Human orthopaedic surgery system, and implantation planning process

Abstract

The present invention relates to a system and a method for planning veterinary orthopaedic surgery, for restoring the volume and / or geometry of a bone, by the expansion, between a folded configuration and a deployed configuration, of at least one expandable bone implant (1) comprising a body extending along a longitudinal axis (L) between a proximal end (11) that can be connected to an implantation instrument (A) for holding the implant, and a distal end (12) intended to be inserted first into the bone, wherein the system comprises a plurality of expandable bone implants (1) and at least one implantation instrument (A) corresponding to each of said implants (1), and at least one planning support having said implants (1) and instrument (A), with reference to at least one standardised classification of the various types of fractures identified, in particular vertebral compression fractures, it being possible for said planning support to be implemented in the form of a human-machine interface.

Description

Description Title of the invention: System for human orthopedic surgery and method for implant planning

[0001] This application relates to the field of surgery, in particular human orthopedic surgery, and specifically the treatment of collapsed bone structures by restoring their volume (or straightening) and / or geometry. This application specifically concerns instruments for the installation of expandable bone implants to repair or restore damaged bone structures, particularly in the spine, for the treatment (often called "reduction") of compression fractures, especially vertebral compression fractures (VCF).

[0002] In this field, the problem of restoring the volume of collapsed bone structure is well known, and the literature abounds with solutions using expandable implants capable of moving from a folded to a deployed configuration to restore the height of the bone structure, preferably in combination with an injection of bone replacement cement, also called bone cement. Many cements are known, and they all have the advantage of being injectable in a liquid or viscous state for a certain period, then hardening (by polymerization) within the bone structure to stabilize it.

[0003] Major challenges in this field involve implant expansion to restore height to damaged bone tissue and cement leakage, as well as implant placement in bones, particularly vertebrae. Indeed, instruments are needed to facilitate implantation and minimize the time and effort required by practitioners.

[0004] Other recurring problems in orthopedic surgery concern invasiveness (i.e., the goal of making the smallest possible incision and lesions) but also the deployment ratio in order to obtain a deployed implant that fills the largest possible volume while being inserted through the smallest possible opening. Furthermore, this deployment ratio will impact the distribution of forces used to straighten the vertebrae: if the implant is too deformable, the pressure from injecting the cement will deform the pocket instead of restoring the height.

[0005] In this context, it is understandable that numerous technical problems related to implants persist in the field, compounded by issues concerning the implantation instruments, which are generally too numerous and complex to address the major challenges of invasiveness, ease of surgery, and duration. Furthermore, selecting implants based on fracture type remains difficult, and solutions offering a pragmatic approach to planning surgical interventions are still lacking.

[0006] In this context, one aim of the present invention is to overcome at least some of the drawbacks advances in the field by proposing a system of orthopedic implants for the restoration of collapsed bone structures.

[0007] This goal is achieved by a system for human orthopedic surgery, for restoring the volume and / or geometry of a bone, through expansion between a folded and an unfolded configuration of at least one expandable bone implant. The implant has a body extending along a longitudinal axis between a proximal end, connectable to an implantation instrument to hold the implant, and a distal end intended to be inserted into the bone first. This proximal end is connectable to a grasping instrument (called an implant holder) and thus capable of cooperating with it, by means of attachment or physical connection, for example, known to those skilled in the art. However, some embodiments provide specific and advantageous attachment means to facilitate grasping the implant by an implant holder and, above all, the release of the implant by an L-shaped movement of the implant holder.On the other hand, by being connectable to the instrument, the implant is generally actuated for expansion (notably by injecting a fluid inside and / or by pushing or pulling on an element of the implant), as was widely known in the prior art. Indeed, many systems include expandable implants that can be actuated when mounted on an implant holder that incorporates an actuation means for implant expansion (generally a conduit and / or a rod passing through the implant holder to open into a cavity of the implant and / or cooperate with an implant component that allows its expansion; the actuation generally involves a pushing and / or pulling force).A person skilled in the art will understand from this application that the implant can be defined without further detail regarding the instrument and its actuation, since these are standard mechanisms in the field. The system comprising the implant and the instrument is, of course, fully defined, but the implant alone is also clearly defined in its ability to be acted upon independently of the instrument and without unnecessary specification of the actuation mechanism (e.g., a sliding rod), as these are perfectly standard or conventional mechanisms in this field. Indeed, within the scope of this application, the term "actable" implies a push or pull (with or without rotation), and this application thus provides sufficient explanation for the implant to be considered clearly defined without further reference to the instrument enabling its actuation.Conversely, some embodiments may relate to the instrument itself, through an originality of its elements allowing the grasping of the implant and / or the actuation for the expansion of the implant, and these characteristics then define the instrument independently of the implant since they do not particularly require details on the implant apart from those relating to the function performed by the instrument.

[0008] In some embodiments, this goal is achieved by a human orthopedic surgery system, for the restoration of volume and / or geometry of a bone, by an expansion between a folded configuration and a deployed configuration of at least one bone implant. an expandable bone implant comprising a body extending along a longitudinal axis between a proximal end adapted to cooperate with an implantation instrument to hold the implant and a distal end intended to be inserted first into the bone, the system being characterized in that it comprises a plurality of expandable bone implants and at least one implantation instrument corresponding to each of said implants and at least one planning support presenting said implants and instrument, with reference to at least one standardized classification of the various types of fractures identified, in particular vertebral compression fractures, characterized in that said implants: - extend along a longitudinal axis between a proximal end that can be connected to an implantation instrument to hold the implant and a distal end intended to be inserted first into the bone; - are deployable from a collapsed configuration to a deployed configuration;- are selected from: a) an implant comprising a hollow body whose wall is formed by a biocompatible metal alloy sheet, sealed upon itself between said proximal and distal ends and having, at least in the folded configuration, a plurality of pairs of folds lying one on top of the other and rolled around the longitudinal axis, said proximal and distal ends comprising, respectively, a ring providing an entry into the hollow body and a base closing the hollow body, said ring and said base being sealed to the folded and rolled folds of said sheet over the entire periphery of their respective proximal or distal ends, said sheet being plastically deformable to allow expansion of the implant from the folded to the deployed configuration upon injection of a fluid into the implant; b) an implant having at least two faces,for example, upper and lower ends, each comprising a platform (13, 14) for contact with bone tissue and connected, via at least one hinge, to at least one pair of support arms, each oriented in opposite directions towards one of said distal and proximal ends, the implant comprising a central axis or a housing suitable for receiving such an axis extending through a sliding sleeve at the proximal end to a traction ring or sleeve at the distal end to allow a rapprochement of said ends causing the pivoting of the support arms, resulting in the separation of the platforms (13, 14) and the expansion of the implant, and either: at least two other faces of said implant are each covered by and secured with at least one sheet of biocompatible metal alloy, in a hermetic manner, said sheet comprising a plurality of folds lying one on top of the other in the folded configuration,said sheet being plastically deformable with a total surface area greater than or equal to the lateral surface area of ​​the implant in its deployed configuration so as to form a sealed compartment capable of housing a fluid inside the cavity obtained by the expansion of the implant, - an envelope formed by a sheet of biocompatible metal alloy, sealed upon itself and enclosing said implant from the end from proximal to distal end, said sheet having a plurality of pairs of folds lying one on top of the other and rolled around the longitudinal axis, said proximal and distal ends comprising, respectively, a ring providing an entry into the hollow body and a base closing the hollow body, said ring and said base being securely attached, in a hermetic manner, to the lying and rolled folds of said sheet over the entire periphery of their respective proximal or distal ends, said sheet being plastically deformable to allow expansion of the implant from the folded configuration to the deployed configuration, upon injection of a fluid into the implant; (c) an implant having at least two faces, for example upper and lower, each comprising at least one tray, each supported by at least two support arms, by means of a respective hinge, an expansion sleeve or ring,at least two expansion arms, each comprising a hinge connecting them to one end of one of the trays and a hinge connecting them to an expansion sleeve or ring that can be moved away from a central axis of the implant to exert traction on the trays, via the expansion arms, thereby causing a pivoting of said support arms, resulting in the trays moving apart and leading to controlled expansion of the implant between said folded and deployed configurations, and: this implant optionally comprising an envelope formed by a biocompatible metal alloy sheet, sealed upon itself and enclosing said implant from the proximal to the distal end, said sheet having a plurality of pairs of folds lying one on top of the other and wound around the longitudinal axis, said proximal and distal ends comprising,respectively a ring providing an entry into the hollow body and a base closing the hollow body, said ring and said base being securely attached, in a hermetic manner, to the horizontal and rolled folds of said sheet over the entire periphery of their respective proximal or distal ends, said sheet being plastically deformable to allow expansion of the implant from the folded configuration to the deployed configuration, upon injection of a fluid into the implant. 2. A system according to claim 1, characterized in that said planning support is implemented by means of computer systems comprising a human-machine interface and executing instructions on a processor enabling: the display of information relating to said standardized classification of the various types of fractures identified, in particular vertebral compression fractures; the selection of at least one type of fracture and at least one piece of information relating to the dimensions of the fractured bone, then the display of the implants and instruments of the system that can be used for the envisaged restoration and possibly instructions or advice on the procedure to be followed, for example with a display of references for the implants or the various systems that can be used for each fracture identified in the classification, then the selection of a choice among these proposals and advice by the user via the human-machine interface, causing the display of subsequent instructions or advice to provide assistance with the intervention or its planning, with the acquisition of user-provided data on the planned surgical intervention.

