Assisting system for the fixation of a surgical implant in a patient's bone

Abstract

The invention relates to an assistance system (1) for fixing a surgical implant (2) to a bone by means of a locking piece inserted into a fixation hole in the bone, which is configured to be positioned opposite a fixation hole of the implant. The assistance system comprises: - a localization module (40) comprising at least one sensor of the image detector or infrared detector type, a processing module (60) and a display module (30); - a first device (10) configured to mechanically engage with the implant and comprising a first positioning element (13) configured to be detected by the localization module; and - a second device (20) comprising a second positioning element (21) configured to be detected by the localization module, and at least one calibration element configured to engage with the fixation hole of the implant during a calibration step.

Description

[Technical field]

[0001] The invention relates to the field of surgical implant fixation and more particularly to an assembly comprising a surgical implant and a system for assisting in the fixation of the implant in a patient's bone. [State of the art]

[0002] Some surgical procedures, particularly in orthopedic surgery, require the insertion of an implant into a bone and then locking that implant in place using at least one key or equivalent. More specifically, the surgery involves inserting the implant into the bone in one direction and locking it in a second direction, different from the first, so that the locking is achieved through the bone without the surgeon being able to visually see the implant.

[0003] In anticipation of locking, the implant includes, on a part inserted into the bone, at least one fixation hole, and preferably at least two fixation holes.

[0004] As described previously, the locking step is performed after the implant has been inserted into the bone. Therefore, the surgeon beginning the locking step can no longer see the implant and thus no longer sees the fixation hole.

[0005] The locking step involves drilling a hole in the bone, hereafter referred to as the attachment hole, opposite the implant's fixation hole. A locking component, which can be a screw, a pin, or a nail, is then inserted into both the attachment and fixation holes. This locking step is repeated for each fixation hole. It is essential that the bone drilling for the attachment hole be precise so that the attachment hole has a diameter close to that of the implant's fixation hole and to that of the locking component.

[0006] There are solutions that make it easier to create the attachment hole in relation to the fixing hole.

[0007] For example, a known solution from document DE102010041914 consists of using a locating frame, one end of which is fixed to the implant and the other end carries a drilling guide, one elongation axis of which coincides with the fixing hole.

[0008] However, the locating frame is bulky, expensive to produce, and requires the prior assembly of several parts, which can lead to positioning errors. Furthermore, the locating frame can sometimes be inadvertently deformed, preventing the attachment hole from being aligned with the fixing hole.

[0009] A solution using X-ray images to determine the location of the fastener hole and the drilling tool is also known from document WO03043485. In this solution, an X-ray image is taken until the drilling tool is in the ideal position to create the fastener hole aligned with the mounting hole.

[0010] This solution results in radiation exposure for both the patient and the surgeon and is time-consuming to implement.

[0011] The prior art can also be illustrated by documents WO2007 / 133168 and US2010 / 0274121, which propose assistive systems with a first sensor inserted inside the implant and a second sensor mounted on a drilling guide. These sensors are active, for example, magnetic, and detect each other. They are connected, usually by wire, to a processing unit that receives the measurement data from both sensors. These solutions therefore require the surgeon to move the drilling guide "blindly" over the bone until the measurement data from the two sensors indicates alignment between the drilling guide and the fixation hole in the implant.Such a procedure is therefore impractical, and also unreliable when it comes to aligning the drilling guide successively with two implant fixation holes, because the measurement data from the sensors often have insufficient sensitivity to distinguish two fixation holes that are close together by 1 to 3 centimeters.

[0012] That is why there is still a need for a reliable technical means of drilling the bone opposite the implant fixation point. [Summary of the invention]

[0013] The invention aims to provide a technical means of resolving at least partially the disadvantages described above.

[0014] Another object of the invention is to provide a technical means to enable the surgeon to save time in order to reduce the level of stress he experiences during the surgical operation, and in order to reduce the risk of infection for the patient.

[0015] Another object of the invention is to enable the surgeon to improve the positioning of the drilling tool relative to the fixation orifice, and thus ultimately to offer the patient optimal implant fixation.

[0016] Another object of the invention is to provide an easy-to-use technical means to reduce the risk of incorrect assembly during use by the surgical team.

[0017] Another object of the invention is to reduce the manufacturing costs of an implant by reducing the precision of the positioning of the fixation orifice on the implant.

