Apparatuses for bone restoration

[0001] The present invention relates to the field of surgery and medical implants, and more particularly relates to devices and methods for reconstructing human or animal bone anatomy using medical bone implants.

BACKGROUND OF THE INVENTION [0002] Various causes may underlie compression bone damage, in particular osteoporosis, which causes (for example) natural compression damage to the vertebrae under the influence of body weight, but also injury, these two causes sometimes being combined. Such compression bone damage can affect the vertebrae, but can also threaten other bones, such as the radius and femur, for example.

[0003] A number of vertebroplasty techniques are known for performing vertebral correction, i.e. restoring the vertebral body to its original shape or a shape similar to the latter. For example, one technique involves introducing an inflatable balloon into the vertebra, and then introducing a pressurized fluid into the balloon to force the vertebral cortical sheath, and especially the lower and upper vertebral plate, to correct the shape of the vertebra under pressure. This technique is known as kyphoplasty. When the cortical bone layer is repaired, the balloon is emptied and withdrawn from the vertebra to allow cement to enter the enveloping cortex layer, which is intended to provide sufficient mechanical strength for correction over a significant period of time.

[0004] The noticeable disadvantage of kyphoplasty is the numerous manipulations associated with it, in particular the filling, as well as the need to withdraw the balloon from the patient's body. Furthermore, balloon expansion is poorly controlled because the volume of the balloon is omnidirectional, which often causes significant pressure to be applied to the cortex covering in the wrong directions. Such significant pressures involve the risk of bursting the cortical enveloping layer, and especially the lateral portion of the cortical enveloping layer and the connection of the lower and upper vertebral plate.

[0005] There are other vertebral implants that are intended to fill the cavity in the vertebra. Such implants, however, generally use the principle of radial expansion obtained by creating a number of points that are perpendicular to the implant axis under the effect of the latter's shrinking action. Such implants act too high pressure on individual points, which can damage the material on which these points are supported. What's more, as with kyphoplasty, very high pressure can cause the tissues or walls of the organ to burst, such as the cortical covering layer, for example. Furthermore, the radial expansion of some implants does not allow favoring expansion in a particular direction. Directional expansion is set in both WO 01/01895 and WO 03/003951, such devices must be blocked.

PZ / 2280 / RW EP 1 778 136 B1 to the final position and do not provide any flexibility, while setting exact height requirements before use is a challenge for the user.

SUMMARY OF THE INVENTION [0006] In embodiments of the present invention, the abovementioned drawbacks are reduced, and additional advantages are presented over prior art bone reconstruction devices. More specifically, certain embodiments allow reconstruction of human or animal bone anatomy, and also allow one or more of the following steps to be performed:

- introducing into the bone, for reconstruction, an expandable implant in accordance with a single defined expansion plane, which is preferably appropriate for the given implant;

- positioning the expandable implant in the bone in such a way that the expansion plane corresponds to the bone reconstruction plane;

- opening the expandable implant in the plane of bone reconstruction; and - injecting the filling material into and / or around the implant.

[0007] This makes it possible to produce a reinforced structure, and hence a solid structure (i.e. an implant made through hardened filling material, due to the implant's expansion).

What's more, the filling material can be injected at a relatively low pressure, because the implant stays in place, which allows the dimensions of the corrected bone structure to be maintained as the implant expands.

[0008] One of the features of one embodiment of the present invention is that the expandable implant can be expanded / expanded in the bone reconstruction plane to a certain value: between the minimum thickness (e.g. implant thickness before any extension) and the maximum thickness (e.g. implant thickness after maximum extension). This feature allows you to control the expansion value, for example, for a certain set circle correction.

[0009] Another advantageous feature of one embodiment of the present invention includes opening the expandable implant by opening the first and / or second opposing plates to form (respectively) first and second supporting surfaces for bone. This feature makes it possible to reduce the pressure at which the implant acts on the tissues in contact with the implant by increasing the contact or support surface on the tissues.

