• 专利附录
  • 专利说明
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    • 专利摘要:
    The invention relates to a resetting device (1) used during the acquisition of images of an anatomical zone of a patient during a robotic assisted surgery, comprising a body (3) made of transparent radio material which comprises fiducial markers (9) made of an opaque radio material, said body (3) having a bearing surface (7) intended to be manually placed on a surface of said anatomical zone of the patient. According to the invention, said fiducial markers (9) are arranged in a specific geometric pattern allowing a certain identification of the position and orientation of the resetting device (1) in a three-dimensional numerical model constructed from the images from the acquisition of the anatomical area.
    公开号:FR3057757A1
    申请号:FR1660264
    申请日:2016-10-21
    公开日:2018-04-27
    发明作者:Sebastien OLIVE；Lucien Blondel；Bertin Nahum
    申请人:MEDTECH；
    IPC主号:
    专利说明:

    ® FRENCH REPUBLIC
    NATIONAL INSTITUTE OF INDUSTRIAL PROPERTY © Publication number: 3,057,757 (to be used only for reproduction orders)
    ©) National registration number: 16 60 264
    COURBEVOIE © IntCI 8
    A 61 B 6/08 (2017.01), A 61 B 6/03, 6/12
    A1 PATENT APPLICATION
    ©) Date of filing: 21.10.16. (© Applicant (s): MEDTECH Société anonyme - FR. (© Priority: @ Inventor (s): OLIVE SEBASTIEN, BLONDEL LUCIEN and NAHUM BERTIN. (43) Date of public availability of the request: 04.27.18 Bulletin 18/17. ©) List of documents cited in the report preliminary research: Refer to end of present booklet (© References to other national documents (® Holder (s): MEDTECH Société anonyme. related: ©) Extension request (s): © Agent (s): CABINET BREV & SUD.
    AUTOMATIC RECORDING DEVICE AND METHOD FOR INTRA OPERATIVE 3D IMAGES.
    FR 3 057 757 - A1 top) The invention relates to a registration device (1) used during the acquisition of images of an anatomical area of a patient during surgery with robotic assistance, comprising a body (3 ) made of transparent radio material which comprises fiducial markers (9) made of an opaque radio material, said body (3) having a bearing surface (7) intended to be placed manually on a surface of said anatomical area of the patient.
    According to the invention, said fiduciary markers (9) are arranged in a specific geometric pattern allowing a certain location of the position and the orientation of the registration device (1) in a three-dimensional digital model constructed from images from the acquisition of the anatomical area.
    Automatic registration device and method for intra-operative 3D images
    The present invention falls within the field of robotic assisted surgery, and more specifically relates to robotic assisted surgery implemented in complex anatomical areas, such as cerebrospinal surgery, in other words neurosurgery, and / or spine surgery.
    In this context, the invention relates to a device and a method of registration between a repository of a three-dimensional digital model derived from medical images and a repository of an anatomical area of a patient during a robotic assisted surgery procedure. . In the rest of this document, a frame of reference corresponds to a specific coordinate system for an element taking part in a registration and / or surgery procedure.
    In this context, the registration device and the registration method of the invention make it possible to match a real position of the patient's anatomical area with a three-dimensional digital model obtained from medical images of the patient's anatomical area.
    Cerebrospinal surgeries focus on the main anatomical structures of the central nervous system, namely the brain and the spine. During operations in these particularly sensitive parts of the human body, the slightest operating error can have extremely serious consequences on the patient's future physical and neurological autonomy. When performing cerebro-spinal surgical procedures, it is essential that the surgeon's actions are extremely precise. Robotic assistance surgery is precisely responsible for assisting your surgeon with remarkable precision tools! than a robotic surgical assistance arm combining the positional rigor of the machines with the operator's know-how.
    The implementation of robotic assisted surgery generally requires the simultaneous operation of several separate tools or devices, each comprising a specific coordinate reference system. The actual surgical operation is generally preceded by a preoperative or intraoperative imaging sequence of the intervention area which is used by the surgeon to plan the actions related to the surgery. As much for spatial reasons as sequential, it is important to make work the tools necessary for the operation in a common coordinate system, consequently including a step of registration of the various reference frames - of each element involved during surgery, including the area patient anatomy, a medical imaging system, and / or an operative monitoring system (including a navigation device and navigation targets) and / or a surgical assistance robot.
    These registration steps are essential for carrying out a robotic assisted surgical intervention. Thus, the precision of the surgical gesture and more generally the success of the surgical intervention depend strongly on the precision of the registration steps between the anatomical work area and the different elements involved in the surgery. The registration steps must be as quick and smooth as possible-so as to integrate perfectly into the operating protocol to be implemented for the required operation. In addition, precise and automated registration steps allow the surgeon to focus on the operational tasks that are at the heart of his know-how.
    In addition, from the patient's point of view and with regard to possible postoperative consequences, it is important that the intervention be there. less traumatic as possible, so that the patient recovers from the operation as quickly as possible. Micro-invasive surgery is developing in this context, with the primary objective of preserving the tissues and anatomical structures located near the operated area as much as possible. In order to achieve this objective, it is crucial that each step of the operating process, including the registration steps, be as minimally invasive as possible.
    For the time being, there are a large number of registration techniques between the frame of reference of an anatomical area of interest of the patient and that of the medical images of this anatomical area of interest. Each of these registration techniques uses a specific registration device as a patient reference system during the acquisition of images of an anatomical area of interest for said patient.
    In general, such a registration device comprises a transparent radio body equipped with opaque radio fiduciary markers and an optical target. The opaque radio fiduciary markers make it possible to locate a position and an orientation of the registration device in the repository of medical images of the anatomical area of interest.
