ROBOTIC SPINE SURGERY SYSTEM

Description

[0001] The present invention relates to a spinal surgery system.

[0002] In spinal surgery, robotics plays an increasingly important role, primarily assisting surgeons in positioning screws in the pedicles of the patient's vertebrae or interbody cages in the patient's intervertebral discs. Commonly used technologies involve a robotic arm with a targeting guide, typically tubular, as its end effector. During surgery, the patient's spine is scanned, and a three-dimensional optical marker is fixed to the spine. This marker establishes a spatial reference point within which screws and other implants are virtually positioned using calibrated spinal images obtained by X-ray imaging in the operating room, for example, with an intraoperative CT scanner or image intensifier.Since the positioning coordinates of the implants are provided in the reference frame of the marker attached to the spine, visualizing this marker during surgery with a camera whose position is known relative to that of the fixed station on which the robotic arm rests allows the latter to be controlled to position its terminal effector organ in space so that the aiming guide formed by this terminal effector organ allows the surgeon to perform the surgical implantation acts in a precise and safe manner.US 2020 / 0222122 A1 discloses a system for forming a traceable dynamic network, comprising a base element removably fixed relative to a navigation space; a movable element capable of moving relative to at least a first position and a second position; a tracking system for the movable element to track the position of the movable element; a tracking system comprising a tracking processor and a locator, separate from the base element and the movable element; and a traceable element configured to be tracked by the tracking system and wherein the traceable element is movable relative to the movable element; wherein the tracking processor is configured to determine the position of the traceable element in at least the first and second positions. Another example of this type of system is disclosed in US 2020 / 222121 A1, which associates a surgical assistance robot and a navigation device.The navigation system tracks three-dimensional optical markers in space, including a marker carried by the robot, a marker carried by a robot end effector, a marker attached to the patient, a marker carried by a hand instrument, and a marker carried by an imaging device, such as an intraoperative scanner. To this end, the navigation system includes a multi-camera optical locator that provides images displaying the various markers mentioned above. The marker attached to the patient includes a fixation device, such as a clamp, capable of attaching to one of the spinous processes of the patient's spine, allowing the navigation system to track the patient's spine within a spatial coordinate system defined by this marker.In order to position the spatial reference point defined by the marker attached to the patient within a navigation coordinate system, the user must identify the marker's location within the navigation system using the hand tool. Then, the navigation system's processing means calculate a map to correlate the different spatial reference points. Similar considerations apply to the various other markers, including the marker carried by the robot's end effector. Therefore, it is understood that the US 2020 / 222121 A1 system is capable of determining, intraoperatively, the relative positioning of the end effector, the marker attached to the patient, and the images of the patient's spine acquired by the intraoperative imaging device.

[0003] However, this technique suffers from several limitations. First, it requires the use of intraoperative X-ray imaging devices, thus entailing significant investments for the healthcare facility, systematic irradiation of the patient and the surgical team, and operational constraints related to wearing lead aprons, moving around the operating room to avoid radiation, etc. Second, it requires the surgeon, through a time-consuming process, to identify each instrument with the camera, which poses occlusion problems when an object obstructs the view between the camera and the object it is tracking and whose position it is supposed to continuously indicate relative to the marker attached to the patient's spine. If the patient moves even slightly, the surgeon is forced to repeat the entire instrument identification process, or even perform a new complete CT scan of the patient.

[0004] Consequently, repositioning techniques based on very high-precision cameras, often infrared, have recently been developed. These techniques allow for highly accurate intraoperative photography of the surface of the anatomical area in question, enabling local comparison of its texture with that of the same object scanned preoperatively. The preoperative CT scan images are then positioned in space, superimposed on the photographed area as if they had been scanned in the operating room. It is then possible to control a robotic arm along planned trajectories that are aligned with the vertebrae.While they reduce radiation exposure during surgery and allow for instant re-acquisition of relative positioning in case of unexpected movement of the marker fixed to the patient's spine, these repositioning techniques require the development of complex image analysis algorithms and the use of very expensive cameras, without fundamentally changing the situation regarding the complexity of the initial phase in the operating room.

[0005] Furthermore, these different techniques present precision issues, in that the further the implantation site is from the marker fixed to the patient's spine, the lower the positioning accuracy due to the relative movements of the vertebrae, which can differ from the movements tracked by the marker fixed to a specific vertebral segment. Because of this lack of precision, the robot's actions are often limited to positioning a aiming guide, leaving the surgeon to perform the actual surgical procedure, such as drilling, without any time savings compared to a procedure performed without a robot, and sometimes with the risk of the surgical instrument slipping on the vertebra.

[0006] The aim of the present invention is to propose a new approach to robotic spinal surgery which, while being simple and inexpensive to implement, allows the robotic arm to be positioned precisely and safely in relation to the vertebrae of a patient to be operated on.

[0007] For this purpose, the invention relates to a spinal surgery system, as defined in claim 1.

[0008] Also presented here is a spinal surgery procedure, which is advantageously implemented by the spinal surgery system according to the invention, and in which: Given preoperative mapping data relating to one or more vertebrae of a patient to be operated on, a vertebral localization element is manufactured which is provided with: a coupling face that is specific to the patient, congruent with a predetermined bony part of the vertebra(s), so as to be able to couple the vertebral localization element to the vertebra in a unique fixed position, by applying the coupling face in custom contact with the bone material of this vertebra so that the coupling face covers the predetermined bony part of the vertebra, conforming to bony prominences of the predetermined bony part and cooperating by contact with these bony prominences to place the vertebral localization element on the vertebra in said unique fixed position, and a three-dimensional optical marker, defining a three-dimensional spatial reference frame which is fixedly linked to the coupling face so that,When the vertebral localization element is coupled to the vertebra, said three-dimensional spatial reference frame is fixedly linked to the vertebra according to a relative positioning resulting from the coupling of the vertebral localization element to the vertebra in said unique fixed position; a robot is also available comprising an arm that is mobile relative to a fixed station of the robot, as well as an end effector organ that is carried by the arm and that is adapted to be applied intraoperatively to the vertebra, after the vertebra has been exposed.The vertebral localization element is intraoperatively coupled to the vertebra in said single fixed position, while the marker of the vertebral localization element is observed by an optical capture device that is at least partially carried by the end effector organ and that deduces in real time positioning data concerning the relative positioning between this marker and the end effector organ. From preoperative mapping data and from the positioning data, the relative positioning between the end effector organ and the vertebra is determined in real time by calculating, in said three-dimensional spatial coordinate system, the position of the end effector organ and comparing this position of the end effector organ with a region of space occupied by the vertebra as modeled by said preoperative mapping data.