[0010] The length of the implant can also be dimensioned to be substantially equal to at least one of the first and second bone support surfaces. This feature allows you to optimize the ratio of support length (on tissues) to the length of the implant. The closer this ratio is to unity, the greater part of this implant will be in places requiring short length. Moreover, this feature also allows the introduction of filling material at low injection pressure. Low injection pressure is advantageous to avoid injection of filling material into unsuitable tissues (e.g., walls of blood vessels).

[0011] The first and second plates may form partially cylindrical support surfaces, some (or more) of which may be parallel to the longitudinal axis of the expandable implant. The cylindrical (curved) support surface can distribute forces that the implant acts on the tissues.

[0012] In another embodiment of the present invention, when opening said first and second plates, one or more brackets under the plates are used. This feature allows the ratio of the length of the support plates to the length of the implant to be increased to a value close to unity (1) as much as possible (see above). Furthermore, this feature allows a more even distribution of thrust forces under the plate to reduce the bracket.

[0013] The filling cement, which can be injected into and / or around the implant to support the compressive load of the implant in bone reconstruction, contains ionic cement, in particular phosphocalcinate, acrylic cement or a compound of the latter. Therefore, the combination of implant and cement does not differ from the structure of steel reinforced concrete for constructing buildings.

[0014] According to the present invention, the expandable bone reconstruction implant comprises a single enlargement plane specific to that implant. This single expansion plane corresponds to the bone reconstruction plane. The implant includes first and second plates opposed to each other, respectively forming first and second supporting surfaces for the bone. The first and second plates are positioned so that they diverge from each other according to a single expansion plane (e.g. during implant expansion). This implant includes a first and a second support for one or more of the first and second support surfaces, and also used under (respectively) both plates. This implant contains means for controlling the expansion of the implant. Such elements may comprise a web of material, applied between each bracket and the corresponding plate, having a certain thickness, which plastically deforms when the first and second ends of the implant are compressed towards each other.

[0015] The means for controlling the expansion can control the expansion value between the minimum thickness of the implant before any expansion of the latter and the maximum thickness of the implant after its maximum expansion.

[0016] The implant may further comprise (preferably) means for positioning this expandable implant in the bone to cause the implant expansion plane to essentially correspond to the plane of bone reconstruction. Such elements may include coupling elements (e.g. threaded coupling), allowing the implant to be angled about the longitudinal axis, and may include one or more flat surfaces at the end of the implant (for example) for attachment to the implant carrier.

[0017] Still other features, advantages, embodiments and objectives of the present invention will become even more clearly understood with reference to the accompanying drawings, the brief description of which is given below, and also in connection with the detailed description that follows.

PZ / 2280 / RW EP 1 778 136 B1

Brief description of the figures [0018]

Fig. 1A illustrates a perspective view of an embodiment of an expandable implant according to one embodiment of this invention in a rest position;

Fig. 1B illustrates the example of Fig. 1A in an open / extended position;

Fig. 2A illustrates a side view of another embodiment of an expandable implant according to another embodiment of the invention in a resting position;

Fig. 2B illustrates the example of Fig. 2A in an open / extended position;

Fig. 3 illustrates a side view of the example of Fig. 1A;

Fig. 4 illustrates a cross-sectional view according to the line II of Fig. 3;

Fig. 5 illustrates a cross-sectional view according to the line II-II of Fig. 3;

Fig. 6 is a view according to F of the example of Fig. 1A;

Fig. 7 illustrates a top view of the example of Fig. 1A;

Fig. 8 illustrates a perspective view of a second embodiment of the expandable implant according to another embodiment of the invention in a rest position;

Fig. 9 illustrates the example of Fig. 8 in an open position;

Fig. 10 illustrates a side view of the example of Fig. 8;

Fig. 11 illustrates a cross-sectional view according to the line III-III of Fig. 10;

Fig. 12 illustrates a cross-sectional view according to the line IV-IV of Fig. 10;

Fig. 13 illustrates a cross-sectional view according to the VV line of Fig. 10;

Fig. 14 illustrates a cross-sectional view according to the line VI-VI of Fig. 10;