[0018] One or more of these objects are fulfilled by the set according to the independent claim.

[0019] Dependent claims further provide solutions to this purpose and / or other benefits.

[0020] The invention relates to an assembly comprising a surgical implant and an assistance system for fixing the implant to a bone by means of a locking piece inserted into an attachment hole in the bone, which is configured to be positioned opposite a fixation hole in the implant, the assistance system comprising: a first device configured to be mechanically coupled to the implant and comprising a first positioning element configured to be detected by a localization module; a second device comprising a second positioning element configured to be detected by the localization module and a drilling guide configured to indicate a drilling axis; a localization module comprising at least one sensor using image detector or infrared detector technology, said localization module being configured to determine a positioning of the first positioning element and the second positioning element in a three-dimensional space of a reference frame associated with the localization module; a processing module connected to the localization module to receive the positioning of the first positioning element and the second positioning;a display module connected to the processing module and capable of displaying visual elements indicating the relative positioning of the fixing hole with respect to the drilling guide determined by said processing module; the assistance system being notable in that the second device also includes at least one calibration element configured to cooperate with the implant fixation orifice during a calibration step, prior to introduction of the implant into the bone, and in that the processing module is configured to: during the calibration step, determine a positioning of the fixation orifice in a reference frame of the first device from the positioning of the first positioning element and the second positioning element and mechanical dimensions referencing the position of at least one calibration element of the second device in a reference frame of the second device;and once the implant is inserted into the bone, determine the relative positioning of the fixation hole with respect to the drilling guide based on the positioning of the first positioning element and the second positioning element, the positioning of the fixation hole in the reference frame of the first device, and mechanical dimensions specifying the position of the drilling guide in the reference frame of the second device.

[0021] Thus, the assistance system allows the drilling guide to be positioned opposite the implant fixation hole without any mechanical, physical, or wired connection between the first and second devices, nor between the first device and the treatment module, or between the second device and the treatment module. It is through the use of the localization module, the display module, and the treatment module, which are located remotely from the first and second devices, that the surgeon performing the implant fixation knows precisely the location of the fixation hole relative to the drilling guide.

[0022] As mentioned above, the localization module includes a sensor based on image detection or infrared detection technology to detect the positions of the first positioning element of the first device and the second positioning element of the second device. In various embodiments, this sensor may be, for example, a camera or a photographic device, capable of operating in the visible or infrared spectrum (or even in another wavelength range).

[0023] It is therefore quite clear that the first positioning element and the second positioning element form passive elements, because they are detected by imaging (in visible, infrared or other), and do not require a connection between them and with the localization and processing modules.

[0024] It should be noted that the processing module is linked to a memory storing the mechanical dimensions referencing the position of at least one calibration element of the second device in a reference frame of the second device, and the mechanical dimensions specifying the position of the drilling guide in the reference frame of the second device.

[0025] It should be noted that the processing module is configured to transmit the relative positioning of the fixing hole with respect to the drilling guide to the display module so that the latter displays and represents it by means of visual elements.

[0026] When the surgeon uses the assistance system, the procedure begins with a mechanical coupling step during which the surgeon attaches the first device to the implant. The first device is thus permanently fixed to the implant. There is no relative movement between the two.

[0027] Next, the surgeon performs a calibration step during which the second device is brought close to the implant so that at least one calibration element of the second device aligns with and cooperates with the implant's fixation port. This calibration step is made possible by the presence of at least one calibration element on the second device. To perform this calibration step, the surgeon therefore makes the at least one calibration element of the second device cooperate with the implant's fixation port by inserting it into the port.During the calibration step, the localization module detects both the first positioning element (which is mounted on the implant) and the second positioning element (which is mounted in the implant's fixation port(s)). This allows it to determine, within its own three-dimensional reference frame, the positioning of the first positioning element of the first device and also the positioning of the second device, which is also expressed in the reference frame associated with the localization module. During the calibration step, the positions of the first and second devices are transmitted to the processing module, which determines, using mechanical dimensions that reference the position of at least one calibration element of the second device in a reference frame of the second device, the positioning of the fixation port in a reference frame of the first device.In addition, since the drill guide is fixed relative to at least one calibration element, the mechanical dimensions also reference a position of the drill guide of the second device in a reference frame of the second device.

