilized by a Pre-formed Spinal Rod
20230076677 · 2023-03-09
Assignee
Inventors
Cpc classification
A61B2090/365
HUMAN NECESSITIES
A61B17/7013
HUMAN NECESSITIES
A61B34/20
HUMAN NECESSITIES
A61B17/8863
HUMAN NECESSITIES
A61B17/7035
HUMAN NECESSITIES
A61B17/84
HUMAN NECESSITIES
A61B2034/107
HUMAN NECESSITIES
A61B2034/108
HUMAN NECESSITIES
A61B2090/3764
HUMAN NECESSITIES
A61B2034/105
HUMAN NECESSITIES
A61B2017/568
HUMAN NECESSITIES
A61B34/10
HUMAN NECESSITIES
International classification
A61B34/10
HUMAN NECESSITIES
A61B17/70
HUMAN NECESSITIES
A61B17/84
HUMAN NECESSITIES
Abstract
A technique is presented for computer-assisted planning of fastener placement in vertebrae that are to be stabilized by a pre-formed spinal rod, wherein two or more fasteners are to couple the rod to the vertebrae. At least one of a target shape of the spine and a shape of the pre-formed rod is defined in patient-specific shape data, a bone density of at least one of the vertebrae is defined in patient-specific bone density data, and patient-specific anatomical data are provided. A force distribution along a length of the rod may be calculated based on the shape data and the anatomical data. A planning result for fastener placement may be generated based on the bone density data of a given vertebra and the calculated force distribution.
Claims
1. A method of computer-assisted planning of fastener placement in vertebrae that are to be stabilized by a pre-formed spinal rod, wherein two or more fasteners are to couple the rod to the vertebrae, wherein at least one of a target shape of the spine and a shape of the pre-formed rod is defined in patient-specific shape data, a bone density of at least one of the vertebrae is defined in patient-specific bone density data, and wherein patient-specific anatomical data are provided, the method comprising: calculating, based on the shape data and the anatomical data, a force distribution along a length of the rod; and generating, based on the bone density data of a given vertebra and the calculated force distribution, a planning result for fastener placement.
2. The method of claim 1, wherein the planning result is indicative of at least one of a fastener extension in the vertebra, a fastener attachment position along a length of the rod and at least one fastener parameter of a fastener to be inserted into the vertebra.
3. The method of claim 1, wherein the step of generating the planning result further comprises analyzing a bone density of the given vertebra, as indicated in the bone density data, wherein the planning result fulfils at least one predefined stability criterion in view of a force, as indicated by the force distribution, acting on a fastener.
4. The method of claim 3, wherein the at least one predefined stability criterion is selected from one or more of a bone stability criterion, a sagittal balance requirement, a static physiological impact and a non-static physiological impact.
5. The method of claim 1, wherein the patient-specific anatomical data underlying calculation of the force distribution include one or more geometry-related anatomical parameters and one or more weight-related anatomical parameters.
6. The method of claim 5, wherein the two anatomical parameter types are jointly evaluated to derive a mass distribution of a patient.
7. The method of claim 6, wherein the force distribution is calculated based on the patient's mass distribution and the shape data.
8. The method of claim 1, further comprising generating a navigation instruction based on the planning result.
9. The method of claim 8, wherein the navigation instruction is configured to guide a surgical tool handled by a surgeon or a surgical robot.
10. The method of claim 2, further comprising outputting the planning result that comprises at least one fastener parameter and an indication of the given vertebra that is to receive a fastener having the at least one fastener parameter.
11. The method of claim 2, wherein the at least one fastener parameter is indicative of at least one of a fastener length, a fastener diameter, a fastener thread, and a fastener type.
12. The method of claim 1, wherein at least one of the fasteners comprises a bone screw, a bone peg, and a K-wire.
13. The method of claim 1, wherein the force distribution is indicative of at least one force vector component that extends non-coaxial to at least one of the fastener extension in the vertebra and a length of a fastener when attached to the rod.