Fig. 15 illustrates an end view according to G of the example of Fig. 8;

Fig. 16 illustrates a top view of the example of Fig. 8;

Figs. 17-29 schematically illustrate various stages of an example of a bone reconstruction method according to this invention;

Figures 30-32 schematically illustrate the steps of another example of a bone reconstruction method according to this invention;

Fig. 33 illustrates a perspective view of an implant carrier device for inserting an implant into a patient's bone;

Fig. 34 illustrates a top view of the implant carrier device of Fig. 33;

Fig. 35 illustrates an expansion meter for the implant carrier of Figs. 33 and 34;

Fig. 36 illustrates a diagram with expansion values ​​for implants according to the disclosed documents using the implant carrier shown in Figs. 33 and 34;

Fig. 37 illustrates the use of a pair of implants.

Detailed Description of Embodiments [0019] The expandable implant 1 shown in Figs. 1A to 7 (as well as other embodiments) may include one or more of the following:

PZ / 2280 / RW EP 1 778 136 B1

- a single specific extension plane 2 that may be appropriate for the implant,

- elements 3 for positioning the expandable implant in the bone, allowing the expansion plane to correspond to the bone reconstruction plane,

- elements 4 for opening the expandable implant in a single extension plane 2,

- means 5 for controlling a given expansion value, between the minimum thickness A of the implant before any expansion of the latter, and the maximum thickness B of the implant after its maximum expansion; and

- first 6 and second 7, opposing plates, which can form respectively first and second 9 supporting surfaces in the bone, intended to slide apart along a single expansion plane 2 during implant expansion 1.

[0020] As shown in Figures 1A and 1B, implant 1 may have a cylindrical shape with a transverse circular outer section, and may also be manufactured from a biologically compatible material (e.g., titanium) as a tubular body, using turning, laser and / or electro-erosive production techniques (casting can also be used). The implant 1 may also include a first end 20 and a second end 21, each respectively taking the shape of a transverse section of the tubular body. These ends are preferably intended to be directed towards each other to allow the implant to open / expand, as shown in Figs. 1B and 2B.

[0021] Accordingly, the two ends 20, 21 are connected to each other via a first 22 (which may be referred to as the "upper" arm) and a second 23 rectilinear arm (which may be referred to as the "lower" arm), and which are parallel when the implant is not open.

These arms can be formed longitudinally in the tubular body, i.e. they can be folded under the first 6 and second 7 plates opposite to each other when the ends 20 and 21 are brought towards each other, which also results in the distance of the first 6 and second 7 plates opposite to each other , from the longitudinal axis of the tubular body.

[0022] Figs. 2A-2C illustrate an embodiment of an implant that is similar to the embodiment disclosed in Figs. 1A and 1B, but with an additional set of brackets (eg, connection with four rods). More specifically, the implant in Figs. 2A-2B includes supports 12A, 128, 13A,

13B, 14A, 14B, 15A and 15B, two pairs for each of the upper and lower plates. These additional brackets may provide additional rigidity to the implant and / or may ensure that the plates 6 and 7 will open in a substantially parallel and / or even manner.

[0023] As shown in Figs. 4-5, to open the arms 22 and 23 in a single expansion plane 2 (with passage through the longitudinal axis 10 of the tubular body), the arms 22 and 23 are preferably diametrically opposed. In this regard, shoulders

22, 23 can be formed of a transverse recess 40 of the tubular body, can traverse the entire tubular body and extend the length of the tubular body between the two ends 20 and the implant 1. As shown in Fig. 5, the arms, 22, 23, connecting the two ends 20 and

21, respectively, take a cross-section limited by a circular arc 26 of the outer po6

PZ / 2280 / RW EP 1 778 136 B1 to the surface of the tubular body. The chord 27 defines a circular arc 26 and may be included in the wall 25 to form a recess 40. This recess 40 may be symmetrical about the longitudinal axis 10.

