专利摘要:
Sacroiliac fixation implant (1) for an intervertebral connecting bar, comprising a one-piece anchoring piece supporting a connecting element (3) of the connecting bar and provided with three holes for the passage of anchoring screws ( 61, 62, 63), wherein the anchor comprises: - an elongate main wall (4) in which are formed two orifices, wherein the connecting element is interposed between the two orifices; and a secondary wall (5) projecting from the main wall at one end so that the anchoring piece has a general "L" shape, a third orifice being provided on said secondary wall; wherein each orifice is delimited internally by a bearing surface in spherical portion extended by a flared face in frustoconical portion centered on a central axis, and wherein the orientations of the central axes and the taper angles of the flared faces are shaped to allow a provision screwing axes of the three anchoring screws according to a tri-orthogonal trihedron.
公开号:FR3038218A1
申请号:FR1556338
申请日:2015-07-03
公开日:2017-01-06
发明作者:Jacques Boulot
申请人:Orthopaedic & Spine Dev (osd);
IPC主号:
专利说明:

The present invention relates to a sacroiliac fixation implant for an intervertebral connecting bar. The invention lies in the field of vertebral osteosynthesis equipment intended to correct the deformations of the spine, and in particular of the lumbar spine.
In this field of vertebral osteosynthesis, the correction or immobilization of a portion of a spine is performed by means of several fixation implants (sometimes called connectors or anchor plates) adapted to cooperate with screws. bone anchoring (or pedicle screws) and to rigidly connect rigid connecting bars between them, in order to anchor these connecting bars to the vertebrae.
In the case of the treatment of the lumbar spine, it is known to ensure anchoring of the rigid connecting bars on the sacrum, or both in the sacrum and in the pelvic bone. As such, it is necessary to use a so-called sacro-iliac fixation implant to cooperate with anchoring screws on the sacrum (called sacral anchoring screws) and with an anchoring screw on the iliac bone. (called iliac anchor screw).
However, the forces experienced by sacral and iliac anchoring screws require a particularly strong bone anchorage in the sacrum region to resist tearing of the screws and implant from the bone.
It is known from WO 2013/153482 to propose a sacroiliac fixation implant consisting of a sacral anchoring plate with two holes for the passage of two sacral anchoring screws, a sacral connecting piece coming from mounted on one of the two orifices of the sacral anchoring plate and having a hole for engaging a connecting bar, means for assembling the connecting piece to the sacral anchoring plate, a plate for iliac anchor being mounted on the other of the two orifices of the sacral anchor plate and having a passage hole of an anchoring screw iliac, as well as clamping nuts. The disadvantage of such an implant lies essentially in its complexity, by multiplying the number of parts to be assembled together (sacral anchoring plate, sacral connection piece, iliac anchor plate, nuts and assembly means), such a multiplication of the assemblies also contributing to increase the dimensions, and especially the overall thickness or height of the implant, and also to significantly increase the time of the surgical procedure, without counting the possible complications that this may cause .
It is also known from US 5 133 717 to propose, in an embodiment illustrated in FIG. 2, a sacroiliac fixation implant composed of a plate provided with three orifices for the passage of sacral anchoring screws and an iliac anchor screw, with a split boss and provided with a threaded hole for clamping a connecting bar. Although this implant has a certain compactness, it does not offer an optimal orientation for the anchoring screws that would ensure sufficient and durable anchoring.
The present invention aims to solve all or part of these problems by providing a simple design implant, providing an orientation anchor screws that ensure optimal and durable anchoring on the sacrum and the pelvic bone, while being relatively compact. For this purpose, it proposes a sacroiliac fixation implant for an intervertebral connecting bar, said implant comprising a monobloc anchoring piece supporting a connection element of the connecting bar and provided with three orifices, a first orifice for the passing a first sacral anchoring screw, a second orifice for the passage of a second sacral anchoring screw, and a third orifice for the passage of an iliac anchoring screw, this implant being remarkable in that a) the anchoring piece comprises: a main wall elongated in a longitudinal direction and having a lower face and an opposite upper face and first and second opposite longitudinal edges, where the first orifice is arranged at a first end of said main wall and the second port is provided at a second end of said main wall, and wherein the connecting member is mounted protruding and integral on the upper face of the main wall and is interposed between the first orifice and the second orifice; and a secondary wall projecting from the second longitudinal edge of the main wall at its second end, so that the anchoring piece has a general "L" shape, said secondary wall having a lower face and an upper face. opposite, where the third port is provided on said secondary wall; b) each orifice is at least internally delimited by a bearing surface in spherical portion extended by a flared face in frustoconical portion of predefined conicity angle, where the bearing face and the flared face together form a centered surface of revolution around a common central axis, including a first central axis associated with the first orifice, a second central axis associated with the second orifice and a third central axis associated with the third orifice; and c) the orientations of said three central axes and the taper angles of said three flared faces are shaped to allow an arrangement of the screwing axes of the three anchoring screws according to a tri-orthogonal trihedron, with the screwing axis of the first sacral anchoring screw orthogonal to the screwing axis of the second sacral anchoring screw and to the screwing axis of the iliac anchoring screw, and with the screwing axis of the second sacral anchoring screw orthogonal to the axis of screwing of the iliac anchor screw.
