SURGICAL GUIDE DEVICE TO SUPPORT OPEN-WEDGE OSTEOTOMY

Description

TECHNICAL FIELD TO WHICH THE INVENTION RELATES

[0001] The present invention relates generally to the field of orthopedic surgery.

[0002] It particularly concerns surgical devices intended to assist opening osteotomy techniques. TECHNOLOGICAL BACKGROUND

[0003] Osteotomy refers to the surgical section of a long bone, to modify its axis, size or shape, for therapeutic or plastic purposes.

[0004] Among the osteotomy techniques, the so-called "opening osteotomy" techniques are particularly well known, which consist of cutting the bone to be treated with a cutting line, then separating the edges of the line by introducing a bone or artificial wedge (metal, cement, bone substitute).

[0005] Once the correction is obtained, the two bone fragments are securely held together by osteosynthesis material, in particular an osteosynthesis plate held by screws.

[0006] Such a surgical intervention is, for example, useful for treating certain types of osteoarthritis located in the knee, in order to correct a deformity of the lower limb and to obtain a straightening of the tibia. In particular, tibial valgus osteotomy remains an intervention of choice for the treatment of internal femoro-tibial osteoarthritis on genu varum.

[0007] Preoperative planning is essential in this type of operation, particularly to precisely determine the value of the spatial correction that will be achieved via the opening (HKA angle and tibial slope in particular). But, to date, this planning remains a difficult exercise in which the operator's experience and empiricism still count for a lot in the success of the operation.

[0008] Similarly, during the operation, it is often difficult for the surgeon to scrupulously follow the preoperative planning file, particularly with regard to the arrangement of the cutting line and the osteosynthesis plate.

[0009] US2016235454 and CN206333941 describe guiding devices according to the preamble of claim 1. US2009254126 describes an osteotomy system.

[0010] There is therefore a need for means to assist the operator throughout the opening osteotomy procedure, so as to effectively follow the preoperative planning. SUBJECT OF THE INVENTION

[0011] In order to overcome the aforementioned drawback of the state of the art, the present invention provides a surgical guiding device as claimed below, intended to be attached against a bone of a patient, to assist an opening osteotomy technique.

[0012] Preferred embodiments of the invention are described in the dependent claims. Related methods are also described herein to facilitate understanding of the invention, but they do not form part of the claimed invention.

[0013] Such a surgical guidance device thus has the advantage of assisting the operator during the opening osteotomy procedure, in order to precisely follow the preoperative planning.

[0014] As subsequently developed, the arrangement of the through holes of the surgical guide device takes into account the planned and previously simulated opening osteotomy technique via a scanner acquisition with a three-dimensional reconstruction of the anatomical area to be corrected.

[0015] This approach thus makes it possible to anticipate: the final position of the screw locations of the osteosynthesis plate added to fix the two bone fragments, and the spatial position of the bone cutting line to be made to generate the desired opening.

[0016] The surgical guidance device then advantageously consists of a patient-specific instrument (also known as a PSI for "Patient Specific Instrument"). The design of this instrument uses imaging technologies and preoperative planning tools for its custom manufacture, taking into account the unique anatomy of each patient.

[0017] This surgical guidance device helps the surgeon to perform operations precisely and safely.

[0018] Other non-limiting and advantageous characteristics of the surgical guiding device according to the invention, taken individually or in all technically possible combinations, are as follows: the surgical guiding device comprises two lateral edges, at least one of which comprises at least one tab adapted to be positioned against a surface of said bone, which tab has an elastic deformation capacity; the proximal part comprises at least two juxtaposed, independent through-holes, which extend in a virtual band intended to be oriented transversely relative to the longitudinal axis of the bone; the proximal part is provided with an upper protrusion, preferably having the shape of a radiopaque cylindrical nipple, intended to help the practitioner to correctly position the guide at the correct distance relative to the patient's tibial plateau;the proximal part also comprises a tubular conduit which is adapted to guide the insertion of a pin within the bone, which tubular conduit is arranged directly above the guide window and is oriented so that its longitudinal axis is parallel to the plane of the guide window to position a pin participating in guiding the cutting line, the distal part comprises at least two juxtaposed, independent through-orifices, extending in a virtual band which is at least approximately perpendicular to the virtual band followed by the orifices of the proximal part and which is intended to be oriented at least approximately parallel to the longitudinal axis of the bone;the distal part comprises at least one through-orifice in the form of a tubular conduit which is adapted to guide the insertion of a pin within the bone: a proximal tubular conduit which is arranged directly below the guide window and which is oriented so that its longitudinal axis is parallel to the plane of the guide window to position a pin participating in the guidance of the cutting line, and / or a distal tubular conduit which is arranged at a distance from the guide window and which is oriented so that its longitudinal axis intersects the plane of the guide window to position a cutting stop pin and / or hinge indication pin;according to a particular embodiment, the distal part comprises at least two distal tubular conduits which are arranged at a distance from the guide window and which are oriented so that their respective longitudinal axes intersect the plane of the guide window to each position a cutting stop pin and / or hinge indication pin; the surgical guide device is made of a plastic material suitable for additive manufacturing and invasive use within the human body.;

[0019] The invention also provides equipment for implementing an opening osteotomy technique, according to claim 7.

[0020] The invention also relates to a method for obtaining a surgical guiding device according to the invention.

[0021] This process includes: a) a step of simulating the correction intended to be applied to a bone by an opening osteotomy technique from the following data: anatomical data taken from the bone to be treated, data relating to the osteosynthesis plate to be placed, and preoperative planning data, relating to the correction intended to be applied to this bone by the opening osteotomy technique, and b) a step of manufacturing the surgical guiding device, taking into account the correction data from said simulation step.