[0024] Each arm 22, 23 can be divided into three consecutive rigid parts that can be articulated with each other in connection with the ends 20 and 21 as follows (for example). With respect to the upper arm 22: the first rigid part 28 is connected at one end to the end 20 via articulation 29. The other end of the rigid portion 28 is connected to the first end of the second adjacent central rigid portion 30 via articulation 31. The second rigid portion 30 can be connected at the other end to the third rigid portion 32 via articulation 33. Second end of the third the rigid part 32 can be connected to the end 21 via articulation 34. Preferably, the articulation joints 29, 31, 33 and 34 can have one degree of freedom of rotation, acting about axes that are perpendicular to the expansion plane 2, respectively. Preferably, the articulation joints 29, 31, 33 and 34 are formed by thinning the wall forming the arm in the respective articulation zone as shown in Figs. 1A-3 (see also e.g. reference numbers 5 and 81).

[0025] Each arm 22, 23 may open in such a way that the central rigid portion 30 deviates from the longitudinal axis 10 of the implant, pushed by two adjacent rigid portions 28 and

32 when the implant ends 20 and 21 are brought toward each other. As shown in more detail in Fig. 3, to initiate arm movement in the correct direction when ends 20 and 21 are brought together, it is preferable to establish a suitable rotatable engagement of different arm parts.

[0026] Accordingly, the ends of the rigid parts 28, 32 of the upper arm 22 can be articulated with the ends 20 and 21, respectively, via a web of material on the rigid parts. The other ends of the rigid portions 28, 32 may also be hingedly connected to the central rigid portion 30 via a web of material formed on the rigid portions 28, 32. The displacement of the articulated joints establishes a rotational engagement on the rigid parts 28 and 32 when the force acts by bringing the ends 20 and 21 towards each other along the longitudinal axis 10 of the implant. This displacement causes the rigid portion 32 to rotate towards the outside of the implant as a result of moving the central rigid portion part further away from the longitudinal axis 10.

The lower arm 23 may be constructed in a similar manner to the upper arm, and it is preferably symmetrical with respect to the upper arm 22 with respect to the plane that is perpendicular to the expansion plane 2, passing through the longitudinal axis 10.

[0028] Thus, according to some embodiments of the present invention, the articulation joints between the upper 22 and lower 23 arms and the corresponding rigid parts are preferably formed by weakened zones formed by grooves 81. These grooves define a thin web of material (i.e., constriction of the material at 31, 33) forming a tubular body, the thickness of which can be determined by the depth of the grooves 81 (as shown in the figures) to allow plastic deformation of the material without causing cracking. More specifically, according to one embodiment, the rigid parts and upper arm 22, as well as the symmetrical parts thereof on the lower arm 23, may

It is necessary to assume a certain position, defined as the extreme position in which the intended rigid parts are perpendicular to the longitudinal axis 10 of the implant 1, after bringing the ends 20 and 21 towards each other (the latter being swung up to maximum expansion possibilities), resulting in plastic deformation of the relevant material. The width of the grooves 81 is preferably predetermined so as to allow a clearance of the lower and upper arms as well as to give a suitable radius of curvature to the webs to provide plastic deformation without breaking the material.

[0029] The first 6 and second 7 opposite plates may be formed in the upper 22 and lower 23 arms. With respect to the upper arm 22, for example, the plate 6 can be formed by the central rigid part 30 and by extensions of the material (rigid parts and 32) extending from both sides thereof. To form the rigid plate 6, the end portions and 32 are separated from the upper arm 22, using a pair of transverse slots and 36, which extend longitudinally along the length of each respective end portion (see Fig. 3-4). The articulated joints 31 and 33 as well as the rigid parts 28 and 32 respectively form the first 12 and the second 13 (Fig. 1B) support for the first plate 6. The same applies to the second plate 7 by symmetry.

[0030] Therefore, according to the illustrated embodiment, the first 6 and second 7 plates may comprise respectively a first 16, 18 and a second 17, 19 supporting ear, wherein their attachment zones are located at the level of the first 12, 14 and the second 13 respectively , bracket. As shown in Fig. 1A-B, the first 16, 18 and the second 17, 19 supporting ear may have a length corresponding substantially to the maximum displacement value of one of the first 6 or the second 7 plate in a single extension plane 2.

