AUXILIARY DEVICE AND METHOD FOR PRODUCING AN AUXILIARY DEVICE

Description

[0001] The present invention relates to the field of orthopedic surgery, and more particularly to a guiding instrument and its manufacturing method. The present invention also relates to a guiding instrument for use in surgery.

[0002] Orthopedic surgery treats diseases, trauma (fractures, ruptures, hematomas), and deformities of the musculoskeletal system: bones, joints, ligaments, tendons, and muscles. Once limited to the treatment of fractures, it is now expanding into other areas: joint prostheses and endoscopic surgery.

[0003] This field is subject to numerous technological advances due to the large quantity of instruments required for its implementation, particularly concerning ancillaries, defined as an instrument intended to guide the tools required for surgical procedures.

[0004] The development of communication technologies, computer tools, and robots has progressed enormously, particularly in orthopedic surgery. The challenge lies in reproducing two-dimensional planning in a three-dimensional environment. Robotic surgery has thus been introduced and presents itself as a tool whose action is performed in whole or in part by a robot. The constraints linked to the use of active or semi-active robots in the operating room may be associated with surgeons' reluctance to allow a machine to perform a surgical procedure, but also with significant investment costs and maintenance issues.

[0005] A passive system has been developed more widely in the following years. Navigation consists of a spatial orientation system related to the patient's anatomy. This navigation system corresponds to a measuring tool whose values ​​are transcribed into a central unit with an interface for the surgeon. Navigation allows an increase in the precision and reproducibility of the surgical procedure. Preoperatively, it is possible to plan the intervention in the navigation system's computer with an image loaded into the computer. The interface shows a representation of the anatomy of the surgical site with the possibility of combining the loaded image boards, graphics or measurements taken in real time and with great precision. During the intervention, it allows the representation of non-visible anatomical parts and the monitoring of instruments or implant alignment in real time.

[0006] Navigation has led to improved accuracy in prosthesis implantation and other orthopedic procedures (scoliosis surgery, corrective osteotomies, trauma). However, the use of navigation increases the operating time. The operating room footprint is also significant. Finally, the initial investment and maintenance costs are significant for small and medium-sized facilities.

[0007] Despite the improvement in precision achieved through robots and remote navigation, the increase in the quantity of instruments and the number of surgical steps, responsible for an increase in the duration of the procedure, are not in favor of economic profitability.

[0008] Personalized guides appeared in the mid-1990s. From volumetric preoperative imaging, specific software defines landmarks to position a so-called personalized guide on the patient, which will allow the planning recorded on the computer to be carried out without modifications or adjustments during the operation.

[0009] Initially, a plastic block was custom-cut to follow the exact contours of the patient's bones modeled in 3D. These blocks can be used as an interface between the bone and standard ancillary equipment or as a guide for positioning a drill bit, a pin, or a saw.

[0010] Subsequently, the technology took off thanks to technical improvements in rapid prototyping allowing for rapid 3D printing with increased accuracy, a wider variety of available materials and lower costs.

[0011] In 2006, Hafez et al. described the modern procedure for performing surgery with customized instrumentation for total knee replacement: Performing computed tomography (CT) or magnetic resonance imaging (MRI) of the lower limb, focusing on the knee, hip, and ankle. The data is securely transferred to a specialized center for 3D reconstruction after segmentation of the slices. 3D preoperative planning (implant size, implant positioning, necessary bone cuts, bone landmarks for the guide seat) is carried out by an engineer by superimposing the implants on the bone and with the alignment of the lower limb as a reference. Final control is the responsibility of the surgeon, who can modify all the data set for the alignment and positioning of the implants. He validates the planning as well as the landmarks adapted to the surgical approach for the positioning of the guide. The cutting guide is manufactured using a rapid prototyping process.

[0012] Personalized guides have been developed in orthopedics to improve the precision of bone cuts and reduce the time associated with this procedure. They allow planning carried out on 3D reconstructed images to be applied during the procedure. They have been most widely developed in knee surgery, particularly in total knee arthroplasty. There are other applications in the knee, hip, shoulder, or ankle, mainly in arthroplasty, but also in the spine for positioning pedicle screws, in tumor resections to guide bone cuts without penetrating the lesion, and for corrective osteotomies of limbs.

[0013] Guides are designed for positioning pins or for directing the cut. Pin positioning guides are used to insert pins that will guide the positioning of the standard cutting guide. Removing the custom guide to position the standard cutting guide increases the risk of inaccuracy due to bone fragility and changes in pin position during manipulation.

[0014] Cutting guides are the most widely used by manufacturers, positioned on the bone using specific bone support markers, fixed by 2 or 3 pins to increase their stability, they are provided with a slot through which the saw used to cut the bone passes exactly. The femoral guide is fixed to the distal part of the femur, it allows the distal cut to be made as well as the marking of markers for the positioning of the so-called "4 in 1" guide, allowing the anterior and posterior cuts to be made as well as the anterior and posterior chamfers. The tibial guide is fixed to the anterior and proximal part of the tibia, it allows the proximal cut of the tibia to be made (Thesis for the state diploma of doctor of medicine: custom-made cutting ancillary: application in orthopedics and results in knee prosthesis).

[0015] Finally, the cutting ancillaries by sawing known from the state of the art are studied and designed in order to implant standard prostheses.

[0016] The surgical technique of total knee replacement is invasive and involves trauma to the anatomical structure. Approaches to the knee joint require dislocation of the joint. In addition, it may be necessary to sacrifice the anterior cruciate ligament and / or posterior cruciate ligament.

[0017] Additionally, custom cutting guides are designed to adapt to each bone surface in order to cut the bone, which can cause a shift and imbalance of the joint when cutting bone.