[0022] According to an advantageous characteristic, the step of manufacturing said surgical guiding device consists of an additive manufacturing step.

[0023] Also described is a computer program comprising program code means recorded on a computer-readable medium, comprising: first program code means, for loading data relating to the correction intended to be applied to a bone by an opening osteotomy technique, from anatomical data of said bone and data relating to the final position of the screws for fixing the osteosynthesis plate in the bone, second program code means, for generating manufacturing data of the surgical guide device, which manufacturing data contain data relating to the arrangement of the through holes of the surgical guide device taking into account said correction data and said final position data of the screws, when said computer program is executed by a computer.

[0024] An unclaimed opening osteotomy surgical method is described, which surgical method comprises: a) a preparation step, during which the surgical guide device is fixed against the surface of the bone, and holes are generated in said bone opposite each of the through holes of said surgical guide device (with optionally the positioning of at least one lower pin arranged to intersect the hinge of the osteotomy focus); b) a step of osteotomy of the bone comprising: a first cutting phase within the guide window of the surgical guide device, a removal of the proximal part of the surgical guide device, and a second cutting phase, bearing on the distal part of the surgical guide device, c) a step of removal of the distal part of the surgical guide device;d) a step of fixing the osteosynthesis plate against a distal fragment of the bone, underlying the cutting line, which osteosynthesis plate is arranged so that its through holes come into contact with holes resulting from step a) which are made in said distal fragment; e) a step of progressively opening the osteotomy focus, until the desired correction is obtained, corresponding to a placing of holes resulting from step a) which are made in a proximal fragment of the bone and overlying the cutting line, with through holes of said osteosynthesis plate; and f) a step of fixing the osteosynthesis plate against the proximal fragment of the bone. ; DETAILED DESCRIPTION OF AN EXAMPLE OF IMPLEMENTATION

[0025] The description which follows with reference to the appended drawings, given as non-limiting examples, will make it clear what the invention consists of and how it can be implemented.

[0026] On the attached drawings: there figure 1 is a general and perspective view of a surgical guiding device according to the invention, attached to a bone of a patient intended to undergo an opening osteotomy technique; figure 2 is a front view of the surgical guide device illustrated in the figure 1 ; there figure 3 is a perspective view of the surgical guide device illustrated in the Figures 1 and 2 ; there figure 4 is a bottom view of the surgical guide device figures 1 to 3 ; there Figure 5 is a front view of a proximal component of the surgical device for guiding the figures 1 to 4 , intended to cooperate with a first bone fragment; the figure 6 is a perspective view of a distal component of the surgical guide device figures 1 to 4 , intended to cooperate with a second bone fragment; the figures 7 to 13represent the main steps during the implementation of the surgical guiding device, within the framework of an opening osteotomy surgical intervention; the figure 14 is a general and perspective view of a second surgical guiding device according to the invention, attached to a bone of a patient intended to undergo an opening osteotomy technique, which differs from that illustrated in the figures 1 to 13 by the presence of a third tubular conduit adapted to guide a second lower spindle; the figure 15 is a general top view of the second surgical guiding device according to the invention, with a transverse cutting plane which passes through the bone and at the level of the future hinge; figure 16 illustrates a step of the surgical process using the second surgical guide device, namely the guiding of a cannulated screw by the second lower pin for its insertion into the hinge.

[0027] As shown on the figure 1 in particular, the surgical guide device 1 is intended to be attached against a bone S of a patient to assist the surgeon in an opening osteotomy technique.

[0028] By "opening osteotomy" we mean a surgical procedure consisting of cutting a patient's bone with a cut line, then separating the edges of the cut by introducing a bone or artificial wedge (metal, cement, bone substitute).

[0029] This surgical technique can be used to treat different bones in the human body.

[0030] Such a surgical intervention is, for example, useful for treating certain types of osteoarthritis located in the knee, in order to correct a deformity of the lower limb and to obtain a straightening of the tibia. In particular, tibial valgus osteotomy remains an intervention of choice for the treatment of internal femoro-tibial osteoarthritis on genu varum.

[0031] Generally speaking, the bone S to be treated has a surface S1 ; and this bone S also has a longitudinal axis S'. Surgical guiding device

[0032] The surgical guiding device 1, shown in more detail on the figures 1 to 4 , comes in the general form of a block.

[0033] This surgical guiding device 1 (also referred to as a guide) comprises a set of faces: a rear face 11, adapted to be positioned against a surface S1of the bone S to be treated, a front face 12, located opposite said rear face 11, and two lateral faces 13, namely: a first lateral face 131 (posterior) and a second lateral face 132 (anterior).

[0034] This surgical guiding device 1 also includes a window 2, in the form of a slit, for guiding the cutting line intended to be made in the bone. S.

[0035] This guide window 2 is delimited by an upper edge 21 and by a lower edge 22, arranged opposite and at a distance from each other.

[0036] These two edges 21 and 22 are rectilinear. They extend parallel to each other, together defining a general plane 2' ( figure 2 ).

[0037] The distance between the two edges 21, 22 advantageously corresponds to the thickness of the cutting blade (to the functional clearance).

[0038] The thickness of the edges 21, 22 (between the rear 11 and front 12 faces) is advantageously between 0.8 mm and 1.6 mm.

[0039] The guide window 2 is a through window, that is to say that it opens at the rear 11 and front 12 faces of the surgical guide device 2.

[0040] This guide window 2 also opens laterally on one side only, at the level of a lateral opening 23 located in the first lateral face 131 of the surgical guide device 1.