[0031] The first 6 and second 7 plates respectively form the first 8 and second 9 supporting surfaces, each having a length that can be substantially equal to the length of the implant, and which can be displaced perpendicular to the longitudinal axis 10 during expansion. In accordance with one embodiment of the present invention, since the implant is formed in a tubular body, the first 6 and second 7 plates form respectively curved support surfaces that are preferably parallel to the longitudinal axis 10.

[0032] The elements 3 for positioning the expandable implant in the bone to allow the extension plane 2 to correspond to the bone reconstruction plane may include coupling elements that allow the implant to be angled about the longitudinal axis 10. For example, such elements may include flat surfaces 37, 38, which are formed on a cylindrical surface with a circular cross-section of the end 20, which may allow rotary coupling of the implant 1. Elements 4 for opening the expandable implant in a single extension plane 2 may include rigid portions 28 and 32 of upper arm 22 and corresponding symmetrical rigid portions on lower arm 23, allowing the first 6 and second 7 plates to be opened.

[0033] The implant carrier 71 (see Fig. 23) may be used to allow the implant ends 20 and 21 to be brought closer together when placed within the bone. The implant carrier 71, through the implant support end 20, for example, allows end 21 to be pulled toward end 20, or vice versa (e.g. end 21 is supported and end 20 is pushed toward

P1 / 2280 / RW 21). To this end, the distal end 21, for example, has an open distal mouth 39 threaded along the longitudinal axis 10 to allow engagement of the carrier 71 for the implant which includes a corresponding threaded portion. The proximal end 20 may include a drilled hole 80 along the longitudinal axis 10 to allow the implant core 71 for the implant to pass through to the distal end 21.

[0034] The control elements may be provided by an implant carrier which may include millimeter control elements for bringing the ends 20 and 21 closer together, preferably by means of screw thread engagement, allowing the expansion to stop at any time as a function of needs. On the other hand, the control elements 5 are provided by articulated joints of the arms 22 and 23, and more particularly, by the thickness of the material webs (e.g. 31, 33) defining each arm which, by deforming in the plastic area, makes it possible to maintain essentially by extending the defined open position of the arms, in addition to elastic contractility, which in practice is negligible.

[0035] The expansion of the plates 6 and 7 of the implant, as well as their stabilization after opening, can be achieved by adapting the plates 6 and 7 to the bone geometry through these plates. Although in some embodiments of this invention, plates 6 and 7 are opened in a parallel arrangement, in other embodiments of this invention it is allowed that the plates 6 and 7 of the implant are opened in a non-parallel displacement, if necessary (e.g. as part of bone anatomy function). For example, the expansion of the plates 6 and 7 may be non-parallel if the length of the individual support arms is different. For example, if the brackets 12 and 14 are longer than the brackets 13 and 15 (see Figs. 1A-2B), opening the implant will force the plates 6 and 7 to gradually diverge. In Figs. 1A-2B, this would result in the plates 6 and 7 at end 21 being further apart than at end 20. As will be understood by one of ordinary skill in the art, depending on the configuration, only one corresponding bracket should be lengthened / shortened to achieve a certain angle.

[0036] Similarly to what is shown in Figs. 2A-2C, when the four-rod connection comprising brackets 12A, 12B, 13A, 13B, 14A, 14B, 15A, 15B, as illustrated, have equal lengths (i.e. 12A = lengths 13A, length 12B = lengths 13B etc.), a parallelogram is obtained after the implant is extended (parallelism is ensured between sections

AD and BC; please see Fig. 2C). By modifying the lengths L1 and L2, the four-rod connection will not produce a parallelogram after expansion, and instead a certain angle between the plates 6 and 7 will appear. This created angle may also depend on how close the ends 20 and 21 are approaching to each other. As the implant is deployed, this angle gradually increases.

