Human orthopaedic surgery instruments for installing expandable bone implants

Abstract

The present invention relates to an instrument for implanting expandable bone implants (1) for human orthopaedic surgery, the instrument (A) having an implant-holder portion (AA) comprising a tube (A0) for gripping the implant, the instrument (A) being characterized in that it has an instrument (Ac) for injecting fluid, such as bone cement, into the implant (1) comprising at least one cavity suitable for receiving the fluid, the injection instrument (Ac) being arranged behind the implant-holder portion (AA) along the longitudinal axis (L) and comprising at least one cannula (A0, A1, A3) for conveying the fluid to the interior of the implant (1) while the latter is still held by the implant-holder portion (AA).

Description

Description Title of the invention: Instruments for human orthopedic surgery for the installation of expandable bone implants

[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 them). 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] Numerous solutions are known from the prior art, including patent applications EP3086729, US11540926, EP3747385, EP2572680, EP3958752, EP2693967, EP2405835, US9579130, EP4216836, WO2023122005, WO2022162418, EP3843668, and US10945861. However, these solutions present various problems related to the difficulty of handling during deployment, as well as stability and reliability issues once deployed. Furthermore, these known solutions generally involve the injection of bone cement but provide no information regarding cement leakage from the implant, even though such leakage can be detrimental to surrounding tissues and potentially even the entire body if the cement's chemicals enter the bloodstream. Indeed, cement generally contains one or more polymerizable chemical substances, for example such as poly(methyl methacrylate) (PMMA, for the English poly-methyl-methacrylate) and possibly additives.Furthermore, the temperature reached during the polymerization of cement is not harmless as it is generally above 60°.

[0005] It is known from the prior art, notably from documents EP1308134, US9510877, US8936627 or EP2467099, of devices for straightening and stabilizing (or reducing bone fractures), particularly of the spine in the form of stents, or in the form of balloons or porous inflatable bags as in documents EP1408888 or EP1379185, possibly equipped with support trays as in document US20060100706. Many documents propose this type of stent, i.e. deformable endoprosthesis similar to endoprostheses, expanders or vascular stents, which are generally in the form of a meshed tubular body, most often metallic and deformable by the introduction of an inflatable balloon to dilate the body by separating the meshes, the balloon being then removed to allow an injection of cement, which hardens and thus forms a straightening and stabilizing structure.However, these devices have the drawback of requiring a two- or even three-stage implantation process, involving balloon inflation followed by cement injection. This slows down and complicates the operation, and also presents a risk of device collapse between balloon deflation and cement filling of the stent. Furthermore, they necessitate the successive use of several different instruments, which implies an increased health risk. Moreover, these solutions fail to address the major problem of cement leakage.

[0006] It is also known, notably from documents EP1938765, EP2351539, and WO200434924, that solutions use mesh-structure implants made of shape-memory metal, which is constrained into a folded shape for insertion into bone tissue and is capable of spontaneously expanding when the constraint is released and / or under the effect of heat. These solutions have the disadvantage of requiring expensive alloys and complex manufacturing to achieve adequate shape memory suitable for the intended implantation. This leads to increased costs by multiplying the number of different implants needed to cover various pathological cases, particularly due to the extent of deformation the shape-memory material is capable of. Furthermore, the force exerted by the metal returning to its unconstrained shape is often insufficient to properly straighten the collapsed bone structure, or at least is limiting in its ability to do so.On the other hand, these solutions also have the disadvantage of not addressing the major problem of cement leaks.

[0007] Prior art, notably documents EP2405835, US9579130, EP2572680, and EP1956990, also describe solutions using expandable implants with a lever mechanism, similar to a car jack, to restore bone structure to a predetermined height. These solutions have the advantage of not risking collapse, unlike stents deployed by a balloon that is removed before cement injection. However, they also have the disadvantage of requiring two or even three implantation stages and a limited surface area for exerting expansion force on the bone tissue, especially compared to stents. Furthermore, they are expensive, difficult to deploy, cannot be adjusted to the morphology of bone structures, and do not address the major problem of cement leakage.

[0008] 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 greatest volume This is possible even though it was introduced through the smallest possible opening. On the other hand, this deployment ratio will impact the distribution of forces to straighten the vertebrae: if it is too deformable, the injection pressure of the cement will deform the pocket instead of restoring the height.

[0009] A problem complementary to that of deployment concerns folding, which is generally not possible with anterior art implants. Controlling folding allows for control of deployment and therefore of the injection site, with homogeneous distribution of cement and pressure to fill the space created by the collapse. Perfect homothety adapts to the fracture, respecting the shape of the bone within the fracture.

[0010] In this context, it is understandable that many technical problems related to implants persist in the field, accompanied by problems concerning implantation instruments which are generally too numerous and complex to address the major problems of invasiveness and the ease and duration of the surgical intervention.

[0011] In this context, one aim of the present invention is to overcome at least some of the drawbacks of the prior art by proposing a surgical implantation instrument for expandable bone implants, for the restoration of collapsed bone structures, which is reliable and simple to handle and implant.