    Among the known systems, a first type of registration device is described in document US Pat. No. 5,799,055. This first type of registration device comprises a transparent radio body adapted to be carried by a surgical assistance arm. In order to recalibrate the patient frame of reference and the frame of reference for the medical image, the transparent radio body is equipped with eight radio opaque fiduciary markers. The use of this type of registration device generates artifacts in medical images during the acquisition of the anatomical area of interest of the patient. These artefacts are due to the robotic assistance arm and have the negative effect of making the identification of fiduciary markers in medical images more complex, thus reducing the accuracy of the registration that follows. In addition, this device does not allow the acquisition of three-dimensional medical images.
    A second type of registration device is described in document US 7,139,418. It comprises a transparent radio body equipped in particular with opaque radio fiduciary markers arranged at determined locations. This transparent radio body is positioned at the anatomical area of interest and in the field of vision of the medical imaging acquisition system. The transparent radio body can be carried by a support 'rigidly connected to the operating table or else carried by the end of a robotic surgical assistance arm. Thus, it is possible to maintain, during the acquisition of imaging data relating to the anatomical area of interest, the transparent radio body in an adequate position predefined by the surgeon. This second type of registration device is coupled to at least one optical target comprising navigation markers detectable by an appropriate navigation device. It should be noted that the spatial relationship between the opaque radio fiduciary markers and the navigation markers is known. When the transparent radio body is supported by a robotic arm, medical images present artifacts due to the robotic arm, which is not made of transparent radio material. When the transparent radio body is carried by a support rigidly connected to the operating table, the attachment of the transparent radio body to the support slows down the operating process. Finally, this registration device is not compatible with the acquisition of a three-dimensional medical image of the anatomical area of interest.
    A third type of registration device is described in document US 8,992,580. It comprises a transparent radio body equipped with opaque radio fiduciary markers arranged in predetermined locations according to two distinct and parallel distribution planes. When acquiring imaging data concerning the anatomical area of interest, this registration device is mechanically fixed to an elf anchor piece itself fixed in a patient's bone structure located near the anatomical area of interest. After the acquisition, the registration device is detached from the anchoring piece which then accommodates a miniature surgical assistance robot for the following surgical operation. Thus, this registration device has the disadvantage of being fixed to a invasive anchor, and can also be a source of reduced accuracy if the anchor moves during the disassembly of the registration device and the assembly of the surgical assistance robot.
    A fourth type of registration device, described in document US 8,104,958, comprises a transparent radio body fitted with opaque radio fiduciary markers arranged at predetermined locations organized in a pyramidal fashion. This registration device is placed and maintained manually, by an operator, in the field of vision of the medical imaging acquisition system, above the anatomical area of interest. This type of registration device also includes an optical or electromagnetic target. Gette target is equipped with optical or electromagnetic navigation markers detectable by a suitable navigation device. This fourth type of registration device certainly has the advantage of being usable with a three-dimensional medical imaging system because of your pyramid configuration of the radio opaque fiduciary markers, but it also has crippling drawbacks: the nursing staff is exposed radiation from medical imaging systems, which is less and less accepted. In addition, since the registration device is maintained manually during the acquisition of medical imagery of the anatomical area of interest, the slightest instability is likely to cause problems with the sharpness of the medical images generated, and therefore a loss of accuracy of the image. subsequent registration.
    A fifth type of registration device, for example described in your documents US 8,238,631, US 8,644,570, US 8,503,745 and US 8,737,708, comprises a transparent radio body equipped with radio opaque fiduciary markers arranged at predetermined locations according to a three-dimensional spatial organization. The transparent radio body also includes an optical target formed by optical navigation markers that can be identified by a navigation device. However, this type of device also has the drawback of using an invasive fixation technique, by clamping onto a close bone structure. 'of the anatomical area of interest j
    A sixth type of registration device, described in document US 8,457,719, comprises a flexible transparent radio body. The transparent radio body has an upper face and a lower face. The underside acts as a support surface intended to be placed on the anatomical area of interest of the patient Said underside of the transparent radio body is equipped with an adhesive surface allowing the transparent radio body to be fixed by gluing soft tissue at the anatomical area of interest. The transparent radio body also includes active navigation markers arranged at predetermined locations. Thus, this type of registration device makes it possible to create a surface digital model by locating active navigation markers, the surface digital model then being readjusted with three-dimensional medical imaging of the anatomical area of interest. This registration device has the advantage of being able to be used as a target for monitoring the movement of the patient's anatomical area during a surgical procedure which would follow the registration. However, due to its positioning by bonding to soft tissues, any mechanical deformation of these soft tissues generates inaccuracies in registration during the operating procedure. In addition, active navigation markers require an on-board energy source which poses sterilization problems in particular. Finally, this type of registration device is for single use, which represents a significant cost during each use and, from an economic point of view, clearly constitutes an additional disadvantage.
    The present invention remedies the shortcomings of the prior art mentioned above, by proposing a high-precision sterilizable registration device allowing a registration of the different reference frames of each element involved during the surgery, namely for example: the anatomical area of the patient, medical imaging system, operative monitoring system, surgical assistance robot etc.
    In support of these objectives, a first aspect of the invention relates to a registration device used during the acquisition of images of an anatomical area of a patient during surgery with robotic assistance, conventionally comprising a body. made of transparent radio material which includes fiducial markers made of a radio opaque material, said body having a bearing surface intended to be placed manually on a surface of said anatomical area of the patient. It is such, according to the invention, that said fiducial markers are arranged in at least one specific geometric pattern allowing a certain location of the position and the orientation of the registration device in a three-dimensional digital model constructed · from the images obtained of the acquisition of the anatomical area.
