EP3880087A1

EP3880087A1 - Cutting device for the placement of a knee prosthesis

Info

Publication number: EP3880087A1
Application number: EP19797758.0A
Authority: EP
Inventors: Sébastien HENRY; Pascal KILIAN; Romain FISSETTE
Original assignee: Pixee Medical SAS
Current assignee: Pixee Medical SAS
Priority date: 2018-11-12
Filing date: 2019-11-08
Publication date: 2021-09-22
Also published as: WO2020099268A1; CN216317822U; US20220000491A1; FR3088188A1; AU2019377964A1; JP2022507471A

Abstract

The invention relates to a cutting device (1) for the placement of a knee prosthesis comprising a bracket (4) and a cutting guide (2) mounted with the ability to move on said bracket (4), wherein the bracket (4) comprises a first marker (43) for identifying it and a fixing element (42) for fixing it to a bone, and wherein the cutting guide (2) comprises a second marker (23) for identifying it and a slot (21) defining a cutting plane suited to guiding a cutting tool. The invention also relates to an assistance device and to a system comprising said cutting device. The invention finally relates to an assistance method and to a computer program product and to a data recording medium for executing the method.

Description

DESCRIPTION

CUTTING DEVICE FOR LAYING A PROSTHESIS

KNEE

The invention relates to a cutting device for fitting a knee prosthesis. The invention also relates to a cutting assistance device comprising such a cutting device. The invention also relates to a method of assisting in the fitting of a knee prosthesis and using said device. The invention finally relates to a support system implementing said method, a computer program product for implementing said method, and a recording medium comprising the steps of said method.

To place a knee prosthesis on a subject, it is necessary to first cut the tibia and the femur on their end close to the knee.

Bone cutting is delicate, the operator must take care to remove as little bone as possible but must remove enough to have a flat surface and a space large enough to place the prosthesis components. In addition, the angle of the cut is decisive. The lack of precision in the operation leads to a significant risk of pain experienced by the subject, instability, premature wear or dislocation. For this, there are very complex devices using many assistance tools: these systems have the disadvantage of a high cost and of not being able to be widely used.

The object of the invention is to provide a device and a method to assist the operator in determining the cutting plane of the tibia or the femur for the fitting of a knee prosthesis. In particular, the object of the invention is to simplify the determination of the cutting plane by optimizing the precision. According to a first aspect, the invention relates to a cutting device for fitting a knee prosthesis comprising a bracket and a cutting guide mounted movably on said bracket, in which the bracket comprises a first marker for its location and an element attachment for attachment to a bone and wherein the cutting guide comprises a second marker for its identification and a slot defining a cutting plane suitable for guiding a cutting tool. In one embodiment, the cutting guide is mounted mobile on the stem according to at least one degree of freedom in translation.

In one embodiment, the cutting guide is mounted mobile on the stem according to at least two degrees of freedom in rotation.

In one embodiment, the cutting guide is mounted mobile on the stem via an articulated assembly allowing the mobility of the cutting guide relative to the stem. In one embodiment, the first marker and the second marker comprise a rectangular planar surface comprising at least one pattern.

In one embodiment, the cutting guide comprises a fixing element for fixing it to a bone.

According to a second aspect, the invention relates to a cutting assistance device for fitting a knee prosthesis comprising at least one cutting device according to the first aspect of the invention and at least one point reading tool including a positioning point and a third marker for its location. In one embodiment, the assistance device comprises a first cutting device according to the first aspect of the invention designed for cutting a tibia and a second cutting device according to the first aspect of the invention designed for cutting section of a femur.

According to a second aspect, the invention relates to a method of assisting with the fitting of a knee prosthesis.

The process includes:

a first phase of positioning a cutting device according to the first aspect of the invention, comprising a movable cutting guide according to three degrees of freedom relative to the stem of the device,

- a second phase of assistance in positioning the cutting guide relative to the stem, comprising

^■ a display step by a single camera of the first marker of the stem and forming a reference frame defined relative to the first marker,

^■ a display step of the first marker and the second marker, and

^■ a step of transmitting and indicating to an operator the three-dimensional relative positioning of the cutting guide and / or its cutting plane relative to the reference frame.

In one embodiment, the reference frame comprises two reference axes.

In one embodiment, the formation of said reference frame comprises the following steps:

- generation of a reference point; - the formation of a first reference axis passing through the reference point and a predetermined point relative to the first marker

- the formation of a second reference axis determined by the projection of a known axis of the bracket on the plane perpendicular to the first reference axis.

In one embodiment, the method is adapted to the bone cutting of a tibia and the reference point is positioned in the mechanical axis of the tibia. In one embodiment, the generation of the reference point is carried out by a step of viewing a third marker of a point reading tool with respect to the first marker for locating said reference point.

In one embodiment, the method is adapted to the bone cutting of a femur and the reference point is positioned in the mechanical axis of the femur. In one embodiment, the generation of the reference point comprises a substep of movement of the patient's leg for determining the center of rotation of said leg and a substep of visualization of several images of the first marker during the movement leg and a third marker fixed relative to the patient's pelvis.

According to a fourth aspect, the invention relates to a system for assisting with the fitting of a prosthesis. The system comprises a cutting device according to the first aspect of the invention, a mobile monocular camera, in particular mounted on a pair of glasses or on a portable object such as a telephone, a display means and means for implementing the method. assistance according to the third aspect of the invention. In one embodiment, the viewing step is performed by said camera and the transmission step is performed by said display means. According to a fifth aspect, the invention relates to a computer program product comprising program code instructions recorded on a computer-readable medium for implementing the steps of the method according to the third aspect of the invention when said program is running on a computer or a computer program product downloadable from a communication network and / or recorded on a data medium readable by a computer and / or executable by a computer, comprising instructions which, when the program is executed by a computer, lead the latter to implement the method according to the third aspect of the invention.