14. The method of claim 1, wherein the force distribution is indicative of force vectors at different positions along a length of the rod.
15. The method of claim 1, wherein the force distribution is further calculated based on generic rod data.
16. The method of claim 15, wherein the generic rod data are indicative of at least one of a rod length, a rod diameter, and a rod material parameter.
17. The method of claim 16, wherein the rod has a generic shape along its longitudinal extension.
18. The method of claim 1, wherein the anatomical data are indicative of one or more of a pelvic tilt, a sagittal vertical axis translation, a pelvic incidence-lumbar lordosis mismatch, a relation of a C7 plumb line to a pelvic tilt centre point, a waist-to-height ratio, a waist-to-hip ratio, a mass distribution along a spine axis, a body-mass-index, a body weight, a pelvic incidence, and a thoracic kyphosis.
19. A computer program product for planning of fastener placement in vertebrae that are to be stabilized by a pre-formed spinal rod, wherein two or more fasteners are to couple the rod to the vertebrae, wherein at least one of a target shape of the spine and a shape of the rod is defined in patient-specific shape data, a bone density of at least one of the vertebrae is defined in patient-specific bone density data, and wherein patient-specific anatomical data are provided, the computer program product comprising program code portions that cause a processor, when executing the computer program product, to: calculate, based on the shape data and the anatomical data, a force distribution along a length of the rod; and generate, based on the bone density data of a given vertebra and the calculated force distribution, a planning result for fastener placement.
20. An apparatus for planning of fastener placement in vertebrae that are to be stabilized by a pre-formed spinal rod, wherein two or more fasteners are to couple the rod to the vertebrae, wherein at least one of a target shape of the spine and a shape of the rod is defined in patient-specific shape data, a bone density of at least one of the vertebrae is defined in patient-specific bone density data, and wherein patient-specific anatomical data are provided, the apparatus being configured to: calculate, based on the shape data and the anatomical data, a force distribution along a length of the rod; and generate, based on the bone density data of a given vertebra and the calculated force distribution, a planning result for fastener placement.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0028] Further details, advantages and aspects of the present disclosure will become apparent from the following embodiments taken in conjunction with the drawings, wherein:
[0029]
[0030]
[0031]
[0032]
[0033]
[0034]
[0035]
[0036]
[0037]
[0038]
DETAILED DESCRIPTION
[0039] In the following description of exemplary realizations of the present disclosure, the same reference numerals are used to denote the same or similar components.
[0040] The realizations described hereinafter pertain to a computer-assisted technique for planning the placement of fasteners 16 in vertebrae 12 that are to be stabilized by a pre-formed spinal rod 10 are (see
[0041]
[0042] The surgical planning system 100 of
[0043] In
[0044] In the scenario of
[0045] The planning apparatus 20 is configured to generate the planning result from input data. Therefore, in an initial stage of the computer-assisted planning technique described herein, the input data have to be obtained by the planning system 100. In the realizations described herein, the input data include at least patient-specific shape data defining a shape of the pre-formed rod 10 or a target shape of a patient's spine 14, patient-specific bone density data defining a bone density of at least one of the vertebrae 12, and patient-specific anatomical data.
[0046] In one implementation, at least some of the input data are obtained using surgical imaging techniques. For this reason the surgical planning system 100 of
[0047] In the exemplary scenario illustrated in
[0048] The exemplary CBCT-based imaging apparatus 24 of
[0049] Once raw data have been obtained with the aid of one or more of the imaging techniques discussed above, or other data acquisition techniques, the raw data are processed to generate one or more, or all, of the patient-specific shape data, the patient-specific bone density data and the patient-specific anatomical data required for generation of the planning result.
[0050] The patient-specific anatomical data are used in combination with the patient-specific shape data to calculate a force distribution at one or more positions along a length of the rod 10.