[0041] The guide window 2 also has a lateral border 24, forming a bottom, which extends between the two edges 21, 22 and which is located opposite the lateral opening 23.

[0042] The surgical guiding device 1 here comprises two parts 4, 5 which are assembled with each other by means of removable fastening means.

[0043] More precisely, this surgical guiding device 1 comprises a first part 4, also called proximal part or part ( Figure 5 ), and a second part 5, also called distal part or part ( figure 6 ).

[0044] These two parts 4, 5 are each intended to cooperate with one of the two bone fragments intended to be generated by the cutting line made in the bone. S through the guide window 2.

[0045] As described in more detail below, these two parts 4, 5 are each provided with several through holes which are adapted to accommodate organs temporarily implanted in the bone. S and / or to guide a drilling of holes in this bone S.

[0046] Each of these parts 4, 5 is advantageously made in one piece from a plastic material suitable for additive manufacturing techniques (also called “3D printing” or “three-dimensional printing”).

[0047] This plastic material is chosen, for example, from polyamides. First piece

[0048] The first piece 4 (proximal piece), shown in more detail and in isolation on the Figure 5 , comprises an upper portion 41 which has: a rear face 411, intended to form an upper portion of the rear face 11 of the surgical guide device 1 ( figure 3 ), and a front face 412, intended to form an upper portion of the front face 12 of the surgical guide device 1.

[0049] The upper portion 41 comprises several through orifices 42, opening through its rear 411 and front 412 faces.

[0050] The through holes 42, also called “proximal through holes”, are suitable for accommodating organs temporarily implanted in the bone S and / or to guide a drilling of holes in this bone S.

[0051] In this case, these through holes 42 are intended in particular to serve as a guide for drilling holes in a proximal fragment of the bone in order to facilitate the subsequent assembly of the osteosynthesis plate.

[0052] The juxtaposed through holes 42 are at least two in number (here three in number).

[0053] These through holes 42 extend in a virtual strip 42' intended to be oriented transversely relative to the longitudinal axis S' bone S ( figure 1 ).

[0054] This upper portion 41 comprises a lower edge 413, intended to form the upper edge 21 of the guide window 2.

[0055] This upper portion 41 is also delimited by two lateral edges 414 forming an upper portion of the lateral faces 13 of the surgical guide device 1.

[0056] One of these lateral borders 414 here comprises a lateral tab 45 (anterior tab) which is adapted to be positioned against a surface of the bone S, as developed below in relation to the figures 7 to 13 .

[0057] The leg 45 has an elastic deformation capacity, so as to optimally fit the surface of the bone S.

[0058] This tab 45 extends approximately parallel to the lower edge 413 and on the side of the rear face 411 of the upper portion 41 ( figure 4 ). Its rear surface corresponds approximately to the anatomical surface of the bone it is intended to cover.

[0059] The upper portion 41 is extended here by a lower portion 44 which is intended to cooperate with the second part 5 with a view to their removable assembly.

[0060] The lower portion 44 is in the general form of a plate intended to fit an additional reservation made in the front face of the second part 5.

[0061] This lower portion 44 then comprises: a rear face 441, intended to cover the second part 5 of the surgical guide device 1 ( figure 3 ), and a front face 442, intended to form a part of the front face 12 of the surgical guide device 1.

[0062] The rear face 441 of the lower portion 44 is set back relative to the rear face 411 of the upper portion 41.

[0063] This lower portion 44 is here further delimited by an upper edge 443 which is intended to form a part of the lower edge 22 and the lateral edge 24 of the guide window 2, in particular intended to form the front part of this lower edge 22.

[0064] This lower portion 44 also includes a slot 444, within which a complementary shape of the second part 5 is intended to be placed, in particular a part including the through-orifices of this second part 5.

[0065] The proximal part 4 is also provided with an upper protrusion 48 which is intended to help the practitioner to correctly position the surgical guide device 1 at the correct distance from the patient's tibial plateau (verification of the altitude of the guide 1).

[0066] This upper protrusion 48 is attached, here in a removable manner, to an upper face 418 (free) of the upper portion 41.

[0067] This upper protrusion 48 preferably has the shape of a cylindrical nipple (also called a rod or pin) which is radiopaque.

[0068] Furthermore, optionally, this first part 4 also includes a tubular conduit 49 adapted to receive an additional pin intended to be temporarily implanted in the bone S to assist the osteosynthesis technique (this tubular conduit 49 is shown in broken lines on the figures 2, 3 And 5 ).

[0069] This tubular conduit 49 is provided here in the upper portion 41, through its other lateral edge 414 and close to its lower edge 413 (intended to form the upper edge 21 of the guide window 2).

[0070] This tubular conduit 49 comprises a longitudinal axis 49' which is oriented parallel, or at least approximately parallel, to the aforementioned lower edge 413 ( figure 2 ).

[0071] This tubular conduit 49 is thus arranged directly above the guide window 2 and it is oriented so that its longitudinal axis 49' is parallel to the plane 2' of the guide window 2 to position a pin participating in the guidance of the cutting line (this “additional” pin 83 is shown schematically on the figure 9 ).

[0072] This tubular conduit 49 extends parallel to the plane defined by the upper edge 21 of the guide window 2, with an offset (or shift) of between 0.5 and 3 mm relative to this upper edge 21 (preferably of the order of 1 mm).

[0073] This tubular conduit 49 also defines an angle of between 10° and 30° relative to the general plane of the first part 4' ( figure 4 ). Second room

[0074] The second piece 5, illustrated in isolation on the figure 6 , also has several sides: two opposite faces: a rear face 51 and a front face 52, two side faces 53: a first side face 531 (on the right on the figure 6 ) and a second side face 532 (on the left on the figure 6 ), forming a lower portion of the lateral faces 13 of the surgical guide device 1, and two end faces: a proximal face 54 and a distal face 55.