    In practice, the specific geometric pattern formed by the radio opaque fiduciary markers is a geometric pattern in which said radio opaque fiduciary markers are organized asymmetrically. This or these specific geometric patterns allow, within said three-dimensional digital model, a certain identification of a minimum number of opaque radio fiduciary markers whatever the angle of view of the three-dimensional digital model. This certain identification of a minimum number of opaque radio fiduciary markers makes it possible to ensure certain identification of the real position and of the orientation of the registration device, resulting in high-precision registration between the three-dimensional model and the;
    coordinate reference system for the patient's anatomical area in real operating space.
    According to an additional possibility, the fiduciary markers of the same geometric J pattern can be arranged in a coplanar manner. In addition, fiduciary markers j within the same geometric pattern can be organized in a | asymmetric. St the transparent radio body comprises a plurality of distinct specific geometric patterns), these can then be organized according to a plurality of planes j parallel to each other. The use of specific geometric patterns organized in parallel planes makes it possible to provide a greater number of fiduciary markers in a reduced space. This compaction phenomenon ensures that the set J of fiduciary markers is in the field of vision of a medical imaging system.
    Depending on a possible configuration, the opaque radio fiduciary markers can by
    S also have a spherical shape, for example with a diameter at least equal to 4 mm.
    According to another advantageous characteristic, the registration device can comprise at the j
    least one navigation target equipped with at least three navigation markers, the j
    geometric relationship with fiduciary markers is predetermined. The navigation target makes it possible in practice to locate the real position of the registration device in j
    a coordinate system of a navigation device.
    For this purpose, the navigation markers can be located precisely by a j f
    conventional tracking method such as triangulation. A specific registration between the coordinate system of the navigation device and a coordinate system i
    i of a surgical assistance robot ensures the location of the real position of the registration device in the coordinate system of the surgical assistance robot.
    According to a first variant, the navigation markers can be of the passive type. f
    In a second variant, said navigation markers can be of the active type.
    In both variants, it can be optical navigation markers, or electromagnetic navigation markers.
    According to an additional characteristic, the navigation markers can be placed on a support comprising removable fixing means relative to the body of the registration device. Preferably, the support is a telescopic arm which can take several positions. In each position, the geometric relationship between!
    navigation markers and fiduciary markers is preferably predetermined. I
    According to an additional characteristic of the registration device of the invention, the latter can be provided with a stabilization system relative to the patient's body, for example made of a malleable material adaptable to the surface of the anatomical area and able to maintain in position the registration device during data acquisition. According to one possibility of the invention, the stabilization system can be formed by two flexible wedges. Each wedge can then be fixed in the vicinity of a lateral edge of the registration device or incorporated into the device. With such a configuration, the stabilization of the registration device is done by pressing on the patient's anatomy.
    This characteristic is part of the overall approach to simplifying the operating process. The fact of eliminating the invasive nature of the positioning of the registration device is in fact clearly a factor of fluidification and acceleration of the operating process.
    It should also be noted that the non-invasive and rapid positioning of the registration device therefore makes it possible to reduce the downtime of a surgical room, which represents a significant reduction in operating costs.
    This also represents a definite advantage from the patient's point of view, since the non-invasive nature can only facilitate your operative suites, since it actually represents one or more fewer incisions in his body, sparing him the corresponding trauma.
    A second aspect of the invention relates to an image-guided robotic assistance surgery system implementing a registration device according to the invention, as defined and explained above.
    According to this second aspect of the invention, the robotic assisted surgery system includes a robotic surgical assist arm and a navigation system.
    A third aspect of the invention relates to a method of acquiring and locating an anatomical area of a patient for the preparation of a surgical operation using a registration device according to the first aspect of the invention in a robotic assisted surgery system defined by the second aspect of the invention.
    This method of acquiring and locating an anatomical area of a patient is characterized in that it comprises:
    • A step of preparing the acquisition of images of the anatomical area of the patient comprising an installation of a patient, a three-dimensional navigation system, a medical imaging system and a robotic arm assistance with surgery, • A step of manual placement of the registration device on a surface of an anatomical area of the patient and in a field of vision of a medical imaging system, • A step of acquiring a position of the registration device by the navigation system, • A step of acquisition by the navigation system of a position of a target for operative monitoring of the patient's anatomical area, • A step of securing the nursing staff, • A step of acquiring images of the anatomical area of the patient and the registration device positioned on the surface of the anatomical area of the patient, • A step of building a three-dimensional digital model from the medical images obtained during the step of acquiring the patient's anatomical area, "A step of identifying radio-opaque fiduciary markers integrated into the registration device, • A step of calculating the registration, • A step of display of the readjusted three-dimensional digital model, and • An intervention planning stage using the readjusted three-dimensional digital model.
    The use of the registration device according to the first aspect of the invention is part of an approach aimed at fluidifying and accelerating the process of acquiring and locating an anatomical area of a patient.
    Other particularities and advantages will appear in the detailed and nonlimiting description of three exemplary embodiments of the invention, illustrated by Figures 1 to 9 placed in the appendix and in which;
    - Figure 1 is a perspective representation of a registration device according to a first embodiment of the invention, this representation revealing the opaque radio fiduciary markers arranged inside ['inside the transparent radio body;
    Figure 2 is a perspective representation of the registration device of Figure 1, in which the · organization plans of the radio opaque fiduciary markers are shown schematically;
    - Figure 3 is a schematic representation of a cross section of the device of Figure 1, in which the fiduciary markers are organized according to two organization plans;
    - The Figure 4 is a perspective representation of the registration device of Figure 1 equipped with a navigation target;
    - Figure 5 is a perspective representation of the registration device of Figure 1 equipped with another type of navigation target;
    - Figure 6 is a perspective representation of the registration device of Figure 1 equipped with yet another type of navigation target;
    - Figure 7 is a perspective representation of the registration device of Figure 1, wherein the registration device comprises a support fixed in the vicinity of the transparent radio body;
    - Figure 8 is a perspective representation of a registration device according to a second embodiment of the invention, wherein the transparent radio body is equipped with a stabilization system;
    - Figure 9 is a perspective representation of the registration device of Figure 8, in which the transparent radio body is equipped with another navigation target; Figure 10 is a perspective representation of the registration device of Figure 8 disposed at an anatomical area of interest of a patient, in this case his spine;
    - Figure 11 is a representation of a side section of the registration device arranged at an anatomical area of interest;
    - Figure 12 is a representation of a robotic assisted surgery system in which is used a registration device according to the invention;
    FIG. 13 is a representation of a semi-automatic locating technique for the opaque radio fiduciary markers of a registration device according to the invention;
    - Figure 14 is a representation of a manual tracking technique of the opaque radio fiduciary markers of a registration device according to the invention; and FIG. 15 is a perspective representation of a type of surgical intervention that can be performed after implementation of a registration process using a registration device according to the invention.