[0012] This goal is achieved by an instrument for the implantation of expandable bone implants in human orthopedic surgery, for the restoration of the volume and / or geometry of a bone, by an expansion between a folded and a deployed configuration of the implant, said instrument comprising a main part graspable by a practitioner, an implant-bearing portion comprising a grasping tube extending along the longitudinal axis and having, at its distal end, complementary retention means for implant cooperation, to hold the implant by its proximal end, said instrument being characterized in that it comprises a fluid injection instrument, such as bone cement, into said implant comprising at least one cavity suitable for receiving the fluid,said injection instrument being disposed behind the implant-bearing portion along the longitudinal axis and comprising at least one cannula for conveying the fluid into the implant while it is still held by said implant-bearing portion.

[0013] According to another feature, the instrument also includes an implant expansion instrument capable of cooperating with mechanical implant expansion means, by means of an expansion rod passing through said implant holder portion and said gripping tube to actuate said mechanical expansion means.

[0014] According to another feature, said expansion rod passes through said injection instrument to the distal end of the grasping tube.

[0015] According to another feature, the instrument retention means and the implant cooperation means of which they are complementary comprise a proximal implant sleeve around which said retention means are fixed and include a movable stud in an L-shaped groove for retaining the implant by a translational and rotational movement, relative to the longitudinal axis, of said stud in said groove.

[0016] According to another feature, the said injection instrument includes a piston that can be operated on the instrument to push the fluid stored in a chamber inside the instrument, through said cannula.

[0017] According to another peculiarity, the said injection cannula is formed by the grasping tube opening onto a proximal sleeve of the implant.

[0018] According to another feature, said injection cannula is formed by an injection tube suitable for insertion inside the grasping tube and opening inside an opening of a proximal sleeve of the implant retained by the grasping tube, directly into a cavity of the implant or on the axis of the implant comprising a conduit and at least one opening for distributing said fluid into the implant.

[0019] According to another feature, said injection cannula is formed by said expansion rod which is hollow and suitable for insertion inside the grasping tube and opening inside an opening of a proximal sleeve of the implant retained by the grasping tube, directly into a cavity of the implant or on the axis of the implant comprising a conduit and at least one opening for distributing said fluid into the implant.

[0020] According to another distinctive feature, the implant-carrying portion has a mounting that is integral to the gripping tube directly in the main instrument.

[0021] According to another feature, the implant-carrying portion includes a removable tip with a housing suitable for mounting on a protrusion of the instrument through which the fluid is routed to the removable tip carrying the grasping tube.

[0022] According to another feature, the removable tip forming the implant holder is retained on the instrument by means of a stud cooperating with an L-shaped groove for locking in a translational and rotational movement relative to the longitudinal axis.

[0023] According to another peculiarity, the direction of rotation for locking said implant holder onto the instrument is opposite to the direction of rotation for locking the implant onto the implant holder.

[0024] According to another feature, the implant holder has a translation latch arranged in a removable manner in said groove to prevent the translation of said plug, until an injection of fluid and / or an actuation of the expansion causing the shortening of said implant in length.

[0025] According to another feature, the implant holder has a rotation latch arranged in a removable manner in said groove to prevent rotation of said block until separation of the implant holder and the instrument is desired.

[0026] Another objective of this application is to address at least some of the drawbacks of the previous art by proposing a surgical intervention system that is easy to use and allows for effective stabilization of bone tissue.

[0027] This goal is achieved by an orthopedic treatment system for damaged bone tissue comprising a bone replacement cement and at least one instrument for implanting and injecting cement into the implant, characterized in that it comprises an implant according to one of the embodiments described in this application.

[0028] Another distinctive feature is that the instrument for implanting and injecting cement includes means for controlling the pressure and / or suction of the cement to fold the implant. in a folded configuration if necessary.

[0029] 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 side view of an implantation instrumentation for an expandable orthopedic implant according to certain embodiments comprising an implant carrier, a cement injection instrument and the implant carried at the end of the implant carrier, and Figure IB represents a perspective view of the instrumentation of Figure 1A with the cement injection instrument extended from the implant carrier; Figure 2A represents a transparent view of an expandable implant implantation instrumentation, Figure 2B represents a perspective view with a partial cross-section of the instrumentation of Figure 2A, Figure 2C represents a perspective view of the end of the implant carrier with an implant mounted on it, with a partial cross-section of the implant showing the implantation instrument inside the implant according to certain embodiments, and Figure 2D represents the same view as Figure 2B but for a double-leaf implant; Figure 3A represents a perspective view of an expandable implant expansion instrumentation according to certain embodiments inserted inside a cement injection instrument, according to certain embodiments, and Figure 3B represents the expansion instrument alone; Figure 4A shows a perspective view of an expandable implant implantation instrumentation comprising an implant holder mounted on a grasping instrument according to certain embodiments, and a cement injection instrument passing through the assembly; Figure 4B shows a detail of the circular part indicated in Figure 4A and Figures 4C and 4D show this same detail after removal of latches on the implant holder; Figure 5A shows, on the left, a top view of a bone anchoring implant implantation instrumentation and, on the right, the implant holder detached from the grasping instrument and Figure 5B shows a detail of the circular area of ​​the right part of Figure 5A, with the cooperation between the implant holder and the implant, according to certain embodiments; Figures 6A, 6B and 6C represent perspective views of vertebrae into which different embodiments of expandable bone implants are inserted; Figures 7A, 7B and 7C represent profile views of vertebrae that have suffered vertebral compression fractures (VCF), respectively at the anterior, midline, and posterior levels; Figure 8A represents a cross-sectional view of part of an instrumentation for implanting an expandable bone implant of the type of that in Figure 4A, Figure 8B represents a cross-sectional view of the implant carried by an instrument of Figure 8A, according to certain embodiments; Figure 9A shows a cross-sectional view of part of an instrumentation for implanting an expandable implant of the type shown in Figure 3A, and Figure 9B shows a cross-sectional view of the implant held by such an instrument as shown in Figure 9A, according to certain modes of realization; Figure 1 OA represents a perspective view of an expandable implant according to certain embodiments in folded configuration, Figure 10B represents a perspective view of the implant of Figure 10A in deployed configuration and Figure 10C represents a detail of the proximal end of this same implant; Figure 11A represents a perspective view of an expandable implant in its folded configuration with an integrated sealed envelope, according to some embodiments; Figure 11B represents a perspective view of the same implant in its deployed configuration; and Figure 11C represents a perspective view of another type of implant whose envelope is not integrated but separate, according to other embodiments, the implant being shown in its deployed configuration with half of its envelope removed to reveal the implant inside.