[0075] The rear face 51 is intended to form a lower portion of the rear face 11 of the surgical guide device 1 ( figure 3 ).

[0076] The front face 52 includes a reservation 521 intended to receive the lower portion 44 of the first part 4.

[0077] The proximal face 54 constitutes an upper edge of the second part 5, which is intended to form a part of the lower edge 22 of the guide window 2 (in this case a rear part of this lower edge 22) in combination here with the upper edge 443 of the lower portion 44 of the first part 4.

[0078] A location 541 dedicated to guiding a bi-planar cut can be provided at the level of this proximal face 54 (visible figure 10 ).

[0079] This location 541 is added to the surgical guide device 1 when the cutting line is in conflict with the tibial tuberosity. It is then necessary to preserve the insertion of the patellar tendon by this process.

[0080] This location 541 is located here on the side opposite the side opening 23.

[0081] This proximal face 54 also comprises, on the side of the lateral opening 23, spacer means 542 to maintain the spacing between the two edges 21, 22 of the guide window 2 ( figures 2 And 10 ).

[0082] These spacer means 542 consist for example of a single-piece pin equipping the proximal face 54, and coming to bear against the lower edge 413 of the first part 4.

[0083] The second part 5 comprises several through holes 56 which are adapted to accommodate organs temporarily implanted in the bone. S and / or to guide a drilling of holes in this bone S.

[0084] In this case, this second part 5 comprises through holes 56, also called “distal through holes” which are intended in particular to serve as a guide for drilling holes in a distal fragment of the bone in order to facilitate the subsequent assembly of the osteosynthesis plate.

[0085] These through holes 56 open through the rear 51 and front 52 faces of the second part 5.

[0086] These through holes 56, juxtaposed, are at least two in number (here three in number).

[0087] These through holes 56 extend in a virtual strip 56' intended to be oriented approximately parallel to the longitudinal axis S' of the bone ( figure 1 ).

[0088] The first lateral face 531 of this second part 5 comprises tabs 57 intended to be positioned against the surface of the bone S, as developed below in relation to the figures 7 to 13 .

[0089] These legs 57 have a rear face which corresponds approximately to the anatomical surface of the bone which they are intended to cover; they have a capacity for elastic deformation, so as to optimally fit the surface of the bone S.

[0090] These legs 57 extend approximately parallel to the proximal face 54 and on the side of the rear face 51.

[0091] In this case, this second part 5 has two legs: an upper leg 571, provided along the proximal face 54, and a lower leg 572, provided on the side of the distal face 55.

[0092] In particular, the upper tab 571 comprises an upper edge 5711 extending in the extension of the proximal face 54 so as to participate in forming the guide surface for the cutting line.

[0093] Furthermore, this second part 5 also includes tubular conduits 58 adapted to receive pins intended to be temporarily implanted in the bone. S to assist the osteosynthesis technique.

[0094] A first tubular conduit 581, upper or proximal (also called “upper shaft”), is provided here through the upper leg 571.

[0095] This upper tubular conduit 581 has a longitudinal axis 581' which is oriented parallel, or at least approximately parallel, to the proximal face 54 ( figure 2 ).

[0096] This longitudinal axis 581' is further advantageously oriented parallel, or at least approximately parallel, to the longitudinal axis 49' of the tubular conduit 49 of the first part 4.

[0097] This proximal tubular conduit 581 is arranged directly below the guide window 2 and is oriented so that its longitudinal axis 581' is parallel to the plane 2' of the guide window 2.

[0098] This upper tubular conduit 581 is adapted to guide an upper spindle which is intended to participate in guiding the cutting line.

[0099] This upper tubular conduit 581 extends parallel to the plane defined by the lower edge 22 of the guide window 2, with an offset (or shift) of between 0.5 and 3 mm relative to this lower edge 22 (preferably of the order of 1 mm).

[0100] This upper tubular conduit 581 also defines an angle of between 10° and 30° relative to the general plane of the second part 5' ( figure 4 ).

[0101] A second tubular conduit 582, lower or distal (also called “lower barrel” or “first distal tubular conduit” or “first lower tubular conduit”), is provided through the lower leg 572.

[0102] This lower tubular conduit 582 is oriented so that its longitudinal axis 582' intersects the general plane 2' of the guide window 2 ( figure 2 ).

[0103] This point of intersection is intended to be located within the bulk of the bone, particularly at the level of the opening focus.

[0104] The intersection point allows to locate a theoretical point located at a determined distance from the surface of the bone and the plate (for example, the theoretical point is located 10 to 11 mm from the external cortex).

[0105] This lower tubular conduit 582 is intended to guide a lower, ascending pin, serving as a cutting stop and / or hinge indicator.

[0106] The orientation of the longitudinal axis 582' of this lower tubular conduit 582 can be defined by two angles: a first angle of inclination defined between the longitudinal axis 582' and the general plane 2' of the guide window 2, between 40° and 70° ( figure 2 ), and a second angle of inclination defined between the longitudinal axis 582' and the general plane of this second part 5', between 35° and 70° ( figure 4 ).

[0107] THE figures 14 and 15 represent a second surgical guiding device according to the invention, a variant of the surgical device described above in relation to the figures 1 to 6 .

[0108] The second surgical guiding device 1 is distinguished only by the presence of a third tubular conduit 583 (also called “second lower tubular conduit” or “second distal tubular conduit”), provided on the second part 5 for receiving a pin intended to be temporarily implanted in the bone S to assist the osteosynthesis technique.