[0009] Thus, the invention relies on preoperative mapping data relating to the vertebra(s) of a patient to be operated on, this data typically being derived from preoperative CT scan images. As detailed below, this preoperative mapping data is advantageously segmented to isolate the vertebra, and / or advantageously subject to selections relating to anatomically significant regions of the vertebra, and / or is advantageously coupled with planning data relating to a surgical procedure to be performed on the vertebra.In all cases, the invention makes use of at least part of this preoperative mapping data to develop and manufacture a vertebral localization element: on the one hand, this vertebral localization element is specific to the patient, more precisely to the vertebra concerned, by having a coupling face which allows the vertebral localization element to be fixedly linked to the vertebra in a unique position, by cooperation in custom contact with the bone material of the vertebra, in particular the bone material of one or more of the aforementioned anatomically remarkable regions; on the other hand, the vertebral localization element allows the vertebra to be located in space optically, thanks to a three-dimensional optical marker which defines a spatial reference which is fixedly linked to the vertebra when, during surgery, the vertebral localization element is coupled to the vertebra.The invention also relies on the use, in the operating room, of both a robot, whose motorized mobile arm is equipped with an end effector, and an optical capture device that is at least partially supported by the end effector. This optical capture device essentially gives the robot eyes, in that it allows the relative positioning between the robot's end effector and the vertebral localization marker coupled to the vertebra to be determined in real time, by observing this marker with the optical capture device.By using both preoperative mapping data and data relating to the positioning between the terminal effector organ and the vertebral element marker of localization, the invention provides for calculating in real time the relative positioning between this terminal effector organ and the vertebra; in other words, the position of the terminal effector organ is calculated in real time in the frame which is defined by the vertebral element marker of localization and is fixedly linked to the vertebra as modeled in this same frame by the preoperative mapping data.The invention thus makes it possible to locate, in real time and with precision, the terminal effector organ in relation to the vertebra, more precisely in relation to the preoperative modeling of the vertebra, in a simple and economical way, in particular by avoiding the use in intraoperative of both an X-ray imaging device, such as a luminance amplifier or an intraoperative scanner, and complex image analysis algorithms to be compared.Thanks to the invention, it is then possible to give the robot control instructions which take into account, in real time, the position of the vertebra in relation to the end effector organ of the robot; in particular, the intraoperative movement of the end effector organ in order to carry out or assist a surgical act can then take into account any possible movement of the vertebra, linked for example to the breathing of the patient, to spasms of the patient or to an unexpected external shock suffered by the operating table on which the patient rests.In practice, as explained in more detail later, the optical capture device belonging to the system according to the invention can take various forms of embodiment; a particularly advantageous embodiment, especially due to its simplicity and performance, consists of this optical capture device comprising a three-dimensional camera which is carried by the end effector of the robot and which, by itself, provides the data relating to the positioning between this end effector and the marker of the vertebral localization element.In all cases, and as also explained in more detail later, the optical capture device advantageously allows reading a two-dimensional or three-dimensional barcode of the vertebral localization element, in order to access the information integrated into this barcode, such as, among other things, the identification of the vertebra to which the vertebral localization element is specifically associated, pre-operative planning data relating to a surgical procedure that the robot is to perform or assist, etc.

[0010] Additional advantageous features of the system according to the invention are specified in the other claims.

[0011] Following additional advantageous characteristics of the aforementioned spinal surgery procedure: At least one surgical procedure to be performed on the vertebra is planned preoperatively, and planning data corresponding to this procedure is calculated based on preoperative mapping data. The end effector is equipped with a tool capable of performing the surgical procedure. Based on the calculation of the relative positioning between the end effector and the vertebra, as well as the planning data, real-time control instructions are generated and sent to the robot so that the tool on the end effector is applied directly to the vertebra by the robotic arm to perform the surgical procedure. The surgical procedure consists of drilling a hole in the vertebra. The planning data includes the orientation of the hole's central axis relative to the vertebra, the hole's entry point on the vertebra, and the hole's depth within the vertebra. The tool is a drill bit.At least one surgical assistance action is planned preoperatively for a procedure to be performed on the vertebra. Planning data corresponding to this assistance action is calculated based on preoperative mapping data. The end effector is equipped with an ancillary capable of performing the assistance action. Based on the calculation of the relative positioning between the end effector and the vertebra, as well as the planning data, real-time control instructions are generated and sent to the robot. These instructions direct the ancillary to be positioned relative to the vertebra by its arm to perform the assistance action while the surgeon, assisted by the ancillary, performs the surgical procedure. The preoperative mapping data is derived from CT scans of the vertebrae. The coupling face is manufactured using this preoperative mapping data.From the preoperative mapping data, specific data, referred to as data of interest, are selected preoperatively. These data relate to at least one anatomically significant region of the vertebra, and the mating surface is fabricated using this data of interest so that, intraoperatively, it is custom-made and applied to the bone of said at least one anatomically significant region. The preoperative mapping data is segmented to form data groups that are respectively related to the patient's vertebrae. Intraoperatively, the patient is anesthetized and lies prone on an operating table that is fixed relative to the robot's station. No X-ray imaging devices are used intraoperatively.

[0012] The invention will be better understood upon reading the following description, given solely by way of example and made with reference to the drawings in which: there figure 1 is a diagram illustrating a part of a system according to the invention; the figures 2 à 4 are views similar to the figure 1 illustrating other parts of the system respectively; figure 5 is also a diagram illustrating other parts of the system; the figure 6 is a larger-scale view of one of the parts shown at the figure 5 ; there figure 7 is an elevation view along arrow VII of the figure 6 ; there figure 8 is a view similar to the figure 6 illustrating a variant of the corresponding part of the system; the figure 9 is a view similar to the figure 6 illustrating another variant of the corresponding part of the system; the figure 10 is a perspective view of a fragment of the part of the system, shown at the figure 9 ; there figure 11 is a view similar to the figure 6 illustrating yet another variant of the corresponding part of the system; and the figure 12 is a view similar to the figure 5 illustrating an alternative embodiment for some of the corresponding parts of the system.