[0030] This application relates primarily to instrumentation for the implantation of at least one implant and an orthopedic surgery system for the treatment of fractured bone and bone tissue in general, as well as a method for manufacturing the implant. 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 bone 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 they 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 can be treated include the femur or the humerus (head), for example, in cases of risk of collapse. Certain embodiments with more than two plates can be particularly effective in treating long bones of this type by distributing the expansion forces over more than two surfaces, thus providing greater stability regardless of the bone type. Furthermore, the tibial plateau is frequently subjected to crushing, and the implants or systems of 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.On the other hand, as taught, for example, in document EP2921142, it is possible to use expandable implants as bone anchors, and such use is also possible for implants like those of the present 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, when used as a bone anchor in a vascularized structure, such as a humeral or femoral head, the size of the implant relative to the bone structure should preferably be limited to preserve vascularization and promote bone healing.

[0031] Some embodiments involve the injection of a fluid (e.g., "bone cement"), generally based on a polymer such as PMMA, for example, and well known to humans.(This is a technical skill, so no details about the cement will be provided here). Thus, once positioned, the implant can be stabilized by such a cement injection. However, since cement leakage remains a major problem in this field, various embodiments propose containing the cement within a sealed envelope. The volume of this envelope after injection can be controlled by the structure and material of the envelope, 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 restrictive, since the level of seal is actually adapted to the viscosity of the cement at the time of injection. Some embodiments, in particular, allow for homothetic expansion of the envelope thanks to the (relative) flexibility of the biocompatible metallic sheet (10).This material is generally a titanium alloy obtained in the form of a very thin sheet, preferably by lamination for a controlled surface condition and thickness, in particular a thickness between 3 and 100 microns, generally between 6 and 50 and preferably 10 and 30 microns.

[0032] In general, the present invention uses at least one sheet (10) of biocompatible metal or biocompatible metal alloy, such as titanium or its alloys, particularly with nickel or other metals, but also nitinol or stainless steel or their alloys. It takes advantage of recent techniques for obtaining very thin sheets of such metals, particularly with a thickness of less than 50 or even 40 µm, 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 the 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 number of times sufficient for the intended application. This is because it offers the possibility of retracting the shell formed by the sheet in case of a problem (biocompatibility and tear resistance). Indeed, generally, the cement dosage control allows monitoring of the fifteen-minute polymerization period, during which the shell can be retracted and the cement aspirated. Furthermore, through cement injection and the swelling of the shell, 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 incorporate external welding, which is simplified and more robust thanks to the layering of materials at these complementary folds.

[0033] Various embodiments allow for the creation of an expandable implant with very small dimensions in its folded configuration while ensuring a satisfactory volume in its deployed configuration. Thus, the passage required for insertion of the implants described in this application is generally smaller than that of known implants, while the expansion is greater than that of these known implants. Indeed, the folded diameter or volume is smaller than the deployed diameter by a factor of between 3 and 20, generally 3 to 8, preferably 4 to 7. This ratio naturally depends on the amount of cement injected, and some embodiments take advantage of the fact that the implant can be designed to expand beyond what is necessary, notably by retaining folds in the deployed configuration. Therefore, the implant volume will be determined based on the reduced size required for insertion into the bone tissue and thus with reference to the folded volume.However, different volumes are planned for the deployed configuration, since the number of folds and the length of the folds allows the deployment ratio to be increased.

[0034] 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.

[0035] 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 exhaustive. 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, etc. closures, constrictions or strangulation and these terms are used interchangeably without any limitation.

[0036] Some embodiments relate to instrumentation for at least one expandable bone implant (1) for human orthopedic surgery, used to restore the volume and / or geometry of a bone by expansion between a folded and an unfolded configuration. The implant comprises 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. 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.Nevertheless, some embodiments provide specific and advantageous attachment methods to facilitate the grasping of the implant by an implant holder and, above all, the release of the implant by an L-shaped movement of the implant holder. Furthermore, by being connectable to the instrument, the implant is generally actuated for expansion (here by injecting a fluid inside), as is 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 actuating mechanism 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 actuating mechanism 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, and this application thus provides sufficient explanation for the implant to be considered clearly defined without further reference to the instrument enabling its actuation.On the other hand, some embodiments may concern 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.