[0109] The third tubular conduit 583, also lower or distal (also called “second lower barrel”), is provided here through the lower leg 572.

[0110] This third tubular conduit 583 is here arranged between the second tubular conduit 582 and the free end 5721 of this lower leg 572. Alternatively, not shown, depending on the primary location of the second tubular conduit 582, the third tubular conduit 583 can also be arranged between the first lateral face 531 of the second part 5 and the second tubular conduit 582; this is for example the case when this second tubular conduit 582 is offset and off-center to take into account the requested change in tibial slope (indeed, the more it is opened posteriorly, the more the first pin will go anteriorly and therefore close to the free end 5721 of the lower leg 572).

[0111] This third tubular conduit 583 is oriented so that its longitudinal axis 583' intersects the general plane 2' of the guide window 2 ( figure 2 ).

[0112] Its point of intersection is intended to be located in the bulk of the bone, in particular at the level of the opening focus and even more precisely at the level of the hinge.

[0113] The intersection point allows to locate a theoretical point located at a determined distance from the surface of the bone and the plate (for example, the theoretical point is located 10 to 11 mm from the external cortex).

[0114] This third tubular conduit 583 is intended to guide a second, lower, ascending pin. As illustrated in the figure 16 , the second lower pin is also useful for guiding the insertion of a cannulated screw through the hinge.

[0115] The orientation of the longitudinal axis 583' of this third tubular conduit 583 is advantageously parallel to the longitudinal axis 582' of the second tubular conduit 582. Removable securing means

[0116] The two parts 4, 5 are secured together by means of removable securing means 59, in this case in the form of complementary interlocking structures.

[0117] For this purpose, at the level of its reservation 521, the front face 51 of the second part 5 comprises tenons 591 ( figure 6 ) intended to cooperate by fitting with complementary mortises (not visible) which are provided at the level of the rear face 441 of the distal portion 44 of the first part 4.

[0118] The second part 5 is still provided with lugs 592 for example in the form of spherical caps or conical pins ( figure 6 ) which are judiciously distributed so as to cooperate by elastic interlocking with complementary housings (not visible) equipping the first part 4.

[0119] Here, these lugs and complementary housings are provided on the edges opposite, on the one hand, the light 444 of the first part 4 and, on the other hand, the reservation 521 of the second part 5. Equipment for opening osteotomy technique

[0120] As shown on the figures 7 and following, the surgical guiding device 1 is intended to be used in combination with a set of other elements for implementing the opening osteotomy technique.

[0121] The corresponding material thus advantageously includes: organs temporarily implantable in the bone, through the through holes 42, 56 of this surgical guide device 1, namely in particular rigid axes 7 (called “pins”), pins 8 temporarily implantable in the bone S, through the through conduits 49, 58 of said surgical guide device 1, a cutting blade 9 ( figure 9), associated with a surgical motor, to produce the cutting line guided by the surgical guide device 1, an osteosynthesis plate 10 ( Figure 11 to 13 ), provided with through holes 101 for receiving fixing screws 102 intended to be implanted in the bone S, and a set of screws 102 for fixing in the bone S, intended to be inserted into the through holes 101 of the osteosynthesis plate 10 to fix the latter to the surface of the bone S.

[0122] The osteosynthesis plate 10 is intended to be secured to the two bone fragments, following the opening osteotomy technique guided by the surgical guiding device 1, so as to fix the correction made by the surgeon.

[0123] Such an osteosynthesis plate 10 is for example described in detail in document FR2980967.

[0124] As described below in connection with the figure 13, this osteosynthesis plate 10 is composed of two elongated parts, here together having a general L shape, namely: a proximal portion 105, intended to be positioned against a proximal fragment Sp bone S, and a distal portion 106, intended to be positioned against a distal fragment Sd of this same bone S.

[0125] Each of these two parts 105, 106 is provided with a group of through holes 1011, 1012 for receiving fixing screws 102.

[0126] According to the invention, the arrangement of each group of through-holes 42, 56 of the surgical guide device 1 corresponds to the arrangement of one of the two groups of through-holes 1011, 1012 of the osteosynthesis plate 1: the arrangement of the through holes 42 of the first part 4 corresponds to the arrangement of the through holes 1011 of the proximal part 105 of the osteosynthesis plate 10, and the arrangement of the through holes 56 of the second part 5 corresponds to the arrangement of the through holes 1012 of the distal part 106 of the osteosynthesis plate 10.

[0127] Still according to the invention, the relative arrangement between the two groups of through holes 42, 56 of the surgical guiding device 1 is a function, on the one hand, of the correction intended to be applied during the opening osteotomy technique and, on the other hand, of the relative arrangement of the two groups of through holes 1011, 1012 of the osteosynthesis plate 1. Manufacturing of the surgical guiding device

[0128] The manufacture of the surgical guiding device 1 is advantageously carried out tailor-made for the patient. This surgical guiding device 1 thus advantageously consists of a patient-specific instrument or “PSI”.

[0129] The manufacture of this surgical guiding device 1, and as a corollary of its two constituent parts 4, 5, advantageously takes into account the following data: of anatomical data taken from the bone to be treated, advantageously obtained by a medical imaging technique (for example by scanner), of data relating to the osteosynthesis plate 10 to be placed, in particular the final position of the locations of the screws 102 for fixing the osteosynthesis plate 10, and of preoperative planning data, relating to the correction intended to be applied to this bone by the opening osteotomy technique.