[0051] Computer simulation tools, for example software tools using the so-called finite element method, FEM, may be used to calculate the force distribution. Examples of such FEM simulation tools include the software programs “SimScale”, “COMSOL” and “ANSYS”. A model of the rod 10 may initially be loaded into the FEM software tool. This model may be defined by the shape data (e.g., the rod length, the rod diameter, etc.). Forces acting on the rod at predefined positions of the rod may be used as input conditions, or constraints, of the FEM simulation. The forces acting on the rod at predefined positions of the rod may correspond to forces acting on the rod via fasteners attached to the rod at the predefined positions. The force distribution along the length of the rod 10 may then be calculated based on the model and the input conditions by the FEM simulation tool such as SimScale, COMSOL or ANSYS. While the model of the rod 10 may be defined by the shape data, the input conditions for the FEM simulation, in particular the forces applied to the rod by each of the fasteners, may be determined based on the anatomical data. For example, a larger pelvic tilt will lead to higher forces acting on the rod 10. The same applies to larger sagittal imbalances and other deviations of the patient's spine from an anatomically correct pose. The anatomical data may be used to determine, for example based on trigonometric calculations, the forces acting on the fasteners attached to the respective vertebrae, as described in the following with reference to
[0052] In some implementations, the patient-specific shape date define at least one of a planned, or target, spine shape and an actual or planned rod shape. For example, the patient-specific shape data may define a planned shape of the spine 14 after implantation of the rod 10 and may be used to manufacture the pre-formed rod 10.
[0053] The pre-formed rod 10 may be manufactured in a multi-step procedure, as exemplarily illustrated in
[0054] In a second step that is illustrated in the center of
[0055] In a third step illustrated on the right-hand side of
[0056] In an alternative variant, the shape of the rod 10 is manually defined by a user (such as a surgeon) by bending a straight or generically pre-bent rod with a bending tool according the patient's needs. The shape of the actual rod 10 is then translated into a data set indicative of the patient-specific shape data by scanning the user-bent rod 10 using a laser scanner, or otherwise.
[0057] The patient-specific bone density data may likewise be derived from image data obtained using one or more of the imaging techniques discussed above, or other data acquisition techniques. In some variants, the patient-specific bone density data are derived from three-dimensional CT image data as illustrated in
[0058]
[0059] In some implementations, a dedicated bone density data set is generated per vertebra 12 of interest. In such implementations, vertebra segmentation techniques are applied on the image data.
[0060] At least some of patient-specific anatomical data may be acquired from image data obtained using one or more of the imaging techniques discussed above, in particular using an EOS scanner. Of course, other data acquisition techniques can be used as well.
[0061] Exemplary patient-specific anatomical parameters that may be comprised by the anatomical data will now be described with reference to
[0062]
[0063] With reference to
[0064] With reference to
[0065] With reference to
[0066] Referring now to
[0067] Further patient-specific anatomic data include parameters such as a waist-to-height ratio, a waist-to-hip ratio, a mass distribution along a spine axis, a body-mass-index, and a body weight. Evidently, one, two or more of the above patient-specific anatomic parameters, and other patient-specific anatomic parameters, may be used to define patient-specific anatomical data as input for the planning apparatus 20.
[0068] Having now discussed how exemplary patient-specific anatomical data, patient-specific shape data and patient-specific bone density data can be obtained, the processing of those input data in the context of surgical planning will now be explained with reference to the flow diagram 1100 of
[0069] In step 1102, the planning apparatus 20 calculates, based on the patient-specific shape data and one or more of patient-specific anatomical parameters (i.e., anatomical data), a force distribution at one or more along a length of the rod 10, as schematically illustrated in
[0070] The force distribution can be calculated for a series of two or more positions along the length of the rod 10 and possibly using the information illustrated in
[0071] As very schematically shown in
[0072] In step 1104 of
[0073] In some implementations, the planning result is indicative of a fastener extension in a particular vertebra 12. The planned fastener extension may be defined by one or more of an extension direction, an extension length, an extension endpoint in the vertebra 12 and an extension startpoint on a surface of the vertebra 12. The planned fastener extension in the vertebra 12 can be used for surgical navigation purposes to define a fastener trajectory towards that vertebra 12. The fastener trajectory towards the vertebra 12 will typically be defined by a line co-linear with the fastener extension in the vertebra 12.