[0037] Generally speaking, it is understood that the implant will retain, even in its deployed configuration, at least some of the horizontal and rolled folds near the proximal and distal ends, but the dimensions and resistance properties of the sheet (10) used allow the implant to be obtained and ensure that these persistent folds do not interfere with function and do not cause mechanical or physiological problems in the bone tissues. In In certain embodiments, the implant, in deployed position, comprises a median portion between its two ends which has a generalized cylindrical shape, with a possible and at least 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 said sleeve and, on the side of the proximal end (12), by a truncated conical portion connecting the median portion to said 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.

[0038] The terms instrumentation and instrument are generally used here to refer to surgical intervention tools for implanting at least one expandable implant, and the set of tools is preferably designated by the term instrumentation, while each individual tool is preferably designated by the term instrument, generally followed by its main function, or even replaced by its function, as for example in the case of an implant holder, which is a term known to designate, for example, ancillary devices used to hold implants during their implantation.

[0039] 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)).

[0040] 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 shell can be expanded with cement and then the tool 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 time of the surgical operation is of course significantly reduced, but also the stability of the implant, which is not released at any point until it is stabilized by the injection of cement filling all the free volumes around it, unlike some solutions of the previous art.

[0041] In general, this application relates to an instrument (A) for the implantation of expandable bone implants (1) in human orthopedic surgery, for the restoration of the volume and / or geometry of a bone, by expansion between a re- configuration folded and deployed configuration of the implant (1) in which the implant forms a closed envelope retaining a fluid. , said instrument (A) comprising a main part graspable by a practitioner, an implant-bearing portion (AA) comprising a grasping tube (AO) 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).This instrumentation or instrument (A) is characterized in that it comprises a fluid injection instrument (Ac), such as for injecting bone cement, into said implant (1), which includes at least one cavity suitable for receiving the fluid. This injection instrument (Ac) is positioned behind the implant-bearing portion (AA) along the longitudinal axis (L) and includes at least one cannula (AO, A1, A3) for delivering the fluid into the implant (1) while it is still held by said implant-bearing portion (AA). An instrument opening directly into a closed shell of an expandable implant is not currently known in the prior art, which has only proposed the idea without succeeding in its realistic realization.

[0042] 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 (AO) 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 (AO).

[0043] In certain embodiments, the instrument retention means (A) and the implant cooperation means (1) of which they are complementary comprise a proximal sleeve of the implant around which said retention means are fixed and include a movable stud in an L-shaped groove for retaining the implant by a translational and rotational movement, relative to the longitudinal axis, of said stud in said groove.

[0044] In some embodiments, said injection instrument (Ac) includes a piston (Pc) actuable on the instrument (A) to push the fluid stored in a chamber inside the instrument (A), through said cannula (A0, Al).

[0045] In some embodiments, said injection cannula (A0, Al) is formed by the grasping tube (A0) opening onto a proximal sleeve of the implant (1). In other embodiments, said injection cannula (A0, Al) is formed by an injection tube (Al) adapted to be inserted inside the grasping tube (A0) and opening inside an opening of a proximal sleeve of the implant (1) retained by the grasping tube (A0), directly into a cavity of the implant (1) or on the axis (3) of the implant (1) comprising a conduit (31) and at least one opening (32) for distributing said fluid into the implant.In yet other embodiments, said injection cannula (A0, A1) is formed by said expansion rod (A3) which is hollow and adapted to be inserted inside the grasping tube (A0) and opening inside an opening of a proximal sleeve of the implant (1) retained by the grasping tube (A0), directly into a cavity of the implant (1) or on the axis (3) of the implant (1) comprising a conduit (31) and at least one opening (32) for distributing said fluid into the implant.

[0046] In some embodiments, the implant-holding portion (AA) includes a mounting of the grasping tube (AO) directly within the main instrument (A). In other embodiments, the implant-holding portion (AA) includes a removable tip having a housing adapted to be mounted on a protrusion of the instrument (A), through which the fluid is conveyed to the removable tip carrying the grasping tube (AO).

[0047] In some embodiments, the removable tip forming the implant holder (AA) is retained on the instrument by means of a pin cooperating with an L-shaped groove for locking during translational and rotational movement about the longitudinal axis (L). In some of these embodiments, the direction of rotation for locking the implant holder (AA) onto the instrument (A) is opposite to the direction of rotation for locking the implant (1) onto the implant holder. In some of these embodiments, the implant holder (AA) includes a translational latch removably disposed in the groove to prevent translation of the pin until fluid is injected and / or the expansion mechanism is activated, causing the implant (1) to shorten in length.On the other hand, in some of these embodiments, the implant holder (AA) has a rotation latch removably disposed in said groove to prevent rotation of said block until separation of the implant holder (AA) and the instrument (A) is desired.

[0048] In some embodiments, locking mechanisms are provided to prevent the implant from folding. The very small diameters of the implants and their central axes make it difficult to use threads for screw-type expansion at the implant level, whereas it is advantageous to screw the instrument actuating the expansion, particularly when the expansion involves bringing the support arms closer together. Thus, as known in the prior art, it is possible to use, for example, a split ring housed in a circular reinforcement of the implant and cooperating with notches on the thrust or traction axis, which are oriented to allow passage of this axis in only one direction. In this way, the axis for expanding the platforms can be actuation achieved by successive passage of the notches, which allows the implant to be locked in the deployed configuration.