    The object representations of the figures show different aspects of several possible models, knowing that they are only of value as an example, and that other configurations are also covered by the invention. All these representations relate to a registration device 1 used during the acquisition of medical images of an anatomical zone 2 of interest of a patient. The anatomical zone 2 of interest corresponds in fact to the anatomical zone 2 on which the surgeon performs surgery.
    It should be noted that in this document, the term reference is used to designate the expression "coordinate reference".
    When acquiring medical images, the use of a registration device 1 positioned at the level of the anatomical area 2 of interest makes it possible to readjust all the reference frames of the elements taking part in the surgery to come with the repository of the three-dimensional digital model obtained from medical images. In other words, said use makes it possible to readjust the reference frame of the three-dimensional digital model with the patient reference frame and the frame of reference of a navigation system so as to locate the real position of the anatomical area 2 of interest in the frame of reference of the system. navigation. Then, a registration of the reference systems of the navigation system and of the robotic arm makes it possible to determine the position of the anatomical zone 2 of interest in the reference system of the robotic arm. Conditions are then in place for the surgery to begin.
    With this in mind and as illustrated in FIGS. 1 to 12, the registration device 1 consists of a body 3 of parallelepipedal shape, in this case a rectangular body in the form of a plate. The plate has an upper face 4 opposite to a lower face 5, the lower 5 and upper 4 faces constituting the long sides of the plate and being connected by lateral edges 6. The lower face 5 of your plate constitutes a surface of support 7 of the registration device 1 intended to be placed manually on the anatomical area 2 of interest of the patient.
    The body 3 of the registration device is a transparent radio body 3 produced from a transparent sterilizable radio material such as, for example, polyetheretherketone, generally designated by the term "PEEK".
    As illustrated in FIGS. 1 to 11, the body 3 of the registration device 1 includes fiduciary markers 9 opaque radios, the radiopacity resulting from the properties of the material from which they are made (for example made of metal). In this case, the fiduciary markers 9 opaque radios are simply formed by spheres of common diameter, for example equal to 4 mm. In order to be identifiable, the fiduciary markers 9 must have dimensions that meet several constraints. More specifically, the dimensions of the fiduciary markers 9 must be large enough to be identifiable in medical images without, however, influencing the dimensions of the device. 1. The latter must also remain compact to maintain its practicality of use and its maneuverability. In this context, each fiduciary marker 9 can then have a diameter of between 3 mm and 5 mm, and preferably a diameter of 4 mm. In addition, from the moment when they are identifiable on medical images, each fiduciary marker 9 can have shapes and dimensions which can be identical or distinct. In the present case, these fiduciary markers 9 opaque radios are arranged inside the body 3 of the registration device 1.
    In your exemplary embodiments illustrated in FIGS. 1 to 12, the fiduciary markers 9 are arranged in the same plane at predetermined locations according to a specific geometric pattern. Preferably, within a specific geometric pattern, the fiduciary markers 9 are organized according to an asymmetrical geometric pattern. The asymmetrical nature of the arrangement of fiduciary markers 9 in a specific geometric pattern has the advantage of ensuring, whatever the angle of view, a certain identification of a minimum number of fiduciary markers 9 within a model three-dimensional digital construction based on images from the acquisition of the anatomical area. This certain identification of the fiduciary markers 9, ensures a certain location of the position and the orientation of the registration device in a three-dimensional digital model constructed from images resulting from the acquisition of the anatomical area.
    In order to further increase the possibilities of locating fiduciary markers 9 in operating shots, the registration device 1 comprises several specific geometric patterns. Advantageously, these specific geometric patterns are distinct from each other and organized according to parallel planes, each geometric pattern corresponding to a given plane and containing a predetermined number of fiduciary markers 9. This organization into different geometric patterns positioned according to parallel planes gives Several advantages of the invention: on the one hand, it ensures better identification of fiduciary markers j in operating shots, and on the other hand it makes it possible to maintain a compact character I with the registration device 1. I
    More particularly, in the configuration shown in FIGS. 2 and 3, the fiduciary markers J are arranged in two specific geometric patterns arranged j) respectively on two parallel planes. As illustrated in FIG. 3, each geometric pattern organizes your fiduciary markers 9 separately: a first geometric pattern j is represented by its fiduciary markers S illustrated by continuous circles I, while a second geometric pattern comprises fiduciary markers 9 which 1 are represented by discontinuous circles. The fiduciary markers 9 of the second geometric pattern do not in any configuration cover the fiduciary markers 9 of the first geometric pattern, thus minimizing the errors of identification of said fiducial markers 9 in the three-dimensional digital model generated from medical images.
    Generally, a three-dimensional medical image acquisition system takes a multitude of two-dimensional images in order to construct a three-dimensional volume of the anatomical area 2 of interest. The data contained in this three-dimensional volume is then processed so as to generate a three-dimensional digital model of the anatomical zone 2 of interest. In this case, the three-dimensional reconstruction uses the same type of two-dimensional sections resulting from the three-dimensional volume generated by the medical image acquisition system. These cuts are then assembled according to a certain number of criteria such as the thickness and the distance between each cut, which must be homogeneous in a series in order to build a three-dimensional model as faithful as possible.