[0009] According to another feature, the system is characterized in that it comprises at least one expandable bone implant and at least one corresponding implantation instrument, selected from a plurality of implants and instruments available through computer means including a human-machine interface and executing instructions on a processor enabling: the display of information relating to at least one standardized classification of the various types of fractures identified, including vertebral compression fractures;the selection of at least one type of fracture and at least one piece of information relating to the dimensions of the fractured bone, then the display of the implants and instruments of the system which are usable for the envisaged restoration and possibly instructions or advice on the procedure to be followed, for example with a display of references of the implants or the various systems usable for each fracture identified in the classification, then the selection of a choice among these proposals and advice, by the user via the human-machine interface, causing the display of subsequent instructions or advice to provide assistance with the intervention or its planning, with the acquisition of data provided by the user on the envisaged surgical intervention.;

[0010] According to another particularity, the said selection of the type of fracture in the classification is carried out either by the user or automatically by computer means through training on fracture databases for their automatic classification from technical information and / or images provided by the user and / or acquired beforehand by computer means, then their connection with the said standardized classification of fractures, the automatic selection being preferably valida- or modifiable by the user.

[0011] According to another feature, one of the selectable implants is an expandable bone implant for human orthopedic surgery for restoring the volume and / or geometry of a bone, by expansion between a folded configuration and a deployed configuration, said implant comprising a hollow body extending along a longitudinal axis between a proximal end connectable to an implantation instrument to hold the implant and a distal end intended to be inserted first into the bone, and which is characterized in that: - the wall of said hollow body is formed by a sheet of biocompatible metal alloy, sealed tightly on itself, between said proximal and distal ends; - said sheet presents, at least in the folded configuration, a plurality of pairs of folds, each pair comprising an antiform fold, called convex, and a synform fold, called concave, said folds being laid one on top of the other in the folded configuration so that the surfaces present between each of said convex and concave folds are rolled around the longitudinal axis, - said proximal end comprises a ring securely attached, in a watertight manner, to the folds laid and rolled of said sheet over the entire periphery of the distal end, the opening passing through the ring providing an entry into the hollow body of the implant, - said distal end comprises a base closing the distal end and securely attached, in a hermetic manner, to the flattened and rolled folds of said sheet over the entire periphery of the distal end of said hollow body - said sheet being plastically deformable to allow the expansion of the implant from the folded configuration to the deployed configuration, when a fluid is injected inside the implant.

[0012] According to another feature, one of the selectable implants is an expandable bone implant for human orthopedic surgery for restoring the volume and / or geometry of a bone, by expansion between a folded configuration and a deployed configuration, said implant extending along a longitudinal axis between a proximal end connectable to an implantation instrument to hold the implant and a distal end intended to be inserted first into the bone, at least two faces of the implant, for example superior and inferior, each comprising a tray for contact with the bone tissues, each of the trays comprising a central portion connected, via at least one hinge, to at least one pair of support arms, each oriented in opposite directions within each pair, one arm of each pair being connected by a hinge to the distal end while the other arm is connected by a hinge to the proximal end,the implant being adapted to receive or comprising a central axis extending through a sliding sleeve at the proximal end to a traction ring or socket at the distal end where it is adapted to transmit traction, when actuation by an instrument, on the distal end to allow it to be brought closer to the proximal end, generating the pivoting of the support arms causing the platforms to move away from each other and, consequently, the expansion of the implant between the folded and deployed configurations.

[0013] According to another distinctive feature, the implant is also characterized by the fact that: - at least two other faces of the implant, between those containing the platforms, are covered with at least one sheet per face, made of a biocompatible metal alloy, and hermetically bonded to the central portions under the platforms, to the lateral faces of the arms and to the lateral faces of the proximal and distal ends, - said sheet is plastically deformable to allow the expansion of the implant and has, at least in the folded configuration, a plurality of antiform folds, said convex, and synform folds, said folds being laid one on top of the other in the folded configuration, the total surface of said sheet being greater than or equal to the lateral surface of the implant in the deployed configuration so as to form a sealed compartment suitable for receiving a fluid inside the cavity obtained by the expansion of the implant.

[0014] According to another feature, the implant comprises a casing enclosing the implant from its proximal end to its distal end, and in that: - said envelope is formed by a sheet of biocompatible metal alloy, sealed tightly upon itself; - said sheet presents, at least in the folded configuration, a plurality of pairs of folds, each of the pairs comprising an antiform fold, called convex, and a synform fold, called concave, said folds being laid one on top of the other in folded configuration so that the surfaces present between each of said convex and concave folds are rolled around the longitudinal axis; - said proximal end extends into a sealing sleeve securely attached to the flattened and rolled folds of said sheet over the entire periphery of the proximal end; - said distal end extends into a socket securely attached, in a watertight manner, to the flattened and rolled folds of said sheet over the entire periphery of the distal end of said implant; - said sheet is plastically deformable to allow the expansion of the implant from the folded configuration to the deployed configuration by forming a sealed envelope enclosing the implant and preventing leaks when injecting a fluid into the implant and the envelope.

[0015] According to another feature, one of the selectable implants is an expandable bone implant for human orthopedic surgery for restoring the volume and / or geometry of a bone, by expansion between a folded configuration and a deployed configuration, said implant comprising a central axis and extending along a longitudinal axis between a proximal end connectable to an implantation instrument to hold the implant and a distal end intended to be inserted first into the bone, at least two faces, for example superior and inferior, of the implant each comprising at least one tray for contact with the bone tissues, each of the trays being supported by at least two support arms each, by means of a hinge on the central axis and a hinge under the respective tray of each of said support arms, characterized in that: - an expansion sleeve or ring arranged in the same axis as said central axis; - at least two expansion arms each have a hinge connecting them to one end of one of the plates and a hinge connecting them to said expansion sleeve or ring; - said expansion sleeve or ring and the proximal end of the central axis are suitable for cooperating, respectively or conversely, with a hollow gripping tube of the implant of an implantation instrument and with an expansion rod of said instrument; -said expansion rod is able to slide inside said hollow tube, so as to cause a separation between said socket and said central axis, exerting a traction on the trays, via the expansion arms, which causes a pivoting of said support arms causing the trays to move away from the central axis, so as to result in a controlled expansion of the implant between said folded configuration and said deployed configuration.

[0016] According to another characteristic, the implant comprises a casing enclosing said implant from the proximal end to the distal end, and in that: - said envelope is formed by a sheet of biocompatible metal alloy, sealed tightly upon itself; - said sheet presents, at least in the folded configuration, a plurality of pairs of folds, each of the pairs comprising an antiform fold, called convex, and a synform fold, called concave, said folds being laid one on top of the other in folded configuration so that the surfaces present between each of said convex and concave folds are rolled around the longitudinal axis; - said proximal end extends into a sealing sleeve securely attached to the flattened and rolled folds of said sheet over the entire periphery of the proximal end; - said distal end extends into a socket securely attached, in a watertight manner, to the flattened and rolled folds of said sheet over the entire periphery of the distal end of said implant; - said sheet is plastically deformable to allow the expansion of the implant from the folded configuration to the deployed configuration by forming a sealed envelope enclosing the implant and preventing leaks when injecting a fluid into the implant and the envelope.