[0028] The surgeon then inserts the implant, still equipped with the first device, into the patient's bone during an insertion step. This first device is fixed to the implant so that, when the implant is inserted into the bone, it remains detectable by the localization module, which can determine its position in the three-dimensional space associated with its reference frame using the first positioning element. The implant, and therefore the fixation port, is then no longer visible to the surgeon. Only the first positioning element of the first device remains detectable (because it is visible) by the localization module. The position of this first positioning element is expressed in the reference frame associated with the localization module. The surgeon can then perform a placement step for the second device based on the visual elements of the display module.

[0029] In other words, the surgeon positions the second device near the bone so that the drilling guide indicates the drilling axis. The localization module then determines the positioning of the first and second devices in the reference frame associated with the localization module. This information is transmitted to the treatment module, which, using the positioning of the first and second devices in the reference frame associated with the localization module, the positioning of the implant fixation port in the reference frame of the first device (as determined beforehand during the calibration step), and the mechanical dimensions specifying the position of the drilling guide in the reference frame of the second device, deduces the relative positioning of the fixation port with respect to the drilling guide. In other words, the treatment module expresses the relative positioning of the fixation port with respect to the drilling guide.

[0030] Thus, during this placement step, the display module indicates, using visual cues, the relative positioning of the fixation hole with respect to the drilling guide. The surgeon, by consulting the display module, moves the drilling guide to position it opposite the fixation hole.

[0031] When the position of the drilling guide is satisfactory to the surgeon, they proceed to drill the patient's bone to create the attachment hole opposite the fixation hole. To do this, they drill the bone along the axis indicated by the drilling guide.

[0032] Finally, the surgeon inserts the locking piece into the attachment hole and the fixation hole. The implant is then securely fixed to the bone.

[0033] The surgeon repeats the steps of placing the second device, and drilling the bone as often as there is a fixation hole on the implant.

[0034] After the implant is fixed, the first device is separated from the implant.

[0035] The assistance system according to the invention can then possibly be cleaned for reuse, if it is not for single use.

[0036] Thus, with the assistance system according to the invention, the surgeon saves time in implementing the assistance system and in positioning the drilling tool so as to create an attachment hole opposite the fixation hole.

[0037] Furthermore, the presence of at least one calibration element, the display module, the processing module, and the localization module, along with the first and second devices, ensures exceptionally precise positioning of the drilling tool relative to the fixation hole. Indeed, the absence of any mechanical or physical link between the first and second devices (and also between these two devices and the localization and processing modules) prevents any deformation of this link, which would lead to incorrect positioning, and also avoids any inconvenience for the surgeon.

[0038] The assistance system according to the invention is a user-friendly technical solution because the number of module parts is limited. The surgeon only handles the first and second devices. Therefore, there is no risk of incorrect assembly during use by the surgical team.

[0039] Finally, the use of the assistance system according to the invention reduces the manufacturing costs of the implant. Indeed, at least one calibration element allows for precise determination of the positioning of at least one fixation hole on the implant. Therefore, it is not necessary for the fixation hole to be manufactured with high positioning accuracy during the implant production process.

[0040] According to one embodiment, the drilling guide is a tube.

[0041] According to one embodiment, the implant comprises a plurality of fixation ports.

[0042] The invention may also have one or more of the following features taken alone or in combination.

[0043] According to one embodiment, the drilling guide includes at least one stabilizing tooth configured to stabilize the drilling guide on the bone.

[0044] According to one embodiment, the drilling guide includes a plurality of stabilizing teeth.

[0045] The stabilizing teeth are positioned at one end of the drill guide, which is designed to be aligned with the patient's bone. These teeth help maintain the drill guide in the position desired by the surgeon.

[0046] According to one embodiment, the second device has a holding part configured to allow it to be held during the use of the assistance system.

[0047] In one embodiment, the retaining portion is combined with the drilling guide. In another embodiment, an inner diameter of the drilling guide is chosen to facilitate the insertion of a drilling tool into the implant's fixing holes.

[0048] According to one embodiment, at least one calibration element is an elongation configured to be introduced into the fixing orifice.

[0049] According to one embodiment, the elongation is chosen from a stud and a pin.

[0050] According to one embodiment, the elongation of at least one calibration element extends along an axis substantially parallel to the drilling axis of the drilling guide.

[0051] According to one embodiment, the elongation of at least one calibration element has a diameter smaller than but close to that of the fixing orifice so as to be able to be introduced into the fixing orifice.