[0018] There is thus a need for an ancillary capable of cooperating with several bone surfaces, allowing for better stability and anchoring of the ancillary. There is also a need for an ancillary that does not require joint dislocation or sacrifice of the related ligaments, and that respects the anatomical structures. Finally, there is a need for a custom-made ancillary, allowing the implantation of a custom-made prosthesis.

[0019] Document D1(FR3024027) describes a surgical device comprising an intra-articular stabilizing member, intended to be positioned between the two bones of the joint, and two guide blocks fixed to the stabilizing member and on either side of a plane defined by said stabilizing member, said guide blocks comprising means for fixing to the bone and each having at least one slot for the engagement and guidance of an instrument intended to carry out operations of cutting parts of the bones.

[0020] Document D2 (WO20216 / 074733) describes a surgical kit for repairing articular surfaces in the tibiotarsal joint, comprising: a surgical implant having a cap with an outer surface that conforms to a surface of the talus dome and an inner surface that has a central implant anchoring peg that extends perpendicularly from said inner surface, a hollow tubular shell for performing a proper pre-drilling for implantation of the surgical joint implant in the talus dome, a saw guide that conforms and is attachable to the lower part of the tibia and provides saw guide surfaces in at least one plane, for performing an osteotomy of a lower part of a tibia to expose the talus dome. SUBJECT OF THE INVENTION

[0021] The present invention aims to overcome the drawbacks of the prior art and to respond to the constraints stated above by proposing a guiding ancillary intended to cooperate with at least two bone surfaces.

[0022] The present invention is defined in claim 1 which discloses a guiding ancillary and also claim 13 which relates to a method of manufacturing the guiding ancillary, while preferred embodiments are described in the dependent claims.

[0023] Related methods are also described herein to facilitate understanding of the invention. These methods are not part of the claimed invention.

[0024] It also concerns a guiding ancillary for its use in orthopedic surgery.

[0025] It also relates to an assembly comprising a guiding ancillary according to the present invention and at least one medical device. BRIEF DESCRIPTION OF THE INVENTION

[0026] The invention thus relates to a guiding ancillary intended to cooperate with at least two bone surfaces, characterized in that it comprises: For each bone surface, a support surface intended to at least partially match a portion of the corresponding bone surface; said support surface further delimits at least one working area on said bone surface when it is in contact with said bone surface; said support surfaces being configured to hold said ancillary in position on the corresponding bone surfaces, and At least one guide means capable of receiving at least one medical device, said at least one guide means guiding the medical device towards said working area on the corresponding bone surface.

[0027] For the purposes of the invention, the term "bone surface" means the end of a bone or the external surface of a part of a bone.

[0028] For the purposes of the invention, the term "bearing surface" means the part of the ancillary intended to come into contact with at least one part of the corresponding bone surface.

[0029] The guiding ancillary within the meaning of the present invention is defined and produced after in particular acquisition of one or more images by computed tomography (CT) and / or Magnetic Resonance Imaging (MRI) or any other method of acquiring images of at least two bone surfaces and 3D representation of the images thus obtained, and determination of the modifications to be made to at least one of the bone surfaces. Thus, the ancillary, through each of its bearing surfaces, at least partially matches a portion of the corresponding bone surface and therefore allows precise referencing of the surface of at least one part of the bone surface. The ancillary will be determined by in particular and at least the determination of at least one modification to be made to at least one of the bone surfaces.Thus, and unlike a personalized ancillary, allowing the placement of a standard implant, the ancillary according to the present invention is a custom-made ancillary adapting not only to the characteristics such as the shape, the dimensions, of the bone surfaces with which it is intended to be implemented but especially to the modifications and / or interventions to be made on at least one of the bone surfaces of each patient. This custom-made ancillary is therefore adapted and personalized for each intervention on each patient and cannot therefore be reusable.

[0030] Advantageously, the support surfaces of the ancillary allow it to be held and secured in position and thus reduce its risk of displacement. The ancillary according to the present invention thus allows better alignment of said ancillary with at least two bone surfaces during the surgical procedure. In addition to this improved support function, each support surface of said guiding ancillary allows a working area to be defined.

[0031] For the purposes of the present invention, the term “working area” means the area of ​​the bone surface delimited by the support surface of the guiding ancillary according to the present invention.

[0032] The support surfaces of the guiding ancillary each delimit a working surface and the guiding means will direct the medical devices towards the working area of ​​each of the corresponding bone surfaces.

[0033] For the purposes of the present invention, a medical device is understood to mean any instrument, apparatus, equipment, material used alone or in combination for its use in the diagnosis, prevention and / or treatment of a disease, the study, replacement or modification of anatomy or a physiological process. Mention will be made, purely by way of illustration, of a sighting instrument, a milling instrument, a drilling instrument, a cementoplasty instrument, a screwing instrument, a cell destruction instrument, a cell excitation instrument, a biopsy instrument, a sawing instrument, a probe, a catheter, a balloon, a stent, and any instrument taking reference from the bone for an intervention or measurement or positioning.

[0034] For the purposes of the present invention, the term "guiding means" means any means for guiding the movement of a medical device towards at least one predefined working area. Examples include a tubular element, oriented slots, a movement path or combinations of these elements.

[0035] Furthermore, the guiding ancillary within the meaning of the present invention makes it possible to position the ancillary on at least two bone surfaces in order to guide at least one medical device. The anatomical structures are thus advantageously preserved. Advantageously, this ancillary therefore does not involve dislocation of the joint during its placement and possible sacrifice of ligaments.

[0036] In different particular embodiments of the guiding ancillary, each having its particular advantages and capable of numerous possible technical combinations: The guiding ancillary is a single piece.