[0017] Another objective of this application is to address at least some of the drawbacks of the previous art by proposing an easy-to-use surgical intervention planning method that allows for effective stabilization of bone tissues or even assistance with the intervention and / or monitoring of healing.

[0018] This goal is achieved by a method of planning the implantation of an implant system according to one of the preceding claims, for the restoration of the volume and / or geometry of a bone, by an expansion between a folded configuration and a deployed configuration, characterized in that it comprises a selection, automatic and / or by the practitioner performing the implantation, of at least one type of fracture identified in at least one standardized classification, via computer means and presented to said practitioner, then access, following this selection, to at least one implant system compatible with said type of fracture and to at least one operative protocol comprising a succession of steps to be carried out according to said selection.

[0019] According to another feature, the method is implemented by computer means executing instructions on a processor enabling: the display of information relating to at least one classification of fracture types identified in traumatology; the selection of at least one fracture type and at least one piece of information relating to the dimensions of the fractured bone, then the display of instructions or advice on the procedure to be followed and on the various systems to be used for the procedure, for example with a display of references of implants or various systems usable for each fracture identified in the classification, then the selection of a choice among these tips, causing the display of subsequent instructions or tips to provide said assistance step by step.

[0020] Another distinctive feature is that the display of instructions or advice includes the display of selectable functions to choose from actions to be performed to continue the procedure and / or from implants to be selected according to the surgical protocol. chosen according to the type of fracture identified according to said classification, allowing the practitioner to validate a choice and possibly propose predefined options in the validated protocol, such as the acquisition of radiographs at the end of certain steps implemented.

[0021] According to another feature, the said selectable functions include functions allowing the practitioner to modify said protocol and generate the display of a protocol modification window, either for a selection of a protocol among other possible protocols for said type of fracture identified according to said classification, or for the creation of a personalized operative protocol for the fracture being repaired.

[0022] According to another feature, these selectable functions allow for the recording of operations and operative protocols, including personalized ones, used by different practitioners and their associations with fractures, with the possible recording of personalized protocols created by practitioners, in order to propose them later.

[0023] Other features and advantages of the present invention will become clearer upon reading the description of various embodiments below, made with reference to the accompanying drawings, in which: Figure 1A represents a perspective view of an implantation instrument carrying an expandable bone implant in a folded configuration, according to certain embodiments, and Figure IB represents the same implant in a deployed configuration; Figure 2A represents a perspective view of an expandable implant according to certain embodiments, Figure 2B represents a perspective view with a coupled part of an expandable implant according to certain embodiments, and Figure 2C represents a profile view of an expandable implant according to yet other embodiments; Figure 3A represents a profile view of an expandable implant according to certain embodiments, Figure 3B represents a perspective view with a coupled part of an expandable implant according to other embodiments, and Figure 3C represents a profile view of an expandable implant according to yet other embodiments; Figure 4A represents a perspective view of the instrumentation for implanting an expandable implant including an implant holder, a cement injection instrument and a grasping instrument; Figure 4B represents a detail of the circular part indicated on Figures 4A, 4B and 4C represent perspective views of vertebrae into which an expandable implant is inserted according to different embodiments; Figures 5A, 5B and 5C represent profile views of vertebrae that have suffered vertebral compression fractures (VCF) at the anterior medial and posterior levels respectively; Figures 6A, 6B, 6C and 5CD represent profile views of expandable implants of the same type but with different geometries for adaptation to vertebral fractures, in particular those of figures 5A, 5B and 5C; Figure 7 represents a schematic view of the intervention planning system using a display of fracture classification and implants that can be used depending on the case.

[0024] This application relates to a human orthopedic surgery system for the treatment of fractured bones and bone tissue in general, and a method for surgical intervention planning and / or intervention assistance. The bone implant is preferably a spinal implant, and in particular a vertebral or even intravertebral implant, but other uses are conceivable elsewhere in the spine (intervertebral spines) or in other bony structures where it is necessary to fill a space left as a result of a fracture (the causes of which can be varied, although they generally involve a decrease in bone density). Thus, vertebral compression fractures (VCFs) are a preferred application but are not the only ones that can be treated with the present invention, and those skilled in the art will appreciate the possibilities offered without needing further detail here.Other bones that could be affected include the femur or humerus (head), for example, in cases of risk of collapse. Furthermore, the tibial plateau is frequently subjected to crushing, and the implants or systems described in this application are useful for restoring height in all types of bone crushing or collapse, for example, in the distal part of the humerus or femur. Moreover, as explained, for example, in document EP2921142, expandable implants can be used as bone anchors, and such use is also possible for implants like those described in this application. In this case, the implants will be extended at their proximal end by an elongated body onto which another type of orthopedic implant or a surgical device for fixing other elements can be attached.However, in the case of use as a bone anchor in a vascularized structure, such as a humeral or femoral head, the size of the implant should preferably be limited relative to the bone structure to preserve vascularization and promote bone healing.

[0025] Certain embodiments with more than two platforms can be used more effectively for treating long bones of this type by distributing the expansion forces over more than two surfaces, which provides better stability regardless of the type of bone.

[0026] Some embodiments involve the injection of a fluid (e.g., "bone cement," generally based on a polymer such as PMMA, which is well-known to those skilled in the art, so no details about the cement will be provided here). Once positioned, the implant can be stabilized by such a cement injection. However, since cement leakage remains a major problem, various embodiments propose containing the cement within a sealed envelope. The volume of this envelope after injection can be controlled by its structure and material, depending on the injected pressure (and the configuration of the bone tissue, preferably assessed beforehand, as is generally practiced in this field). The seal is, of course, relative, and this term is not exhaustive, since the level of sealing is actually adapted to the viscosity of the cement at the time of injection.Certain embodiments allow, in particular, a homothetic swelling of the envelope thanks to the (relative) flexibility of the sheet (10) of biocompatible metallic material. This material is generally a titanium alloy obtained in the form of a very thin sheet, preferably by lamination for a controlled surface finish and thickness, in particular a thickness. The thickness ranges from 3 to 100 microns, generally from 6 to 50 microns, and preferably from 10 to 30 microns. In general, the present invention uses at least one sheet (10) of biocompatible metal or a biocompatible metal alloy, such as titanium or its alloys, particularly with nickel or other metals, but also nitinol or stainless steel or their alloys. Recent techniques are used to obtain very thin sheets of such metals, particularly with a thickness of less than 50 or even 40 microns, which makes it possible to obtain relatively flexible and elastic sheets, but above all, sheets whose plastic deformation can be used reversibly without reaching their tearing limit, by creating folds arranged longitudinally on the implant.In particular, it is possible to design a maximum deployed volume that exceeds the volume required for the intended applications, ensuring that this limit is never reached and allowing the implant to be folded and redeployed repeatedly (for example, in case of incorrect implant positioning) without risk of uncontrolled tearing and leakage. Thus, thanks to this type of sheet and the configuration of its interlocking folds, expansion ratios between the folded and deployed volumes can be achieved, ranging from 2 to 20, or even 30. Furthermore, the shape of the implant in its deployed configuration can be controlled by adjusting the fold arrangement, much like origami.Finally, although a primary goal here is to prevent cement leakage, it can sometimes be advantageous to control the cement's release from the implant, so that we no longer speak of leakage but of controlled release, for example, to allow adhesion to certain surrounding structures (generally bone structures). Similarly, since the injected fluid is not necessarily cement (or at least not the fluid that would exit the implant), it can be beneficial to administer molecules through such a controlled release of this fluid. Thus, various embodiments incorporate a certain porosity in the sheets (10), at least in certain portions of the implant, for example, through microscopically sized holes of controlled number and density.In any case, this type of sheet is capable of reversible plastic deformation a sufficient number of times for the intended application, as it notably offers the possibility of retracting the sheet's outer layer in case of problems (biocompatibility and tear resistance). Indeed, generally, the cement dosage control allows monitoring of the fifteen-minute polymerization period, during which it is possible to retract the outer layer and aspirate the cement. Furthermore, through cement injection and the swelling of the outer layer, the implant fills the spaces in the damaged tissues according to the compressive forces and bone resistance relative to the hydraulic pressure provided during the cement injection. From such a sheet, it is necessary to obtain a closed structure, which requires folding the sheet back on itself and locking it in position.To achieve this, a weld (or a bond or a braze, these terms are not exhaustive here) can be made between two overlapping edges or on edges with interlocking folds, to facilitate and strengthen the weld. Some designs therefore involve a welded closure from the outside, simplified and stronger thanks to the layering of materials at these complementary folds.