[0037] Figs. 8-16 relate to a second embodiment of the expandable implant 101, the elements of which are functionally similar to the corresponding elements of the embodiment of the implant illustrated in Figs. 1-7. Furthermore, the respective features in Figs. 8-16 regarding the embodiment illustrated in Figs. 1-7 have the same reference numbers, respectively, with the addition of the number 100, and will therefore no longer be described.

[0038] The implant 101 shown here differs from the implant 1 in the absence of the wing portion on the plates 106 and 107, as shown in more detail in Fig. 9. The implant 101 includes a distorted parallelogram-shaped arrangement 141 on one of the rigid parts 128 or 132 of each of the arms 122 (upper) and 123 (lower). In the example illustrated here, the parallelogram arrangement is depicted on the rigid portion 128 of the upper arm 122 connected to the end 120, as well as the corresponding arrangement on the lower arm 123. These parallelogram systems can be used to provide displacement of the plates of each of the arms 122 and 123 in parallel longitudinal axis 110 of the implant. As shown in the drawings, the rigid part 128 of the arm 122 (similarly on the corresponding arm 123) is separated, like the articulated joints 131 and 129 (respectively) over the central part 130 and over the end 120 of the implant, to form a parallelogram that may deform while moving the corresponding tile.

[0039] The articulation joints of the deformable parallelogram 141 can be made in the same manner as the other articulation joints 131, 133, 134 of the arm 122, as shown in Figs. 8-16. The geometry disclosed herein as explained above and shown in Fig. 1114 establishes the coupling of forces on various parts 129, 130, 132 of the arm. This allows the desired displacement when the ends 120 and 121 of the implant 101 come closer.

[0040] In order to obtain a deformable parallelogram 141, the rigid arm part 128 is preferably divided into three longitudinal levers: two side levers 142 and a central lever 143 which form the two sides of the deformable parallelogram 141. The other two sides of the parallelogram may be formed by lengthening 144 the central part of the arm 122, located in the extension axis of the central lever 143, as well as by double extending the 145 end 120, running parallel to the longitudinal axis 110 of the implant and located in the extension axis of the two lateral levers 142 (please see Fig. 8).

[0041] It is noteworthy that the arms 122 and 123 may be symmetrical with respect to a plane that is substantially perpendicular to the expansion plane 102 passing through the longitudinal axis 110 of the implant 101 to obtain, when the implant is expanded, displacement of the two plates 106 and 107 in a parallel manner about the longitudinal axis 110.

Examples of bone reconstruction [0042] A first example of a method of bone reconstruction using an expandable implant will now be described with reference to Figs. 17-29. It relates in more detail to the method of bone reconstruction in the case of the vertebra via the path through the posterolateral fissure, with reduced fracture. Accordingly, this method may comprise one or more (and preferably all) of the following steps. A person skilled in the art will be aware that the implant according to embodiments of the present invention pushes / divides tissues within the bone in such a way that the implant support surfaces preferably come into contact with bone tissue for reconstruction.

[0043] The expandable implant, expandable (preferably) in a single specific extension plane 2 (specific for a given implant), is inserted into the vertebra 60, the shape of which has

PZ / 2280 / RW EP 1 778 136 B1 become reconstructed. To perform this operation, the rod / pin 61 (e.g., such as Kirschner wire) is placed transdermally via the path through the posterolateral slit in such a way that the threaded end 62 can be attached (e.g. bolted) to the cortex 63 of the bone opposite the layer cortical bone 64 through which the wire is passed (Fig. 17). This wire 61 is received in the first tube tube 65 until the end of this first tube 65 makes contact (e.g., can be supported) with the outer surface of the cortex 64 of the bone (Fig. 18).

[0044] The first tube 65 is received by the second tube 66 until the end of the second tube 66 contacts (e.g., is supported by) the outer surface of the cortex 64 bone (Fig. 19). The second tube tube is further received by a third tube tube 67 that comes into contact (e.g., is supported) on the outer surface of the cortex 64 of the bone (Fig. 20). Teeth 68 at the end of the third tube tube 67 cause this tube to anchor to the cortex 64 of the bone.