[0037] The single-piece guiding ancillary according to the present invention therefore allows intimate and stable contact with at least two bone surfaces, thus imposing a unique orientation and providing maximum stability to the ancillary according to the present invention. The guiding ancillary comprises at least two ancillary parts, each of the ancillary parts being intended to cooperate with at least one distinct bone surface.

[0038] Typically, and in this embodiment, the ancillary comprises at least one assembly means making it possible to link said at least two ancillary parts.

[0039] Typically, the means of assembly or connection is rigid or not. Each ancillary part comprises a female assembly portion and / or a male assembly portion, two ancillary parts intended to be immediately contiguous when said ancillary is assembled, having a female assembly zone and a male assembly zone intended to cooperate with each other to ensure the assembly of said two ancillary parts, at least some of said ancillary parts comprising at least one guide means, said guide means being distinct or at least some of said ancillary parts comprising a portion of guide means, said portions of guide means being distinct and intended to form a guide means when said ancillary parts are assembled with each other.

[0040] For purely illustrative purposes, and in the case where the ancillary consists of two ancillary parts, a first ancillary part comprises at its end opposite that intended to bear on the corresponding bone surface, a male assembly portion, which is intended to cooperate with a female assembly portion placed at a corresponding end of the second ancillary part in order to ensure a stable assembly of said first and second ancillary parts. Of course, and advantageously, these assembly portions allow their separation after assembly so that this can be temporary. The assembly can thus be of the clip-on type, by interlocking, ...

[0041] For purely illustrative purposes, the assembly means is chosen from a hinge, an articulation, a guiding means allowing a translational or rotational movement.

[0042] The assembly means may be a reference surface allowing movement by sliding, a stop. Typically, the reference surface allowing sliding movement may be chosen from a rail or a movement path. Said ancillary parts comprise, for each male or female assembly zone, at least one foolproofing means to prevent the assembly of ancillary parts not intended to be immediately adjacent when the ancillary is assembled. The ancillary parts are configured to define at least 2 guide axes of one or more different medical devices when they are assembled together.

[0043] In a preferred embodiment, the ancillary parts are configured to define 4 or 5 guidance axes of one or more different medical devices when assembled together. Each part of the ancillary comprises for each bone surface a bearing surface intended to fit at least in part a portion of said corresponding bone surface, said bearing surface delimiting a working area on said bone surface, each part comprising at least two guide means, said at least two guide means defining distinct working axes, to guide the movement of at least one medical device along said working axes on the corresponding bone surface. The guiding ancillary is configured to cooperate with two bone surfaces.

[0044] Preferably, the two bone surfaces are the bone surface of the tibia and the bone surface of the femur, preferably, the bone surface of the distal end of the tibia and the bone surface of the proximal end of the femur.

[0045] Preferably again, each support surface is an imprint of the portion of the bone surface of the distal femoral end and the proximal tibial end, when the knee is in the reference anatomical position, and does not match the bone surfaces of the intra-articular cavity.

[0046] Thus and very advantageously, when the ancillary according to the present invention is configured to cooperate with two bone surfaces, such as the bone surface of the tibia and the bone surface of the femur, the ancillary does not require dislocation of the joint when it is placed on the two bone surfaces, nor does it sacrifice any of the ligaments of the joint. The ancillary according to the present invention cooperates with the bone surfaces without being inserted into the intra-articular cavity. This custom-made ancillary adapts to the morphology of the patient and makes it possible to implant a custom-made prosthesis according to the pathology and / or dysfunction.

[0047] Advantageously, each part of the ancillary comprises, for the tibial surface and the femoral surface, a bearing surface intended to fit at least in part a portion of the corresponding bone surface, said bearing surface delimiting a working area on said bone surface, each part comprising at least two guide means, said at least two guide means defining distinct working axes, to guide the movement of at least one medical device along said working axes on the corresponding bone surface. This configuration thus makes it possible to avoid dislocation of the joint and to preserve the anatomy and the tissue and muscle structures of the patient.

[0048] In another embodiment, the guiding ancillary is configured to cooperate with three bone surfaces. Said or at least one of said guide means is configured to define a stop for the movement of said corresponding guide device.

[0049] For example, to limit the travel of the medical guide device along the axis of movement defined by said guide means - For example, the axial dimension d1 of the guide means limits the travel of a tool with axial dimension d2 greater than d1 such that d2-d1 = depth of penetration of the medical device into the damaged area to be repaired. The at least one guide means is selected from a tubular member, oriented slots, a travel path, a hollow elongated member, or combinations of these members.

[0050] For the purposes of the present invention, a movement path or guide path means an object having a raised surface, continuous or discontinuous, making it possible to guide the movement of at least one medical device towards at least one work area.

[0051] For purely illustrative purposes, this object may have grooves, opening at each of their ends, to allow the guidance and passage through each of them of at least one medical device. These grooves may have different shapes to guide said at least one corresponding medical device differently depending on the nature of the local modification to be made to the corresponding bone surface. An oriented slot is understood to mean an element having an opening allowing a medical device to pass through, in order to guide said medical device towards the working area on the surface of the bone end.

[0052] A tubular element is understood to be a rectilinear element, pierced in its center with a light that is also rectilinear, parallel to the main dimension of the tubular element.

[0053] In another embodiment, the guide ancillary comprises several guide means, said guide means being a combination of at least two guide means chosen from a tubular element, a guide path, an oriented slot.

[0054] A hollow elongate element is understood to mean an element comprising an interior channel or guide channel, capable of receiving a medical device, the interior surface of said interior channel being a guide element for guiding and moving the tool towards the working area on the surface of the bone end. each hollow elongated element comprises a channel for the passage of at least one medical device through said corresponding hollow elongated element, the inner wall of said hollow elongated element delimiting said channel defining a surface for movement of said medical device against at least a part of which said medical device is intended to be moved in order to delimit the excursion of said medical device in said working zone of said corresponding bone surface.