[0027] It should also be noted that the number of folds is not limited either, and that it allows for Conversely, preserving the irregularity or actual shape of the implant during deployment also offers advantages, particularly in terms of stabilization. Furthermore, ensuring an equal distribution of surface area between the folds for uniform deployment is preferable. However, the invention also envisions other applications, including folds of varying sizes depending on the implant region, to achieve asymmetrical deployment and improved therapeutic outcomes. Moreover, the present invention allows for control of the implant's shape once deployed by also controlling the distance between the folds. Indeed, the distance between the synformal / antiformal folds, and therefore the distance between the long and short folds, determines the deployment pattern.Advantageously, if the density is higher at a certain point on the periphery, the deployment will be greater, and if it is lower, the envelope will be able to deploy less. It is understood that this results in asymmetry and curvature through a more extensive deployment in the areas with the most folds. Similarly, it is possible to use more material (a large surface area of ​​the sheet on one side, for example) so that the lateral expansion is greater on that side than the other. Furthermore, in some embodiments, the sheet is welded to the platens and therefore cannot deploy beyond the distance between the platens, which is set by the lifting mechanism. In some embodiments, the number of fold pairs is between 3 and 16, generally 4 to 2, preferably around 8.However, three folds may sometimes suffice, but the greater the number of folds, the less material deformation will occur, the lower the risk of tearing, and the easier the deployment. Thus, it is possible to use up to 20 folds. Generally speaking, it is understood that the implant will retain, even in its deployed configuration, at least some of the folds of the sheet near the proximal and distal ends, but the dimensions and strength properties of the sheet (10) used allow the implant to be produced without these persistent folds interfering with function or causing mechanical or physiological problems in the bone tissue.In certain embodiments, the implant, in the deployed position, comprises a median portion between its two ends which has a generalized cylindrical shape of length greater than or equal to that of the plates, with a possible and partial persistence of said folds, said median portion extending, on the side of the proximal end (11), by a truncated conical portion connecting the median portion to the sleeve and, on the side of the distal end (12), by a truncated conical portion connecting the median portion to the socket, the truncated conical portions having a permanent persistence of at least a part of the folds lying down and rolled up near the proximal (11) and distal (12) ends.In certain embodiments, the sheet is plastically deformable from its deployed to its folded configuration without tearing, thanks to its thinness and, in particular, the persistence of the horizontal and rolled folds at the proximal and distal ends, facilitating the reversibility of expansion. This results in an implant whose expansion is limited in one dimension (generally the essential dimension, where a precise height or width is desired), but not in another dimension, so that the cement injection will deploy the shell into any volumes of low bone density that may be present around the implant. Note. Furthermore, the fluid injection instrument (AI) can be equipped with means to control the injected pressure (a manometer, for example) and to determine the resulting volume, in order to effectively control expansion within the bone tissue. Finally, it is understood that the instrumentation proposed in this application, in certain embodiments, using a relatively conventional implant holder (or ancillary device) to hold the implant and insert it into the bone tissue, but also a less conventional one for expanding it within the bone tissue, also offers the advantage of being able to perform all the implantation and stabilization steps with a single instrument in a continuous operation. Indeed, the ancillary device, with a hollow tube for delivering the cement through the tube that retains the cement, provides an instrument that allows the surgical operation to be performed quickly and efficiently.After drilling, the implant is inserted, and without removing the instrument, the outer shell can be inflated with cement. The tool can then be removed before, during, or even after the cement has polymerized (for example, using a mechanism that cuts the hardened cement by rotating the instrument). The surgical time is significantly reduced, and so is the stability of the implant, which remains securely in place until it is stabilized by the injection of cement that fills all the surrounding free space, unlike some previous surgical techniques.

[0028] In some embodiments, the implant may include a second sheet (10b) surrounding the first sheet, made of the same or a different material, to form a double envelope, for example as shown in Figure 2B. Such a double envelope can offer many different advantages, including thermal insulation protecting the tissues from the heat of polymerization (for example, through a heat-limiting fluid) or simply to ensure additional security by preventing cement leakage in the event of a tear in one of the sheets.In this case, at least one end of the implant, particularly the proximal end (11), may have an additional concentric ring or base around the first ring or base, or, for example as shown in Figure 2B, a two-channel ring or a double ring, to secure this second leaf (10b) while maintaining a space between it and the first leaf (10). However, it is also possible to join these two leaves (10, 10b) together at their ends. In the case of two leaves spaced further apart, an injection port can be provided between the two leaves (10, 10b) for a fluid different from or identical to the first, for example, via a double ring or a single two-channel ring.Such a double ring can, for example, include spacers between a first ring and a second ring (11b) concentric with the first, forming an annular conduit between them for injecting this second fluid (such as a lubricant that improves the sliding of one sheet relative to the other, thus facilitating deployment). Of course, other arrangements are possible, provided they include a conduit opening into the envelope formed by the first sheet and another opening into the space between the two sheets. These two sheets can then be folded and rolled simultaneously or successively during manufacturing, but their welds (or compression bonds), to each other and / or to the ring and / or the base, will be made sequentially to maintain the space between them. These double-sheet embodiments allow for preforming of the injection site (by compressing the cancellous bone tissue) but can also, for example, allow for two-stage injection of the fluid for better adjustment of the shape, the resulting temperature in the tissues, and / or the polymerization rate of the fluid (for example, by adjusting the cement compound mixture). Furthermore, since it is possible to use a second fluid, different from the cement, inside, the compartment between the two sheets can be used as a cooling circuit by circulating a fluid during cement polymerization, thus protecting the tissues from the heat produced during said polymerization.Such a double-leaf implant (1) therefore requires a double cannula comprising two concentric or parallel conduits each opening into one of the spaces provided, as the skilled person will understand from figure 2B without further explanation being necessary.

[0029] The term "joined" here means that two elements are joined together, either permanently (or almost permanently), but also sometimes that a connection is made to allow one element to be operated by another. Thus, a screw or a form-based locking mechanism to temporarily secure the elements together is covered by this non-exhaustive term.

[0030] The terms ring, sleeve, or tube refer to hollow structures such as rings, conduits, or pipes, but not exclusively, including various shapes (both internally and externally), although the cylindrical shape is preferred. The term channel, on the other hand, is preferably used here to designate a passage rather than the element containing it, and the term opening refers to the fact that an element is open and capable of being traversed, leading into another structure or element. Generally, the terms sleeve and tubes or conduits refer to elements longer than rings or rings, but their use here is also not restrictive. Furthermore, the terms socket or base also refer to hollow structures that are open at one end but closed at the other, such as plugs, closures, constrictions, or constrictions, and these terms are used interchangeably without any limitation.

[0031] It should be noted that the fluid injection instrument (FI) may be equipped with means to control the pressure and / or the quantity injected (a pressure gauge or at least graduations, for example) and to determine the resulting volume, in order to effectively control expansion in the bone tissue. Advantageously, means to control the injected air may be present to adapt the cement injection according to the evacuation of air in the hollow tubes or cannulas of the instruments (air generally escaping easily from the implant to the instrument due to the play between the instrument's parts (rods and tubes or cannulas)).

[0032] Finally, it is understood that the instrumentation proposed in this application, in certain embodiments, using a relatively conventional implant holder (or ancillary device) to hold the implant and introduce it into the bone tissue, but also a less conventional one for expanding it within the bone tissue, also has the advantage of being able to perform All implantation and stabilization steps are performed with a single instrument in a continuous operation. The instrument, with its hollow tube for delivering cement through a tube that retains it, allows for a rapid and efficient surgical procedure. After drilling, the implant is inserted, and without removing the instrument, the outer shell can be inflated with cement. The tool can then be removed before, during, or even after the cement has polymerized (for example, using a mechanism that cuts the hardened cement during a rotation of the instrument). The surgical time is significantly reduced, and so is the stability of the implant, which remains securely in place until it is stabilized by the injection of cement that fills all surrounding free spaces, unlike some previous surgical techniques.

[0033] In general, the present application relates to a human orthopedic surgery system for restoring the volume and / or geometry of a bone by expansion between a folded and a deployed configuration of at least one expandable bone implant (1) having a body extending along a longitudinal axis (L) between a proximal end (11) connectable to an implantation instrument (A) to hold the implant and a distal end (12) intended to be inserted first into the bone, the system being characterized in that it comprises at least one expandable bone implant (1) and at least one corresponding implantation instrument (A), selected from a plurality of implants (1) and instruments (A) available by means of computer (PC) means.