Thus, the three orifices have central axes and frustoconical portions such that the three anchoring screws, once in place with their degrees of freedom allowed by the spherical and frustoconical portions, are allowed to extend along their screwing axes. respective tri-orthogonal trihedron and together provide increased and durable anchoring.
Indeed, the anchoring in three directions (axes of screwing) orthogonal to each other results in none of the three anchor screws working in tension along its own screw axis, that is to say that it does not tend to tear when traction forces are exerted on the implant via the intervertebral connecting bar. The three anchoring screws are not mobilized during the solicitations, it follows therefore a better primary fixation of the implant and the risk of loosening due to the efforts of the patient's movements is reduced to zero.
Moreover, thanks to this optimization of the orientations of the central axes of the orifices, the implant can be reduced in its dimensions because it is not necessary to envisage additional means of assembly or reinforcement, justifying the use of An integral monoblock anchor with "L" geometry optimized in terms of compactness and mechanical strength.
Finally, the spherical shapes of the bearing faces of the orifices of the anchoring piece will make it possible to provide supports with polyaxiality anchoring screws, in other words supports with the possibility of multidirectional inclination anchor screws relative to to the anchoring piece, in order to allow the practitioner or surgeon to adapt to the different morphologies of the patients, and not to exactly respect if necessary the orientation of the screw axes according to a tri-orthogonal trihedron; the conicities of the flared faces of the orifices allowing, within predetermined limits, the angular multidirectional deflections of the anchoring screws.
It should be noted that the "L" shape of the part has the advantage of contributing to the compactness and the mechanical strength of the implant, in perfect adequacy with the anchoring constraints imposed by the anchoring screws. The lower faces of the main and secondary walls form the bearing faces on the framework, and in particular on the sacrum and on the iliac bone. These lower faces may be smooth or have attachment elements on the frame, in other words have a surface state with a controlled roughness to promote bone grip; such fastening elements may for example be in the form of teeth or points.
According to one feature, the connecting element comprises a fastener cooperating with a clamping member for clamping the connecting bar on said fastener, wherein said fastener is pivotally mounted on a ball joint secured to the anchor piece so that said fastener attachment has three degrees of freedom in rotation on said ball joint.
In this way, the fastener has a freedom of orientation that makes it possible to make up for any misalignment of the intervertebral connecting bar.
According to another characteristic, the secondary wall is inclined upwards with respect to the main wall with an inclination of between 30 and 60 degrees, preferably between 40 and 50 degrees.
This inclination of the secondary wall which rises with respect to the main wall (in other words which defines an upwardly inclined slope by associating top and upper face and associating bottom and bottom face), offers a geometry particularly suitable for a three-dimensional anchorage. orthogonal anchor screws, and optimal placement of the iliac anchor screw on the pelvic bone.
Advantageously, the lower face of the secondary wall comes in the continuity of the lower face of the secondary wall with an inclination of between 30 and 60 degrees, preferably between 40 and 50 degrees.
According to another characteristic, considering a first point corresponding to the intersection between the first central axis and the plane of the lower face of the main wall, a second point corresponding to the intersection between the second central axis and the plane of the lower face of the main wall, and a third point corresponding to the intersection between the third central axis and the plane of the lower face of the secondary wall, and considering a first line passing through the first point and by the second point, and a second line passing through the third point and the second point, said first line and said second line intersect on the second point at an angle between 100 and 120 degrees, and preferably between 105 and 115 degrees.
These orientations of the two lines also contribute to optimizing the orientation of the anchoring screws in order to make the anchoring on the sacrum and on the iliac bone reliable.
According to another characteristic, the first orifice and the second orifice are shaped so that: the first central axis is oriented, in an orientation direction going from the upper face towards the lower face of the main wall, in the direction of the first longitudinal edge of the main wall; and - the second central axis is oriented, in an orientation direction from the upper face to the lower face of the main wall, towards the second longitudinal edge of the main wall and to the first orifice.
Thus, the first sacral anchoring screw will be implanted in a so-called radial-anterior direction, while the second sacral anchoring screw will be implanted in a so-called external-anterior direction.
In a particular embodiment, the secondary wall has a first transverse edge and a second opposite transverse edge, where the first transverse edge is closer to the first end of the main wall than the second transverse edge, and the third axis is oriented, in an orientation direction from the upper face to the lower face of the secondary wall, towards the second transverse edge and away from the main wall.
Thus, the iliac anchor screw will be implanted in a totally external direction in the iliac bone, orthogonally to the first and second sacral anchor screws.