[0130] The method for obtaining the surgical guiding device 1 according to the invention advantageously comprises the following steps: a / a step of simulating the correction intended to be applied to the bone S by an opening osteotomy technique from the aforementioned data, then b / a manufacturing step proper of the surgical guiding device 1, taking into account the correction data from the simulation step.

[0131] For the implementation of the simulation step, a preoperative planning tool is proposed in the form of a computer program intended to generate data for the manufacture of the surgical guiding device 1 on the basis of the aforementioned data.

[0132] In this case, this computer program comprises program code means recorded on a computer-readable medium, comprising: first program code means, for loading data relating to the correction intended to be applied to a bone by an opening osteotomy technique, from anatomical data of the bone to be treated and data relating to the final position of the screws for fixing the osteosynthesis plate in the bone, and second program code means, for generating manufacturing data of the surgical guide device 1, which manufacturing data contain data relating, on the one hand, to the shape of the rear face 11 of the surgical guide device 1 and, on the other hand, to the arrangement of the through holes 42, 56 of the surgical guide device 1 taking into account said correction data and said final position data of the screws, when said computer program is executed by a computer.

[0133] The anatomical data of the bone to be treated consists, for example, of data from a scanner acquisition, from which a three-dimensional modeling of all the parts involved in the correction process is carried out.

[0134] Correction data is provided by the surgeon as part of his pre-operative planning.

[0135] The final position of the screws and the plate respects the usual principles necessary to obtain the mechanical performance sought for this material (in particular anatomical positioning of the implant).

[0136] The second program code means advantageously consist of three-dimensional modeling means which are intended to generate the manufacturing data of the surgical guiding device 1 in the form of a “three-dimensional file” (or “3D file”) which corresponds to a three-dimensional model usable by a three-dimensional printer.

[0137] As illustrated in connection with the figures 7 and following, in this manufacturing data, the arrangement of the through holes 42, 56 of the surgical guide device 1 takes into account the planned opening osteotomy technique and anticipates the final position of the screw locations of the osteosynthesis plate 10 added to fix the two bone fragments Sp And Sd.

[0138] The manufacturing step of the surgical guiding device 1 consists of an additive manufacturing step. Unclaimed opening osteotomy surgical procedure

[0139] A first step in the surgical procedure consists of a preparation step ( figures 7 and 8 ).

[0140] During this preparation step, the surgical guide device 1 (with its two parts 4 and 5 assembled) is positioned so that its rear face 11 comes to rest on the surface of the bone S, in place of the future location of the osteosynthesis plate 10.

[0141] In the case of an internal opening tibial valgus osteotomy, the surgical guide device 1 is placed at the level of the antero-internal zone of the tibia.

[0142] In this case, as shown in the figure 7 , the tab 45 of the first part 4 then presses on the insertion of the patellar tendon T,at the level of the anterior tibial tuberosity; the tabs 57 of the second part 5 allow good application of the surgical guide device 1 on the bone and compensation of the play, so that the aforementioned tab 45 comes to be applied effectively on the posterior face of the patellar tendon T (position adjustment perpendicular to the S' axis of the S bone).

[0143] The upper protrusion 48 (located at the top of the surgical guide device 1) allows a first visual height adjustment of the surgical guide device 1 (verification of the altitude of the guide 1).

[0144] Then, the upper pin 81 (see the additional pin 83) makes it possible to check and validate this correct positioning of the surgical guide device 1 via visualization with a brightness amplifier.

[0145] The upper pin 81, inserted into the second part 5 of the surgical guide device 1 and into the bone Sthrough the upper tubular conduit 581, temporarily fixes the surgical guide device 1 on the bone.

[0146] Optionally, the additional pin 83, inserted into the first part 4 of the surgical guide device 1 and into the bone S through the dedicated tubular conduit 49, also participates in temporarily fixing the surgical guide device 1 on the bone.

[0147] This upper pin 81 (or also the additional pin 83) also allows a verification of the altitude of the surgical guide device 1, in accordance with the planning file. For this, the path of this upper pin 81 (or also the additional pin 83), radiopaque, is superimposed with the theoretical path determined during the simulation, this information appearing in the surgical planning file provided to the surgeon.

[0148] The preparation stage also includes a "drilling" stage, i.e. a stage of forming holes in the bone S opposite each of the through holes 42, 56 of the surgical guide device 1.

[0149] For example, the holes are, respectively, blind at the level of the through holes 42 (proximal) of the first part 4 and, on the other hand, through (bicortical) at the level of the through holes 56 (distal) of the second part 5.

[0150] This surgical guide device 1 is then temporarily fixed against the surface of the bone S, by means of pins 7 inserted through at least some of the through holes 42, 56 ( figure 8 ).

[0151] This temporary fixation allows a robust hold of the surgical guide device 1, in order to ensure a very precise cut within the guide window 2.

[0152] When this preparation step is completed, an osteotomy step of the bone can be performed.

[0153] The start of the cut is made using the guide window 2, custom-designed and dedicated to the previously known thickness of the cutting blade 9 ( figure 9 ).

[0154] The upper spindle 81 (or also the additional spindle 83) also allows the path of the cutting blade 9 to be followed. This upper spindle 81 (or also the additional spindle 83) allows a visual check that there is no loss of the correct direction of the cut (for example if the adjustment between the thickness of the blade and that of the window is too wide).

[0155] A lower pin 82 (also called “first lower pin 82”) is then inserted into the bone, guided by the lower tubular conduit 582 ( figure 10 ).