[0045] The first 65 and second 66 tube tubes, as shown in Fig. 21, are then removed, leaving only the wire 61 surrounded by the tube 67, which are separated from each other by the tubular spacer 80. Proximal cortical layer 64 of bone and the spongy bone 70 is then pierced with a drill 69 (e.g.) through a wire 61, as shown in Fig. 22. In one example, the spongy bone is pierced to the distal end (approximately), and then drill 69 can be retracted (wire 61 can also be retracted).

[0046] The proximal end of the implant 1 is detachably attached to the distal end of the hollow core (preferably) of the implant carrier 71, which is then inserted into the core of the tube 67, as shown in Fig. 23. This implant can be removably attached to implant carrier via a threaded coupling (e.g.). Inside the implant core 71 for the implant, a rod 72 may be inserted (see also Fig.

33, reference numeral 3316), having a distal end that has engaging elements, for engaging the distal end of the implant (and which may also include an enlarged proximal end larger than the diameter of the rod). As with the implant being attached to the implant carrier, the coupling elements of the rod to the implant can function through threaded engagement.

[0047] The implant carrier 71, as shown in Fig. 33, includes operating elements 3310 for controlled movement of the rod relative to the implant carrier (for example).

The operating elements may comprise a gripping block 3312 having a central drilled hole through which the implant carrier 71 is positioned and held at least rotationally, but preferably rotationally and linearly. In this regard, the proximal end of the gripping member and the proximal end of the implant carrier are preferably surface-aligned. The handle 3314 may be attached to the proximal end of any or one of the handle member and implant carrier, but preferably it can freely rotate relative to it in one or both of clockwise and counterclockwise directions. In yet another embodiment of the invention, the handle may not be attached to one or both of the handle block and the implant carrier. The holder may include a central hole that preferably includes an internal helical thread with a predetermined thread pitch.

[0048] The rod 3316, which is received inside the implant carrier, preferably includes an external thread corresponding to the pitch of the thread of the handle 3314. The blocking device slides relative to the handle block and may contain wire 3321 that cooperates with bar 3316 to lock the bar in place (i.e. without rotational displacement).

[0049] The rod thread is preferably used at least along most of the length of the rod. The rod, implant carrier, gripping block and grip can be pre-assembled.

A threaded distal end of the rod can be inserted into the hole in the center of the proximal end of the implant where it can be received in the appropriately threaded portion of the center of the distal end of the implant. The distal end (i.e. the location of the implant) of the implant assembly together with the implant carrier / gripping elements can then be inserted into the tube 67.

[0050] Fig. 34 illustrates another view of the implant carrier and also includes a 3320 meter that can be used to indicate the extent of implant extension (e.g., determining the rotation range of the 3316 rod). The meter may include a window for the 3316 rod. As shown in Fig. 35, the visible part of the rod may not include a thread. Instead, this bar section may contain 3322 markings that indicate the percentage of extension. Additional 3324 markings used adjacent to the window allow the user to measure the percentage of extension based on the displacement between the two markings.

[0051] Depending on the predetermined thread pitch and thread direction of the 3316 rod, rotation of the handle displaces the rod 3316 relative to the implant carrier, linearly in a certain direction. Preferably, the thread is applied to the rod in such a way that clockwise rotation of the handle causes the rod to move outwardly further from the area in which the implant is to expand (implant area). For example, for an M5 thread, a pitch of 0.8 mm can be used. Nevertheless, a person skilled in the art will be aware that a thread pitch of between about 0.5 mm and about 1.0 mm (for example) can be used here. Fig. 36 is a diagram illustrating expansion, in the absence of implant loading, by a number of rod revolutions for three specific implant sizes.

[0052] Accordingly, in light of the above example, when the implant is positioned inside the tube tube and slid down therein, it is thus positioned inside the circle 60. This implant is preferably located in such a way that a single the enlargement plane 2 corresponds to the desired bone reconstruction plane (Fig. 24). The implant location can be verified using any known imaging technique, including, for example, X-ray and ultrasound imaging.