[0074] It is generally desirable to select the fastener extension in the vertebra 12 such that the fastener 16 is securely anchored therein. As such, the fastener 16 should extend in and/or adjacent to a region of high bone density. Selecting, however, fastener extension solely based on the bone density data such that, for example, the pullout force is optimized neglects the finding that the forces transmitted on a given fastener 16 by the rod 10 (that connects multiple such fasteners 16) will have force vector components that extend obliquely to the extension of the given fastener 16 in the vertebra 12 or even in a direction opposite to a pullout direction, as illustrated in
[0075]
[0076] Consequently, the bone density data may be evaluated to determine if a predetermined bone stability criterion is fulfilled. The bone stability criterion may be defined based on the force distribution.
[0077] Assume, for example, that the force distribution indicates for a given (e.g., user-selected, iteratively varied or automatically planned) fastener attachment position along a length of the rod 10 (not illustrated in
[0078] For generating a proper fastener extension in a given vertebra 12, and for a given force vector F.sub.1, the planning apparatus 20 may thus start with evaluating a pre-determined fastener extension (e.g., that extends perpendicularly from and, optionally, lies within a plane of the pre-formed rod 10). The fastener extension may then (e.g., iteratively) be modified (e.g., with respect to its angular extension relative to the rod 10) to maximize the aggregated bone density along the fastener extension or until the aggregated fastener extension lies above the selected threshold.
[0079] If, on the other hand, the force distribution indicates for a given (e.g., user-selected, iteratively varied or automatically planned) fastener attachment position along a length of the rod 10 that the force vector acting at this position on the fastener 16 has a significant vector component obliquely to a length of the fastener 16 (see force vectors F.sub.2 and F.sub.3 in
[0080] For generating a proper fastener extension in a given vertebra 12 and for a given force vector F.sub.2 or F.sub.3, the planning apparatus 20 may thus start with evaluating a pre-determined fastener extension (e.g., that extends perpendicularly from the rod 10 and, optionally, lies within a plane of the pre-formed rod 10). The fastener extension may then (e.g., iteratively) be modified (e.g., with respect to its angular extension relatively to the rod 10 and/or with respect to a fastener attachment position along a length of the rod 10) until the fastener extension is found to be adjacent a region of high bone density at the required position.
[0081] In some implementations, the planning result is—additionally to the fastener extension, or only—indicative of a fastener attachment position along a length of the rod 10. As will be appreciated from
[0082] In the example of
[0083] In some implementations, the planning result is—for example in addition to one of both of the fastener extension and fastener attachment position—indicative of at least one fastener parameter of a fastener 16 that is to be inserted into a given vertebra 12. The at least one fastener parameter may be indicative of at least one of a fastener length, a fastener diameter, a fastener thread (e.g., thread type, thread pith, thread length), and a fastener type. The types of fasteners 16 intended to couple the rod to the vertebrae may comprise at least one of a bone screw (e.g., a pedicle screw, see
[0084] The planning result may comprise, in addition to the at least one fastener parameter, and an indication of the given vertebra that is to receive a fastener having the at least one fastener parameter. The vertebra may be indicated visually (e.g., in the context of a visualization of CT data) or using a conventional (such as L1, L2, etc.) or proprietary notation.
[0085] As has become apparent from the above, generating the planning result may include analyzing a bone density of a given vertebra 12, as indicated in the bone density data, to determine at least one of the fastener extension, the fastener attachment position and the fastener parameter such that at least one predefined stability criterion is fulfilled in view of a force, as indicated by the force distribution, acting on a fastener 16. The at least one predefined stability criterion may be a bone stability criterion, as explained above. In other scenarios, the predefined stability criterion may be at least one of a sagittal balance requirement, a static physiological impact and a non-static physiological impact.