According to a sixth aspect, the invention relates to a data recording medium, readable by a computer, on which is recorded a computer program comprising code instructions for implementing the method according to the third aspect of the invention or a computer-readable recording medium comprising instructions which, when executed by a computer, lead the latter to implement the method according to the third aspect of the invention.

The accompanying drawings show, by way of example, an embodiment of a cutting device according to the invention and an embodiment of a system according to the invention.

Figure 1 shows a perspective view of the cutting device according to an embodiment of the invention.

FIG. 2 represents a front view of the cutting device according to an embodiment of the invention. FIG. 3 represents a front view of the cutting device in which the cutting guide has been moved by a first means of piloting the articulated assembly.

FIG. 4 represents a side view of the cutting device according to an embodiment of the invention.

FIG. 5 represents a side view of the device according to an embodiment of the invention in which the cutting guide has been moved by a second means of piloting the articulated assembly.

FIG. 6 represents a perspective view of a pointer for the implementation of the method according to an embodiment of the invention.

FIG. 7 represents a perspective view of a clamp for implementing the method according to an embodiment of the invention.

FIG. 8 represents a transparent view of the clamp of FIG. 7.

FIG. 9 represents a perspective view of the cutting guide according to an embodiment of the invention.

FIG. 10 represents a diagram of an assistance system according to an embodiment of the invention.

Figure 1 1 shows a diagram of the steps performed by the assistance system computer according to one embodiment of the invention.

FIG. 12 represents a profile view of a tibia on which is fixed a cutting device according to an embodiment of the invention. An example of a cutting device 1 for fitting a knee prosthesis according to an embodiment of the invention is described below with reference to FIG. 1.

The cutting device 1 comprises a positioning frame 3 and a cutting guide 2. The positioning frame 3 makes it possible to fix the device 1 on the bone to be cut and the movable cutting guide 2 comprises a slot 21 and makes it possible to guide a cutting device through its slot 21 for cutting the bone.

The positioning frame 3 comprises a bracket 4 and an articulated assembly 5. The bracket 4 is designed to be mounted on the bone to be cut. The cutting guide 2 is movably mounted on said stem 4. The articulated assembly 5 is designed to be movable relative to the stem 4 and to support the cutting guide 2.

The stem 4 includes a fixing 41 making it possible to ensure a stable fixing without degree of freedom between the stem 4 and the bone to be cut.

As illustrated in FIG. 1, the fixing means 41 can comprise at least a first bore 42 designed to receive a first threaded pin or a nail. The stem 4 is placed against the bone to be cut at a fixing point and the first threaded pin or the nail is inserted into the bone through the first bore 42 of the stem 4.

The bracket 4 advantageously makes it possible to fix the positioning frame 3 near the cutting plane of the cutting guide 2 described below.

In one embodiment, the bracket 4 comprises at least a second bore 44 designed to receive a second threaded pin or a second nail for fixing the bracket 4 to the bone. The longitudinal axis of the at least one second bore 44 is oblique to the longitudinal axis of the first bore 42. In other words, the second bore 44 is designed so that the threaded pin or the nail which it receives is in a direction inclined with respect to the direction of the first screw. This at least one second bore 44 in an inclined direction advantageously makes it possible to block the dissociation and / or the play of the stem 4 once mounted on the bone to be cut. The second bore 44 may include a diameter less than the diameter of the first bore 42.

The bracket 4 is mechanically linked to the articulated assembly 5 of the positioning frame 3. The mechanical connection between the bracket 4 and the articulated assembly 5 comprises at least one degree of freedom. Preferably, the mechanical connection between the bracket 4 and the articulated assembly 5 comprises at least one degree of freedom in rotation, preferably two degrees of freedom in rotation and a degree of freedom in translation.

Preferably, the bracket 4 comprises a mast 45. The mast 45 comprises a portion extending longitudinally and designed to receive the articulated assembly 5. The mast 45 may comprise a groove forming a sliding connection with the articulated assembly 5. Preferably, the mast 45 is designed to receive a carriage 531 of the articulated assembly 5 so that the carriage 531 can slide along the longitudinal axis of the mast 45.

The mobility of the cutting guide 2 relative to the bracket 4 advantageously makes it possible to control the movement of the cutting guide 2 relative to the bone concerned in order to optimally position the cutting guide 2 for cutting the bone.

In one embodiment, the positioning frame 3 comprises at least one means for controlling the articulated assembly with the bracket. Said control means allows the articulated assembly 5 to move relative to the bracket 4 according to at least one degree of freedom.

More generally, the articulated assembly 5 and the bracket 4 comprise at least two or a plurality of control means each allowing to control the mobility of the articulated assembly 5 or of the cutting guide 2 relative to the bracket 4 according to a degree of freedom.

Said at least one control means authorizes the displacement of the articulated assembly 5 relative to the bracket 4 according to at least one degree of freedom in rotation or in translation.

As illustrated in FIGS. 1 to 5, the articulated assembly 5 comprises a first control means 51 authorizing the rotation of the articulated assembly along a first axis B, a second control means 52 authorizing the rotation of the articulated assembly according to a second axis C and a third control means 53 allowing the mobility of the articulated assembly 5 relative to the bracket by a translation along a third axis A.

Said control means can comprise a clamping mechanism and / or a rack.