[0055] Advantageously, the movement surface of the medical device is configured so that the movement of the tool on this surface determines the perimeter of the local modification to be made to the bone surface. the hollow elongated element comprises a free end, the inner wall of at least said free end is flared or oblong in shape, or flattened tubular in shape, with a cross section of elliptical, polygonal shape such as rectangular, square.

[0056] The free end of the hollow elongated element is the part closest to the bone surface.

[0057] By way of illustration, when the inner wall of said free end is oblong, the inner surface of said inner channel makes it possible to guide the medical device towards the working area on the surface of the bone end as well as the lateral movement of the medical device on the working area on the surface of the bone end.

[0058] The guiding means and the shape of the internal canal will thus be determined according to the action to be carried out in the working area on the surface of the bone end.

[0059] According to this embodiment, the opening diameter of the internal channel will be determined according to the action to be carried out.

[0060] In another embodiment, when the ancillary according to the present invention comprises at least two guide means comprising an internal channel, the guide means may be either identical or different, the diameter and / or the shape of the internal channel of each of the guide elements may be distinct, depending on the action to be carried out.

[0061] In a preferred embodiment, all of the guide members are tubular members. each tubular element is a function of the corresponding bone surface of the patient to receive a medical device of which at least the diameter is related to the dimensions of said bone surface. the tubular element comprises a lumen defining a longitudinal axis for the movement of at least one medical device along said axis.

[0062] The dimensions of the tubular element are such that said tubular element is suitable and intended to receive a medical device and to guide said medical device towards the working area on the surface of the bone surface, said medical device being inserted into the lumen of said tubular element.

[0063] In one embodiment, the tubular members are identical.

[0064] In another embodiment, the diameter of the lumen of the tubular elements may be different depending on the medical device to be inserted into the lumen of said tubular element. The guiding ancillary comprises at least two guiding means.

[0065] In a particularly preferred embodiment, the guide ancillary comprises eight guide means, said eight guide means being tubular elements. The guiding means defines at least one working axis for guiding a medical device over said at least one working area on the bone surface in order to locally modify at least a portion of said corresponding bone surface in said at least one working area. The tubular element comprises a main axis, this main axis is coincident with the working axis, the working axis of said guiding element being directed along a tangent or substantially tangent axis at a point in the working area. The guiding means is configured so as to direct the medical device in a part of at least one of the working areas, said part being separated from a sensitive area.

[0066] A sensitive area is understood to mean, in particular, an innervated area, a vascularized area, a medullary area. Thus, a sensitive area is understood to mean the vascular-nervous bundle and the spinal cord, said sensitive area being distinct from a bone area.

[0067] Advantageously, the ancillary according to the present invention makes it possible to support the surgical procedure and guide it in order to avoid any of the sensitive areas. The guiding ancillary is made of a thermofusible and biocompatible material.

[0068] For the purposes of the present invention, a hot-melt material is understood to mean a material that becomes fluid under the effect of heat. Advantageously, the material of the ancillary device for the purposes of the present invention is biocompatible, that is to say, it has the capacity not to interfere with or degrade the biological environment in which it is used. Examples include metals and metal alloys such as stainless steels, stainless steel, and more particularly 316L stainless steel or 17-4PH stainless steel, titanium and titanium alloys such as grade 1, grade 2, grade 4, grade 5, grade 23 titanium, ceramics such as alumina and zirconia, polymers such as lactic and glycolic acid copolymers, polyanhydrides, polyamino acids, polyamides, materials of natural origin such as chitin, fucans, cellulose, coral, collagen.

[0069] Preferably, the material of the ancillary is polyamide 12 or titanium. Typically, the ancillary according to the present invention can be used during any surgical operation.

[0070] For purely illustrative purposes, we will mention osteosynthesis, arthrodesis, arthroplasty, cementoplasty, osteotomy, neurosurgery and kyphoplasty.

[0071] Alternatively, the ancillary can be used in a system ex vivo surgical training (training model, training before surgery, validation of the operating procedure). It can also be used on cadaver models to obtain proof of concept.

[0072] Another aspect of the invention is a method of manufacturing a guiding ancillary.

[0073] Thus and according to the invention, the method of manufacturing the guiding ancillary comprises the following steps: i. Acquisition of one or more images by computed tomography (Scanner, X-ray) and / or Magnetic Resonance Imaging, of at least two bone surfaces; ii. 3D representation of the imaging of the at least two bone surfaces acquired in step i.; iii. Determination of at least one working axis for locally modifying at least one portion of at least one of said bone surfaces; iv. Determination of at least one bearing surface on said bone surfaces for maintaining the ancillary in position, at least one of said bearing surfaces delimiting at least one working zone in which it is sought to locally modify said at least one portion of at least one bone surface; v. Positioning of at least one guiding means, said at least one guiding means being configured so as to guide at least one medical device along said at least one working axis obtained in step iii; vi.Determination of the shape and dimensions of the ancillary from the working axes, at least one support surface and at least one guide means; vii. Production of the ancillary.

[0074] Very advantageously, the method according to the invention makes it possible to produce an ancillary, this ancillary being a custom-made ancillary. The quality of the images obtained will depend on the correct positioning of the ancillary and thus its precision. Image acquisition can be carried out by computed tomography (CT) or by Magnetic Resonance Imaging (MRI) or by the combination of CAD of computed tomography / Magnetic Resonance Imaging.

[0075] Computed tomography has better spatial resolution and the acquisition of images of the bone parts is more precise. In a preferred embodiment, Magnetic Resonance Imaging would be used, where MRI allows for precise visualization of the cartilage. In an even more preferred embodiment, the acquisition of images is done by the combination of CAD of CT / Magnetic Resonance Imaging.