[0086] In some variants, the bone density data are correlated with the calculated force distribution. In bone positions where high forces will be acting there is a need for a high (e.g., maximal) bone density. In bone positions where low forces will be acting no high bone density is required. Threshold decisions may be applied for assessing forces as high/low and bone densities as high/low (of course, the present disclosure is not limited to such binary decisions but could also be implemented with a higher granularity). The resulting force distribution, or force accommodation requirement, can be derived from the one or more stability criteria. As an example, the sagittal balance requirement influences the resulting force distribution in that a sagittal balance of the spine has to be (re-)established.
[0087] In an optional step 1106, a navigation instruction is generated based on the planning result, and the navigation instruction is output to a surgeon or a surgical robot. Generation of the navigation instruction will in some scenarios require a tracking of a surgical tool operated by the surgeon or surgical robot. To this end, as illustrated in
[0088] The source of electromagnetic radiation 1416 is configured to emit at least one of infrared light and visible light. The source of electromagnetic radiation 1416 may specifically be configured to flood the entire surgical site with electromagnetic radiation. Each of the one or more trackers 1412 comprises three or more reflectors (e.g., spherically shaped bodies) that reflect the electromagnetic radiation emitted by the source of electromagnetic radiation 1416. As such, the one or more trackers 1412 are configured as so-called passive trackers. In other variants, at least one of the one or more trackers 1412 may be realized as an active device configured to emit electromagnetic radiation. As an example, each active tracker 1412 may comprise three or more light emitting diodes (LEDs) emitting electromagnetic radiation in the infrared or visible spectrum. If all the trackers 1412 are configured as active devices, the source of electromagnetic radiation 1416 may in some variants be omitted.
[0089] The camera 1414 has at least one image sensor, such as a charged couple device (CCD) or a complementary metal-oxide-semiconductor sensor (CMOS). The image sensor is configured to detect the electromagnetic radiation reflected (or emitted) by the one or more trackers 1412. In some variants, the camera 1414 may have multiple image sensors. In particular, the camera 1414 may be a stereo camera with at least two image sensors.
[0090] The tracking controller 1418 is configured to process the image data generated by the camera 1414 and to calculate the position and orientation of the one or more trackers 1412 in a tracking coordinate system. This calculation is typically performed in 5 or 6 DOF. The tracking coordinate system may have a rigid relationship relative to the camera 1414 and may in particular be centred in a centre of the camera 1414.
[0091] In the exemplary scenario illustrated in
[0092] As shown in
[0093]
[0094] The navigation instruction in the navigation view 1500 is representative of a current tip position 1502 of the tracked surgical tool 1436 (or of a fastener attached to the surgical tool 1436) relative to a planned fastener trajectory 1504 as derived from the planned fastener extension in the vertebra 12 to be surgically treated. In other scenarios, a tool trajectory may be visualized instead of the tool tip.
[0095] As has been explained above, the planned fastener trajectory 1504 may be derived by extrapolating the planned fastener extension outside the particular vertebra 12 that is to receive the fastener 16. The navigation instruction, when output to the surgeon, will cause the surgeon to attempt to align the actual tool tip or trajectory with the planned fastener trajectory. In the scenario illustrated in
[0096] Once all the required bone fasteners 16 have been implanted in the vertebrae 12 in accordance with the respectively associated planning result (e.g., a fastener extension), the pre-formed rod 10 is coupled to the fastener heads 16A, as illustrated in
[0097] If the vertebrae 12 are tracked also (either individually or collectively), any movement of the one or more tracked vertebrae 12 will be detected by the tracking controller 1418 (in 5 or 6 DOF). The movement, which can involve one or both of a rotation and a translation, can then be considered in real-time upon generating the navigation instruction by, for example, updating a visual representation of the vertebrae 12 in the navigation view 1500.
[0098] As has become apparent from the above description of exemplary realizations of the present disclosure, the technique presented herein improves surgical planning of fastener placement by not merely relying on bone density data, but additionally considering an estimated force distribution in bone. It will be apparent that the exemplary realizations discussed above can be modified in many ways.