[0052] According to one possibility, at least one calibration element comprises at least two calibration elements extending in parallel, which is advantageous for having a stable mounting of the second device in the implant fixing holes during the calibration step.

[0053] In one embodiment, the first positioning element and / or the second positioning element are selected from a sensor and a geometry, said geometry being selected from: a QR code, a still image, a rigid body comprising at least one reflective marker, or at least three elongations positioned along three different directions. In one embodiment, the rigid body comprises at least three reflective spheres. When the positioning module comprises a sensor based on one or more infrared cameras, the first positioning element and / or the second positioning element have reflective markers that are rigidly attached. The markers may be spheres reflecting infrared rays.

[0054] The rigid body can include, for example, at least three elongations positioned along three different directions, the relative positioning of the elongations with respect to each other being fixed.

[0055] The elongations allow a reference plane to be determined and thus allow the localization module and the processing module to determine the position of the first device and the second device in the localization module's reference frame.

[0056] A localization module using infrared detectors offers significant accuracy.

[0057] According to one embodiment, the localization module used has an accuracy of less than 0.5 mm RMS according to ASTM F2554-18, or 0.2 mm and preferably less than 0.15 mm.

[0058] In one embodiment, each of the at least three reflective spheres is positioned respectively at a free end of one of the at least three elongations. In another embodiment, the localization module is fixed in a reference frame associated with the display module.

[0059] Thus the localization module and the display module have the same reference frame.

[0060] In one embodiment, the localization module and the display module are integrally connected. In another embodiment, the processing module is integrally connected to the display module.

[0061] Thus, the assistance system is particularly easy to install.

[0062] According to one embodiment, the display module is a screen, for example a television screen or a computer screen.

[0063] According to one embodiment, the visual elements show the drilling axis and a drilling target configured to indicate optimal positioning of a drilling tool relative to the fixing hole.

[0064] According to one embodiment, the visual elements indicate the fixing hole closest to the drilling guide.

[0065] According to one embodiment, the assistance system uses augmented reality technology in which the display module is capable of representing visual elements, superimposed in the field of vision of a user of the assistance system.

[0066] In this case, the display module is integrated into a helmet, glasses, or contact lenses worn by the surgeon. This allows the surgeon to directly see the bone to be drilled and, superimposed on this image, visual elements to assist in positioning the drilling guide.

[0067] According to one embodiment, the display module includes a localization device, the assistance system includes a matching module capable of determining a spatial relationship allowing the transformation of geometric descriptions expressed in a reference frame associated with the localization module, into geometric descriptions expressed in a reference frame associated with the localization device.

[0068] To achieve high accuracy, the augmented reality assistance system has a display module whose position relative to the localization device is known. Thus, the position of the display module is known within the localization module's reference frame.

[0069] The pairing module is an element detectable by both the location module and the location device.

[0070] According to one embodiment, the matching module includes at least one matching element selected from: a still image, a QR code, a three-dimensional geometry, at least three reflective spheres, a rigid body comprising at least one reflective marker or at least three elongations positioned along three different directions.

[0071] A method for using an assistance system according to the invention is also described, comprising: A mechanical coupling step during which the first device is attached to the implant; A calibration step during which at least one calibration element of the second device cooperates with the fixation hole of the implant; A step of introducing the implant into a patient's bone; A step of positioning the second device according to the visual elements of the display module; A step of drilling the bone so as to create the attachment hole opposite the fixation hole; A step of inserting the locking piece into the attachment hole and into the fixation hole.

[0072] When the implant has multiple fixation holes, the placement, drilling and insertion steps are repeated as many times as there are fixation holes.

[0073] The invention relates to an assembly comprising: an implant equipped with a fixation port, and an assistance system as described above; in which the first device of the assistance system is configured to be mechanically coupled to the implant, and at least one calibration element of the second device of the assistance system is conformed to collaborate with the fixation orifice of the implant during the calibration step to be performed before an introduction of the implant into a bone.