[0013] On the figures 1 à 7 Figures show parts of a spinal surgery system, hereafter referred to as System S. System S enables the implementation of a spinal surgery procedure, which will be described as the parts of System S are described below. As an example, the procedure aims to implant pedicle screws into the vertebrae of a human patient. The example illustrated in the figures involves five vertebrae, namely vertebrae designated V1 to V5 hereafter, which correspond to the patient's lumbar vertebrae. However, the invention is obviously not limited by the number and / or position of the vertebrae to which System S and the spinal surgery procedure are applied.

[0014] In all cases, as explained in detail below, the procedure includes preoperative steps, that is, steps implemented before any surgical procedure, strictly speaking, applied to the patient's body, and intraoperative steps, that is, steps implemented on the patient's body. The preoperative steps are implemented by a competent operator, using parts of the S system which will be described, in particular, with regard to the figures 1 à 4 These preoperative steps can be implemented several days before the intraoperative steps, which are performed by a surgeon or similar healthcare professional, using parts of the S system that will be described alongside the figures 5 à 7 Unlike preoperative steps, intraoperative steps are necessarily implemented in a surgical suite of a healthcare facility.

[0015] As illustrated by the figure 1 The system S includes bone mapping means 10 that provide preoperative mapping data relating to one or more of the patient's vertebrae to be operated on, i.e., vertebrae V1 to V5 in the example considered. These mapping means 10 enable the implementation of an initial step in the procedure, in which the operator has access to the aforementioned preoperative mapping data via the bone mapping means 10. In the example illustrated in the figure 1 The preoperative mapping data are integrated into a CT scan image 11, belonging to the bone mapping methods 10, that is, a tomographic image obtained by preoperative irradiation of vertebrae V1 to V5. In practice, several CT scan images belonging to the bone mapping methods 10, such as image 11, provide the aforementioned preoperative mapping data. In all cases, this preoperative mapping data provides a morphological mesh of the bony structures of vertebrae V1 to V5, as schematically illustrated in the figure 1 The acquisition of such preoperative mapping data relating to vertebral bone material being well known in the field, it will not be detailed further here.

[0016] As illustrated by the figure 2 The system S advantageously includes planning means 20 that allow for the preoperative planning of one or more surgical procedures to be performed on vertebrae V1 to V5, as well as the calculation of planning data corresponding to these surgical procedures, based on preoperative mapping data provided by bone mapping means 10. The planning means 20 are, for example, a software device capable of processing preoperative mapping data. In all cases, the planning means 20 enable the implementation of a step in the process, called the planning step, which is subsequent to the initial step and in which the operator plans the aforementioned surgical procedures. In the example illustrated in the figure 2 These surgical procedures consist of drilling T-shaped holes in vertebrae V1 to V5, designed to receive the pedicle screws mentioned above. In this planning stage, the surgeon determines, using planning tools 20, the planning data corresponding to the surgical procedures, characterizing their implementation parameters. The definition of the planning data is based on the preoperative mapping data, in the sense that the planning data is defined in relation to the preoperative mapping data.In the example considered here, relating to the T-holes to be drilled in vertebrae V1 to V5, the operator determines, notably by calculation, the entry point of each T-hole on the vertebra in question, the orientation of the central axis of each T-hole relative to the vertebra, and the depth of each T-hole in the vertebra, taking into account the size of the pedicle screw to be placed in the hole. The planning data is advantageously displayed, using planning tools 20, superimposed on the preoperative mapping data, as schematically illustrated in Figure 20. figure 2 In practice, the specifics relating to this planning stage and the planning means 20 are not limiting to the invention, it being noted that various planning techniques are known in the field.

[0017] As illustrated by the figure 3 The system S also advantageously includes selection means 30 that allow for the preoperative selection, from among the aforementioned preoperative mapping data, of data, referred to as data of interest, relating to one or more anatomically significant regions of each of the vertebrae V1 to V5. The selection means 30 are, for example, a software device capable of processing the preoperative mapping data provided by the bone mapping means 10. In all cases, the selection means 30 allow for the implementation of a step in the process, which is necessarily subsequent to the initial step, while advantageously being implemented after the planning step, and in which the aforementioned data of interest are selected. On the figure 3 The V1 vertebra is thus associated with three anatomically significant regions, respectively referenced as R1, R2, and R3. During the selection step, the operator uses the selection tools 30 to identify, from the preoperative mapping data, possibly supplemented by planning data, the anatomically significant regions of each vertebra, typically through a display of this data that allows the operator to point to each of the anatomically significant regions, as schematically illustrated on the figure 3 where three arrow-shaped pointers 31 are drawn. The selection means 30 advantageously allow the selection to be automatically extended around the points made by the operator, so as to obtain, for each vertebra, corresponding portions of the mesh formed by the preoperative mapping data, such that these portions of the mesh respectively describe the anatomically significant regions. Alternatively, the selection of the anatomically significant regions can be at least partially performed automatically by the selection means 30, provided that the latter are programmed accordingly, in particular by learning.In all cases, the portion of the preoperative mapping data corresponding to the anatomically significant region(s) of each vertebra constitutes the aforementioned data of interest and is identified ad hoc, notably by being retained in its entirety, as this data of interest is intended to be used in subsequent stages of the procedure, as explained below. Conversely, the remaining preoperative mapping data can be ignored or processed to limit its file size. In practice, the anatomically significant region(s) of each vertebra are typically those with which the surgical procedures planned during the planning stage will interfere, as well as, where applicable and for reasons that will become clear later, the spinous process of the vertebra, such as region R1 for vertebra V1 on the [missing information]. figure 3 , and / or the left and right laminae of the vertebra, such as the R2 and R3 regions of vertebra V1, and / or the left and right articular processes of the vertebra, and / or the left and right transverse processes of the vertebra.