    According to an additional characteristic of the invention, each fiduciary marker 9 can have predetermined specific dimensions. This property further reduces the risk of confusion when locating fiduciary markers 9 in the operating images by adding additional recognition data for said fiduciary markers 9 opaque radios, data which is a function of dimensions.
    In the example illustrated in FIGS. 4 to 10, the registration device 1 comprises navigation markers 1.0 located in the vicinity of the upper face 4 of the transparent radio body 3. In the present case, the navigation markers 10 are optical type navigation markers 10, that is to say, they can be located by an optical navigation system. Preferably, these inactive optical navigation markers 10 are formed by reflective spheres. The reflecting spheres are covered with a coating which is advantageously sterilizable and which reflects light and more particularly infrared rays. In order to further improve their recognition, each reflective sphere can have its own dimensions.
    According to a variant of the invention, an active type optical navigation marker 10 can also be chosen. In this case, it can be formed by a light-emitting diode called "-LED". Unlike an inactive optical navigation marker 10, which can be identified by an optical navigation system due to the nature of its external coating, an active optical navigation marker 10 is only visible by an adequate optical system when powered by an energy source.
    According to another variant of the invention, a navigation marker 10 can be chosen of the electromagnetic type, capable of being identified by an electromagnetic navigation system. In one possible example, it may be induction coils immersed in a magnetic field.
    Ultimately, due to the known geometric relationship between the fiduciary markers 9 and the navigation markers 10 of a registration device 1, it is possible to locate the position and the orientation of the registration device 1, and therefore of the anatomical zone 2 of the patient by a navigation system.
    For reasons relating to the quality of the location of the actual position and orientation of the registration device 1, the latter must include at least three navigation markers 10 arranged in a predetermined spatial configuration. Advantageously, as already mentioned, each navigation marker 10 can moreover have different dimensions, making it possible to identify it more quickly and with certainty.
    The navigation markers 10 are fixed in the vicinity of one of the edges 6 of the transparent radio body 3 of the registration device 1. They may be dependent on a support 11 distinct from the body 3 of the device 1 of the invention. Preferably, in this case, the support for these navigation markers 10 is made of a transparent radio material.
    As illustrated in FIGS. 4 and 9, the registration device 1 comprises five navigation markers 10 arranged spatially in a cross pattern with diagonal branches. A navigation marker 10 is placed in the center, and the other four are placed at each corner of the body 3. In the configuration shown in these figures, each optical navigation marker 10 is individually fixed to the body 3 of the transparent registration device 1 via a rod-shaped support 11.
    In the variant illustrated in FIGS. 5 to 8 and 10, the navigation markers 10 comprise a support 11 with four branches. At each end of each branch is disposed a navigation marker 10 forming a navigation target 12 orientable in a predetermined direction. According to this configuration example, the navigation target can be in the form of a cross with four branches (as illustrated in FIGS. 5, 6, 8 and 10).
    According to a feature illustrated in Figures 5 and 6, the support 11 is formed by a telescopic arm which can take several positions by axial longitudinal translation.
    In each position, the geometric relationship between the navigation markers 10 and the fiduciary markers 9 is known.
    In the particular case of FIG. 6, the support 11 is connected to one of the edges 6 via a pivot attachment 13 allowing the navigation target 12 to take several known positions, in this case three positions. This characteristic makes it possible to vary the orientation of the target 12 and avoids any problem of masking and / or confusion with navigation markers of an operative monitoring target 14 anchored in a bone near the anatomical area of interest. (as illustrated in Figures 10 and 12).
    The support 11 also comprises removable fixing means 15, which can preferably be manipulated without tools relative to the body 3 of the registration device 1. In the present example, the removable fixing means 15 are formed by a clip 16 (illustrated in the figures 5 and 6). However, the removable fixing means 15 can also be formed by any means (for example a screw) making it possible, on the one hand, to hold the support 11 in a certain position, and on the other hand, to withdraw at leisure and manually.
    In the examples illustrated in FIGS. 8 to 10, the registration device 1 is provided with a stabilization system 17 able to adapt to your morphology of the anatomical area 2 of the patient. The stabilization system 17 is in this case formed by two lateral wings of curved shape forming shims 18. Each shim 18 is fixed in the vicinity of a lateral edge 6 of the registration device 1. Preferably, each shim 18 is connected to the registration device via an articulated mechanical junction allowing the wedges 18 to pivot and adapt to the patient's morphology.
    The two wedges 18 placed on either side of the body 3 cooperate in stabilizing the registration device 1 by resting on the patient's anatomy Their slightly curved configuration and the symmetry of their arrangement with respect to the body 3 of the 1 recalibration of the invention allow to exert on your anatomical area 2 of the resulting forces comprising vertical components, therefore parallel, oriented downwards, promoting stabilization by gravity, and opposite horizontal components, which work together to maintain the device 1 registration with respect to the patient's body.
    According to another possibility of the invention, the stabilization system 17 is made of a malleable material, at the very least flexible, and sterilizable capable of adapting to the morphology of the patient. In order to keep the registration device 1 in a stable position during the acquisition of the images, the malleable material used also has a certain mechanical rigidity. This stabilization system 17 allows immediate manual positioning of the resection device 1 at the level of the anatomical area 2 of interest to the patient. By a simple manual application by the operator, the shape of the stabilization system 17 can be "shaped" so as to adapt to the patient's morphology.
    During the acquisition of medical images, said stabilization system 17 is sufficiently successful to keep the registration device 1 stable, in the correct position, and this in a non-invasive manner. This stabilization system 17 therefore offers great simplicity of installation, also contributing to increasing the speed and fluidity of the installation procedure, while maintaining a non-invasive character eminently beneficial to the patient.