[0074] In other words, the calibration element of the second device is of complementary shape to the implant fixing orifice, to allow engagement by geometric correspondence. [Brief description of the figures]

[0075] The invention will be better understood from the following description, which relates to several embodiments of the present invention, given by way of non-limiting examples and explained with reference to the accompanying schematic drawings, in which: Figure 1 is a representation of a first device coupled to a surgical implant and a second device according to the invention; Figure 2 is a representation of the first device seen from the front; Figure 3 a representation of the second device from a side view; Figure 4 a representation of the second device seen from the front; Figure 5 a representation of the first device coupled to the surgical implant and of the second device during a calibration step; Figure 6 is a representation of a matching module that can be used in the invention; Figure 7 is a representation of the localization module, the processing module and the display module according to a first embodiment; Figure 8 is a representation of the visual elements of the display module according to the first embodiment when a drilling guide is not opposite a fixing hole; Figure 9 is a representation of the visual elements of the display module according to the first embodiment when the drilling guide is opposite the fixing hole; Figure 10 is a representation of the visual elements of the display module according to a second embodiment using augmented reality technology when the drilling guide is not opposite the fixing hole; Figure 11 is a representation of the first device coupled to a surgical implant and of the second device according to the invention during a drilling step; Figure 12 is a schematic representation of the assistance system and the implant during the calibration step. [Detailed description of one or more embodiments of the invention]

[0076] An assistance system 1 according to the invention, represented in figures 1 à 12 This allows a surgical implant 2 to be fixed in a patient's bone 3 by means of one or more locking pieces (such as a screw or pin), each locking piece being inserted into an attachment hole in the bone 3 and into a fixation hole 4 in the implant 2, which is located opposite the attachment hole. In this case, the implant 2 has two fixation holes 4 extending parallel to a transverse axis of the implant 2, and which are of the same diameter. The assistance system 1 comprises a first device 10, a second device 20, a display module 30, a localization module 40, and a processing module 60 connected to a memory 61, and with reference to the Figure 12 This assistance system 1 can be combined with implant 2 to form a set 100.

[0077] The first device 10 is more particularly represented in figure 2 This first device 10 includes a coupling part 11 which allows it to be mechanically and removably assembled to the implant 2. The first device 10 and the implant 2 are thus fixed to each other. In other words, any movement of one causes a movement of the other, and determining the position of one allows the position of the other to be determined.

[0078] The first device 10 includes at the end of a rod 12 a first positioning element 13. The first positioning element 13 is a rigid body having four elongations, each equipped at its free end with a reflective sphere 14. The four reflective spheres 14 define a spatial reference frame and are configured to be detected by the localization module 40, and more specifically by at least one infrared camera of the localization module 40.

[0079] The second device 20 is more particularly represented in figures 3 et 4 This second device 20 includes a second positioning element 21. The second positioning element 21, like the first positioning element 13, is also a rigid body having four elongations, each equipped at its free end with a reflective sphere 22. These four reflective spheres 22 define a spatial reference frame and are configured to be detected by at least one infrared camera of the localization module 40. The second device 20 also includes a drilling guide 23 and two calibration elements 24. The drilling guide 23, the calibration elements 24, and the second positioning element 21 are fixed together.

[0080] One end of the drilling guide 23 includes stabilizing teeth 25 which have a saw-tooth shape.

[0081] The drilling guide 23 is combined with a retaining part of the second device 20. The drilling guide 23 therefore has a length that allows for easy positioning of a hand or a mechanical attachment.

[0082] The drilling guide 23 has a diameter greater than a drilling tool 5 (and in particular a drill bit) used to make the attachment hole.

[0083] The calibration elements 24 comprise two extensions, which are studs or pins extending along an axis substantially parallel to the drilling axis of the drilling guide 23. The extensions have a diameter smaller than, but close to, that of the two mounting holes 4 so that they can be inserted into the two mounting holes 4 as shown in figure 5 , thus allowing the surgeon to implement the calibration step.

[0084] The localization module 40 includes, for example, two infrared cameras configured to detect the positioning of the reflective spheres 14, 22 equipping the first 13 and the second 21 positioning elements in a three-dimensional space. A distance between the two infrared cameras is fixed and known.

[0085] We will then detail several methods of implementation.

[0086] The first embodiment is that in which the display module 30 is a computer screen as shown in figure 7 This method of implementation is detailed in the following paragraphs.