As illustrated more particularly in FIG. 2 and FIG. 3, the first control means 51 comprises a control wheel 510 connected to a screw 514. A movable element 513 is disposed on the thread of said screw 514. During the rotation of the screw 514, the movable element 513 is therefore moved to one side or the other of the screw 514 according to the direction of rotation of the screw 514. The displacement of the movable element 513 causes a rotation illustrated on the Figure 3 of the articulated assembly 5 along the axis B. Preferably, the movement of the mobile element 513 along the screw 514 is converted into a rotary movement of a drive element 512 of the cutting guide 2 by a sliding link 51 1 between the mobile element 513 and the drive element 512. Said drive element 512 being mechanically connected to the cutting guide 2 via a pivot link 51 6, it causes its rotation along a first axis B (shown in FIG. 4) passing through the pivot link 51 6.

Preferably, the first control means 51 comprises a drive wheel 510 of the screw 514, very preferably two drive wheels 510 of the screw 514, one on each side of the screw.

As illustrated more particularly in FIGS. 4 and 5, the second control means 52 comprises a control wheel 520 driving a screw 521 secured to said control wheel 520. The distal end 522 of the screw 521 is in contact with the carriage 531. Said end 522 is preferably of spherical shape. The purpose of said spherical shape is to guarantee a point connection between the end of the screw 522 and the carriage 45.

The second control means 52 comprises a slope pivot 524. The slope pivot 524 comprises a thread 525. The screw 521 is screwed into the thread 525. More particularly, the thread 525 may comprise a threaded through hole. Thus, the rotation of the screw 521 causes a longitudinal displacement of the thread 525 along the screw 521. The slope pivot 524 further comprises a connection with the cutting guide 2 so that the rotation of the slope pivot 524 causes the rotation of the cutting guide 2. The slope pivot 524 also comprises a pivot connection 523 with the jib 4 or with the carriage 531. Said pivot link 523 is preferably disposed between the thread 525 and the connection with the cutting guide. The longitudinal displacement of the thread 525 along the screw 521 thus causes a rotational movement around the pivot 523 of the pivot slope 524, and therefore a rotational movement of the cutting guide 2 along a second axis C illustrated in FIG. 2. Said second axis passing through the pivot 523.

The first control means 51 and the second control means 52 are preferably arranged so that the first axis B and the second axis C are perpendicular and / or intersecting at a point on the pivot 523.

The third control means 53 comprises a sliding connection between the mast 45 of the bracket 4 and the carriage 531 of the articulated assembly 5. Said sliding connection can comprise a means of abutment of said translation. For example, a stop screw 532 arranged at the end of the mast 45.

The stop screw 532 is screwed onto the end of the mast 45 so as to be displaced along the translation axis A. The stop screw 532 then makes it possible to block the translation of the carriage 531 in a direction at the height or at the desired position. In an embodiment not shown, the third control means 53 may comprise a second stop means for blocking the translation of the carriage 531 in a direction opposite to the stop screw 532,

Said slide link preferably authorizes the translational movement of the cutting guide 2 along an axis parallel to the longitudinal axis of the first bore 42.

In an embodiment not shown, the positioning frame 3 may also include connecting elements forming a rack. The rack includes a sliding link between the articulated assembly and the stem. The slide connection comprises a first threaded branch and a second branch in slide connection with the first branch. The rack comprises, between the first and the second branch, a gear whose rotary movement around the first threaded branch is transformed into a linear movement along said first branch, said linear movement of the gear causing the second branch. The rack can also be designed so that a full revolution of the gear corresponds to a linear displacement of a predefined distance.

Thus, the mobility of the cutting guide 2 relative to the bracket 4 is controlled to allow the operator to precisely and stably position the cutting guide 2 at the desired position and / or orientation.

Preferably, the articulated assembly 5 and the stem 4 are removable. The articulated assembly 5 can indeed be removed from the bracket 4 once the cutting guide 2 fixed to the bone.

As illustrated in FIG. 9, the cutting guide 2 comprises a slot 21. The slot 21 is designed to be in contact with the bone to be cut. It forms a through passage designed to allow a sharp tool to pass through the cutting guide 2 to make the bone cut. The slot 21 therefore defines a cutting plane suitable for guiding a cutting tool through said slot 21. In the following description, the plane passing through said slot will be called a “cutting plane”.

The articulated assembly 5 comprises at least one connecting element 54 with the cutting guide 2 and the cutting guide 2 comprises at least one connecting element 25 complementary to the at least one connecting element 54 of the articulated assembly 5 , for example, male / female means. This fixed connection allows the cutting guide to be driven by the articulated assembly 5.

Preferably, this connection is removable so as to remove the articulated assembly 5 from the cutting guide 2 when the cutting guide 2 is fixed to the bone concerned. The articulated assembly 5 may include a key of tightening 515. Said tightening key 515 is integral with a screw (not shown) passing through the mast 45 of the bracket 4 to the fixing 54 or to the cutting guide 2. This tightening key 515 has for purpose of securing the cutting guide 2 to its attachment 54.

Thus, the operator can remove the positioning frame 3 (the bracket 4 and the articulated assembly 5) from the bone before proceeding with the bone cutting by unscrewing the tightening key 515. Thus, the pin or pins or nails used for fixing the positioning frame 3 to the bone are removed and will not interfere with the cut.

In one embodiment, the cutting guide 2 also comprises at least one fixing element 22. The fixing element 22 of the cutting guide allows the cutting guide 2 to be fixed to the bone to be cut. In this way, once the operator has the cutting guide 2 in the desired position via the articulated assembly, he can fix the cutting guide 2 to the bone before cutting the bone.

In one embodiment, the cutting guide 2 can be removed from the device.

The fastener 22 of the cutting guide 2 may include a surface designed to be placed on the surface of the bone and a first bore designed to receive a first screw in the same manner as the bracket fixing element. Preferably, the fixing element of the cutting guide is arranged so that the screw does not interfere with the bone cutting.