    As illustrated in FIG. 11, the registration device 1 has dimensions calibrated so that it is fully integrated into a field of vision 19 of a medical imaging system. The objective of this calibration is to facilitate the identification of a maximum of fiduciary markers 9 by adapting the registration device 1 to the field of vision 19 of the imaging system with which it must in principle operate. In this specific case, the registration device 1 rests on a surface 20 of the anatomical area of interest 2, in this case on the patient's skin. The field of vision 19 of the medical imaging system encompasses the entire device. 1 and also the anatomical area of interest 2, in this case the patient's spine.
    In the example illustrated in FIG. 12, the use of the registration device 1 is part of the more general context of a surgery system 21 with robotic assistance guided by imagery.
    In this case, said system 21 includes a robotic arm 22 for surgical assistance, preferably a robotic arm having six degrees of mobility, a navigation system 23, preferably an optical navigation system, and also a data acquisition system. 'conventional three-dimensional medical imaging 24, of the "C-arm" type in the example shown. This surgery system 21 makes it possible to support the surgical procedure by displaying in real time an image of a three-dimensional digital model of the anatomical surfaces and images of the linked sections (axial, coronal and sagittal), in which one can observe the position and / or the action of the surgical tools on screens coupled to the robotic arm 22 and to the navigation system 23.
    In the context of a surgical operation carried out with this surgery system 21 illustrated in FIG. 12, in this case for spine surgery, the patient is installed in the prone position, that is to say on the belly, so that its spine is available to position the registration device 1.
    The surgical procedure includes real-time operative monitoring based on a navigation system 23 and a target 14 for operative monitoring. In the example illustrated in FIG. 10, the operative monitoring target is a target 14 which is implanted in a bone part I of the patient's spine during the preparation of the patient. This operative monitoring target j makes it possible to follow the movements of the patient during the entire operating protocol. The navigation device is suitable for locating j optical navigation markers in a three-dimensional coordinate system, the j system of which
    K navigation 23 is the origin. As a result, the navigation device 23 makes it possible in particular to detect and follow the movements of the tracking target 14 anchored in the spine, which makes it possible to keep under control the trajectory of the robotic arm 22 which is slaved to the detected movements. The detected movements can be displacements of the spine resulting from 1a. breathing of the patient or efforts exerted by the surgeon.
    The operative monitoring target 14 also makes it possible to identify the position of the patient relative to the position of the registration device 1, and thus to locate the actual position of the patient relative to the registration device 1.
    The navigation system 23 can also be used during the acquisition of the images in order to check if the registration device 1 is not moving. If a movement is detected, a warning is sent to the user, asking him to restart a new procedure for acquiring images of the anatomical area 2 d
    S of interest. j
    Surgical procedure using robotic assisted surgery system 21 | also includes a step of resetting the robot and the navigation system 23 by one!
    optical tracking. To this end, an optical target is positioned at the end of the robotic arm 22. The robotic arm 22 equipped with the optical target then takes at least three predefined positions around the operating field. During this tracking, the navigation system 23 locates the robotic arm 22 in its repository. At the same time, the | navigation system 23 controls that a navigation target fixed to the robot remains j
    I 'immobile, meaning that the base of the robot does not move. In the opposite hypothesis, that is to say in the event of movements of the robot base, a new robot / system registration of 1
    I navigation is done. I
    I
    Another step in the operating protocol obviously involves putting the patient under anesthesia, and also under respiratory apnea for the entire duration of the acquisition of medical images. This step makes it possible to limit the patient's respiratory movements, thereby improving the clarity of the images resulting from the acquisition of the patient's anatomical area of interest.
    In order to locate the patient's actual position on the operating table, the navigation system 23 locates in its repository the target 14 for operative monitoring. The coordinates of the operative monitoring target 14 can then be transposed into the repository of the robotic arm 22 via the specific registration between the robotic arm 22 and the navigation system 23.
    At this stage, the acquisition and identification of the anatomical area 2 of interest begins: it is during this phase that the registration device 1 of the invention finds its usefulness. In practice, this phase makes it possible to precisely locate the position of the anatomical area 1 of interest in the repository of the navigation device 23 and indirectly of the robotic arm 22.
    The acquisition phase includes a step of positioning the registration device 1 at the anatomical area 2 of interest. In this. Indeed, the surgeon or an operator manually deposits and positions the registration device 1 of the invention on the patient's back. More precisely, the registration device 1 is placed, in the field of vision 19 of the medical imaging system 24, at the level of the anatomical zone 2 of interest, Celtic which will be the subject of a surgical operation, by example at the level of a vertebra.
    The nursing staff is then placed in safety in order to be protected from the ionizing rays which are emitted during the acquisition of data on the anatomical area 2 of interest, while the registration device 1 is in position. This acquisition is carried out by a conventional three-dimensional medical imaging acquisition system, for example of the "Oarm" or "C-arm 24" type.
    This acquisition phase is followed by a step of constructing a three-dimensional intraoperative digital model of the anatomical area 2 of interest from two-dimensional medical images - according to a single type of cut, for example axial. This construction stage consists in assembling two-dimensional medical images, for example in the context of a “multi-planar reconstruction”.
    A step of locating fiduciary markers 9 radiopaque in the intraoperative three-dimensional digital model is then implemented. It is performed by an operator, for example the surgeon, on a control screen. Fiduciary markers 9 can be identified in medical images because of their radio opaque nature and the specific geometric pattern according to which they are organized. Thus, during the acquisition of your anatomical area 2 of interest, a residual image of each fiduciary marker 9 is generated in the form of a white spot of a certain light intensity.
    In order to identify each fiduciary marker 9 in the three-dimensional digital model, there are three methods, an automatic method, a semi-automatic method as illustrated in FIG. 13 and a manual method illustrated in FIG. 14.