[0087] The display module 30 allows for the representation of visual elements 31 indicating the relative positioning of the fixation holes 4 with respect to the drilling guide 23 in a top view and a side view of the implant 2. The visual elements 31 correspond to the drilling axis 32, a drilling target 33 corresponding to the optimal positioning of the drilling tool 5 with respect to the corresponding fixation hole 4, and also to two orientation circles 34, 35 which indicate the drilling axis as seen from above, as illustrated in figures 8 And 9 When the two orientation circles 34, 35 coincide with each other and are concentric with the drilling target 33, as shown in figure 9 , the drilling tool 5 is in an optimal position.

[0088] The processing module 60 is, for example, an electronic board, a processor, a controller, or a computer. This processing module 60 transforms the positioning of the first positioning element 13 and the second positioning element 21 into the relative positioning of the fixing holes 4 with respect to the drilling guide 23.

[0089] In this embodiment, the display module 30, the processing module 60 and the localization module 40 are connected together.

[0090] The second embodiment is in which the display module 30 is an augmented reality headset and the localization module 40 is integrated into the virtual reality headset. It is explained with reference to the figure 10 This method of implementation is detailed in the following paragraphs.

[0091] The display module 30 allows visual elements 31' to be displayed indicating the relative positioning of the fixation hole 4 with respect to the drilling guide 23, superimposed in the field of vision of a surgeon using the assistance system. The visual elements 31' correspond to the drilling axis 32', a drilling target 33', 33" corresponding to the optimal positioning of the drilling tool 5 with respect to the fixation hole 4, and also two orientation circles 34', 34", which indicate the drilling axis, as illustrated in figure 10 . When the orientation circles 34', 34" are coaxial with the drilling targets 33', 33" the drilling tool 5 is in an optimal position.

[0092] In this embodiment, the display module 30, the processing module 60 and the localization module 40 can be attached to the augmented reality headset.

[0093] The processing module 60 is integrated into the augmented reality headset and transforms the positioning of the first positioning element 13 and the second positioning element 21 into the relative positioning of the fixing holes 4 with respect to the drilling guide 23.

[0094] The display module 30, as in the second embodiment, allows visual elements 31' to be displayed indicating the relative positioning of the fixation hole 4 with respect to the drilling guide 23, superimposed in the field of vision of a surgeon using the assistance system. The visual elements 31' correspond to the drilling axis 32' and the drilling target 33', 33" corresponding to the optimal positioning of the drilling tool 5 with respect to the fixation hole 4, as well as two orientation circles 34', 34" which indicate the drilling axis, as illustrated in figure 10 . When the orientation circles 34', 34" are coaxial with the drilling targets 33', 33" the drilling tool 5 is in an optimal position.

[0095] The augmented reality headset includes a localization device (which comprises at least one camera), defining a reference frame associated with the localization device, hereafter referred to as MLCRA, allowing the augmented reality headset to determine its own positioning in three-dimensional space. Its positioning is expressed in the MLCRA reference frame. The augmented reality headset therefore includes a camera defining a reference frame associated with the camera, hereafter referred to as MLC, enabling the recognition of geometric shapes or printed images and the determination of their positioning in the MLCRA localization device's reference frame via a known and fixed transformation of the MLC2MLCRA system.

[0096] The augmented reality headset includes a processing module 60 (like an electronic board or a processor) which allows the display module 30 to display graphic representations superimposed on reality as long as they are expressed in the MLCRA reference so as to correspond to their real positioning.

[0097] The third embodiment is one in which the display module 30 is an augmented reality headset and the localization module 40 (which includes one or more cameras) is not integrated into the virtual reality headset. The display module 30 is therefore not fixed to the localization module 40, which thus determines the positioning of the first 10 and second 20 devices in a reference frame associated with the localization module 40, hereafter referred to as the MLE reference frame. Therefore, there is relative movement between the display module (or the augmented reality headset) and the localization module 40. This embodiment is detailed in the following paragraphs, with reference to the figure 10 .

[0098] In this third embodiment, the assistance system 1 also includes a matching module 50 which enables the processing module 60 to define a spatial relationship MLE2MLCRA between the localization module 40 and the localization device (namely the camera worn by the virtual reality headset). This spatial relationship MLE2MLCRA makes it possible to transform geometric descriptions expressed in the MLE reference frame into geometric descriptions expressed in the MLCRA reference frame.In other words, the pairing module 50 links the modules so that the processing module 60, potentially integrated into the augmented reality headset or the display module 30, transforms the positioning of the first device 10 and the second device 20, both expressed in the MLE reference frame, into the relative positioning of the mounting hole 4 with respect to the drilling guide 23, and expresses this in a reference frame associated with the display module 30 via the reference frame of the MLCRA localization device. This MLE2MLCRA transformation will remain valid as long as the localization module 40 and the localization device are not moved in space.