[0076] The images thus acquired will then be segmented and modeled in 3D on a computer. The transmission of these images is done by encoding. For purely illustrative purposes, the format used is STL (Surface Tesselation Language).

[0077] The 3D modeling of said at least two bone surfaces will make it possible to determine at least one support surface on said bone surfaces for maintaining the ancillary in position, at least one of said support surfaces delimiting at least one working zone in which said at least one portion of at least one bone surface is locally modified.

[0078] Thanks to 3D modeling, it will subsequently be possible to determine at least one working axis to locally modify at least one portion of at least one of said bone surfaces, and to position at least one guiding means, said guiding means being configured so as to guide at least one medical device along said working axis.

[0079] Thus, and advantageously, the at least one guiding means will be in the extension of the working axis determined according to the surgical procedure, in order to guide the medical device towards the working area, via the working axis.

[0080] Local modification of at least one of the bone ends can be chosen from osteosynthesis, arthrodesis, arthroplasty, cementoplasty, osteotomy, neurosurgery and kyphoplasty.

[0081] Osteosynthesis refers to all the procedures used to treat fractures or mechanical problems. Examples include the use of pins, screws, plates, rods, and nails.

[0082] Arthrodesis is the procedure intended to fix a joint by bone fusion and blocked by osteosynthesis.

[0083] Arthroplasty is a surgical procedure that restores mobility to a joint by creating a new joint space.

[0084] Cementoplasty is the surgical procedure consisting of injecting cement into a pathological vertebral body.

[0085] Kyphoplasty is the surgical procedure consisting of transcutaneously introducing a balloon, which can be inflated to several atmospheres, into the fractured vertebral body.

[0086] Osteotomy is understood to mean the surgical procedure consisting of a diaphyseal cut of a long bone intended to best reorient one or more axes of said bone in order to best reposition the above and below joints.

[0087] An example of arthroplasty is the creation of a recess on at least one bone surface. In the context of creating a recess, this will be determined by a person skilled in the art on the 3D representation of at least one of the bone surfaces. In one embodiment, the recess will be created in order to be suitable and intended to accommodate an implant or prosthesis. In an even more preferred embodiment, the recess will be created on at least two bone surfaces, so as to be suitable and intended to accommodate an implant or prosthesis.

[0088] In one embodiment, the implant or prosthesis has a shape chosen from a U-shape, a V-shape, a W-shape and will be a personalized implant depending on the pathology and / or morphology of the patient.

[0089] Thus, the end of at least one of the bone surfaces must be modified locally so as to be suitable and intended to accommodate an implant or prosthesis, said implant or prosthesis having a shape chosen from a U, V or W shape. From the shape of said identified implant or prosthesis and thus from the projection of the local modification of the end of at least one of the bone surfaces, the practitioner will be able to determine at least one working axis so as to modify at least a portion of at least one of the bone ends. said or at least one of said guide means being a hollow elongated element, each hollow elongated element comprising a channel delimited by an inner wall of said elongated element for the passage of at least one medical device through said corresponding hollow elongated element, in step v), at least the shape of said inner wall of each hollow elongated element is configured to delimit the excursion of said medical device in the corresponding working area as a function of the local modification to be made in said corresponding bone surface.

[0090] The guiding means and the shape of the internal canal will thus be determined according to the action to be carried out in the working area on the surface of the bone end.

[0091] In one embodiment, the inner wall of the free end, i.e., the end closest to the bone surface, of the hollow elongated member is flared or oblong in shape, or flattened tubular in shape, with a cross section of elliptical, polygonal shape such as rectangular, square.

[0092] Thus and advantageously, the movement surface of the medical device is configured so that the movement of the tool on this surface determines the perimeter of the local modification to be made to the bone surface. The method of manufacturing the ancillary further comprises an additional step of additive manufacturing of the at least two bone surfaces acquired in step ii.

[0093] Advantageously, the additive manufacturing of the at least two bone surfaces makes it possible to verify the suitability of the guiding ancillary within the meaning of the present invention, with the at least two bone surfaces. The ancillary is made by additive manufacturing.

[0094] Additive manufacturing is chosen from stereolithography, Selective Laser Sintering (SLS), Fused Deposition Modeling (FDM), Selective Laser Melting (SLM), or any additive manufacturing process such as EBM (Electron Beam Melting). The invention also relates to an ancillary device within the meaning of the present invention for use in osteosynthesis, arthrodesis, arthroplasty, cementoplasty, osteotomy, biopsy, neurosurgery and kyphoplasty.

[0095] By way of example, the present application also relates to a method of treating a subject in need thereof, said method comprising the use of an ancillary device for carrying out osteosynthesis, arthrodesis, arthroplasty, cementoplasty, osteotomy, biopsy and / or kyphoplasty. The ancillary is used to create a recess on at least one bone surface. For example, the two bone surfaces correspond to the juxtaposition zone defining a joint.

[0096] For purely illustrative purposes, we will cite the intervertebral joints, the lumbosacral joint, the sacrococcygeal joint, the intercoccygeal joints, the sacroiliac joints, the pubic symphysis, the glenohumeral joint, the acromioclavicular joint, the humeroulnar joint, the humeroradial joint, the proximal radioulnar joint, the radiocarpal joint, the distal radioulnar joint, the joints between the carpal bones, the carpometacarpal joints, the intermetacarpal joints, the metacarpophalangeal joints, the interphalangeal joints, the coxofemoral joint, the tibiofemoral joint, the patellofemoral joint, the proximal tibiofibular joint, the talocrural joint, the distal tibiofibular joint, the joints between the bones of the carpus, the carpo-meta ... the tarsal bones, the tarsometatarsal joints, the intermetatarsal joints,the metatarsophalangeal joints, the interphalangeal joints.,

[0097] For example, the ancillary is intended to cooperate with the tibiofemoral joint.