[0034] Certain embodiments of this application relate to a human orthopedic surgery system for restoring the volume and / or geometry of a bone by expansion between a folded and a deployed configuration of at least one expandable bone implant (1) having a body extending along a longitudinal axis (L) between a proximal end (11) adapted to cooperate with an implantation instrument (A) to hold the implant and a distal end (12) intended to be inserted first into the bone, the system being characterized in that it comprises a plurality of expandable bone implants (1) and at least one implantation instrument (A) corresponding to each of said implants (1) and at least one planning support presenting said implants (1) and instrument (A), with reference to at least one standardized classification of the various types of fractures identified, including vertebral compression fractures,characterized in that said implants: - extend along a longitudinal axis (L) between a proximal end (11) connectable to an implantation instrument (A) to hold the implant (1) and a distal end (12) intended to be inserted first into the bone; - are deployable from a collapsed configuration to a deployed configuration; - are selected from: a) an implant comprising a hollow body whose wall is formed by a sheet (10) of biocompatible metal alloy, sealed upon itself between said proximal (11) and distal (12) ends and having, at least in the folded configuration, a plurality of pairs of folds lying one on top of the other and rolled around the longitudinal axis (L), said proximal (11) and distal (12) ends comprising, respectively a ring providing an entry into the hollow body and a base closing the hollow body, said ring and said base being securely attached, in a sealed manner, to the horizontal and rolled folds of said sheet (10) over the entire periphery of their respective proximal (11) or distal (12) end, said sheet (10) being plastically deformable to allow expansion of the implant from the folded configuration to the deployed configuration, upon injection of a fluid into the implant (1); b) an implant having at least two faces, for example upper and lower, each comprising a tray (13, 14) for contact with bone tissue and connected, via at least one hinge, to at least one pair of support arms (131, 141) each oriented in opposite directions towards one of said distal (11) and proximal (12) ends,the implant (1) comprising a central axis (3) or a housing adapted to receive such an axis extending through a sliding sleeve at the proximal end (11) to a traction ring or sleeve at the distal end (12) to allow a rapprochement of said ends generating the pivoting of the support arms (131, 141) causing the separation of the platforms (13, 14) and the expansion of the implant and either: at least two other faces of said implant are each covered by and secured by at least one sheet (10) of a biocompatible metal alloy, in a watertight manner, said sheet (10) comprising a plurality of folds lying one on top of the other in folded configuration, said sheet being plastically deformable with a total surface area greater than or equal to the lateral surface of the implant in deployed configuration so as to form a watertight compartment adapted to receive a fluid inside the cavity obtained by the expansion of the implant,- an envelope formed by a sheet (10) of biocompatible metal alloy, closed upon itself in a hermetic manner and enclosing said implant from the proximal end (11) to the distal end (12), said sheet (10) having a plurality of pairs of folds lying on top of each other and rolled around the longitudinal axis (L), said proximal (11) and distal (12) ends comprising, respectively, a ring providing an entry into the hollow body and a butt closing the hollow body, said ring and said butt being securely attached, in a hermetic manner, to the lying and rolled folds of said sheet (10) over the entire periphery of their respective proximal (11) or distal (12) end, said sheet (10) being plastically deformable to allow the expansion of the implant from the folded configuration to the deployed configuration, when a fluid is injected into the implant (1);(c) an implant (1) having at least two faces, for example upper and lower, each comprising at least one platform (13, 14, 15), each supported by at least two support arms (131, 141, 151), by means of a respective hinge, an expansion sleeve or ring (20), at least two expansion arms (132, 142, 152) each comprising a hinge connecting them to one end of one of the platforms (13, 14, 15) and a hinge connecting them to an expansion sleeve or ring (20) which can be moved away from a central axis (3) of the implant (1) to exert traction on the platforms (13, 14, 15), by means of the expansion arms (132, 142, 152), thereby causing a pivoting of said support arms (131,; 141, 151) causing the plates (13, 14, 15) to move apart and resulting in a controlled expansion of the implant (1) between said folded configuration and said deployed configuration, and: this implant (1) optionally comprising an envelope formed by a sheet (10) of biocompatible metal alloy, closed upon itself in a hermetic manner and enclosing said implant from the proximal end (11) to the distal end (12), said sheet (10) having a plurality of pairs of folds lying one on top of the other and rolled around the longitudinal axis (L), said proximal (11) and distal (12) ends comprising, respectively, a ring providing an entry into the hollow body and a base closing the hollow body, said ring and said base being securely attached, in a hermetic manner, to the lying and rolled folds of said sheet (10) over the entire periphery of their respective proximal (11) or distal (12) end,said sheet (10) being plastically deformable to allow the expansion of the implant from the folded configuration to the deployed configuration, during the injection of a fluid inside the implant (1).

[0035] Some embodiments of this application relate to a human orthopedic surgery system as detailed above or elsewhere in this application, but with a combination of implants, instruments and planning support.

[0036] In some embodiments, said planning support is implemented using computer means (PC) comprising a human-machine interface and executing instructions on a processor enabling: the display of information relating to at least one standardized classification of the various types of fractures identified, including vertebral compression fractures;the selection of at least one type of fracture and at least one piece of information relating to the dimensions of the fractured bone, then the display of the implants (1) and instruments (A) of the system which are usable for the envisaged restoration and possibly instructions or advice on the procedure to be followed, for example with a display of references of the implants or the various systems usable for each fracture identified in the classification, then the selection of a choice among these proposals and advice, by the user via the human-machine interface, causing the display of subsequent instructions or advice to provide assistance with the intervention or its planning, with the acquisition of data provided by the user on the envisaged surgical intervention.;

[0037] In some embodiments, said selection of the type of fracture in the classification is carried out either by the user or automatically by computer means (PC) through training on fracture databases for their automatic classification from technical information and / or images provided by the user and / or acquired beforehand by computer means, then relating them to said standardized classification of fractures, the automatic selection preferably being validatable or modifiable by the user.

[0038] In some embodiments, one of the selectable implants is an expandable bone implant (1) for human orthopedic surgery for volume restoration and / or geometry of a bone, by an expansion between a folded configuration and an deployed configuration, said implant comprising a hollow body extending along a longitudinal axis (L) between a proximal end (11) connectable to an implantation instrument (A) to hold the implant and a distal end (12) intended to be inserted first into the bone, and which is characterized in that: - the wall of said hollow body is formed by a sheet (10) of biocompatible metal alloy, closed on itself in a sealed manner, between said proximal (11) and distal (12) ends; - said sheet (10) has, at least in the folded configuration, a plurality of pairs of folds, each pair comprising an antiform fold (101), said convex, and a synform fold (102), said concave, said folds being laid one on top of the other in the folded configuration so that the surfaces present between each of said convex and concave folds are rolled around the longitudinal axis (L), - said proximal end (11) has a ring securely attached to the flattened and rolled folds of said sheet (10) over the entire periphery of the distal end (11), the opening through the ring providing an entry into the hollow body of the implant (1), - said distal end (12) comprises a base closing the distal end (12) and securely attached to the flattened and rolled folds of said sheet (10) over the entire periphery of the distal end of said hollow body - said sheet (10) being plastically deformable to allow the expansion of the implant from the folded configuration to the deployed configuration, when a fluid is injected inside the implant (1).

[0039] In some embodiments, one of the selectable implants is an expandable bone implant (1) for human orthopedic surgery for restoring the volume and / or geometry of a bone, by expansion between a folded configuration and a deployed configuration, said implant extending along a longitudinal axis (L) between a proximal end (11) connectable to an implantation instrument (A) for holding the implant and a distal end (12) intended to be inserted first into the bone, at least two faces of the implant, for example upper and lower, each comprising a tray (13, 14) for contact with the bone tissues, each of the trays comprising a central portion (130, 140) connected, via at least one hinge, to at least one pair of support arms (131, 141) each oriented in opposite directions within each pair,one arm of each pair being connected by a hinge to the distal end (11) while the other arm is connected by a hinge to the proximal end (12), the implant (1) being adapted to receive or having a central axis (3) extending through a sliding sleeve at the proximal end (11) to a traction ring or sleeve at the distal end (12) where it is adapted to transmit traction, when actuation by an instrument (A), on the distal end (12) to allow it to be brought closer to the proximal end (11), causing the pivoting of the support arms (131, 141) resulting in the separation of the platforms (13, 14) from each other and, consequently, the expansion of the implant between the folded and deployed configurations.