[0018] As illustrated by the figure 4 The system S also advantageously includes segmentation means 40 that allow the preoperative mapping data, provided by the bone mapping means 10, to be segmented so that this data forms groups that are respectively related to the patient's V1 to V5 vertebrae. The segmentation means 40 are, for example, a software device capable of processing the preoperative mapping data. In all cases, these segmentation means 40 enable the implementation of a step in the process, which is necessarily subsequent to the initial step, and in which the preoperative mapping data are segmented to form the aforementioned data groups, respectively related to the V1 to V5 vertebrae.During this segmentation step, the segmentation means 40 process the preoperative mapping data to delimit the contours of each of the vertebrae V1 to V5 and thus distinguish them individually from the others and from the rest of the vertebral column, as shown schematically for vertebrae V1 to V3 on the . figure 4 Each vertebra thus distinguished corresponds to a corresponding portion of the mesh formed by the preoperative mapping data, this portion of the mesh forming the data group relating to the vertebra in question. It is understood that some of the initial preoperative mapping data, that is, data provided by the bone mapping methods 10, are not found in the aforementioned data groups. In other words, the volume of data, constituted by all the aforementioned data groups, is less than the volume of preoperative mapping data from the initial stage. In practice, the processing performed by the segmentation methods 40 can be advantageously automated, that is, it relies on algorithms that do not require operator intervention, apart from their possible activation.Regardless of the specific implementation details of the segmentation step, it is carried out before or after the planning and / or selection steps.

[0019] In practice, the same software device can advantageously integrate the respective functionalities of planning means 20, selection means 30 and segmentation means 40.

[0020] In all cases, following the pre-operational steps—namely the initial step and the planning, selection, and segmentation steps—the pre-operational mapping data, which may be advantageously limited to the data groups resulting from the segmentation step and which advantageously incorporate the definition of the data of interest selected in the selection step, as well as the planning data, are saved in an exportable computer format well-known in the field. All of this data is hereafter referred to as E.

[0021] As depicted on the figure 5 The S system also includes a vertebral localization element 50, which allows the vertebra to be located in space and to which this vertebral localization element is associated. In the example shown in the figures, the vertebral localization element 50 is thus associated with vertebra V1, as clearly visible in the figures 6 And 7 .

[0022] The vertebral element of location 50 is patient-specific, more precisely to a vertebra of that patient, here vertebra V1, in the sense that, as explained below, the vertebral element of location 50 is custom-designed for the patient in question, being shaped to correspond to the negative of the bone topography of certain areas of vertebra V1, hereafter referred to as the predetermined bony part of this vertebra V1. In the embodiment considered on the figures 5 à 7 The vertebral element in location 50 is unique in that it is hemivertebral, meaning that, as explained later, it is designed to be applied exclusively to one half, left or right, of the vertebra to which it is attached, without interacting with the other half of that vertebra. As an example illustrated on the figures 5 à 7 , the vertebral element of location 50 is thus specifically adapted to the right hemivertebra of vertebra V1.

[0023] The vertebral support element 50 comprises a body 51 with opposite sides, respectively proximal and distal. When the vertebral support element 50 is used on vertebra V1, the distal side of its body 51 is oriented towards vertebra V1, specifically towards the posterior side of that vertebra. In the embodiment considered here, the vertebral support element 50 comprises a proximal portion 52 and a distal portion 53, which are fixedly connected to each other by an intermediate portion 54 of the body 51, which is advantageously tapered.

[0024] Body 51 has, on its distal side, a coupling face 55, which is delimited here by the distal portion 53. The coupling face 55 allows the body 51 to be mechanically coupled to the bone of vertebra 1, here the right hemivertebra of vertebra 1, and is patient-specific so that it can be applied in a custom-made contact with this bone in a single, fixed position. To this end, the coupling face 55 is morphoadapted to vertebra 1, being congruent with the predetermined bone portion of vertebra V1, this predetermined bone portion being preferentially located on the posterior side of the vertebra.When the coupling face 55 is applied to the right hemivertebra of vertebra V1, the coupling face 55 covers the predetermined bony portion of vertebra V1, conforming to its bony contours and cooperating with them through contact to position the vertebral element 50 on vertebra V1 in the aforementioned fixed position. The uniqueness and fixity of the positioning result from the shape adjustment between the predetermined bony portion of vertebra V1 and the morpho-adapted coupling face 55.

[0025] In practice, the shaping of the mating face 55 is carried out preoperatively, advantageously using preoperative mapping data provided by bone mapping equipment 10, which relates to vertebra V1, specifically to the predetermined bony portion of this vertebra. This preoperative mapping data is used preoperatively to shape the mating face 55 so that it adopts the topographic negative of the morphological mesh of the predetermined bony portion of vertebra V1. This shaping is implemented using any suitable manufacturing technique, including additive manufacturing, also known as 3D printing, and in a manner known per se.Advantageously, the predetermined bony part of vertebra V1 corresponds to at least one of the anatomically remarkable regions of this vertebra, which have been described above in connection with the selection means 30; this amounts to saying that the mating face 55 is designed to be applied in custom contact with the bone material of one or more of these anatomically remarkable regions of vertebra V1: the preoperative mapping data which are actually used to shape the mating face 55 are thus advantageously included in the data of interest which have been selected by the selection means 30 during the selection step which has been described above.

[0026] The vertebral body 51 of vertebral element 50 is also provided with a marker 56, which is here delimited by the proximal part 52 of the vertebral body 51. This marker 56 is a three-dimensional optical marker which, as explained in more detail later, is designed to be observed and tracked by appropriate optical means. On the figures 5 à 7 The marker 56 comprises balls 57 which are fixedly distributed on the body 51. Other embodiments, known as such in the field, are conceivable for the marker 56 as long as the latter defines a three-dimensional spatial reference frame, which is fixedly linked to the body 51 and thus to the coupling face 55, by the structure of this body 51. When the vertebral localization element 50 is coupled, via its coupling face 55, to the vertebra V1, the reference frame defined by the marker 56 is thus fixedly linked to the vertebra V1, and this with a relative positioning which is known due to the coupling of the vertebral localization element 50 to the vertebra V1 in the aforementioned unique fixed position.

[0027] According to an advantageous optional provision, which is illustrated in figures 5 à 7 The vertebral body 51 of the vertebral element located at position 50 is provided with a two-dimensional barcode 58, which is delimited here by the proximal part 52 of the body 51, advantageously adjacent to the marker 56. The embodiment of this two-dimensional barcode 58 is not limiting; the barcode 58 could, for example, be a QR code or a Data Matrix code. In all cases, and by definition, the barcode 58 incorporates information that is encoded graphically using graphic symbols that typically conform to pre-established standards.For reasons that will become clear later, the barcode 58 thus incorporates information relating to the identification of the vertebra to which the vertebral element of location 50 is coupled, in other words, here, the identification of vertebra V1; advantageously, the barcode 58 also incorporates information corresponding to the planning data described above, in connection with the planning means 20, for vertebra V1. In all cases, obtaining the barcode 58 and its integration into the body 51, in particular into the proximal part 52 thereof, involve techniques that are known per se and will therefore not be detailed further here.