[0053] The handle 3314 is then rotated to "pull" the rod out of the implantation area.

Due to the fact that the proximal end of the implant is supported by the implant carrier, pulling the rod causes the distal end of the implant to move towards the proximal end (or vice versa). As a result, the implant ends are pulled towards each other, which causes the implant to open.

More specifically, opposing plates 6 and 7 are expanded, and preferably form respectively a first 8 and a second 9 supporting surface in the circle 60, which surfaces can be continuous along their length, which can be substantially equal to the length of the implant

EP 1 778 136 B1 1 (Fig. 25). During expansion, controlling the reduction of the crack due to millimeter control elements, and also after obtaining the desired expansion, for example, with a predetermined value between the minimum thickness of the implant before any expansion of the latter and the maximum thickness of the implant after its maximum expansion, and then the carrier is released 71 for the implant by unscrewing it from implant 1, followed by extraction of the tube 67, as shown in Fig. 26, with the implant in an open position remaining in place in the vertebra 60.

[0054] Accordingly, the expansion of the implant in the vertebra is obtained through support under the plates, which allows distribution of the thrust force over the length of the plates under the latter. Thus, a sufficient length of the tiles can be provided, while limiting excessive thickness dimensioning of the latter, to impart flexural strength. It will be understood by specialists with average knowledge in the field that the implant may have certain spatial requirements regarding the ratio of the length (in its expanded state) to the length of the raised plate, which is extremely optimized, allowing beneficial use of intra-bone spaces, e.g. crack reduction.

[0055] The rod 3316 may also include uncoupling elements, which may be an internal six-arm element at the proximal end 3318 of the rod. In this way, it can be easier to disengage the rod from the implant once the implant has been opened. Alternatively, when the handle is not attached to the handle block and / or implant carrier, the handle can be rotated in the opposite direction (i.e. rotated so that the rod does not move away from the implant), thereby moving away from the surface-aligned portion handle block and implant carrier so that it engages the proximal end of the rod. What's more, the opposite rotation of the handle (after opening the implant) causes the rod to rotate in the same opposite direction of rotation as the handle, and thus causes the rod to disengage from the implant. Depending on the specific thread pitch, such uncoupling can take place after any number of turns (e.g. after more or less than one turn). Please also look at Fig. 26.

[0056] Preferably, after the rod has been removed, the filler material 74 is injected around the implant. Such a filling material may contain, for example, ionic cement, in particular phosphine cement, acrylic cement or a compound of the latter, to fill the space around the implant. To do this, the injector needle 73 slides in the tube 67 until the tip of the needle reaches the distal outlet 39 of implant 1 (Fig. 27). The filling material is then injected via a needle. Further injection in a roll-back manner can be performed up to the proximal exit in cortex 64 of the vertebra 60 (Fig. 28). The injector needle may then be withdrawn from the tube 67 (Fig. 29).

[0057] A second example of a method of reconstructing human bone anatomy will now be described with reference to Figs. 30-32. This example essentially relates to methods of reconstruction of the vertebral bone through a transpedicular pathway, with fracture reduction.

[0058] This second example is similar to the first, but differs from the latter by passing the implant to the vertebra 60, which this time is done in a transpedicular manner (Fig.

30) instead of the path through the posterolateral aperture used in the first method. As a result, only a few steps of the second method are shown in Figs. 30-32, in order

PZ / 2280 / RW EP 1 778 136 B1 shows a different path used to insert implant 1 into the vertebra. For Figures 30 to 32, elements identical to those of the first method have the same reference numerals, and these figures correspond to the steps of Figs. 24, 15 and 28 of the first method example. As for the stage shown in Fig. 32, the latter differs slightly from Fig. 28 the position of the needle 73, which is closer to the distal end of the implant in Fig. 32.

[0059] Practitioners working in the art will be aware that the method, device and system configurations, illustrated and described in this document, are examples of many possible system configurations that fall within the scope of the present invention.

VP / 2280 / RW

EP 1 778 136 B1