    In all three cases, specific data processing software displays in a first window 25 the three-dimensional digital model resulting from the acquisition of the anatomical area 2 of interest, in a second window 26 an image of an axial section of the model three-dimensional digital image, in a third window 27 an image of a sagittal section of the three-dimensional digital model, and in a fourth window 28 an image of a coronal section of said three-dimensional digital model, The user can thus "navigate" in the digital model three-dimensional while viewing the different sections displayed by the software. He must then select the sections in which a maximum of fiduciary markers 9 are visible, and preferably all of the fiduciary markers 9 of the registration device 1.
    The manual identification technique illustrated in FIG. 14 consists in manually selecting with the aid of a cursor the center of each fiduciary marker 9. The fiduciary markers 9 can be identified in the three-dimensional digital model by means of their remanent image, of a certain intensity. Once a fiduciary marker 9 has been identified in an image of the three-dimensional model, the operator selects it using the cursor, which zooms in on the desired part of the image. The operator can then point, using the cursor, the center of said fiduciary marker 9. The software then records the coordinates of the positions of the centers of each fiduciary marker 9 selected by the user in the repository of the three-dimensional digital model.
    In order to help the operator to best select the center of each fiduciary marker 9, the selection of the center being carried out visually, an option of the software allows via a specific algorithm, once the fiduciary marker 9 manually selected by the operator, to identify the center of each fiduciary markers 9 by calculating the weighted barycenter of each afterimage of the fiduciary markers 9.
    In the case of the semi-automatic identification technique illustrated in FIG. 13, the operator manually defines a box including the most visible fiduciary markers 9 possible on each cut. This bounding box makes it possible to define a volume containing the fiduciary markers 9 and to select the set of fiduciary markers 9 contained in the defined volume.
    A specific algorithm then allows automatic recognition in this defined volume, by use of an intensity threshold effect, of fiduciary markers 9 in the three-dimensional digital model, by calculating the weighted barycenter of the apparent afterimages of fiduciary markers 9,
    To this end, the luminous character of each retentive image of fiduciary markers 9 is used to distinguish the pixels corresponding to the fiduciary markers 9 from the pixels of the rest of each medical image. In practice, a luminance threshold is calculated, for each medical image, making it possible to distinguish your pixels belonging to each fiduciary marker 9, and then to calculate a weighted barycenter from these pixels. The luminance threshold corresponds to the value for which the number of pixels in the image corresponds to the number of pixels making up a 2 mm radius disc. This disc corresponds to the intersection of a fiduciary marker 9 of the registration device 1 with a plane passing through its center.
    In the case of the automatic identification technique, a specific algorithm makes it possible to automatically identify the fiduciary markers 9 present in the three-dimensional digital model by scanning the entire volume of the three-dimensional digital model, each remanent image of fiduciary marker being identified using a luminance threshold representative of the intensity of a fiduciary marker 9 in medical images.
    In order to ensure a certain identification of the registration device 1, a minimum of fiduciary markers 9 must be identified. An insufficient number of fiduciary markers 9, for example less than eight, would imply several solutions for locating its orientation and would cause an inaccuracy of the re-registration.
    This extreme case can occur within the framework of each identification technique previously described. The software then informs the user that there are not enough fiduciary markers 9 identified to locate the registration device 1 with certainty, which can generate registration errors which in turn generate an imprecise registration which inevitably leads to imprecise monitoring and operational guidance.
    When a sufficient number of fiduciary markers 9 is identified within the three-dimensional digital model, the software, knowing the geometric relationship between the navigation markers 10 of the registration device 1 and the fiduciary markers 9, is able to locate with certainty the anatomical area 2 of interest in the reference system of the navigation system 23, the robotic arm 22 and the patient
    Thus, the surgeon is able to plan the surgical intervention during the intervention planning stage. This uses the recalibrated three-dimensional digital model. The surgeon can choose the type of tool or implant (for example pedicle screws, the diameter and length of which can be set by the surgeon), and then set the most appropriate path for positioning the tools or implants. Out of this, the surgeon can select a target point and an entry point in the three-dimensional model. The images of the tools and / or implants can then be viewed, by overlay, on the images of the three-dimensional model readjusted in order to simulate the intervention in real time.
    As shown in FIG. 15, the operating protocol then includes a step of preparing the robotic arm 22 for surgical intervention. In this step, the surgeon mounts an instrument holder 29 at a free end 30 of the robotic arm 22. The robotic arm 22 equipped with the instrument holder is then guided on the path previously defined in the planning step.
    Then, the operating protocol includes a piercing step in which the surgeon inserts a rigid cannula 31 in the instrument holder 29 until reaching the bones of the vertebra to be pierced. A drill 32 is introduced inside the cannula 31 and brought into contact with the area to be drilled so as to form a hole in a pedicle. The drill 32 is removed is replaced by a second cannula thinner than the rigid cannula 31, which guides the insertion of a guide pin into the body of the vertebra.
    It should be noted that throughout this operation, the movements of the patient, in particular related to his breathing, are followed in real time by the navigation system 23. These movements of the patient can be taken into account so as to constrain the efforts exerted by the surgeon according to the movements of the patient.
    权利要求:
    Claims (16)
    [1" id="c-fr-0001]
    Claims
    1. Registration device (1) used during the acquisition of images of an anatomical area (2) of a patient during surgery with robotic assistance, comprising a body (3) of transparent radio material which comprises fiduciary markers (9) made of a radio opaque material, said body (3) having a bearing surface (7) intended to be placed manually on a surface (20) of said anatomical area (2) of the patient, characterized in that that said fiduciary markers (9) are arranged according to at least one specific geometric pattern allowing a certain location of the position and the orientation of the registration device (1) in a three-dimensional digital model constructed from images resulting from the acquisition of the anatomical area (2).