[0028] According to another advantageous optional provision, which is also illustrated on the figures 5 à 7 The body 51 of the vertebral positioning element 50 is also provided with at least one cannula 59, which is delimited here by the intermediate portion 54 of the body 51. The cannula 59 allows for the reception of a removable bone anchoring element, such as a pin. Thus, when using the vertebral positioning element 50, and once the coupling face 55 is applied to vertebra V1 in the aforementioned fixed position, the body 51 can, if necessary, be locked onto vertebra V1 in this fixed position by inserting a pin into vertebra V1 via the cannula 59. In this way, the body 51 does not have to be held manually continuously during the use of the vertebral positioning element 50, without the risk of the latter moving relative to the vertebra. The body 51 can therefore advantageously be devoid of a corresponding gripping element, such as a handle.

[0029] In practice, the body 51 is manufactured pre-operatively using any appropriate technique. The additive manufacturing techniques mentioned above for manufacturing the coupling face 55 are feasible for manufacturing the entire distal portion 53, or even the whole of the body 51. Alternatively, at least the intermediate portion 54 is prefabricated according to a fixed geometry, then serves as a support for all or part of the distal portion 53 and proximal portion 52, which are manufactured taking into account their specific characteristics in relation to vertebra V1.

[0030] As depicted on the figure 5 The system S also includes a robot 60. The robot 60 comprises a fixed station 61, which is fixed relative to an operating table 70 of the system S and which, in the example shown in the figure, forms a bridge table that spans the upper surface of the operating table 70. The robot 60 also includes an arm 62 that is motor-movable relative to the fixed station 61, its movement controlled by motors integrated into the robot 60 and driven by a control unit 63 of the robot. The embodiment of the robotic arm 62, particularly with regard to its kinematic capabilities and motors, is not limiting as long as the arm 62 is capable of participating in spinal surgery. The robot 60 further includes an end effector 64, which is carried by the arm 62, typically at the end of the arm opposite the fixed station 61.As detailed below, the end effector 64 is adapted for intraoperative use on vertebrae V1 to V5. In the embodiment illustrated in the figures, the end effector 64 is equipped with a tool 65 capable of performing at least one of the surgical procedures planned during the planning stage described above. In the surgical example involving drilling T-holes in vertebrae V1 to V5, the tool 65 is typically a drill bit capable of drilling the T-hole(s) in vertebra V1. The robot 60 is a commercially available device.

[0031] Also as depicted on the figure 5 The system S also includes an optical capture device 80 which is at least partially supported by the end effector 64. In the embodiment considered on the figure 5 The optical capture device 80 comprises a three-dimensional camera 81 which is carried by the end effector 64. In this document, the term "three-dimensional camera" refers to an optical sensor that captures three-dimensional data using an optical technique such as laser profiling, fringe projection, or time-of-flight. Among the time-of-flight optical techniques, laser remote sensing, commonly known as LIDAR (an acronym for "light detection and ranging"), is particularly noteworthy.Thus, according to a preferred embodiment, the three-dimensional camera 81 is an optical sensor using laser triangulation to calculate the distance separating it from an object based on the deformation of a laser line projected onto that object; the three-dimensional camera 81 can therefore advantageously use LIDAR technology to determine the spatial positioning of a device whose shape it recognizes. More generally, the three-dimensional camera 81 of the S system has the advantage of being very close to the vertebral localization element 50, which gives it good accuracy in positioning this vertebral localization element 50. Furthermore, this proximity also reduces the bulk of the vertebral localization element 50, whose balls 57 do not need to be as far apart as if they were observed several meters from the intervention site and therefore from the vertebral localization element 50.

[0032] Regardless of the embodiment of the three-dimensional camera 81, when the vertebral localization element 50 is coupled to vertebra V1, it allows observation of the marker 56 of this vertebral localization element 50 and the deduction, in real time, of positioning data concerning the relative positioning between this marker 56 and the end effector organ 64. Naturally, this relies on the fact that the position of the three-dimensional camera 81 on the end effector organ 64 is known in a pre-established manner and entered ad hoc into the three-dimensional camera 81. This position can be either fixed, since the three-dimensional camera 81 is fixedly attached to the end effector organ 64, or controllable in movement according to a precise and controlled kinematic, as illustrated by the dashed arrows on the figure 5 .

[0033] In the form of realization of the figure 5 The optical capture device 80 is advantageously adapted for observing and reading the barcode 58 of the vertebral localization element 50 when the vertebral localization element 50 is coupled to vertebra V1. For this purpose, the optical capture device 80 comprises an optical sensor, for example, a two-dimensional sensor, capable of reading the graphic symbols of the barcode 58 and deducing the information contained within it. Multiple embodiments, known as such in the art, are conceivable for this optical sensor, it being understood that the latter is advantageously integrated into the three-dimensional camera 81.

[0034] Also as depicted on the figure 5 The system S comprises processing means 90, typically electronic, designed to process both the data from assembly E and the positioning data determined by the three-dimensional camera 81 or, more generally, by the optical capture device 80, as well as advantageously to process the information from the barcode 58, read by the optical capture device 80. The processing means 70 are advantageously also designed to generate control instructions for the robot 60, sent to its control unit 63. Data transmission between the processing means 90, the optical capture device 80, and the control unit 63 of the robot 60 is carried out by any suitable means, including wired or wireless.In practice, the processing means 90 include, in particular, a microprocessor and are typically integrated into a computer unit; these hardware aspects of the processing means 90 are not exhaustive. The functional capabilities of the processing means 90 will become clearer in the following description, which relates to the intraoperative steps of the process implemented using system S.