[0049] However, unlike some prior art implants where the traction axis for bringing them together must remain in place, the implants of this application are deployed without bringing the support arms together. This advantageously allows them to be locked with a screw lock, eliminating the need for notches that make the task difficult and offer reduced reliability. For example, a threaded sleeve configured to fit inside the hollow tube of the implantation instrument (A) holding the implant (and surrounding any fluid injection channel present inside) can be used. Such a sleeve has a thread designed to engage with a tapped hole in the proximal end of the implant and provides actuating means for tightening or loosening it.

[0050] In some embodiments, the implantation (A) and cement injection (Ac) instrument includes means for controlling the pressure and / or suction of the cement to fold the implant into the folded configuration if necessary.

[0051] In some embodiments, the implantation instrument (A) is separate but complementary to the injection instrument (Ac) whose cement injection channel passes through a channel inside the stem of the implantation instrument (A) holding the proximal end of the implant (1) by means of its distal end.

[0052] The illustrative and non-limiting figures in this application will now be described in detail to better explain the various embodiments and provide examples of structural elements usable in the context of the above. The following should therefore not be considered exhaustive, as the various elements or components illustrated are only examples, and the figures may combine elements or components that are not necessarily dependent on one another.

[0053] Figure 1A represents a side view of an implantation instrumentation for an expandable orthopedic implant according to certain embodiments comprising an implant carrier, a cement injection instrument and the implant carried at the end of the implant carrier, and Figure IB represents a perspective view of the instrumentation of Figure 1A with the cement injection instrument extended from the implant carrier.

[0054] Figure 1A shows a side view of a deployable implant implantation instrumentation in certain embodiments, with an implant (1) mounted on an implant holder (1) assembled with a cement injection instrument (Ac) for injecting cement into the implant. This instrumentation (A, Ac) includes a loading port (Oc) for loading cement into the instrument body and an air evacuation needle (PE) for expelling air during cement loading through the loading port. This needle, which has a frustoconical portion particularly visible in Figure 8B, is screwable to close the compartment into which the cement has been loaded once the air has been expelled.The cement injection instrument (Ac), as shown in Figure IB, preferably includes a handle for screwing on a piston having a threaded portion and a smooth portion equipped with seals, so that the piston, attached to the handle, can be advanced and the cement pushed through the instrument. The implant holder has a hollow body adapted to receive the piston and a threaded hole to engage with the thread. However, cement injection can be designed to use other means of propulsion than screwing, such as pressure, particularly hydraulic pressure.The main thing is to be able to push the cement through a cannula A0 into the implant to allow the increase in volume of a shell (10) of the implant (1) to expand and fill the shell, for example as shown in Figure 1 A, by controlling the injected volume using the injection instrument (via the screw handle in this example and preferably with graduations allowing to quantify the injected volume).

[0055] Figure 2A shows a partial cross-sectional or transparent view of an expandable implant implantation instrumentation; Figure 2B shows a perspective view with a partial cross-section of the instrumentation shown in Figure 2A; and Figure 2C shows a perspective view of the end of the implant carrier with an implant mounted on it. according to certain embodiments. Figure 2A shows the cement injection instrument pushed to the end of its stroke, once the casing is fully deployed, and Figure 2B shows the sealing gaskets at the loading port (OC) into which the cement can be introduced by expelling air via the vent post (PE). Once the advance of the injection instrument's piston pushes the cement to the distal end of the instrument, this cement is directed towards a cannula (AO) of the implant holder, which serves to hold the implant. This cannula (AO) of the implant holder freely accommodates, in translation, a hollow cannula (Al), through which the cement can pass to be injected into the implant. This cannula (Al) has a distal end that cooperates with a hollow base that closes the implant at its distal end (12). The distal end of the injection cannula (Al) has either a plug (A12, fig.2C and 8B) closing the cannula, or an open end for cement injection. The cap (A12) ensures that when the injection cannula (A1) is withdrawn, as partially shown in Figure 2C, at the end of the cement injection, when the holes (A2) of the cannula are sealed inside the cannula (AO) of the implant carrier, the latter is not invaded by cement and, on the contrary, the cement is confined within the implant and polymerizes without reaching the implant carrier. If the end is open without such a cap (A12), it is then necessary to provide for the cannula to be breakable and possibly equipped with a means of cutting or breaking the polymerized cement it contains when releasing the implant into the implantation site. Figure 8B shows a cross-sectional view of this end of the instrumentation with the cap (A12) sealing the distal end in certain embodiments.In other embodiments, the distal end of the cannula (Al) is open to allow the cement to be injected through this end and the holes (A2) can then be omitted, but it is still preferable to use such holes (A2) allowing the cement to exit laterally inside the implant, on the circumference of the cannula (Al) and over a portion of significant size relative to the size of the implant.

[0056] Figure 3A shows a perspective view of an expandable implant expansion instrumentation, according to certain embodiments, inserted inside a cement injection instrument, according to certain embodiments, and Figure 3B shows the expansion instrument alone. Figure 3A shows other embodiments of instrumentation in which the implant-carrying instrument and the injection instrument are supplemented by an implant expansion instrument (Ae), according to other embodiments, which is deployable by a mechanical expansion mechanism. This expansion instrument (Ae) includes an expansion wheel (ME) for controlling the implant expansion (by its position when the expansion instrument is screwed in or by adjusting the wheel's position on the instrument).This wheel allows adjustment of the advancement of a rod or cannula (A3) positioned in the center of the other cannulas (AO, Al) and extending into the implant to push or pull on the implant's mechanical components, thus enabling its deployment. Figure 3B shows this expansion instrument inserted through the injection instrument with its expansion cord (EM), and Figure 3C shows the same expansion instrument alone, thus better illustrating the role of the expansion cord. letter to adjust the depth to which it can penetrate through the rest of the instrumentation.