[0098] For example, the ancillary is intended to cooperate with the coxofemoral joint.

[0099] In another example, the joints involved are those of the lumbar and cervical spine.

[0100] In another example, the joint is the shoulder joint.

[0101] Finally, in another example, the ancillary is used to cooperate with at least one of the vertebrae of the cervical spine.

[0102] In one example, the guiding ancillary is used in the production of a recess, preferably for the production of a recess capable of receiving an implant, said implant being a total knee prosthesis (TKA), more preferably a personalized resurfacing total knee prosthesis.

[0103] The present application also relates to an assembly comprising a guiding ancillary within the meaning of the present invention and at least one medical device BRIEF DESCRIPTION OF THE DRAWINGS

[0104] Other advantages, aims and particular characteristics of the present invention will emerge from the description which follows, given, for explanatory and in no way limiting purposes, with reference to the appended drawings, in which: There Figure 1is a perspective view of the proximal end of the tibia and the distal end of the femur, as well as of the ancillary according to a first embodiment, said ancillary being in one piece and cooperating with said proximal end of the tibia and said distal end of the femur. Figure 2 is a photograph taken from the front and showing the tibial bearing surface. Figure 3 is a photograph taken from below of the ancillary according to a first embodiment, showing the femoral support surface DETAILED DESCRIPTION OF THE INVENTION

[0105] First of all, note that the figures are not to scale. FIRST METHOD OF IMPLEMENTATION: ANCILARITY FOR PLACEMENT OF A KNEE RESURFACING IMPLANT

[0106] There Figure 1 is a perspective view of a guide ancillary 10 according to a first embodiment intended to cooperate with at least two bone surfaces, said two bone surfaces corresponding to the proximal end 30 of the tibia and the distal end 40 of the femur.

[0107] The guide ancillary 10 comprises eight guide means, said guide means being tubular elements 13, 14, 15, 16, 17, 18, 19, 20. The tubular elements 13, 14, 15, 16, 17, 18, 19, 20 of the guide ancillary 10 are capable of receiving at least one medical device.

[0108] Advantageously, the single-piece guiding ancillary according to this first embodiment perfectly fits the proximal end of the tibia and the distal end of the femur and makes it possible to maintain the guiding ancillary 10 in position. Even more advantageously, its preoperative positioning does not require dislocation of the tibiofemoral joint, nor ligament sacrifice.

[0109] The guide ancillary 10 according to this first embodiment, as well as the eight tubular elements 13, 14, 15, 16, 17, 18, 19, 20 of the guide ancillary 10 are made of biocompatible polyamide 12 or titanium depending on the strength requirements of the ancillary.

[0110] There Figure 2 is a photograph taken from the front and showing the tibial bearing surface. The Figure 3 is a photograph taken from below of the ancillary according to a first embodiment, showing the femoral support surface

[0111] The elements represented on the Figure 2 and bearing the same references as those of the Figure 1 represent the same objects, which are not described again below.

[0112] The guide ancillary 10 comprises for the proximal end of the tibia a tibial bearing surface 11 intended to fit a part of the proximal end of the tibia and for the distal end of the femur, a femoral bearing surface 12 intended to fit the distal femoral end, said tibial 11 and femoral 12 bearing surfaces advantageously make it possible to maintain the ancillary 10 in position on respectively the proximal end of the tibia and the distal end of the femur. The tibial bearing surface 11 and the femoral bearing surface 12 each delimit a working zone on the surface of each of the bone ends, respectively the distal end of the femur for the femoral bearing surface 12 and the proximal end of the tibia for the tibial bearing surface 11.

[0113] Thus, according to this first embodiment, the guide ancillary 10 comprises eight tubular elements 13, 14, 15, 16, 17, 18, 19, 20, each of the tubular elements has a lumen 131, 141, 151, 161, 171, 181, 191, 201, the lumen of each of the tubular elements 13, 14, 15, 16, 17, 18, 19, 20 allows the rectilinear movement of at least one medical device along a longitudinal axis.

[0114] According to this first embodiment, the guiding ancillary 10 makes it possible to make recesses at the end of the proximal tibial bone surface and at the end of the distal femoral bone surface.

[0115] According to this embodiment, the recesses at the end of the proximal tibial bone surface and at the end of the distal femoral bone surface are suitable and intended to accommodate a total knee prosthesis (TKA).

[0116] Thus, the guiding ancillary 10 according to the first embodiment comprising eight tubular elements 13, 14, 15, 16, 17, 18, 19, 20, each of the tubular elements corresponds to a working axis for guiding a medical device on each of the two working zones, respectively the tibial bearing surface 11 and the femoral bearing surface 12 in order to locally modify at least a portion of each of the bone ends in each of said working zones in order to make a recess.

[0117] Each of the working axes is coincident with the main axis of the lumen 131, 141, 151, 161, 171, 181, 191, 201 of each of the tubular elements 13, 14, 15, 16, 17, 18, 19, 20 of the guide ancillary 10, the working axis of each of the tubular elements 13, 14, 15, 16, 17, 18, 19, 20, being directed along a tangent or substantially tangent axis at a point on the proximal femoral bone surface and the distal tibial bone surface.

[0118] A working axis XX' is represented on the Figure 3 .

[0119] According to this first embodiment, the guiding ancillary is used for producing a recess, said recess being suitable and intended to accommodate a total knee prosthesis. Thus, the ancillary according to this first embodiment is used to guide at least one medical device making it possible to produce at least one recess at the tibial distal end and at least one recess at the femoral proximal end.