[0035] During the first intraoperative step of the procedure, the patient to be operated on is anesthetized after being laid face down under the operating table 70, as illustrated in the figure 5 The surgeon then makes an incision in the patient's spine to expose, without damaging, a section of vertebra V1. This exposed section is freed from all soft tissue, such as skin and flesh, to leave the bone of this area of ​​vertebra V1 exposed. The exposed section includes, at a minimum, the predetermined bony portion of vertebra V1, on which vertebral element 50 is designed to be placed in the aforementioned fixed position, through the cooperation of contact between this predetermined bony portion of vertebra V1 and the mating face 55 of vertebral element 50.The exposed area can advantageously be limited to the predetermined bony portion of the V1 vertebra, thus being exposed via a minimally invasive approach which, in this case, involves only one lateral side, namely the right side, of the V1 vertebra, through a small, lateral incision in the patient's spine. Alternatively, the exposed area can, of course, be more extensive, being exposed via a wide open approach, potentially involving both lateral sides of the spine.

[0036] During a second intraoperative step, the surgeon uses the vertebral localization element 50, applying its mating face 55 to the exposed area of ​​vertebra V1 so as to position the body 51 on vertebra 1 in the single fixed position defined above. The vertebral localization element 50 is then in the configuration illustrated in the figures 5 à 7 Once coupled to vertebra 1, here to the right hemivertebra of this vertebra 1, the vertebral element at location 50 can be released by the surgeon, while remaining fixedly and stably in place on vertebra 1. The surgeon can then easily visually control the surgical site, especially since the body 51 is particularly compact, notably due to the tapering of its intermediate portion 54.

[0037] During a third intraoperative step, after the robot 60, the optical capture device 80, and the processing means 90 have been activated, the three-dimensional camera 81 is positioned opposite the marker 56 of the vertebral localization element 50. By observing the marker 56 of the vertebral localization element 50 coupled to vertebra V1, the three-dimensional camera 81 determines in real time the relative positioning between this marker 56 and the end effector organ 64 of the robot 60, as explained above. The corresponding positioning data, thus determined by the three-dimensional camera 81, are transmitted instantaneously to the processing means 90, which, using this positioning data and the preoperative mapping data of assembly E, calculate in real time the relative positioning between the end effector organ 64 and vertebra V1.For the processing means 90, this amounts to calculating, in the spatial frame defined by the marker 56 and fixedly attached to vertebra V1 according to a known positioning, the position of the end effector organ 64 in real time and comparing this position with the region of space occupied by vertebra V1 as modeled by the preoperative mapping data relating to this vertebra V1. This obviously assumes that the vertebra to which the vertebral localization element 50 is coupled is identified by the processing means 90 as vertebra V1, which advantageously results from the reading of the barcode 58 by the optical capture device 80 which transmits the information from this barcode 58 to the processing means 90; alternatively, this can also result from ad hoc input of the corresponding information into the processing means 90 by the surgeon.In all cases, it is understood that the notion of "real time" implies that the optical capture device 80 and the processing means 90 are inherently capable of controlling and guiding the arm 62 of the robot 60 at a speed adapted to any movements of vertebra V1 and therefore of marker 56 observed by the three-dimensional camera 81. These potential movements are linked, for example, to the patient's breathing, patient spasms, or an unexpected external shock to the operating table 70. This real-time processing capability is linked to a high update frequency for determining the relevant relative positions. For example, this frequency is on the order of 100 kHz. The system S thus makes it possible to correct in real time the displacement of the end effector 64 during its application to vertebra V1 according to any movements of the latter.

[0038] In line with the preceding considerations, the processing means 90 are advantageously provided to, during the third intraoperative step, also exploit the planning data defined above, so as to develop in real time, from this planning data and from the calculation performed by the processing means 90 regarding the relative positioning between the end effector organ 64 and the vertebra V1, control instructions which are sent to the control unit 63 of the robot 60 to make the tool 65 of the end effector organ 64 apply to the vertebra V1 by the arm 62 so as to carry out at least one of the surgical acts corresponding to the planning data.In the surgical example involving drilling T-holes in vertebrae V1 to V5, the drill bit forming tool 65 is applied by arm 62 directly to vertebra V1 to drill a hole whose central axis orientation, entry point, and depth conform to those planned during the preoperative planning stage. During the application of this drill bit to vertebra V1, any unexpected movement of the vertebra triggers, via the three-dimensional camera 81 and processing means 90, a positional recalculation that updates the control instructions sent by the processing means 90 to the control unit 63 of the robot 60.In practice, the planning data is provided to the processing means 90 either by extraction directly from the data set E, or preferably via the optical capture device 80 reading the barcode 58 in which information corresponding to the planning data relating to vertebra V1 has been integrated.

[0039] Throughout the actuation of the robot 50 during the third intraoperative step, the marker 56 remains easily and efficiently observable by the three-dimensional camera 81 because the latter is mounted on the end effector organ 64. This operational proximity between the marker 56 and the three-dimensional camera 81 is particularly beneficial for the accuracy of optical tracking, while significantly limiting the risk of interruption of optical tracking due to occlusion between the marker 56 and the three-dimensional camera 81. Furthermore, the complexity of the calculations performed by the means 90 remains moderate because it can advantageously be limited to calculating the positioning of three points respectively associated with the balls 57, typically the respective centers of the balls 57, allowing the localization in space of the V1 vertebra and the relative positioning of the end effector organ 64 with respect to said V1 vertebra.

[0040] The procedure then continues taking into account the preoperative planning, repeating if necessary the third intraoperative step in order to drill one or more other T holes in the V1 vertebra, then repeating the second and third intraoperative steps but applying them successively to each of the V2 to V5 vertebrae to drill the different other T holes. Of course, to repeat the second intraoperative step by applying it to the V2 to V5 vertebrae, it is necessary to have, for each of these V2 to V5 vertebrae, a vertebral localization element which is functionally similar to the vertebral localization organ 50 described so far, but which is specific to the vertebra concerned, having its coupling face which is specific to the vertebra concerned and having its barcode whose information concerns the vertebra concerned.

[0041] At the end of the procedure, vertebrae V1 to V5 are found to have holes drilled with the T holes which were planned during the preoperative planning stage, each of these holes having been drilled by the robot 60.

[0042] On the figure 8 is represented a variant of the vertebral localization element 50, referenced 150. The vertebral localization element 150 is functionally similar to the vertebral localization organ 50, but differs structurally from it in that its coupling face 155, which is functionally similar to the coupling face 55, is designed to be applied in custom contact with simultaneously the bone material of the left half of vertebra V1 and the bone material of the right half of this vertebra V1. For this purpose, the vertebral element of location 150 comprises a body 151, a distal portion 153 of which, delimiting the coupling face 155, is distributed on either side of the spinous process of vertebra V1 when the vertebral element of location 150 is coupled by its coupling face 155 to vertebra V1, in particular to the left and right laminae of the latter, as illustrated in the figure 8 Of course, the surgical procedures implemented in the first and second intraoperative stages are adapted accordingly.