Preferably, the cutting guide comprises at least two fixing elements, each of which comprises a bore for the passage of a screw intended to penetrate into the bone to be cut. Each bore can extend in a different direction to block the return of the cutting guide. In one embodiment, the cutting guide 2 is adapted to the morphology of the bone to be cut. In the case of a cutting guide suitable for cutting a tibia, the cutting guide may be asymmetrical.

The cutting guide may further comprise at least one means for fixing a physical probe 24.

In addition, the bracket 4 comprises at least a first position marker 43 for its identification and the cutting guide 2 comprises a second position marker 23 for its identification.

The first marker 43 and the second marker 23 are designed and arranged to be identified by an optical sensor such as a camera.

The image obtained by the camera of a position marker makes it possible to detect its position and its orientation by an algorithm. Each marker includes a predefined dimension, shape and pattern. The algorithm knows the shape, size and optionally the pattern of the marker. For this, the algorithm has access to an electronic memory on which are stored the digital data representative of the geometry of the elements it analyzes. In particular by comparing them to the shape, size and pattern of the marker on the image, the algorithm is able to deduce its positioning and orientation. For example, if a marker comprises a square surface pattern and this same pattern appears trapezoidal on the image, the angles of the trapezoid allow the algorithm to deduce the orientation of said surface. In addition, the number of pixels between two opposite sides of a square makes it possible to deduce the distance between the marker and the camera. Each marker can include a different pattern, so the algorithm, by recognizing the pattern, can associate with the position marker a tool, for example, the cutting guide for the second position marker. The markers of position being fixed to tools without degree of freedom, the image obtained from the first marker and the second marker therefore makes it possible to determine the position and orientation of the first and second marker, and therefore respectively of the stem and of the cutting guide.

In fact, the use of this type of marker makes it possible to improve its position and its three-dimensional orientation in a frame of reference of one or more cameras for each image acquisition. This marker can be of different size and geometry.

The pattern can be three-dimensional or two-dimensional. Preferably, the markers comprise a flat surface capable of receiving, for example by gluing, a label comprising the pattern. In another example, the pattern is produced by screen printing on said flat surface. The pattern can be in black and white, but the pattern can also be in color.

This pattern differs from those generally used by infrared surgical navigation systems in that it is reusable. Indeed, it can be sterilized by autoclave. This saves consumables.

The pattern can include simple or complex geometric shapes. This makes it easier to identify the marker. It also improves the estimation of the position and orientation of the marker by processing images from one or more cameras.

In fact, the markers according to the embodiment of the invention described here have a rectangular planar surface comprising at least one pattern. The particular shape of the first marker and of the second marker therefore makes it possible to determine the position and the orientation respectively of the bracket and of the cutting guide as indicated above. This simply constitutes positioning and orientation means of the first and second marker, and therefore of the stem and the cutting guide. An advantage of this particular shape of the markers is also that the estimations of the positions and orientations of the stem and of the cutting guide can be made with a single optical sensor such as a camera.

Another advantage is that the image to be processed can be obtained by a single monocular optical sensor, preferably in the visible field, in particular of the camera type. By "visible field optical sensor" is meant that the optical sensor records images visible to the human eye including so-called "black and white" cameras and so-called "color" cameras. This makes it possible to choose a more economical camera than a system composed of infrared cameras, generally used by surgical navigation devices.

The optical sensor can be integrated into various devices such as a phone, a tablet, connected glasses or any other system integrating one or more cameras. All surgical navigation algorithms can be performed on an on-board platform or on a remote computer.

However, the at least one pattern can also be identified by the monocular optical sensor used to identify the shape of the markers. By processing the image of the pattern according to a process similar to processing the image of the shape of the marker, it is also possible to determine the position and the orientation of the first and of the second marker, and therefore respectively of the stem and of the guide. chopped off. This simply constitutes additional means for positioning and orienting the first and second markers, and therefore the stem and the cutting guide.

An advantage of this or these patterns is that the estimations of the positions and orientations of the first and of the second marker, and therefore of the stem and of the cutting guide, are made by two different means, which further improves the positioning accuracy and orientation of the first and second markers, and therefore of the stem and the cutting guide. Thus, with a single camera filming in the visible field, a better positioning and orientation of the first and second markers, and therefore of the stem and of the cutting guide, are obtained.

The invention also relates to a cutting assistance device for fitting a knee prosthesis, characterized in that it comprises at least one cutting device as described above and at least one point reading tool, described below, comprising a positioning point and a third marker for its location. The cutting assist device may include a first cutting device designed to cut a tibia and a second cutting device designed to cut a femur. The assistance device also includes at least one complementary tool making it possible to locate a particular position, in particular anatomical, which we will call "point reading tool". Said point reading tool also includes a third marker for locating it, similar to the first marker and / or to the second marker. The third marker includes a particular shape and a unique pattern allowing their identification on an image by the algorithm.

In a first embodiment illustrated in FIG. 6, the point reading tool is a pointer 6.

The pointer 6 comprises a rod 61, a contact point 62 and the third position marker 63. The algorithm uses the data representative of the geometry of the pointer 6 so as to know the position of the contact point 62 relative to the third marker position 63. This data can be stored in an electronic memory of the assistance system, which will be described later. For the generation of a point in a given coordinate system, it is therefore sufficient to point with the contact point 62 the point to be recorded, then to take an image of the third marker 63 and of another marker associated with said formed coordinate system. In a second embodiment illustrated in Figures 7 and 8, the point reading tool is a clamp 7. The clamp 7 comprises a base 70 and two arms 71 movable relative to the base 70. Each arm 71 of the clamp 7 may include at its end a tab 72 for its positioning. Said tab 72 may include a pivot degree of freedom with the arm 71 of the clamp. In the embodiment, the tab 72 is preferably designed to receive a malleolus of an ankle.