[0120] Imaging is performed by Magnetic Resonance Imaging of the tibiofemoral joint, and more specifically of the proximal tibial end and the distal femoral end.

[0121] The images of the bone surfaces thus acquired by Magnetic Resonance Imaging will subsequently be segmented and modeled in 3D on a computer, the transmission of said images being carried out in STL format. 3D imaging of the tibiofemoral joint, i.e. the proximal tibial end and the distal femoral end is thus acquired.

[0122] Based on this 3D imaging of the tibiofemoral joint, the practitioner will determine the recesses necessary to accommodate a total knee prosthesis, and therefore to locally modify the proximal femoral and distal tibial bone ends.

[0123] For the purposes of this invention, a practitioner means an engineer / prosthetist.

[0124] According to this embodiment, the total knee prosthesis corresponds to a U-shaped femoral implant as well as a U-shaped tibial implant.

[0125] The recess envisaged is the imprint of each of the implants, so that the external surface of each of the implants is flush or substantially flush with the bone surface of the tibial and femoral ends. The implant in this embodiment is a custom-made implant adapted to the morphology / pathology of the patient.

[0126] From the said recess projected onto the 3D imaging of the tibiofemoral joint, eight working axes will be determined for the creation of the recess on the surface of the distal femoral and proximal tibial bone ends respectively. Two axes will be directed towards the femoral condyles, respectively the medial condyle and the lateral condyle. One axis will be directed towards the patellar surface of the distal femoral end. Two axes will have as direction and respectively, the juxtaposition zone between the medial condyle of the distal end of the femur and the tibial plateau of the proximal end of the femur and the juxtaposition zone between the lateral condyle of the distal end of the femur and the lateral plateau of the proximal end of the tibia. Two axes will have as direction respectively the medial tibial plateau and the lateral tibial plateau of the proximal end of the tibia.An axis will pass through the juxtaposition zone of the medial tibial plateau and the medial femoral condyle as well as through the juxtaposition zone between the lateral tibial plateau and the lateral femoral condyle. This axis is represented on the . Figure 3 , as being the XX' axis.

[0127] From the working axes modifying the surface of the proximal femoral end, the working surface of the proximal femoral end will be determined and from the working axes modifying the distal tibial end, the working surface of the distal tibial end will be determined.

[0128] The working surface of the tibial distal end and the working surface of the femoral proximal end thus correspond respectively to the tibial bearing surface 11 and to the femoral bearing surface 12 of the guide ancillary 10.

[0129] The eight tubular elements 13, 14, 15, 16, 17, 18, 19, 20 will be positioned so that the longitudinal axis of the lumen 131, 141, 151, 161, 171, 181, 191, 201 of each of the tubular elements coincides with the eight working axes determined by the practitioner.

[0130] There Figure 1 is a representation of a patient's right tibiofemoral joint, when the joint is at 90°.

[0131] Also, the longitudinal axis of the lumen 131 of the tubular element 13 will correspond substantially to the working axis passing through the lateral condyle of the distal femoral end.

[0132] The longitudinal axis of the lumen 141 of the tubular element 14 of the ancillary will correspond substantially to the working axis passing through the medial condyle of the distal femoral end.

[0133] The longitudinal axis of the lumen 171 of the tubular element 17 will correspond substantially to the working axis directed towards the patellar surface of the distal femoral end.

[0134] The longitudinal axis of the lumen 201 of the tubular element 20 will correspond to the working axis XX' directed and crossing respectively the zone of juxtaposition of the medial tibial plateau and the medial femoral condyle as well as by the zone of juxtaposition between the lateral tibial plateau and the lateral femoral condyle and this in order to produce a recess flush with the glenoid surface of the tibial plateau and the surface of the femoral condyle.

[0135] The longitudinal axis of the lumen 151 of the tubular element 15 will correspond substantially to the working axis directed towards the zone of juxtaposition between the lateral condyle of the distal end of the femur and the lateral plateau of the proximal end of the tibia and this in order to produce a recess flush with the glenoid surface of the tibial plateau and the surface of the femoral condyle.

[0136] The longitudinal axis of the lumen 191 of the tubular element 19 will correspond substantially to the working axis of the juxtaposition zone between the medial condyle of the distal end of the femur and the tibial plateau of the proximal end of the femur. The longitudinal axis of the lumen 161 of the tubular element 16 will correspond substantially to the working axis directed towards the lateral tibial plateau of the proximal end of the tibia.

[0137] Finally, the longitudinal axis of the lumen 181 of the tubular element 18 will correspond substantially to the working axis directed towards the medial tibial plateau of the proximal end of the tibia.

[0138] The medical device according to the first embodiment is a milling device.

[0139] The eight tubular elements 13, 14, 15, 16, 17, 18, 19, 20, each comprising a lumen 131, 141, 151, 161, 171, 181, 191, 201 comprising a longitudinal axis corresponding to each of the eight working axes previously determined on the surface of the bone surface, as well as the tibial bearing surface 11 and the femoral bearing surface 12 of the guide ancillary 10, corresponding to the working surfaces of the tibial distal end and the femoral proximal end will thus be determined in order to produce the guide ancillary 10 by 3D printing, using either the stereolithography technique if the ancillary is to be made of titanium or 316L stainless steel, or by powder sintering if the ancillary is to be made of polyamide 12.

[0140] Thus, the ancillary according to this first embodiment is used in the creation of a recess for the installation of a total knee prosthesis.