[0040] In some of these embodiments, the implant (1) is also characterized in that: - at least two other faces of the implant, between those containing the platforms, are covered with at least one sheet (10) per face, made of a biocompatible metal alloy, and hermetically bonded to the central portions (130, 140) under the platforms, to the lateral faces of the arms (131, 141) and to the lateral faces of the proximal end (11) and the distal end (12), - said sheet (10) is plastically deformable to allow expansion of the implant and has, at least in the folded configuration, a plurality of antiform folds (101), said convex, and synform folds (102), said concave, said folds being laid one on top of the other in the folded configuration, the total surface of said sheet being greater than or equal to the lateral surface of the implant in the deployed configuration so as to form a sealed compartment suitable for receiving a fluid inside the cavity obtained by the expansion of the implant.

[0041] In certain embodiments, said implant (1) comprises a casing enclosing said implant from the proximal end (11) to the distal end (12) and in that: - said envelope is formed by a sheet (10) of biocompatible metal alloy, sealed tightly upon itself; - said sheet (10) has, at least in the folded configuration, a plurality of pairs of folds, each of the pairs comprising an antiform fold (101), said convex, and a synform fold (102), said concave, said folds being laid one on top of the other in folded configuration so that the surfaces present between each of said convex and concave folds are rolled around the longitudinal axis (L); - said proximal end (11) extends by means of a sealing sleeve securely attached to the flattened and rolled folds of said sheet (10) over the entire periphery of the proximal end (11); - said distal end (12) extends into a socket securely attached, in a watertight manner, to the flattened and rolled folds of said sheet (10) over the entire periphery of the distal end (12) of said implant (1); - said sheet (10) is plastically deformable to allow the expansion of the implant from the folded configuration to the deployed configuration by forming a sealed envelope enclosing the implant and preventing leaks when injecting a fluid into the implant (1) and the envelope.

[0042] In certain embodiments, one of the selectable implants is an expandable bone implant (1) for human orthopedic surgery for restoring the volume and / or geometry of a bone, by expansion between a folded and an unfolded configuration, said implant having a central axis (3) and extending along a longitudinal axis (L) between a proximal end (11) connectable to an implantation instrument (A) for holding the implant and a distal end (12) intended to be inserted first into the bone, at least two faces, for example superior and inferior, of the implant each having at least one platform (13, 14, 15) for contact with the bone tissue, each of the trays being supported by at least two support arms (131, 141, 151) each, by means of a hinge on the central axis (3) and a hinge under the respective tray (13, 14, 15) of each of said support arms (131, 141, 151), characterized in that: - an expansion sleeve or ring (20) arranged in the same axis as said central axis (3); - at least two expansion arms (132, 142, 152) each have a hinge connecting them to one end of one of the plates (13, 14, 15) and a hinge connecting them to said expansion sleeve or ring (20); - said expansion sleeve or ring (20) and the proximal end of the central axis (3) are able to cooperate, respectively or conversely, with a hollow tube (Al) for gripping the implant (1) of an implantation instrument (A) and with an expansion rod (A3) of said instrument (A); -said expansion rod (A3) is able to slide inside said hollow tube (Al), so as to cause a separation between said sleeve (3) and said central axis (3), exerting a traction on the plates (13, 14, 15), by means of the expansion arms (132, 142, 152), which generates a pivoting of said support arms (131, 141, 151) causing the plates (13, 14, 15) to move away from the central axis (3), so as to result in a controlled expansion of the implant (1) between said folded configuration and said deployed configuration.

[0043] In some of these embodiments, the implant (1) comprises a casing enclosing said implant from the proximal end (11) to the distal end (12) and in that: - said envelope is formed by a sheet (10) of biocompatible metal alloy, sealed tightly upon itself; - said sheet (10) has, at least in the folded configuration, a plurality of pairs of folds, each of the pairs comprising an antiform fold (101), said convex, and a synform fold (102), said concave, said folds being laid one on top of the other in folded configuration so that the surfaces present between each of said convex and concave folds are rolled around the longitudinal axis (L); - said proximal end (11) extends by means of a sealing sleeve securely attached to the flattened and rolled folds of said sheet (10) over the entire periphery of the proximal end (11); - said distal end (12) extends into a socket securely attached, in a watertight manner, to the flattened and rolled folds of said sheet (10) over the entire periphery of the distal end (12) of said implant (1); - said sheet (10) is plastically deformable to allow the expansion of the implant from the folded configuration to the deployed configuration by forming a sealed envelope enclosing the implant and preventing leaks when injecting a fluid into the implant (1) and the envelope.

[0044] This application also relates to a method for planning the implantation of an implant system according to one of the preceding claims, for restoring the volume and / or geometry of a bone, by an expansion between a folded configuration and a deployed configuration, characterized in that it includes a selection, automatic and / or by the practitioner performing the implantation, of at least one type of fracture identified in at least one standardized classification, via computer means (PC) and presented to said practitioner, then access, following this selection, to at least one implant system compatible with said type of fracture and to at least one operative protocol comprising a succession of steps to be carried out according to said selection.

[0045] In some embodiments, the method is implemented by computer means executing instructions on a processor enabling: the display of information relating to at least one classification of fracture types identified in traumatology; the selection of at least one fracture type and at least one piece of information relating to the dimensions of the fractured bone, then the display of instructions or advice on the procedure to be followed and on the various systems to be used for the procedure, for example with a display of references to implants or the various systems usable for each fracture identified in the classification, then the selection of a choice among these tips, causing the display of subsequent instructions or tips to provide said assistance step by step.

[0046] In some embodiments, the display of instructions or advice includes the display of selectable functions to make a choice among actions to be performed to continue the procedure and / or among implants to be selected according to the operative protocol chosen according to the type of fracture identified according to said classification, allowing the practitioner to validate a choice and possibly propose predefined options in the validated protocol, such as the acquisition of radiographs at the end of certain steps implemented.

[0047] In certain embodiments, said selectable functions include functions enabling the practitioner to modify said protocol and generate the display of a protocol modification window, either for selecting a protocol from among other possible protocols for said type of fracture identified according to said classification, or for creating a personalized operative protocol for the fracture being repaired.

[0048] In certain embodiments, these selectable functions allow for the recording of operations and operative protocols, including personalized ones, used by the various practitioners and their associations with fractures, with the possible recording of personalized protocols created by the practitioners, in order to propose them later.

[0049] In some embodiments, the method includes: Fracture detection is achieved through an artificial intelligence-based identification system. Using X-rays, CT scans, and MRIs loaded into the software, and by recognizing defects and / or differences from the presumed fracture, the suspected fractured area is identified, facilitating the practitioner's identification of any unique features. The database is continuously updated based on the practitioner's preferences.

[0050] Some embodiments provide for recognition of the fracture type with identification according to the AO (Orthopedic Association) Classification or any other classification stored in the computer system (PC). The software can then classify the type, severity, and location of the fracture, defined for example by: -The Zone: Distal / Median / Proximal, described as cuneiform, biconcave, or pancake-shaped -Importance: Normal vertebra / Minor fracture / Moderate fracture / Severe fracture.

[0051] Preferably, an osteodensitometry scan is then performed so that the software can analyze and compare with a model in order to establish the direct and future risks of the fracture.

[0052] On the other hand, based on the identification and level of the fracture according to the reduction required, the software can suggest the type of implant and protocol best suited to the morphology / bone density, the type, and the extent of the fracture. The most suitable implant is generally chosen based on the type of correction; and preferably, the software makes a suggestion, but the practitioner must validate and / or can modify the software's recommendation.

[0053] Some implementation methods provide assistance during the operation with control of compliance of the protocol chosen by the practitioner and / or corrected by the practitioner, with an increase and / or reduction of the corrected volume.

[0054] On the other hand, in certain embodiments, the system comprises at least one instrument (A) extending along a longitudinal axis (L) between a proximal end (11) adapted to cooperate with said implantation instrument (A) to hold the implant and a distal end (12) intended to be inserted first into the bone, said instrument (A) comprising a main part graspable by a practitioner, an implant-bearing portion (AA) comprising a grasping tube (A0) extending along the longitudinal axis (L) and having, at its distal end, additional retention means for cooperating with the implant, to hold the implant by its proximal end (11), said instrument (A) being characterized in that it comprises an instrument (Ac) for injecting fluid, such as bone cement, into said implant (1) comprising at least one cavity adapted to receive the fluid,said injection instrument (Ac) being disposed behind the implant-bearing portion (AA) along the longitudinal axis (L) and comprising at least one cannula (A0, A1, A3) for conveying the fluid into the implant (1) while it is still held by said implant-bearing portion (AA).