[0043] In the form of implementation envisaged at the figure 8 The body 151 of the vertebral localization element 150 has a proximal part 152, which is functionally and structurally similar to the proximal part 52, in particular being provided with a marker 156 and a barcode 158 which are respectively similar to the marker 56 and the barcode 58. The body 151 also has an intermediate part 154 which connects the proximal 152 and distal 153 parts together by forming an arch, which straddles the spinous process of vertebra V1 when the vertebral localization element 250 is coupled to vertebra V1 and which incorporates two cannulas 159 individually similar to cannula 59.

[0044] On the figure 9 is represented a variant of the vertebral localization element 150, referenced 250. The vertebral localization element 250 is functionally similar to the vertebral localization element 50 or 150, but differs structurally from the vertebral localization element 150 by, on the one hand, the embodiment of its three-dimensional optical marker, which is referenced 256 and is functionally similar to marker 56 or 156, and, on the other hand, the fact that its barcode 258, which is functionally similar to barcode 58 or 158, is not two-dimensional, but three-dimensional, partly constituting marker 256. For this purpose, faces 257 of marker 256, observable by the three-dimensional camera 81 of the optical capture device 80 when the vertebral localization element 250 is coupled to vertebra V1, each incorporate the three-dimensional patterns that together form the 258 barcode, one of its faces 257 being represented alone at the figure 10 . Due to their three-dimensional relief, the three-dimensional patterns of the faces 257 ensure a function similar to the balls 57 of the marker 56, in particular a spatial reference which is fixedly linked to the marker 256 and which can be located by the three-dimensional camera 81. Due to their graphic design, the three-dimensional patterns of the faces 257 also allow to ensure a function similar to the barcode 58 or 158, in particular by integrating information identical to that described above for the barcode 58.

[0045] In the form of embodiment considered on the figure 9 , the marker 256 and the barcode 258 are delimited by a proximal part 252 of a body 251 of the vertebral element 250, this proximal part 252 being functionally similar to the proximal part 52 or 152 of the vertebral elements of location 50 and 150. This body 250 has a distal part 253, which is functionally and structurally similar to the distal part 153, in particular being provided with a mating face 255 similar to the mating face 155, as well as an intermediate part 254 which is functionally and structurally similar to the intermediate part 154, in particular being provided with cannulas 259 which are similar to the cannulas 159.

[0046] On the figure 11 A variant of vertebral localization element 150, referenced as 350, is shown. Vertebral localization element 350 is functionally similar to vertebral localization elements 50, 150, or 250, except that vertebral localization element 350 lacks a barcode, such as barcodes 58, 158, and 258. Vertebral localization element 350 can therefore be used as a replacement for vertebral localization elements 50, 150, or 250, provided that the integration of information similar to that detailed above in connection with barcode 58 is not done in barcode form. As mentioned previously, this information must then be provided to the processing means 90 by means other than reading a barcode integrated into vertebral localization element 350, specifically by entering this information. directly into the processing means 90, where appropriate by extraction from the dataset E for part of this information.

[0047] In the form of embodiment considered on the figure 11 , the vertebral localization element 350 has a three-dimensional optical marker, which is referenced 356 and which, while being functionally similar to marker 56 or 156, is structurally different from the latter, having balls 357 which are functionally similar to balls 57 but which are here arranged differently from each other. The marker 356 is here delimited by a proximal part 352 of a body 351 of the vertebral element of localization 350. This body 351 has a distal part 353, which is functionally and structurally similar to the distal part 153, in particular being provided with a mating face 355 which is similar to the mating face 155, as well as an intermediate part 354, which is functionally and structurally similar to the part 154, in particular being provided with cannulas 359 similar to the cannulas 159.

[0048] On the figure 12 An alternative embodiment of system S, referenced S', is shown. This system S' comprises the vertebral localization element 350, the robot 60, the operating table 70, and the processing means 90 of system S, but, unlike the latter, lacks the optical capture device 80 in favor of an optical capture device 80'. The optical capture device 80' is functionally similar to the optical capture device 80, but differs from it structurally. To this end, the optical capture device 80' includes a three-dimensional optical marker, referenced 81', which is mounted, in particular, permanently on the end effector of the robot 60, as clearly visible on the figure 12 Although distinct from marker 356 of the vertebral localization element 350, marker 81' has a similar purpose to marker 356 but applied to the terminal effector organ 64, in that marker 81' allows the terminal effector organ 64 to be located optically in space. To this end, marker 81' includes, for example, balls 82', similar to the balls 357 of marker 356, but other embodiments are conceivable for marker 81'. In all cases, the optical capture system 80' also includes at least two two-dimensional cameras 83' and 84' which, as schematically illustrated in the figure 12 These cameras allow, when the vertebral positioning element 350 is coupled to vertebra V1, observation of both marker 356 and marker 81' from different viewing angles. The two-dimensional cameras 83' and 84' are designed to deduce, from their observation of markers 356 and 81', the relative positioning between marker 356 and the end effector organ 64. It is understood that the positioning data thus determined by the two two-dimensional cameras 83' and 84' are similar to those determined by the single three-dimensional camera 81. The positioning data determined by the two-dimensional cameras 83' and 84' are provided to the processing means 90 to enable them to calculate in real time the relative positioning between the end effector organ 64 and vertebra V1, as explained above for system S.

[0049] In unrepresented variants, the surgical procedure performed by robot 60 of system S or S' on vertebrae V1 to V5 is not limited to drilling holes. More generally, the surgical procedure(s) that can be performed by robot 60 involve applying energy that breaks down the bone of the vertebrae; this energy can be mechanical, radiative, laser, etc. The tool 65 of the end effector organ 64 of robot 60 is chosen accordingly, being appropriate for the nature of the surgical procedure to be performed by robot 60. This tool 65 is also interchangeable during the same surgical procedure.