[0099] The matching module 50, represented in figure 6 The QR code 52 is a detectable element by both the localization module 40 and the virtual reality headset's localization device. The matching module 50 includes, for example, reflective spheres 51 detectable by the infrared camera(s) of the localization module 40 and a QR code 52 detectable by the camera of the augmented reality headset's localization device. Since the QR code 52 and the reflective spheres 51 are fixed together, the processing module 60 knows a fixed spatial relationship SPHERE2QR between the reflective spheres 51 and the QR code 52.

[0100] During the module linking step, the matching module 50 is positioned at a fixed location and then detected simultaneously, or sequentially, by the localization module 40 and by the localization device or the augmented reality headset camera. The processing module 60 then determines the spatial relationship MLE2MLCRA, transforming the geometric descriptions expressed in the MLE reference frame into geometric descriptions expressed in the MLCRA reference frame. More precisely, the detection of the matching module 50 by the localization module 40 determines the relationship MLE2SPHERE. The detection of the matching module 50 by the localization device or the augmented reality headset camera determines the relationship QR2MLC in the reference frame of the first device 10. Thus, the spatial relationship MLE2MLCRA determined by the processing module corresponds to the transformations MLE2SPHERE x SPERE2QR x QR2MLC x MLC2MLCRA.

[0101] In the case of using the assistance system 1 according to the third embodiment, the surgeon puts the augmented reality headset on his head and performs the module linking step as described above.

[0102] Next the surgeon performs a mechanical coupling step during which he assembles the first device 10 to the implant 2.

[0103] Then, the surgeon performs a calibration step during which the second device 20 is brought close to the implant 2 so that the calibration elements 24 of the second device 20 are inserted simultaneously or not into the fixation holes 4 of the implant 2; the calibration elements 24 coming into engagement by geometric correspondence in the fixation holes 4 of the implant 2.

[0104] During the calibration step, the positions of the first 10 and the second 20 device are determined / detected by the localization module 40. This information is transmitted to the processing module 60 which thus precisely determines, by means of the positions of the first 10 and the second 20 device and mechanical dimensions referencing the position of the calibration elements 24 of the second device 20 in a reference frame of the second device 20, a positioning of the fixation holes 4 in the reference frame of the first device 10. At the end of this calibration step, the surgeon uncouples the second device 20 from the implant 2.

[0105] The surgeon then inserts implant 2 into bone 3 during an implant insertion step. Implant 2, and therefore the fixation holes 4, are then no longer visible to the surgeon. Only the first positioning element 13 is detectable by the localization module 40.

[0106] The surgeon performs a step of placing the second device 20, as illustrated in figure 11 , by approaching the second device 20 to bone 3. The localization module 40 again determines the positioning of the first device 10 and the second device 20 in the reference frame associated with the localization module 40. This information is transmitted to the processing module 60 which, using the positioning of the first 10 and the second 20 devices in the reference frame associated with the localization module, the positioning of the fixation holes 4 of the implant 2 in the reference frame of the first device 10 and mechanical dimensions specifying the position of the drilling guide 23 in the reference frame of the second device 20, deduces the relative positioning of the fixation hole 4 with respect to the drilling guide 23.

[0107] It should be noted that the mechanical dimensions referencing the position of the calibration elements 24 and the drilling guide 23 of the second device 20 in a reference of the second device 20, are stored in the memory 61 connected to the processing module 60.

[0108] The processing module 60 is in communication with the display module 30 in order to transmit to it the relative positioning of the fixing hole 4 with respect to the drilling guide 23, so that this display module 30 displays and represents this relative positioning by means of the visual elements 31, 31'.

[0109] The visual elements 31' of the display module then indicate the relative positioning of the fixation orifice(s) 4 in relation to the drilling guide 23. The surgeon, by consulting the display module 30, moves the drilling guide 23 so as to position it opposite the fixation orifice 4 concerned.

[0110] Once the position of the drilling guide 23 is confirmed, the surgeon performs a drilling step in the patient's bone 3 to create the attachment hole in bone 3 opposite the corresponding fixation hole 4. To do this, the surgeon drills bone 3 by inserting the drilling tool 5 into the drilling guide 23.