[0055] In some embodiments, the instrument (A) also includes an implant expansion instrument (Ae) (1) adapted to cooperate with mechanical implant expansion means (1) by means of an expansion rod (A3) passing through said implant-bearing portion (AA) and said grasping tube (A0) to actuate said mechanical expansion means. In some of these embodiments, said expansion rod (A3) passes through said injection instrument (Ac) to the distal end of the grasping tube (A0).

[0056] This application describes various technical features and advantages with reference to the figures and / or various embodiments. Those skilled in the art will understand that the technical features of a given embodiment can in fact be combined with features of another embodiment unless the contrary is explicitly stated or it is obvious that such features are incompatible. that the combination does not provide a solution to at least one of the technical problems mentioned in this application. Furthermore, the technical features described in a given embodiment may be isolated from the other features of that embodiment unless the contrary is explicitly stated.

[0057] Detailed list of references in the figures: I implant 10 sheets II proximal end 101 anti-forming fold 102 synformal fold 110 proximal weld 12 distal end 120 distal weld (watertight connection) 121 Compression fastening (e.g., split ring) 3 central axis 31 leads along the central axis 32 openings in the central axis conduit 13th first plateau 14 second plateau 15 third plateau 20 expansion ring 131 support arms for the first tray 141 support arms for the second platform 151 support arms for the third platform 132 expansion arms of the first plateau 142 second plateau expansion arms 152 third plateau expansion arms 130 central support arms of the first platform 140 central support arms of the second platform 150 central support arms for the third platform An implantation instrument AC fluid injection instrument A0 hollow gripping tube Al injection cannula A3 expansion rod V vertebra VCF Vertebral Compression Fracture

Claims

Demands

1. A human orthopedic surgery system for restoring the volume and / or geometry of a bone by expansion between a folded and an unfolded configuration of at least one expandable bone implant (1) having a body extending along a longitudinal axis (L) between a proximal end (11) adapted to cooperate with an implantation instrument (A) to hold the implant and a distal end (12) intended to be inserted first into the bone, the system being characterized in that it comprises a plurality of expandable bone implants (1) and at least one implantation instrument (A) corresponding to each of said implants (1) and at least one planning support presenting said implants (1) and instrument (A), with reference to at least one standardized classification of the various types of fractures identified, including vertebral compression fractures, characterized in that said implants: - extend along a longitudinal axis (L) between a proximal end (11) connectable to an implantation instrument (A) to hold the implant (1) and a distal end (12) intended to be inserted first into the bone; - are deployable from a collapsed configuration to a deployed configuration; - are selected from: d) an implant comprising a hollow body whose wall is formed by a sheet (10) of biocompatible metal alloy, sealed upon itself between said proximal (11) and distal (12) ends and having, at least in the folded configuration, a plurality of pairs of folds lying one on top of the other and rolled around the longitudinal axis (L), said proximal (11) and distal (12) ends comprising, respectively, a ring providing an entry into the hollow body and a base closing the hollow body, said ring and said base being sealed together with the lying and rolled folds of said sheet (10) over the entire periphery of their respective proximal (11) or distal (12) end, said sheet (10) being plastically deformable to allow the expansion of the implant from the folded configuration to the deployed configuration,during the injection of a fluid into the implant (1); (e) an implant having at least two faces, for example upper and lower, each comprising a platform (13, 14) for contact with bone tissue and connected, by means of at least one hinge, to at least one pair of support arms (131, 141) each oriented in opposite directions towards one of said distal (11) and proximal (12) ends, the implant (1) comprising a central axis (3) or a housing adapted to receive such an axis extending through a sliding sleeve at the proximal end (11) to a traction ring or sleeve at the distal end (12) to allow a rapprochement of said ends causing the pivoting of the support arms (131, 141) causing the platforms (13, 141) to move apart14) and the expansion of the implant and either: at least two other faces of said implant are each covered by and secured with at least one sheet (10) of biocompatible metal alloy, in a hermetic manner, said sheet (10) comprising a plurality of folds lying one on top of the other in folded configuration, said sheet being plastically deformable with a surface, total area greater than or equal to the lateral surface area of ​​the implant in its deployed configuration, so as to form a sealed compartment capable of holding a fluid inside the cavity obtained by the expansion of the implant - an envelope formed by a sheet (10) of biocompatible metal alloy, closed upon itself in a hermetic manner and enclosing said implant from the proximal end (11) to the distal end (12), said sheet (10) having a plurality of pairs of folds lying on top of each other and rolled around the longitudinal axis (L), said proximal (11) and distal (12) ends comprising, respectively, a ring providing an entry into the hollow body and a butt closing the hollow body, said ring and said butt being securely attached, in a hermetic manner, to the lying and rolled folds of said sheet (10) over the entire periphery of their respective proximal (11) or distal (12) end, said sheet (10) being plastically deformable to allow the expansion of the implant from the folded configuration to the deployed configuration, when a fluid is injected into the implant (1); (f) an implant (1) of which at least two faces,for example upper and lower, each comprising at least one platform (13, 14, 15), each supported by at least two support arms (131, 141, 151), via a respective hinge, an expansion sleeve or ring (20), at least two expansion arms (132, 142, 152) each comprising a hinge connecting them to one end of one of the platforms (13, 14, 15) and a hinge connecting them to an expansion sleeve or ring (20) that can be moved away from a central axis (3) of the implant (1) to exert traction on the platforms (13, 14, 15), via the expansion arms (132, 142, 152), causing a pivoting of said support arms (131, 141, 151) resulting in the platform (13, 14, 15) moving away 14, 15) and resulting in a controlled expansion of the implant (1) between said folded configuration and said deployed configuration, and: this implant (1) optionally comprising an envelope formed by a sheet (10) of biocompatible metal alloy,closed upon itself in a sealed manner and enclosing said implant from the proximal end (11) to the distal end (12), said sheet (10) having a plurality of pairs of folds lying one on top of the other and rolled around the longitudinal axis (L), said proximal (11) and distal (12) ends comprising, respectively, a ring providing an entry into the hollow body and a butt closing the hollow body, said ring and said butt being securely attached, in a sealed manner, to the folded and rolled folds of said sheet (10) over the entire periphery of their respective proximal (11) or distal (12) ends, said sheet (10) being plastically deformable to allow the expansion of the implant from the folded configuration to the deployed configuration, upon injection of a fluid into the implant (1).

3. A system according to claim 1, characterized in that said planning support is implemented by means of computer means (PC) comprising a human-machine interface and executing instructions on a processor enabling: the display of information relating to said standardized classification of the various types of fractures identified, including vertebral compression fractures; the selection of at least one type of fracture and at least one piece of information relating to the dimensions of the fractured bone, then the display of the implants (1) and instruments (A) of the system which are usable for the envisaged restoration and possibly instructions or advice on the procedure to be followed, for example with a display of references of the implants or the various systems usable for each fracture identified in the classification, then the selection of a choice among these proposals and advice, by the user via the human-machine interface, causing the display of subsequent instructions or advice to provide assistance with the intervention or its planning, with the acquisition of data provided by the user on the envisaged surgical intervention.

4. System according to claim 2, characterized in that said selection of the type of fracture in the classification is carried out either by the user or automatically by computer means (PC) through training on fracture databases for their automatic classification from technical information and / or images provided by the user and / or acquired beforehand by computer means, then relating them to said standardized classification of fractures, the automatic selection preferably being validatable or modifiable by the user.