[0141] The guiding ancillary 10 is therefore intended to cooperate with the proximal femoral end 40 and the distal tibial end 30, and comprises: for the distal end 40 of the femur, a femoral bearing surface 12 intended to fit the distal femoral end 40, for the proximal end 30 of the tibia a tibial bearing surface 11 intended to fit a part of the proximal end 30 of the tibia, said bearing surfaces 11 and 12 each delimiting a working zone at the distal end of the femur for the femoral bearing surface 12 and the proximal end of the tibia for the tibial bearing surface 11; eight tubular elements 13, 14, 15, 16, 17, 18, 19, 20 capable of receiving a milling device, said eight tubular elements guiding the milling device towards the two working zones, one at the distal end of the femur delimited by the femoral bearing surface 12 and one at the proximal end of the tibia for the tibial bearing surface 11.

Claims

1. A guiding ancillary (10) intended to cooperate with at least two bone surfaces (11, 12), characterised in that it comprises: - For each bone surface, a bearing surface which is an impression of a portion of the corresponding bone surface to at least partially match a portion of the corresponding bone surface; said bearing surface delimiting a working area on said bone surface when it is in contact with said bone surface; - said bearing surfaces being configured to hold said ancillary in position on the corresponding bone surfaces and - At least one guide means (13, 14, 15, 16, 17, 18, 19, 20) capable of receiving at least one medical device, said at least one guide means guiding the medical device towards said working area on the corresponding bone surface, each guide means defining a working axis (131, 141, 151, 161, 171, 181, 191) for moving the medical device along said working axis, said working area being determined by said working axes.

2. The guiding ancillary according to claim 1, characterised in that the ancillary includes at least two ancillary parts, each of the ancillary parts being intended to cooperate with at least one distinct bone surface.

3. The guiding ancillary according to claim 2, characterised in that the ancillary comprises at least one assembly means allowing connecting said at least two ancillary parts.

4. The guiding ancillary according to claim 3, characterised in that each ancillary part includes a female assembly portion and / or a male assembly portion, two ancillary parts intended to be immediately contiguous when said ancillary is assembled, having a female assembly area and a male assembly area intended to cooperate together to ensure the assembly of said two ancillary parts, at least some of said ancillary parts comprising at least one guide means, said guide means being distinct or at least some of said ancillary parts comprising a guide means portion, said guide means portions being distinct and intended to form a guide means when said ancillary parts are assembled together.

5. The guiding ancillary according to claim 4, characterised in that said ancillary parts comprise, for each male or female assembly area, at least one foolproof means to prevent assembly of ancillary parts not intended to be immediately adjacent when the ancillary is assembled.

6. The guiding ancillary according to any one of claims 2 to 5, characterised in that said ancillary parts are configured to define at least 2 guide axes of one or more different medical device(s) when they are assembled together.

7. The guiding ancillary according to claims 1 to 6, characterised in that each part of said ancillary comprises for each bone surface a bearing surface which is an impression of a portion of the corresponding bone surface to at least partially match a portion of said corresponding bone surface, said bearing surface delimiting a working area on said bone surface, each part comprising at least two guide means, said at least two guide means defining distinct working axes, for guiding the movement of at least one medical device along said working axes on the corresponding bone surface.

8. The guiding ancillary according to any one of claims 1 to 7, characterised in that each bearing surface is an impression of the portion of the bone surface it is intended to match, said bone surface being selected from among the bone surfaces of the femoral distal end and the tibial proximal end, the bone surfaces of the femoral distal end and of the tibial proximal end, the bone surface of the lumbar and cervical vertebrae, the bone surface of the acromion of the scapula and the bone surface of the humeral head, the bone surface of the femur.

9. The guiding ancillary according to any one of the preceding claims, characterised in that said or at least one of said guide means is configured to define a stop for the movement of said corresponding guide device.

10. The ancillary according to any one of the preceding claims, characterised in that the at least one guide means is selected from among a hollow elongate element, a tubular element, oriented slots, a movement track, and combinations of these elements.

11. The ancillary according to any one of the preceding claims, characterised in that each guide means is a tubular element, the tubular element includes an aperture defining a longitudinal axis for the movement of at least one medical device along said axis.

12. The ancillary according to any one of the preceding claims, characterised in that each hollow elongate element includes a channel for the passage of at least one medical device throughout said corresponding hollow elongate element, the internal wall of said hollow elongate element delimiting said channel defining a surface for moving said medical device against at least part of which said medical device is intended to be moved in order to delimit the excursion of said medical device in said working area of said corresponding bone surface.

13. A method for manufacturing a guiding ancillary according to any one of the preceding claims, characterised in that it comprises the following steps: i. Acquisition of one or more image(s) by computed tomography and / or Magnetic Resonance Imaging of at least two bone surfaces; ii. 3D representation of the imaging of the at least two bone surfaces acquired in step i.; iii. Determination of at least one working axis to locally modify at least a portion of at least one of said bone surfaces; iv. Determination of at least one bearing surface on said bone surfaces for holding the ancillary in position, at least one of said bearing surfaces delimiting at least one working area in which it is sought to locally modify said at least a portion of at least one bone surface; v. Positioning of at least one guide means, said at least one guide means being configured so as to guide at least one medical device along said at least one working axis obtained in step iii; vi. Determination of the shape and of the dimensions of the ancillary from the working axes, of at least one bearing surface and of the at least one guide means; vii. Making of the auxiliary.

14. The method according to claim 13, characterised in that said or at least one of said guide means is a hollow elongate element, each hollow elongate element including a channel delimited by an internal wall of said elongate element for the passage of at least one medical device throughout said corresponding hollow elongate element, in step v), at least the shape of said internal wall of each hollow elongate element is configured to delimit the excursion of said medical device in the corresponding working area according to the local modification to be made in said corresponding bone surface.

15. The method for manufacturing a guiding ancillary according to claims 13 or 14, characterised in that the ancillary is made by additive manufacturing.