[0057] Figure 9A shows a cross-sectional view of part of an expandable implant implantation instrument of the type shown in Figure 3A, and Figure 9B shows a cross-sectional view of the implant held by such an instrument of Figure 9A, according to certain embodiments. Figure 8A shows a cross-sectional view of part of an expandable bone implant implantation instrument of the type shown in Figure 4A, and Figure 8B shows a cross-sectional view of the implant held by an instrument of Figure 8A, according to certain embodiments. Figures 9A and 9B show paired views of various proximal parts of this expansion instrument and the path of its components through the two other instruments, respectively the cement injection and implant holder. It can thus be seen that such an expansion instrument passes through the two instruments at their center to reach the implant (1) held at the distal end.Figure 9B shows a paired view of this instrument with an expansion knob that is not adjustable, but its screw position can nevertheless be identified by markings or by a known number of turns corresponding to a specific distance, generally a few millimeters or centimeters. Figure 8B also shows a detail of the cement injection holes (A2), visible in Figure 2C, with a cross-sectional view of the distal end of the instrument and the A2 holes inside an implant (1) in its folded configuration.

[0058] Figure 4A shows a perspective view of an expandable implant implantation instrumentation comprising an implant holder mounted on a grasping instrument (A) according to certain embodiments, and a cement injection instrument (Ac) passing through the assembly. Figure 4B shows a detail of the circular portion indicated in Figure 4A, and Figures 4C and 4D show this same detail after the removal of latches on the implant holder. In particular, Figure 4A shows a perspective view of a grasping instrument (A) comprising a grippable handle and on which an implant holder (AA) and cement injection instrument are removably mounted, with the implant (1) retained at the distal end. This figure specifically shows the presence of a loading latch (LC) for sealing the cement loading orifice (Oc) and also the air evacuation needle (PE).Figure 4B shows an enlargement of the area outlined in Figure 4A, including the evacuation needle and the removable implant holder (AA) mounted on the grasping instrument (A). The implant holder is equipped with a translation stop (BT) and a translation latch (LT), as shown in Figure 4C. The instrument's translation stop (BT) is locked by a removable latch (LT), preventing the implant holder (AA) from moving relative to the grasping instrument (A). Figure 4D shows a removable rotation latch (LR) that reversibly prevents the implant holder (A) from rotating on the grasping instrument. Therefore, moving the implant holder in both translation and rotation releases the implant, which is held by the holder via an L-shaped mechanism requiring rotation followed by translation. Figure 8A shows a view. in cross-section of this same end with this translation stop (BT) and the translation latch (LT) and figure 5B represents the cooperation of the implant holder (AA) with the implant via this L-shaped retention mechanism.

[0059] Figure 5A shows, on the left, a top view of bone anchoring implant implantation instrumentation and, on the right, the implant holder separated from the grasping instrument. Figure 5B shows a detail of the circular area on the right side of Figure 5A, illustrating the interaction between the implant holder and the implant in certain embodiments. In particular, Figure 5A shows a top view of a grasping instrument (A) with the cement injection instrument (Ac) on the left, while the right side shows only the implant holder portion (AA), which is designed to be mounted on the end of the grasping instrument and held in place by means of the latches (LT) and rotation latches (LR) in certain embodiments.Figure 5B shows an enlargement of the circle outlined on the right side of Figure 5A, showing the implant carrier (AA). It demonstrates that the cannula (AO) of the implant carrier (AA) has an internal channel with projections designed to cooperate with an L-shaped groove on the proximal end (AA) of the implant (1). Figures 4A to 4D and Figure 5B illustrate the role of the translation latch (LT) and the rotation latch (LR) in retaining the implant during implantation and releasing it once implantation is complete, particularly after cement injection, which is generally finished by withdrawing the injection cannula (A1).Indeed, the proximal end of the implant features an L-shaped groove that allows the implant to be gripped by a tool incorporating a gripping mechanism activated by a quarter-turn movement complementary to the L-shape. This facilitates assembly with the implant carrier and, most importantly, the release of the implant at the end of the procedure. The term "quarter-turn" can be used here to refer to a standard mechanism, but it is clear that such a mechanism does not necessarily require a 90° rotation and can involve more or less, although a significant rotation before releasing the implant is preferable.

[0060] Figures 6A, 6B, and 6C show perspective views of vertebrae into which different embodiments of expandable bone implants are inserted using instrumentation in various embodiments. In Figure 6A, the implant consists only of a deployable shell and does not require a mechanical expansion instrument (Ae), and the instrumentation therefore consists only of the implant carrier cannula (A0) (AA) and the cement injection cannula (Al), whereas in Figures 6B and 6C, the implants have mechanical expansion mechanisms and require a cannula (A3) to actuate an expansion instrument (Ae).