5. A system according to any one of the preceding claims, characterized in that one of the selectable implants is an expandable bone implant (1) for human orthopedic surgery for restoring the volume and / or geometry of a bone, by expansion between a folded configuration and a deployed configuration, said implant comprising a hollow body extending along a longitudinal axis (L) between a proximal end (11) connectable to an implantation instrument (A) for holding the implant and a distal end (12) intended to be inserted first into the bone, and which is characterized in that: - the wall of said hollow body is formed by a sheet (10) of biocompatible metal alloy, closed on itself in a sealed manner, between said proximal (11) and distal (12) ends; - said sheet (10) has, at least in the folded configuration, a plurality of pairs of folds, each pair comprising an antiform fold (101), said convex, and a synform fold (102), said concave, said folds being laid one on top of the other in the folded configuration so that the surfaces present between each of said convex and concave folds are rolled around the longitudinal axis (L), - said proximal end (11) has a ring securely attached to the flattened and rolled folds of said sheet (10) over the entire periphery of the distal end (11), the opening through the ring providing an entry into the hollow body of the implant (1), - said distal end (12) comprises a base closing the distal end (12) and securely attached to the flattened and rolled folds of said sheet (10) over the entire periphery of the distal end of said hollow body - said sheet (10) being plastically deformable to allow the expansion of the implant from the folded configuration to the deployed configuration, during the injection of a fluid inside the implant (1).

6. A system according to any one of the preceding claims, characterized in that one of the selectable implants is an expandable bone implant (1) for human orthopedic surgery for restoring the volume and / or geometry of a bone, by expansion between a folded configuration and a deployed configuration, said implant extending along a longitudinal axis (L) between a proximal end (11) connectable to an implantation instrument (A) for holding the implant and a distal end (12) intended to be inserted first into the bone, at least two faces of the implant, for example upper and lower, each comprising a tray (13, 14) for contact with bone tissue, each of the trays comprising a central portion (130, 140) connected, via at least one hinge, to at least one pair of support arms (131, 141) each oriented in opposite directions within each pair,one arm of each pair being connected by a hinge to the distal end (11) while the other arm is connected by a hinge to the proximal end (12), the implant (1) being adapted to receive or having a central axis (3) extending through a sliding sleeve at the proximal end (11) to a traction ring or sleeve at the distal end (12) where it is adapted to transmit traction, when actuation by an instrument (A), on the distal end (12) to allow it to be brought closer to the proximal end (11), causing the pivoting of the support arms (131, 141) resulting in the separation of the platforms (13, 14) from each other and, consequently, the expansion of the implant between the folded and deployed configurations.

7. System according to claim 4, characterized in that the implant (1) is also characterized in that: - at least two other faces of the implant, between those containing the platforms, are covered with at least one sheet (10) per face, made of a biocompatible metal alloy, and hermetically bonded to the central portions (130, 140) under the platforms, to the lateral faces of the arms (131, 141) and to the lateral faces of the proximal end (11) and the distal end (12), - said sheet (10) is plastically deformable to allow expansion of the implant and has, at least in the folded configuration, a plurality of antiform folds (101), said convex, and synform folds (102), said concave, said folds being laid one on top of the other in the folded configuration, the total surface of said sheet being greater than or equal to the lateral surface of the implant in the deployed configuration so as to form a sealed compartment suitable for receiving a fluid inside the cavity obtained by the expansion of the implant.

8. A system according to any one of claims 4 and 5, characterized in that said implant (1) comprises a casing enclosing said implant from the proximal end (11) to the distal end (12) and in that: - said envelope is formed by a sheet (10) of biocompatible metal alloy, sealed tightly upon itself; - said sheet (10) has, at least in the folded configuration, a plurality of pairs of folds, each pair comprising an antiform fold (101), called convex, and a synform fold (102), called concave, said folds being laid one on top of the other in folded configuration so that the surfaces present between each of said convex and concave folds are rolled around the longitudinal axis (L); - said proximal end (11) extends by means of a sealing sleeve securely attached to the flattened and rolled folds of said sheet (10) over the entire periphery of the proximal end (11); - said distal end (12) extends into a socket securely attached, in a watertight manner, to the flattened and rolled folds of said sheet (10) over the entire periphery of the distal end (12) of said implant (1); - said sheet (10) is plastically deformable to allow the expansion of the implant from the folded configuration to the deployed configuration by forming a sealed envelope enclosing the implant and preventing leaks when injecting a fluid into the implant (1) and the envelope.

9. A system according to any one of the preceding claims, characterized in that one of the selectable implants is an expandable bone implant (1) for human orthopedic surgery for restoring the volume and / or geometry of a bone, by expansion between a folded configuration and a deployed configuration, said implant comprising a central axis (3) and extending along a longitudinal axis (L) between a proximal end (11) connectable to an implantation instrument (A) for holding the implant and a distal end (12) intended to be inserted first into the bone, at least two faces, for example superior and inferior, of the implant each comprising at least one tray (13, 14, 15) for contact with the bone tissues, each of the trays being supported by at least two support arms (131, 141, 151) each, by means of a hinge on the central axis (3) and a hinge under the tray (13, 14, 15) respective of each of the said support arms (131,141, 151), characterized in that: - an expansion sleeve or ring (20) arranged in the same axis as said central axis (3); - at least two expansion arms (132, 142, 152) each have a hinge connecting them to one end of one of the plates (13, 14, 15) and a hinge connecting them to said expansion sleeve or ring (20); - said expansion sleeve or ring (20) and the proximal end of the central axis (3) are able to cooperate, respectively or conversely, with a hollow tube (Al) for gripping the implant (1) of an implantation instrument (A) and with an expansion rod (A3) of said instrument (A); -said expansion rod (A3) is able to slide inside said hollow tube (Al), so as to cause a separation between said sleeve (3) and said central axis (3), exerting a traction on the plates (13, 14, 15), by means of the expansion arms (132, 142, 152), which generates a pivoting of said support arms (131, 141, 151) causing the plates (13, 14, 15) to move away from the central axis (3), so as to result in a controlled expansion of the implant (1) between said folded configuration and said deployed configuration.

10. System according to claim 7, characterized in that the implant (1) comprises a casing enclosing said implant from the proximal end (11) to the distal end (12) and in that: - said envelope is formed by a sheet (10) of biocompatible metal alloy, sealed tightly upon itself; - said sheet (10) has, at least in the folded configuration, a plurality of pairs of folds, each of the pairs comprising an antiform fold (101), said convex, and a synform fold (102), said concave, said folds being laid one on top of the other in folded configuration so that the surfaces present between each of said convex and concave folds are rolled around the longitudinal axis (L); - said proximal end (11) extends by means of a sealing sleeve securely attached to the flattened and rolled folds of said sheet (10) over the entire periphery of the proximal end (11); - said distal end (12) extends into a socket securely attached, in a watertight manner, to the flattened and rolled folds of said sheet (10) over the entire periphery of the distal end (12) of said implant (1); - said sheet (10) is plastically deformable to allow the expansion of the implant from the folded configuration to the deployed configuration by forming a sealed envelope enclosing the implant and preventing leaks when injecting a fluid into the implant (1) and the envelope.

11. A method for planning the implantation of an implant system according to any one of the preceding claims, for the restoration of the volume and / or geometry of a bone, by an expansion between a folded configuration and a deployed configuration, characterized in that it comprises a selection, automatic and / or by the practitioner performing the implantation, of at least one type of fracture identified in at least one standardized classification, via computer means (PC) and presented to said practitioner, then access, following this selection, to at least one implant system compatible with said type of fracture and to at least one operative protocol comprising a succession of steps to be carried out according to said selection.

12. Planning method according to claim 9, characterized in that it is implemented by computer means executing instructions on a processor enabling: the display of information relating to at least one classification of fracture types identified in traumatology; the selection of at least one fracture type and at least one piece of information relating to the dimensions of the fractured bone, then the display of instructions or advice on the procedure to be followed and on the various systems to be used for the procedure, for example with a display of references of implants or the various systems usable for each fracture identified in the classification, then the selection of a choice among these tips, causing the display of subsequent instructions or tips to provide said step-by-step assistance.

13. Planning method according to claim 10, characterized in that the display of instructions or advice includes the display of selectable functions to make a choice among actions to be performed to continue the procedure and / or among implants to be selected according to the operative protocol chosen according to the type of fracture identified according to said classification, allowing the practitioner to validate a choice and possibly propose predefined options in the validated protocol, such as for example the acquisition of radiographs at the end of certain steps implemented.

14. Planning method according to claim 11, characterized in that said selectable functions include functions enabling the practitioner to modify said protocol and generate the display of a protocol modification window, either for selecting a protocol from among other possible protocols for said type of fracture identified according to said classification, or for creating a personalized surgical protocol for the fracture being repaired.

15. Planning method according to claim 12, characterized in that said selectable functions allow a recording of the operations and operative protocols, including personalized ones, used by the different practitioners and their associations with fractures, with a possible recording of personalized protocols created by the practitioners, in order to propose them later.

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