The base 70 of the clamp 7 includes a third positioning marker 73. Said marker 73 is integral with the base 70. The two arms 71 are connected to each other by a pivot link 74. Said pivot link comprises a central pinion 75 designed to slide inside a central groove 76.

Each arm 71 further comprises a lateral groove designed to cooperate with a lateral pinion 78 of the base 70. When the arm 71 moves relative to the base 70 the lateral pinion 78 slides along the lateral groove 77.

The lateral groove 77 and the central groove 76 are designed so that the projection of the tab 72 along an axis x parallel to the longitudinal axis of the central groove 76 is constant during the various movements of the arms 71 of the clamp 7 .

In addition, the central pivot link 74 imposes on the first arm a similar movement of the second arm. Thus, the point located in the middle of the segment between the two tabs 72 is always located in the same position relative to the base and relative to the position marker of the clamp. When an arm 71 is moved to shorten the distance between the two legs 72, the rotational movement of the arms 71 around the pivot link 74 causes the lateral pinions 78 to move along the lateral grooves 77 and the linear movement of the central pinion 75 along the central central groove 76 so that the point O in the middle of the segment between the two legs is stationary relative to the base 70 and therefore to the third marker 73. Preferably, the clamp 7 comprises a return element ( not shown) allowing the central pinion 75 to be held on one of the two ends of the central groove 76, very preferably on the end closest to the tabs. Said element may be a return spring disposed in the groove or an elastic. This return element allows the return of the ends of the clamps towards one another.

The algorithm uses the position data of a point O in the middle of the segment between the two legs 72 relative to the third position marker 73. For the generation of a point O in a given marker, it suffices therefore to position the tabs 72 and take an image of the third marker 73 and of another marker associated with said given marker.

In a third embodiment, not shown, the point reading tool comprises a marker fixed to a flat surface.

The algorithm uses the data of the structure of the survey tool so as to know the position of the points of said planar surface relative to the third position marker. The invention therefore relates to an assistance device comprising a cutting device as described above and a point reading tool as described above. For the generation of a plane in a given coordinate system, it suffices to place the planar surface of the survey tool on the plane to be recorded and then to take an image of the third marker and of another associated marker given audit benchmark.

An example of an assistance system 100 comprising a cutting device 1 is described below with reference to FIG. 10. The invention relates to an assistance system 100 comprising a cutting device 1 as described above , an optical capture means 200, in particular a camera, and a means of transmitting information 400. The system advantageously makes it possible, by taking the position markers, to determine the position of the cutting plane relative to the stem or the position of the point to be surveyed O, 62 of the point survey tool.

The information transmission means 400 makes it possible to transmit information to an operator on the position and the orientation of the cutting plane.

Preferably, the optical capture means 200 is a video capture means in order to be able to follow in real time the position of the cutting guide. The optical capture means can be a camera or a camera.

In one embodiment, the assistance system 100 only comprises a single monocular capture means, preferably in the visible field. By “visible field capture means”, it is meant that the optical capture means records images visible to the human eye comprising the so-called “black and white” cameras and the so-called “color” cameras. The assistance system 100 also includes an information transmission means 400. Said information transmission means 400 can be a means of transmitting visual or auditory information.

The information transmission means 400 can be any means making it possible to communicate to an operator position and / or orientation information of the cutting plane from the image taken by the optical capture means 200.

The information transmission means 400 may be a display means and may include a screen, an image projection means, a speaker, an audio earphone.

Preferably, the information transmission means 400 comprises a pair of glasses or a monocle intended to be worn by the operator. Said pair of glasses or the monocle may comprise the optical capture means 200, for example in the form of a single camera integrated in the frame or on a branch, and comprising the information transmission means 400, for example under the form of a means making it possible to project information into the operator's field of vision, at the level of a lens of the pair of glasses.

The assistance system 100 also includes a computer 300 connected to a data memory support 301, comprising an algorithm for assisting the fitting of a prosthesis. The computer 300 is connected to the optical capture means for receiving the images taken and is connected to the information transmission means for controlling said information transmission means.

The assistance system 100 may also include an interaction means 250 so that the operator can interact with the software. The interaction means 250 can be located on the pair of glasses or on the monocle. This means of interaction can include a microphone, a control button, a tactile surface, a camera for tracking eye movement (called “Eye Tracking” in English).

The interaction means 250 can comprise the pointer 6. In one embodiment, the pair of glasses or the monocle displays a graphical interface comprising icons or pictograms. The user can manipulate these icons or pictogram and thus interact with the software thanks to a pointing device. The pointing device may include, the pointer 6, a mouse, etc. The user can also interact with the graphical interface thanks to a system for recognizing hand gestures or accelerometers.

Preferably, the assistance system is started by voice command or a movement of the body, for example a movement of the head. Once the system is activated, the pair of glasses or the monocle displays a graphic interface including icons or pictograms. The user can manipulate these icons or pictogram and thus interact with the assistance system software using a pointing device such as the pointer described above or using a hand gesture recognition system.

The graphical interface can include virtual interaction buttons. Preferably, the graphical interface comprises a rosette on which the virtual interaction buttons are represented around the center of said rosette. The user can manipulate the rosette buttons and thus interact with the software using a pointing device such as the pointer described above or using a hand gesture recognition system. The invention also relates to a method of assisting with the fitting of a knee prosthesis using the use of a cutting device 1 and / or of an assisting system 100 as described above.

The method aims to assist an operator, for example by providing him with information on the position and / or the orientation of the cutting plane of the device relative to a mark formed. As a note, the assistance method of the invention relates to a phase upstream of the surgical treatment as such. It only concerns the correct positioning of the tools for assisting future surgery. Thus, this process is exclusively linked only to the correct use of the device, without preventing the surgeon from practicing the surgical treatment in a different way without using said device.