[0061] Figures 7A, 7B, and 7C show profile views of vertebrae with vertebral compression fractures (VCF), respectively at the anterior, midline, and posterior levels. The invention allows for the treatment of this type of vertebral fracture by positioning the deployable implant correctly in the plane of the implantation site, with an anteroposterior and / or mediolateral positioning, and by adjusting the insertion depth and / or insertion angle of the implant, according to the type of surgical approach used (e.g., lateral, anterior, dorsal, transforaminal, transpedicular, etc.).

[0062] 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 2D. 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 providing additional security to prevent 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 2D, 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 the same as 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 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 generated 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 2D without further explanation being necessary.

[0063] The instrumentation of this application can be used for the implantation of various types of implants. For example, Figure 10A shows a perspective view of an expandable implant usable with instrumentation according to certain embodiments, such as those of Figures 9A and 9B, which include an expansion instrument. (Ae), notably with an expansion rod (A3). In Figure 10A, the implant is in its folded configuration, and Figure 10B shows a potential lifespan for the implant in Figure 10A in its deployed configuration. In Figure 10A, it should be noted that the expansion ring has an L-shaped groove allowing the implant to be gripped by a tool comprising a gripping mechanism actuated by a quarter-turn movement complementary to the L-shape, facilitating assembly with the implant carrier and, above all, the release of the implant at the end of the procedure. The term quarter-turn can be used here to refer to a conventional mechanism, but it is clear that such a mechanism does not necessarily require a 90° rotation and that it can be more or less, although a significant rotation before releasing the implant is preferable.In Figure 10A, but more visibly in Figure 10C which represents a detail of the implant, it will be noted that the proximal end (11) has a channel (31) allowing the injection of cement into the implant and in Figures 10A, 10B and 10C it will also be noted that the central axis (3) has holes (32) provided so that the cement injected via the proximal end can reach the inside of the axis (3) which is then equipped with a central channel (31) opening itself onto the holes (32), so as to facilitate the distribution of the cement inside the implant and in particular the space freed up by the deployment of the implant by the spreading of the platforms.

[0064] Other examples of expandable implants usable with instrumentation of the type illustrated in Figures 9A and 9B of this application are shown in Figures 11A and 11B for certain embodiments where the implant comprises a sealed casing welded to the implant's expansion arms, and also in Figure 11C for other embodiments where the implant is integrated into a separate casing, for example, as in the embodiments of Figures 10A, 10B, and 10C. Figure 11A shows a perspective view of an expandable implant in its folded configuration, according to certain embodiments, and Figure 11B shows a perspective view of the same implant in its deployed configuration. In Figure 11B,We can observe that the sheet (10) is welded to the arms (131-141) between the plates and the latter are therefore free to move apart from each other and the sheet will conform to the shape of the implant during its deployment. In these examples, the 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 (1) 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, at least two faces of the implant, for example superior and inferior, 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) having a central axis (3), or a housing suitable for receiving such an axis extending through a sliding sleeve at the proximal end (11) to a traction ring or sleeve at the distal end (12) where said axis is configured to transmit a traction, when actuation by said instrument (A), on the distal end (12) to enable it to be brought closer to the proximal end (11), causing the pivoting of the support arms (131, 141) causing the platforms (13, 14) to move away from each other and, consequently, the expansion of the implant between the folded and deployed configurations.

[0065] In the examples in Figures 11A and 11B, the implant (1) is configured such 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.

[0066] In the example in Figure 11C, the implant (1) is configured such that it comprises a casing enclosing said implant from the proximal end (11) to the distal end (12) and 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 sleeve 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.

[0067] It is therefore understood from this application that the proposed instrumentation allows for the implantation of expandable implants into bone tissue and the injection of fluid directly into the implants, in a single operation without releasing the implant and / or the instrument between expansion and injection. This avoids any risk of misalignment during removal (except for the variants in Figures 8A and 8B where it is necessary to remove the expansion instrument before adding the injection instrument). Indeed, when dealing with an implant, for example, of the type shown in Figures 2A, 2B, 2C, and even 2D, the instrumentation allows for the automatic deployment of the implant (expansion) by injecting fluid, unlike the prior art where a flexible balloon is generally used first, then removed, before injecting polymerizing cement.This type of implant usable with the instrumentation of this application can be defined as 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) to hold the implant (1) and a distal end (12) intended to be inserted first into the bone. This type of implant (1) is generally configured such 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 proximal 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 (12) 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).

[0068] Similarly, when dealing with an implant, for example, of the type shown in Figures 10A, 10B, 11B, or 11C, it is necessary first to expand the implant using an expansion rod (A3) and then inject the cement. However, the instrumentation in this application, and in particular that shown in Figures 9A and 9B, allows the cement to be injected without having to remove any component, thus ensuring unparalleled stability and reliability of the surgical procedure. In all these examples, with the mechanical expansion of the implant, the fluid injection stabilizes the implant and even locks it in the deployed configuration when the The fluid is a polymerizable cement, such as those known in the prior art. It is therefore understood that the present application also relates to a system comprising the instrumentation described herein, in combination with at least one implant as described herein. However, it is not essential to limit the scope of the invention to a single system, since the instrumentation disclosed in this application is suitable for a large number of implants, the main characteristics of which, necessary for implementing the present invention, are readily accessible to those skilled in the art, such as the actuation of mechanical means for expanding the implant. In the case of a simple injection of fluid into a balloon, those skilled in the art will understand that the instrument is specific in that it is adapted to retain the implant itself for a single operation, rather than retaining or releasing the implant simultaneously with the inflation of a balloon. Regarding implants, generally speaking, the number of fold pairs ranges from 3 to 16, typically 4 to 12, and preferably around 8. However, 3 folds can 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. Therefore, it is possible to use up to 20 folds.