    [2" id="c-fr-0002]
    2. Registration device (1) according to claim 1 characterized in that your fiduciary markers (9) of the same geometric pattern are arranged in a coplanar manner.
    [3" id="c-fr-0003]
    3. Registration device (1) according to one of claims 1 and 2, characterized in that the fiduciary markers (9) within the same geometric pattern are organized asymmetrically.
    [4" id="c-fr-0004]
    4. Registration device (1) according to one of claims 1 to 3, characterized in that it comprises a plurality of distinct specific geometric patterns organized according to a plurality of parallel planes.
    [5" id="c-fr-0005]
    5. Registration device (1) according to one of claims 1 to 4, characterized in that your fiduciary markers (9) have a spherical shape.
    [6" id="c-fr-0006]
    6. Registration device (1) according to one of claims 1 to 5, characterized in that it comprises at least one navigation target (12) equipped with at least three navigation markers (10), the relation of which geometric with fiduciary markers (9) is predetermined.
    [7" id="c-fr-0007]
    7. Registration device (1) according to claim 6, characterized in that the navigation markers (10) are of passive type.
    [8" id="c-fr-0008]
    8. Registration device (1) according to claim 6, characterized in that the navigation markers (10) are of the active type.
    [9" id="c-fr-0009]
    9. Registration device (1) according to claims 7 and 8, characterized in that Its navigation markers (10) are optical navigation markers.
    [10" id="c-fr-0010]
    10. Registration device (1) according to claims 7 and 8, characterized in that the navigation markers (10) are electromagnetic navigation markers.
    [11" id="c-fr-0011]
    11. Registration device (1) according to one of claims 6 to 10, characterized in that the navigation markers (10) are placed on a support (11) comprising removable fixing means (15),
    [12" id="c-fr-0012]
    12. Registration device (1) according to claim 11, characterized in that the support- (it) is a telescopic arm which can take several positions, the geometric relationship between the navigation markers (10) and your fiduciary markers (9) in each position being predetermined.
    [13" id="c-fr-0013]
    13. Registration device (i) according to one of claims 1 to 12, characterized in that it is provided with a stabilization system (17) relative to the patient's body.
    [14" id="c-fr-0014]
    14. Registration device (1) according to claim 13, characterized in that the stabilization system is made of a malleable material adaptable to the surface (20) of the anatomical area (2) and capable of holding the device in position. registration (1) during image acquisition.
    [15" id="c-fr-0015]
    15. Surgical system (21) with robotic assistance guided by the image implementing a registration device (1) according to one of claims 1 to 14, characterized in that it comprises a robotic arm (22) d assistance and a navigation system (23).
    [16" id="c-fr-0016]
    18. A method of acquiring and locating an anatomical area of a patient for the preparation of a surgical intervention using a registration device (1) according to one of claims 1 to 14 in a surgery system (21) according to claim 15, characterized in that it comprises:
    • A step of preparing the acquisition of images of the anatomical area of the patient comprising an installation of a patient, a navigation system (23), a medical imaging system and a robotic arm (22) for assistance with surgery, • A step of manually placing the registration device (1) on a surface (20) of an anatomical area (2) of the patient and in a field of vision (19) of a medical imaging system (24), • A step of acquiring a position of the registration device (1) by the navigation system (23), • A step of acquiring by the navigation system (23) of a position of a target 14 for operative monitoring of the anatomical area (2) of the patient, • A step of securing the nursing staff, • A step of acquiring images of the anatomical area- (2) of the patient and of the registration device (1) positioned on the surface (20) of the patient's anatomical area (2), • One step of construction of a three-dimensional digital model from medical images obtained during the step of acquiring the patient's anatomical area (2), • A step of identification of radio opaque fiducial markers (9)
    5 integrated into the registration device (1), • A step of calculating the registration, • A display step of the re-aligned three-dimensional digital model, and • A step of planning the intervention using the recalibrated three-dimensional digital model.
    3/6
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    同族专利:
    公开号 | 公开日
    US11234789B2|2022-02-01|
    US10675116B2|2020-06-09|
    EP3528738A1|2019-08-28|
    CA3050516A1|2018-04-26|
    CN110352042A|2019-10-18|
    US20200330180A1|2020-10-22|
    US20190274775A1|2019-09-12|
    FR3057757B1|2021-04-16|
    WO2018073452A1|2018-04-26|
    CA3050516C|2021-04-13|
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    法律状态:
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    2018-04-27| PLSC| Publication of the preliminary search report|Effective date: 20180427 |
    2018-10-15| PLFP| Fee payment|Year of fee payment: 3 |
    2019-09-20| PLFP| Fee payment|Year of fee payment: 4 |
    2020-09-17| PLFP| Fee payment|Year of fee payment: 5 |
    2021-09-13| PLFP| Fee payment|Year of fee payment: 6 |
    优先权:
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    FR1660264A|FR3057757B1|2016-10-21|2016-10-21|AUTOMATIC REGISTRATION DEVICE AND METHOD FOR 3D INTRA-OPERATIVE IMAGES|
    FR1660264|2016-10-21|FR1660264A| FR3057757B1|2016-10-21|2016-10-21|AUTOMATIC REGISTRATION DEVICE AND METHOD FOR 3D INTRA-OPERATIVE IMAGES|
    EP17798110.7A| EP3528738A1|2016-10-21|2017-10-23|Device and method for automatic recalibration for 3d intraoperative images|
    US16/343,743| US10675116B2|2016-10-21|2017-10-23|Device and method for automatic recalibration for 3D intraoperative images|
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    PCT/EP2017/077003| WO2018073452A1|2016-10-21|2017-10-23|Device and method for automatic recalibration for 3d intraoperative images|
    US16/868,139| US11234789B2|2016-10-21|2020-05-06|Device and method for automatic recalibration for 3D intraoperative images|
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