[0111] Finally, the surgeon inserts a locking piece into the attachment hole and the fixation hole 4. The drilling operations are repeated depending on the number of fixation holes 4 and therefore the number of fixations to be installed. Implant 2 is then securely fixed to bone 3, and the first device 10 is then separated from implant 2.

[0112] Of course, the invention is not limited to the embodiments described and shown in the accompanying figures. Modifications remain possible, particularly with regard to the composition of the various elements or by substitution of technical equivalents, without departing from the scope of protection of the invention.

Claims

1. An assembly comprising: - an implant (2) provided with at least one fastening orifice (4), and - an assistance system (1) for fastening said surgical implant (2) to a bone (3) by means of a locking part inserted into a bone attachment orifice, which is configured to be positioned facing the fastening orifice (4) of the implant (2), the assistance system (1) comprising: - a first device (10) configured to be mechanically coupled to the implant (2) et comprising a first positioning element (13) configured to be detected by a localization module (40); - a second device (20) comprising a second positioning element (21) configured to be detected by the localization module (40) and a drilling guide (23) configured to indicate a drilling axis (32, 32'); - the localization module (40) that comprises at least one sensor using an image detector or infrared detector technology, said localization module (40) being configured to determine a positioning of the first positioning element (13) and the second positioning element (21) in a three-dimensional space of a reference frame associated with the localization module (40); - a processing module (60) connected to the localization module (40) for receiving the positioning of the first positioning element (13) and the second positioning element (21); - a display module (30) connected to the processing module (60) and capable of representing visual elements (31, 31') indicating a relative positioning of the fastening orifice (4) relative to the drilling guide (23) determined by the processing module (60); the assembly being characterized in that the second device (20) also comprises at least one calibration element (24) configured to cooperate with the fastening orifice (4) of the implant (2) during a calibration step, before introducing the implant (2) into the bone (3), and in that the processing module (60) is designed to: - during the calibration step, determine a positioning of the fastening orifice (4) in a reference frame of the first device (10) from the positioning of the first positioning element (13) and the second positioning element (21) and mechanical dimensions referencing the position of the at least one calibration element (24) of the second device (20) in a reference frame of the second device (20); and to - after introduction of the implant (2) into the bone (3), determine the relative positioning of the fastening orifice (4) relative to the drilling guide (23) from the positioning of the first positioning element (13) and the second positioning element (21), the positioning of the fastening orifice (4) in the reference frame of the first device (10), and mechanical dimensions specifying the position of the drilling guide (23) in the reference frame of the second device (20).

2. The assembly according to claim 1, wherein the drilling guide (23) comprises at least one stabilization tooth (25) configured to stabilize the drilling guide (23) on the bone (3).

3. The assembly according to any one of the preceding claims, wherein the at least one calibration element (24) is an elongation configured to be introduced into the fastening orifice (4).

4. The assembly according to claim 3, wherein the elongation is selected from a stud and a pin.

5. The assembly according to claim 3 or 4, wherein the elongation of the at least one calibration element (24) extends along an axis substantially parallel to the drilling axis (32, 32') of the drilling guide (23).

6. The assembly according to any one of the preceding claims, wherein the at least one calibration element (24) comprises at least two calibration elements (24) extending in parallel.

7. The assembly according to any one of the preceding claims, wherein the first positioning element (13) and / or the second positioning element (21) are selected from a sensor and a geometry, said geometry being selected from: a QR code, a still image, a rigid body comprising at least one reflective marker or at least three elongations positioned along three different directions.

8. The assembly according to any one of the preceding claims, wherein the localization module is fixed in a reference frame associated with the display module.

9. The assembly according to any one of the preceding claims, wherein the visual elements (31, 31') show the drilling axis (32, 32') and a drilling sight (33, 33', 33") configured to indicate an optimal positioning of a drilling tool (5) relative to the fastening orifice (4).

10. The assembly according to any one of the preceding claims, using an augmented reality technology, wherein the display module is capable of representing the visual elements (31'), in superposition in the visual field of a user of the assistance system.

11. The assembly according to claim 10, wherein the display module comprises a localization device, the assistance system comprising a matching module (50) capable of determining a spatial relationship making it possible to transform geometrical descriptions expressed in a reference frame associated with the localization module, into geometrical descriptions expressed in a reference frame associated with the localization device.

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