[0156] This lower pin 82 is arranged to intersect the hinge of the osteotomy focus (the focus represents the empty space that will be created when the tibia is opened by the saw cut). In other words, this lower pin 82 intersects an axis of rotation A ( figure 15 ), extending from the posterior part to the anterior part of the tibia, which represents the line of flight of the rotation around which the opening is made; this lower pin 82 further advantageously extends perpendicularly, or at least approximately perpendicularly, to this axis of rotation A.

[0157] This arrangement also provides protection for the hinge during the opening movement, serving as a deformation “guide” and preventing any breakage.

[0158] It also forms a cutting stop but also indicates the ideal position of the hinge.

[0159] According to the second embodiment, a second lower pin 84 can be inserted into the bone, guided by the third tubular conduit 583 ( figures 14 to 16 ).

[0160] This second lower pin 84 is also arranged to intersect the hinge of the osteotomy focus, close to the point of intersection of the first lower pin 82. In other words, here again, this second lower pin 84 intersects the axis of rotation A ( figure 15 ) which represents the vanishing line of the rotation around which the opening is made; this second lower pin 84 furthermore advantageously extends perpendicularly, or at least approximately perpendicularly, relative to this axis of rotation A.

[0161] In this regard, this second lower pin 84 is advantageously strictly parallel to the first lower pin 82. This arrangement allows the second lower pin 84 to cross the axis of rotation of the hinge in exactly the same conditions as the first lower pin 82.

[0162] Preferably, the point of intersection of the second lower pin 84 within the hinge is located in a central portion L1 of the length L of this hinge ( figure 15 ).

[0163] Such an arrangement aims to balance, in the depth of the frontal plane, the location of the second lower pin 84 so that the screw slides on the latter and rebalances the fixing forces in the event of a hinge breakage.

[0164] For example, this central portion L1 (centered on the length of the hinge L)has a length corresponding to 1 / 3 (or even 1 / 4, possibly 1 / 5) of the length of said hinge.

[0165] In an alternative embodiment, the first lower pin 82 may be centered along the length of the hinge. In this case, the second lower pin 84 is offset along the length of this hinge, while remaining as close as possible to this first lower pin 82.

[0166] In practice, the second lower pin 84 is inserted after the cut has been completed. It can also be useful for restoring the integrity of the hinge if it were to give way despite the presence of the first lower pin 82.

[0167] In addition, its presence and visualization beyond the cut and beyond the lateral cortex allows, if necessary, to come through the external route, to thread the cannulated screw and to reinforce / synthesize the external hinge.

[0168] The first part 4 can then be removed after extracting the retaining pins 7 ( figure 10 ).

[0169] The cutting blade 9 will be able to rest on the distal part 5 still fixed to the bone, and in particular on its upper leg 571, in order to continue to follow the ideal path.

[0170] The operator can then find the hinge point by mechanically coming into contact with the first lower pin 82 which extends at the level of the osteotomy focus.

[0171] The hinge between the two bone fragments Sp , Sd is thus protected by this first lower pin 82 (or also by the second lower pin 84) which crosses the cutting line.

[0172] The first lower pin 82 (or also the second lower pin 84) is left until the end of the operation when the plate is completely secured to the bone. Thus all intermediate manipulations that traumatize the hinge, and which risk weakening it (or even breaking it), are preserved thanks to the constant presence of this first lower pin 82 (or also the second lower pin 84).

[0173] Note that, once the second (distal) part 5 is removed, it can slide along this first lower pin 82 (or also the second lower pin 84) so ​​that it(they) remains(remain) in place. The first lower pin 82 (or also the second lower pin 84) thus plays a role of “stress absorber” and protects the bone from the risk of fracture, which can create the separation of the two bone fragments.

[0174] Once the cutting line is completed, the second part 5 is also removed, while keeping the lower pin 82 (or also the second lower pin 84) in the same position.

[0175] The osteosynthesis plate 10 is positioned by reinserting the pins 7 through its distal through holes 1012 and so that they penetrate into the holes of the distal fragment Sd obtained thanks to the second part 5 ( figure 11 ).

[0176] The bone opening movement is performed by the operator. This opening movement is achieved, for example, by means of a wedge inserted between the two bone fragments. To And Sd (or any other suitable instrument, such as a Mehari clamp).

[0177] Correction is achieved in all planes when the holes in the proximal bone fragment Sp(obtained by the first part 4) are found opposite the proximal through holes 1011 of the osteosynthesis plate 10 ( figure 11 ).

[0178] Indeed, as specified above, the relative arrangement between the two groups of through holes 42, 56 of the surgical guiding device 1 takes into account, on the one hand, the correction intended to be applied during the opening osteotomy technique and, on the other hand, the relative arrangement of the two groups of through holes 1011, 1012 of the osteosynthesis plate 10.

[0179] Pins 7 are then inserted through these proximal through holes 1011 to maintain the opening ( figure 12 ).

[0180] The various fixing screws 102 are then inserted successively into the bone S, through the various orifices 101 of the osteosynthesis plate 10.

[0181] When the osteosynthesis plate 10 is definitively fixed, if desired, the operator can fill the opening obtained with, for example, solid or injectable synthetic bone substitutes, bone grafts (iliac grafts).

[0182] If desired, after opening, the operator can also use the second lower pin 84 to guide the insertion of a cannulated screw 103 through the hinge ( figure 16 ).

[0183] This cannulated screw 103 thus helps to maintain the opening (and also the bone substitute), in association with the osteosynthesis plate 10.

[0184] This cannulated screw 103 also aims to reinforce the integrity of the hinge, and thus further reduce the risk of post-operative rupture. It also helps to contribute to the integrity of the hinge and therefore to the correct opening value defined by the surgical guide device 1.