[0069] 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, or 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 can be isolated from the other features of that embodiment unless the contrary is explicitly stated.

[0070] Detailed list of references in the figures: I implant 10 sheets 10b second sheet II proximal end 11b second ring 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 (or bushing) 131 support arms for the first platform 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 of the third platform An implantation instrument AA implant carrier Ae expansion instrument AC fluid injection instrument AO (or Ao) grasping tube (or cannula) The injection tube (or cannula) A2 injection holes A3 expansion rod Al 2 distal plug

Claims

Demands 1. Instrument (A) for the implantation of expandable bone implants (1) for human orthopedic surgery, for the restoration of the volume and / or geometry of a bone, by expansion between a folded and a deployed configuration of the implant (1), said instrument (A) comprising a main part graspable by a practitioner, an implant-bearing portion (AA) comprising a grasping tube (AO) extending along the longitudinal axis (L) and having, at its distal end, additional retention means for implant cooperation, to hold the implant by its proximal end (11), said instrument (A) being characterized in that it comprises a fluid injection instrument (Ac), such as bone cement, into said implant (1) comprising at least one cavity suitable for receiving 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 (AO,A1, A3) to convey the fluid into the implant (1) while it is still held by said implant-bearing portion (AA).

2. Instrument (A) according to claim 1, characterized in that it also comprises an implant expansion instrument (Ae) capable of cooperating with mechanical implant expansion means (1), by means of an expansion rod (A3) passing through said implant-carrying portion (AA) and said gripping tube (AO) to actuate said mechanical expansion means.

3. Instrument (A) according to claim 2, characterized in that said expansion rod (A3) passes through said injection instrument (Ac) to the distal end of the gripping tube (AO).

4. Instrument (A) according to any one of the preceding claims, characterized in that the instrument (A) retention means and the implant (1) cooperation means of which they are complementary comprise a proximal sleeve of the implant around which said retention means are fixed and include a movable stud in an L-shaped groove for retaining the implant by a translational and rotational movement, relative to the longitudinal axis, of said stud in said groove.

5. Instrument (A) according to any one of the preceding claims, characterized in that said injection instrument (Ac) comprises a piston (Pc) actuable on the instrument (A) to push the fluid stored in a chamber inside the instrument (A), through said cannula (AO, Al).

6. Instrument (A) according to any one of the preceding claims, characterized in that said injection cannula (AO, Al) is formed by the gripping tube (AO) opening onto a proximal sleeve of the implant (1).

7. Instrument (A) according to any one of claims 1 to 5, characterized in that said injection cannula (AO, Al) is formed by an injection tube (Al) adapted to be inserted inside the grasping tube (AO) and opening into an opening in a proximal sleeve of the implant (1) retained by the grasping tube (AO), directly into a cavity of the implant (1) or on axis (3) of the implant (1) comprising a conduit (31) and at least one opening (32) for distributing said fluid in the implant.

8. Instrument (A) according to any one of claims 2 to 5, characterized in that said injection cannula (AO, Al) is formed by said expansion rod (A3) which is hollow and adapted to be inserted inside the grasping tube (AO) and opening inside an opening of a proximal sleeve of the implant (1) retained by the grasping tube (AO), directly into a cavity of the implant (1) or on axis (3) of the implant (1) comprising a conduit (31) and at least one opening (32) for distributing said fluid into the implant.

9. Instrument (A) according to any one of the preceding claims, characterized in that the implant-carrying portion (AA) comprises an assembly integral with the grasping tube (AO) directly in the main instrument (A).

10. Instrument (A) according to any one of claims 1 to 8, characterized in that the implant-carrying portion (AA) comprises a removable tip having a housing suitable for mounting on a protrusion of the instrument (A) through which the fluid is conveyed to the removable tip carrying the grasping tube (AO).

11. Instrument (A) according to claim 10, characterized in that said removable tip forming the implant holder (AA) is retained on the instrument by means of a stud cooperating with an L-shaped groove for locking in a translational and rotational movement relative to the longitudinal axis (L).

12. Instrument (A) according to claim 11, characterized in that the direction of rotation for locking said implant holder (AA) on the instrument (A) is opposite to the direction of rotation for locking the implant (1) on the implant holder.

13. Instrument (A) according to any one of claims 10 and 11, characterized in that the implant holder (AA) has a translation latch removably disposed in said groove to prevent the translation of said stud, until an injection of fluid and / or an actuation of the expansion causing the shortening of said implant (1) in length.

14. Instrument (A) according to any one of claims 10 and 11, characterized in that the implant holder (AA) has a rotation latch removably disposed in said groove to prevent rotation of said pin until separation of the implant holder (AA) and the instrument (A) is desired.

15. Human orthopedic surgery system comprising at least one expandable bone implant (1) for restoring the volume and / or geometry of a bone, by expansion between a folded configuration and a deployed configuration of the implant (1) and at least one instrument (A) for implanting said implant, characterized in that said instrument of said system is an instrument according to one of the preceding claims.

Images