The method comprises a first phase of positioning a positioning frame 3 of a cutting device 1 as described above. This step includes the attachment of the bracket 4 to a bone to be cut via the at least one attachment as well as the attachment of the cutting guide 2 to the articulated assembly 5.

The method then comprises the use of an optical capture means 200 such as a monocular camera in the visible so that said camera can detect the first marker of the stem and the second marker of the cutting guide. An information transmission means 400 is also positioned so as to be able to transmit information to the user.

The cutting device 1 is placed against the tibia or the femur. The cutting device can be placed on one of the aforementioned bones on the articular surface of the knee. The cutting device is placed against the tibia or the femur so that the cutting plane allows a cut to be made between 2mm and 20mm thick, preferably between 6mm and 10mm.

The stem is thus fixed to the bone and the cutting guide remains movable relative to the stem and relative to the bone on which said stem is fixed.

The method then comprises a second phase of assistance in positioning the cutting guide relative to the stem, and therefore relatively to the bone.

For this, the method comprises a step of viewing the first marker 43 and the second marker 23 by the optical capture means.

The method can implement an algorithm for recognizing a marker in the image taken by the optical capture means. The algorithm makes it possible to define, thanks to the particular shape of the marker and / or the unique pattern affixed to the marker, the position and the orientation in a three-dimensional space of said marker.

From the visualization step, the method then includes a step of forming a reference.

The coordinate system formed is a coordinate system comprising two or three orthogonal axes of references.

The coordinate system formed comprises a first reference axis, a second reference axis orthogonal to the first reference axis and optionally a third reference axis orthogonal to the first reference axis and to the second reference axis. The first reference axis N, shown in Figure 12, is the mechanical axis of the bone to be cut. By mechanical axis is meant the support axis of the mechanical forces of the bone concerned. The mechanical axis differs from the anatomical or longitudinal axis of the bone extending along the diaphysis of the bone concerned.

The first reference axis N is formed by the identification of a first point and a second point.

The position of the first point is generated relative to the first marker of the cutting device. Indeed, the stem of the cutting device occupies a reference position, which is visualized by means of its first marker. The algorithm can therefore generate the first point representative of the attachment of the bracket to the bone and whose position is fixed relative to the marker of the bracket. The first point is fixed relative to the gallows. The stem is therefore designed so that the first point, when the stem is fixed to the bone, passes through the mechanical axis of the bone to be cut.

In the case of the tibia, the position of the second point can be determined using a point reading tool. As illustrated in FIG. 12 on the example of a tibia 10, the first point K is determined by the position and the orientation of the first marker.

The mechanical axis of the tibia 10 passes through a point located equidistant from the outside point of the left malleolus and the right malleolus of the leg concerned. By external point, we designate here the point of the malleolus surface furthest from the anatomical axis of the tibia.

In one embodiment, the second point M is generated by raising the external point of each malleolus of the patient, preferably using the pointer 6 described above. From these two points, the algorithm generates the second point M as the point located equidistant from the outside point of each malleolus of the patient.

In an alternative embodiment, the clamp 7 as described above is used to determine the second point M. The two tabs 72 of the clamp 7 are each placed on the outside point of each malleolus. The second point M then corresponds to the point O equidistant from the two legs 72 of the clamp 7. Such a clamp thus makes it possible to identify in a reliable, easy and automatic manner a central anatomical point (or interior) from two lateral supports respectively on two easily identifiable anatomical areas, and in a single survey. In the embodiment described, the clamp is designed for two supports respectively on each ankle ankle. Of course, such a clamp could alternatively be used for the location of many other anatomical points.

Thus, the invention provides a solution to the technical problem of reading an anatomical point inside the body, in a user-friendly and reliable manner.

The solution is based on a clamp, characterized by two articulated arms 71 each comprising a tab 72 allowing positioning on an anatomical area of the human body. The clamp is equipped with a fixed marker 73 making it possible to automatically determine its positioning and to deduce therefrom an anatomical interior point, deductible from the two legs 72 of the clamp. In particular, the invention relates to a clamp comprising a base, a first arm and a second arm each comprising a lug, the first arm and the second arm being connected together by a movable articulated connection such that the movement of an arm causes the displacement of the movable articulated link along a groove of the base so that the middle of the segment connecting the two legs is stationary relative to the base. In the case of the femur, the mechanical axis passes through the femoral head of the femur. In order to generate the second point, we use the fact that the femoral head forms the center of rotation of the femur to deduce the position of the second point.

In a first step, the user places a position marker on a fixed support relative to the patient's pelvis. Preferably, the position marker is placed on the patient's pelvis but can also be placed on a table on which the patient is lying or on another fixed support in the field of vision of the camera.

In a second step, the camera takes different images of the fixed position marker and the first position marker. In each image, the patient's knee is moved to another position.

On each image, the algorithm generates and records a first point on the mechanical axis of the femur by determining the position of the first position marker 43 relative to the fixed position marker.

Then, the algorithm calculates a sphere comprising all the points of the mechanical axis. The sphere can be a sphere which is as close as possible to all the points via a statistical method.

The algorithm finally determines the center of this sphere as the second reference point.

The position of the second reference point as a function of the first position marker is thus recorded in a memory.

The algorithm then generates the first reference axis relative to the first position marker passing through the first point and the second point. The second reference axis is generated by the projection of a known axis of the bracket 4 on the plane perpendicular to the first reference axis N. The second reference axis preferably passes through the center of the knee or through the first point K.

The first reference axis N and the second reference axis are thus determined as a function of the first reference marker 43. On each image taken by the camera from this step, the algorithm is thus able, from the image taken from the first reference marker, to generate an orthonormal reference frame defined by the first and second reference axes.