[0185] Such a cannulated screw 103 may also be of interest in the context of an intraoperative repair, in order to repair a hinge which has given way despite the first lower pin 82 (following an excessively abrupt movement, large opening, etc.).

[0186] In general, the surgical guidance device 1 thus helps the surgeon to carry out his operation precisely and safely.

[0187] This surgical guidance device has the advantage of assisting the operator throughout the opening osteotomy procedure (particularly for making the cutting line and the opening), so as to precisely follow the preoperative planning.

[0188] This surgical guide device can be used to perform an opening osteotomy technique on other bones, for example the distal femur, wrist, distal tibia.

[0189] This device still provides access to complex corrections in three dimensions, with continuous control of the operating process.

Claims

1. A surgical guide device, intended to be placed against a patient's bone, for assisting an opening wedge osteotomy technique, said surgical guide device (1) being characterized in that it comprises: - a rear face (11) adapted to be positioned against a surface of said bone (S), and - a window (2) for guiding a cut line intended to be made into said bone (S), wherein said guide window (2) is delimited by an upper edge (21) and a lower edge (22), arranged opposite to each other and spaced apart from each other, wherein said surgical guide device (1) comprises two parts (4, 5) that are assembled to each other through detachable fastening means, i.e.: - a proximal part (4), having a lower edge (413) defining at least one portion of said upper edge (21) of said guide window (2), and - a distal part (5), having an upper edge (54) defining at least one portion of said lower edge (22) of said guide window (2), wherein said proximal (4) and distal (5) parts are each provided with several through-orifices (42, 56) opening through the rear face (11), adapted to receive elements (7) temporarily implantable into said bone (S) and / or adapted to guide a drilling of holes into said bone (S), the distal part (5) comprises tubulars ducts (58) that are adapted to guide the insertion of a rod within the bone (S), characterized in that the distal part (5) comprises at least two distal tubular ducts (582, 583) that are arranged remote from the guide window (2) and that are directed in such a manner that their respective longitudinal axes (582', 583') intersect the plane (2') of the guide window (2) in order to each position a cut stop and / or hinge indication rod (82, 84).

2. The surgical guide device according to claim 1, characterized in that it has two lateral edges (13), at least one of which comprises at least one tab (45, 57) adapted to be positioned against a surface of said bone (S), wherein said tab (45, 57) has an ability of elastic deformation.

3. The surgical guide device according to any one of claims 1 or 2, characterized in that: - the proximal part (4) comprises at least two through-orifices (42), juxtaposed and independent of each other, that extend in a virtual strip (42') intended to be directed transversally with respect to the longitudinal axis (S') of the bone (S), and - the distal part (5) comprises at least two through-orifices (56), juxtaposed and independent of each other, extending in a virtual strip (56') intended to be directed at least approximately parallel to the longitudinal axis (S') of the bone (S).

4. The surgical guide device according to any one of claims 1 to 3, characterized in that the tubular ducts (58) comprise a proximal tubular duct (581) that is arranged directly underlying the guide window (2) and that is directed in such a manner that its longitudinal axis (581') is parallel to the plane (2') of the guide window (2) in order to position a rod (81) helping in the guiding of the cut line.

5. The surgical guide device according to any one of claims 1 to 4, characterized in that the proximal part (4) is provided with an upper protrusion (48), advantageously intended to help the practitioner to correctly position the surgical guide device (1) at the good distance with respect to the tibial plateau of a patient.

6. The surgical guide device according to any one of claims 1 to 5, characterized in that it is made of a plastic material adapted to the additive manufacturing.

7. Equipment for implementing an opening wedge osteotomy technique, characterized in that it comprises: - a surgical guide device (1) according to any one of claims 1 to 6, - elements (7) temporarily implantable into said bone (S), through the through-orifices (42, 56) of said surgical guide device (1), - rods (8) temporarily implantable into said bone (S), through the through-ducts (58) of said surgical guide device (1), - a cutting blade (9), for making the cut line guided by the surgical guide device (1), - an osteosynthesis plate (10) provided with two groups of through-orifices (1011, 1012), a proximal one and a distal one, each of said groups (1011, 1012) being intended to receive fastening screws (102) intended to be implanted into one of the two bone fragments, - a set of screws (102) for the fastening to the bone (S), intended to be inserted through the through-orifices (1011, 1012) of said osteosynthesis plate (10) to fasten the latter to the surface of the bone (S), in that the arrangement of the through-orifices (42) of the proximal part (4) corresponds to the arrangement of the proximal through-orifices (1011) of the osteosynthesis plate (10), in that the arrangement of the through-orifices (56) of the distal part (5) corresponds to the arrangement of the distal through-orifices (1012) of the osteosynthesis plate (10), and in that the relative arrangement between the two groups of through-orifices (42, 56) of the surgical guide device (1) is function, on the one hand, of the correction intended to be applied during the opening wedge osteotomy technique and, on the other hand, of the relative arrangement of the two groups of through-orifices (1011, 1012) of the osteosynthesis plate (10).

8. A method for obtaining a surgical guide device according to any one of claims 1 to 6, characterized in that it comprises: a) a step of simulating the correction intended to be applied to a bone (S) by an opening wedge osteotomy technique from the above-mentioned data: - anatomic data taken on the bone (S) to be treated, - data relating to the osteosynthesis plate (10) to be installed, and - preoperative planning data, relating to the correction intended to be applied to this bone (S) by the opening wedge osteotomy technique, b) a step of manufacturing said surgical guide device (1), taking into account the correction data coming from said simulation step.

9. The method according to claim 8, characterized in that the step of manufacturing said surgical guide device (1) consists of a step of additive manufacturing.