[0050] Also, as an alternative not shown, rather than using robot 60 to perform a surgical procedure as described above, robot 60 can, in both system S and system S', be used to assist a surgical procedure performed by the surgeon, for example, to guide the surgeon's action when applying a drilling tool or other instrument to the vertebrae. In this case, during the preoperative planning stage, planning data is calculated that corresponds to an action to assist the surgical procedure and is based on the preoperative mapping data. Then, during the intraoperative stage in which the surgical procedure is performed by the surgeon, the tool 65 of the end effector organ 64 is replaced by an ancillary instrument capable of performing the corresponding assistance action.The assistance action is carried out by the robot 60: from the planning data corresponding to the assistance action, as well as from the calculation of the relative positioning between the terminal effector organ 64 and the vertebra V1, control instructions are developed in real time by the processing means 90 and sent to the robot 60 so that the ancillary is placed opposite the vertebra V1 by the arm 62 in order to carry out the assistance action, while the surgical act is carried out by the surgeon, being assisted by the ancillary.

[0051] Finally, various modifications and options to the systems S and S', as well as to the process described so far, are conceivable. In particular, the different embodiments mentioned above for respective parts of the system S or S' can be combined in all possible ways to give new embodiments. For example, the distal and intermediate parts of the body 251 or 351 of the vertebral elements of location 250 and 350 can be replaced by the distal 53 and intermediate 54 parts of the body 51. Similarly, the vertebral element of location 50 can be associated with the three-dimensional barcode schematized in figure 10in place of the two-dimensional barcode 58. In this configuration, the optical capture device 80 no longer includes an optical sensor and is limited to a three-dimensional camera which allows on the one hand to determine the position of the vertebral element 50 in relation to the terminal effector organ 64 and on the other hand to read the information contained in the aforementioned three-dimensional barcode.

Claims

1. A spine surgery system (S; S'), including: - bone mapping means (10) which provides preoperative mapping data relative to one or more vertebrae (V1 to V5) of a patient, - a vertebral localization element (50; 150; 250; 350) which is provided with: - a mating surface (55; 155; 255; 355) which is specific to the patient, being congruent with a predetermined bony part of the vertebra or one of the vertebrae (V1), so as to be able to couple the vertebral localization element to the vertebra (V1) in a unique fixed position, applying the mating surface in customized contact with the bony material of this vertebra so that the mating surface covers the predetermined bony part of the vertebra, by matching the bony reliefs of the predetermined bone portion and by cooperating by contact with these bony reliefs to place the vertebral localization element on the vertebra in said unique fixed position, and - a three-dimensional optical marker (56; 156; 256; 356), defining a three-dimensional spatial marker which is fixedly linked to the mating surface (55; 155; 255; 355) so that, when the vertebral element (50; 150; 250; 350) is coupled to the vertebra (V1), said three-dimensional spatial marker is fixedly linked to the vertebra according to a relative position resulting from the coupling of the vertebral localization element to the vertebra in said unique fixed position, - a robot (60) comprising an arm (62) which is movable relative to a fixed station (61) of the robot, as well as an end effector member (64) which is carried by the arm and which is able to be applied intraoperatively on the vertebra (V1), - an optical sensor device (80; 80'), which is at least partially carried by the end effector member (64) and which is able, when the vertebral localization element (50; 150; 250; 350) is coupled to the vertebra (V1), to observe the marker (56; 156; 256; 356) of the vertebral localization element and deducing therefrom, in real time, the positioning data concerning the relative position between this marker and the end effector member, and - processing means (90) which, from said preoperative mapping data and said positioning data, calculates, in real time, the relative position between the end effector member (64) and the vertebra (V1), by calculating, in said three-dimensional spatial reference, the position of the end effector member and by comparing this position of the end effector member with a region of space occupied by the vertebra as modeled by said preoperative mapping data.

2. The spine surgery system according to claim 1, wherein the spine surgery system (S; S') also includes a planning means (20), which is able to plan preoperatively at least one surgical act to be performed on the vertebra (V1) and to calculate planning data corresponding to this surgical act, based on the preoperative mapping data, wherein the end effector member (64) is equipped with a tool (65) able to perform the surgical act, and wherein the processing means (90) elaborates in real time, from the calculation of the relative position between the end effector member (64) and the vertebra (V1), calculated by the processing means, and from said planning data, control instructions sent to the robot (60) to cause the tool (65) of the end effector member to be applied directly to the vertebra by the arm (62) so as to perform said surgical act.

3. The spine surgery system according to one of claims 1 or 2, wherein the vertebral localization element (50; 150; 250) is provided with a barcode (58; 158; 258) integrating the information relative to the identification of the vertebra (V1) to which the vertebral localization element is to be coupled, and wherein the optical sensor device (80) is able to, when the vertebral localization element (50; 150; 250) is coupled to the vertebra (V1), observe and read the barcode (58; 158; 258).

4. The spine surgery system according to claims 2 and 3 taken together, wherein the barcode (58; 158; 258) also incorporates the information corresponding to the planning data.

5. The spine surgery system according to one of claims 3 or 4, wherein the barcode (58; 158) is two-dimensional, being for example a QR code or a Data Matrix code.

6. The spine surgery system according to one of claims 3 or 4, wherein the barcode (258) is three-dimensional and constitutes at least in part the marker (256) of the vertebral localization element (250).

7. The spine surgery system according to any one of the preceding claims, wherein the optical sensor device (80) includes a three-dimensional camera (81), which is carried by the end effector member (64) and which determines said positioning data.

8. The spine surgery system according to any one of claims 1 to 6, wherein the optical sensor device (80 ') includes: - a three-dimensional optical marker (81'), which is distinct from the marker (56; 156; 256; 356) of the vertebral localization element (50; 150; 250; 350) and which is carried by the end effector member (64), and - at least two, two-dimensional cameras (83', 84') which are able, when the vertebral localization element is coupled to the vertebra (V1), to observe, according to respective viewing angles, which are different the one from the other, at the same time the marker of the vertebral localization element and the marker of the optical sensor device and deduce said positioning data in real time.

9. The spine surgery system according to any one of the preceding claims, wherein the mating surface (55) is designed to be applied in customized contact with the bony material of only one half, left or right, of the vertebra (V1).

10. The spine surgery system according to any one of claims 1 to 8, wherein the mating surface (155; 255; 355) is designed to be applied in customized contact with the bony material of the left half of the vertebra (V1) and the bony material of the right half of the vertebra.