The intersection of the cutting plane with the first reference axis makes it possible to evaluate the height of the cutting plane relative to the mechanical axis of the bone to be cut. The projected cutting plane on the first axis makes it possible to determine the cutting thickness. For this, the algorithm determines the distance between the intersection of the section plane with the first reference axis and a thickness reference point.

The thickness reference point is the point located on the articular surface of the knee, preferably at an extremum of the surface of the bone at the joint. In the example of the femur, said point is located on the extremum of one of the protruding condyles, that is to say on the most distal point of the protruding curvature of a condyle. In the example of the tibia, said point is the point of the bottom of the cup of the tibial plateau or the most distal point of the convex lateral condyle.

In a first embodiment, the thickness reference point is generated by the point reading tool. The user points with the pointer to the extremum of the condyle while the camera captures an image of the pointer position marker and the first position marker. The position of the thickness reference point relative to the first marker is thus recorded.

In a second embodiment, the cutting guide comprises a physical probe 24. The physical probe 24 is designed so that its end 26 can rest on the extremum of the condyle. For example, when the articulated assembly 5 is moved relative to the stem 4 via a sliding link, the projection of the cutting plane on the mechanical axis N varies, until the end 26 of the probe reaches the extremity of the condyle. As illustrated in FIG. 4, the probe can comprise two ends 26, 27. The probe is designed so that the first end can rest on an extremum of a concave portion and so that the second end can rest on an extremum of a convex portion.

The cutting guide is preferably designed so that the intersection of the cutting plane with the first reference axis is at a predetermined distance from said distal end of the probe and therefore from the thickness reference point, preferably about 9mm. The cutting guide may include means for varying this distance between 6mm and 10mm.

The coordinate system is thus formed from the first position marker.

Once the mark has been formed, the method makes it possible to determine the position and the orientation of the cutting plane relative to said mark formed or reference mark. Preferably, the position and orientation of the cutting guide are controlled by the control means 51, 52, 53 of the positioning frame 3. The method comprises a step of taking an image comprising the first position marker and the second position of the cutting guide.

From such an image and the orientation of the two markers, this step makes it possible to locate the section plane in the reference frame formed.

The algorithm identifies the first marker and deduces the reference mark from it. By identifying the second marker of the cutting guide on the same image, the position and orientation of the cutting guide or the cutting plane in the reference frame are determined.

The method is therefore advantageously compatible with a mobile camera or a mobile optical capture means, since the first marker serves as a reference mark for the position and the orientation of the cutting plane.

Once the reference mark has been determined, and the position and orientation of the cutting plane determined in said reference mark, the method generates at least one parameter of position and / or orientation of the plane of the cutting guide relative to said reference mark.

The parameter can represent an angle of the section plane with respect to the first reference axis and / or with respect to the second reference axis of the reference frame. The step of generating at least one parameter is preferably carried out by computer.

A first parameter generated can for example be the angle or a value depending on the angle between the section plane and the second reference axis, representing the angle of varus / valgus. A second parameter generated can for example be the angle or a function of the angle between the cutting plane and the first reference axis, representing the posterior / anterior slope of the articular surface of the knee for the tibia or the flexion parameter / femoral extension.

A third parameter generated can be the cutting thickness. The cutting thickness is determined by the coordinate of the projected cutting plane on the first reference axis or the distance between this coordinate and the thickness reference point described above.

Thus, when the operator moves the cutting guide thanks to the articulated assembly and thanks to the control means, the camera records the first position marker and the second position marker. From the image taken and the reference frame, the algorithm calculates in real time the position and orientation parameters of the cutting plane.

In an embodiment where the means of transmitting information comprises the display of the axes forming the reference frame, this display is preferably superimposed on the real image of the knee. This display can be generated with mixed reality glasses.

Finally, the method comprises a step of transmitting to the operator the above-mentioned parameter (s). The transmission is done by the information transmission means 400 of the assistance system 100 according to the invention.

The optical capture means can be mobile. Indeed, the first marker 43 serving as a reference, the camera can move without unduly disrupting the process. Thus, the method is compatible with the use of a camera placed in a portable object, such as a mobile phone or on glasses. The invention also relates to a method for monitoring a cutting plane according to the second phase of the method described above.

Once the cutting plane has been placed in the place desired by the operator, the operator fixes the cutting guide to the bone with the fixing of the cutting guide. He can then separate the positioning frame 3 from the cutting guide 2 and remove the positioning frame 3 from the bone. Thus, only the cutting guide 2 remains fixed to the bone.

In one embodiment, this step previously comprises a sub-step for transposing the reference frame. For this, said reference mark, which has been formed with respect to the first position marker, is then transposed with respect to the second position marker linked to the cutting guide which remains alone positioned. In this way, the assistance system makes it possible to keep the reference mark, despite the removal of the bracket and the first marker.

After implementing the process, the operator can then perform the actual surgical treatment, and make the section of the bone according to the cutting plane thanks to the cutting guide, positioned beforehand.

In one embodiment, once the bone has been cut, the method comprises a step of controlling the cut surface made.

The control step includes the provision of a point reading tool comprising a marker fixed to a flat surface as described above. The surface of the tool is arranged on the cutting surface produced. The position and the orientation of the tool marker relative to the second position marker makes it possible to compare the cutting surface with the mark formed. The algorithm can then calculate the parameters as above. The operator can thus advantageously validate that the cutting surface is indeed similar to the cutting plane, as expected. The assistance system comprises hardware and / or software elements implementing or governing a method of assistance with the fitting of a knee prosthesis. In particular, the system comprises the hardware and / or software elements making it possible to implement the steps of the method of assistance with the fitting of a knee prosthesis. These different elements can include software modules.

For example, the hardware and / or software elements may include all or part of the following elements:

optical capture means 200 such as a camera; at least one cutting device 1 according to the invention; an interaction device 250;

a computer 300;

- a means of transmitting information 400;

a memory or a data storage medium 301;

at least one point reading tool such as a pointer 6 or pliers 7.

In one embodiment, the data recording medium 301 includes the instructions 1000 for performing the following steps, represented by FIG. 11:

- the reception 1100 of a first image comprising the first marker;

- the formation 1200 of an orthogonal coordinate system from the image of the first marker;

- the reception 1300 of a second image comprising the first marker and the second marker;

- the determination 1400 of a section plane in the space of the reference frame formed from the position and orientation of the second marker relative to the first marker on the second image;

- The determination 1500 of at least one position and / or orientation parameter of the cutting plane relative to the mark formed; and

- the transmission 1600 by means of transmission of the information of at least one determined parameter.

In one embodiment, the step of forming a reference 1200 includes the following sub-steps:

- the determination 1210 of a first point in space relative to the first marker;

- the determination 1220 of a second point in space on the mechanical axis of the bone to be cut;

- the creation 1230 of a first axis passing through the first point and the second point;

- the formation 1240 of a reference comprising the first axis and a second perpendicular axis, in particular formed by the projection of a known axis of the bracket on the plane perpendicular to the first reference axis.

In a first embodiment adapted to the tibia, the sub-step of determining a second point comprises the following phases:

- receiving at least one image comprising the first marker and a third marker;

- determining the position of the second point in space relative to the position of the third marker relative to the first marker on the image.

In a second embodiment adapted to the femur, the sub-step of determining a second point comprises the following phases:

- the reception of several images each comprising the first marker and another marker; - determining, from the images, a center of rotation of the first marker relative to the other marker;

- the determination of the second point as the center of rotation of the first marker.

Claims

Claims:

1. Cutting device (1) for fitting a knee prosthesis comprising a bracket (4) and a cutting guide (2) mounted movably on said bracket (4),

the bracket (4) comprising:

- A first marker (43) for its location;

- a fixing element (42) for fixing it to a bone; and the cutting guide (2) comprising:

- a second marker (23) for its location;

- a slot (21) defining a cutting plane suitable for guiding a cutting tool,

characterized in that the first marker (43) and the second marker (23) comprise a rectangular planar surface comprising at least one pattern.

2. Cutting device (1) according to the preceding claim, wherein the cutting guide (2) is movably mounted on the bracket (4) according to at least one degree of freedom in translation.

3. Cutting device (1) according to one of the preceding claims, in which the cutting guide (2) is movably mounted on the bracket (4) according to at least two degrees of freedom in rotation.

4. Cutting device (1) according to one of the preceding claims, in which the cutting guide (2) is movably mounted on the bracket (4) via an articulated assembly (5) allowing the mobility of the cutting guide (2 ) relative to the stem (4).

5. Cutting device (1) according to one of the preceding claims wherein the cutting guide (2) comprises a fixing element (22) for fixing it on a bone.

6. A cutting assistance device for fitting a knee prosthesis, characterized in that it comprises at least one cutting device (1) according to one of the preceding claims and at least one tool for reading out point (6, 7) comprising a positioning point and a third marker for its location.

7. Cutting assistance device according to the preceding claim, comprising a first cutting device (1) according to one of claims 1 to 5 designed for cutting a tibia and a second cutting device according to one of claims 1 to 5 designed for cutting a femur.

8. Assistance method (1000) for fitting a knee prosthesis, characterized in that it comprises:

- A first phase of positioning a cutting device (1) according to one of claims 1 to 5, comprising a cutting guide (2) movable according to three degrees of freedom relative to the bracket (4) of the device ( 1),

- a second phase of assistance in positioning the cutting guide (2) relative to the bracket (4), comprising i. a step of viewing by a single camera the first marker of the stem and the formation of a reference mark defined with respect to the first marker,

ii. a step of viewing the first marker and the second marker, and

iii. a step of transmitting and indicating to an operator the three-dimensional relative positioning of the cutting guide and / or of its cutting plane relative to the reference frame.

9. Assistance method (1000) according to the preceding claim, in which the reference frame comprises two reference axes and in that the formation of said reference frame comprises the following steps:

- generation of a reference point;

- the formation of a first reference axis passing through the reference point and a predetermined point relative to the first marker;

10. Assistance method (1000) according to the preceding claim, characterized in that it is suitable for bone cutting of a tibia and in which the reference point is positioned in the mechanical axis of the tibia and in that the generation of the reference point is carried out by a step of viewing a third marker of a point reading tool with respect to the first marker for locating said reference point.

1 1. Assistance method according to claim 9, characterized in that it is suitable for bone cutting of a femur and in which the reference point is positioned in the mechanical axis of the femur and in that the generation of the reference point comprises a sub-step of movement of the patient's leg for determining the center of rotation of said leg and a sub-step of viewing several images of the first marker during movement of the leg and of a third marker fixed relative to the patient's pelvis.

12. Assistance system (100) for fitting a prosthesis comprising a cutting device (1) according to one of claims 1 to 5, a mobile monocular camera, in particular mounted on a pair of glasses or on a portable object such as a telephone, a display means and means for implementing the assistance method according to one of claims 8 to 1 1, in which the viewing step is performed by said camera and the transmission step is performed by said display means.

13. Computer program product comprising program code instructions, recorded on a computer-readable medium or downloadable by a computer from a communication network, for implementing the steps of the method according to any one of claims 8 to 1 1 when said program is running on a computer.

14. A data recording medium, readable by a computer or a computer, on which a computer program is recorded comprising instructions for the code for implementing the method according to one of claims 8 to 11.