Advantageously, considering an orthonormal coordinate system composed of a longitudinal axis (X) parallel to the longitudinal and oriented direction of the second orifice towards the first orifice, of a transverse axis (Y) orthogonal to the longitudinal axis where the longitudinal axis and the transverse axis define a plane (X, Y) parallel to the lower face of the main wall and wherein said transverse axis (Y) is oriented from the first longitudinal edge to the second longitudinal edge, and from a vertical axis (Z ) orthogonal to the lower face of the main wall and oriented from the lower face to the upper face, at least one of the following geometrical conditions is fulfilled: the first central axis has an angle with the vertical axis (Z) in the plane (Y, Z) between +5 and +15 degrees, and especially between +8 and +12 degrees; the first central axis has an angle with the vertical axis (Z) in the plane (X, Z) of between -5 and +5 degrees, and in particular between -2 and +2 degrees; the first central axis has an angle with the transverse axis (Y) in the plane (X, Y) of between -5 and +5 degrees, and in particular between -2 and +2 degrees; the second central axis has an angle with the vertical axis (Z) in the plane (Y, Z) of between -15 and -25 degrees, and especially between -18 and -22 degrees; the second central axis has an angle with the vertical axis (Z) in the plane (X, Z) between -18 and -28 degrees, and in particular between -21 and -25 degrees; - The second central axis has an angle with the transverse axis (Y) in the plane (X, Y) between + 37 and + 47 degrees, and especially between + 40 and + 44 degrees; the third central axis has an angle with the vertical axis (Z) in the plane (Y, Z) between -40 and -50 degrees, and especially between -43 and -47 degrees; the third central axis has an angle with the vertical axis (Z) in the plane (X, Z) of between -5 and +5 degrees, and in particular between -2 and +2 degrees; - The third central axis has an angle with the transverse axis (Y) in the plane (Y, Z) between -5 and +5 degrees, and in particular between - 2 and + 2 degrees.
These geometric conditions also contribute to optimizing the orientation of the anchoring screws to make the anchorage on the sacrum and on the iliac bone reliable.
In a particular embodiment, the main wall has, in the longitudinal direction, a length of between 35 and 50 millimeters, preferably between 38 and 42 millimeters, a width between its two longitudinal edges of between 10 and 15 millimeters, and a thickness between its lower face and its upper face of between 2.5 and 4.5 millimeters, preferably between 3.2 and 3.8 millimeters.
The dimensions are thus adapted to the anatomy of the sacroiliac region, while offering a compactness, and especially a low height or thickness, which will facilitate the positioning of the connecting bar in the connection element.
According to a possibility of the invention, the anchoring piece has an overall height, taken along a vertical axis (Z) orthogonal to the lower face of the main wall, between 13 and 17 millimeters, preferably between 14 and 16 millimeters .
According to a possibility of the invention, the flared face in frustoconical portion of each orifice has a taper angle of between 20 and 50 degrees.
Advantageously, the taper angle for the first port is between 20 and 25 degrees, the taper angle for the second port is between 40 and 50 degrees, and the taper angle for the third port is between 35 and 50 degrees. and 45 degrees.
These taper angles have been optimized to ensure reliable anchoring.
Advantageously, the main wall has an extra thickness at the second end, which forms a raised step, and the second hole is formed in this extra thickness, and the secondary wall extends transversely, in a transverse direction orthogonal to the longitudinal direction of the main wall, said overthickness.
Such an extra thickness promotes the desired orientation of the central axis of the second orifice. The invention also relates to a sacroiliac fixation system for an intervertebral connecting bar, this system comprising an implant according to the invention, and three anchoring screws comprising a first sacral anchoring screw engaged in the first orifice of the anchor piece, a second anchor screw engaged in the second orifice of the anchor piece and an anchor anchor screw engaged in the third orifice of the anchor piece, each anchor screw having a threaded rod extended by a head having a bearing surface in spherical portion, wherein said bearing surface bears directly and with polyaxiality on the bearing face of the corresponding orifice, where the orientations of the three central axes and the taper angles of the flared faces of the three orifices allow an arrangement of the screwing axes of the three anchor screws according to a tri-orthogonal trihedron, with the screw axis of the first sacral anchoring screw orthogonal to the screwing axis of the second sacral anchoring screw and to the screwing axis of the iliac anchoring screw, and with the screwing axis of the second screw sacral anchorage orthogonal to the screw axis of the iliac anchor screw. Other features and advantages of the present invention will appear on reading the detailed description below, of an example of non-limiting implementation, with reference to the appended figures in which: - Figure 1 is a schematic view in perspective of a sacroiliac fixation implant according to the invention; - Figures 2 to 4 are schematic views respectively of side, front and top of the implant of Figure 1; FIGS. 5 to 7 are diagrammatic views respectively of side, front and top of the implant of FIG. 1, with the anchoring screws in place on the implant and with the screwing shafts of the screws of FIG. anchoring schematized to illustrate the perpendicularities of the axes of screwing them; - Figure 8 is a schematic top view of the implant of Figure 1 with three sectional views along the cutting axes A-A, B-B and C-C; FIGS. 9a and 9b are schematic views of the implant of FIG. 1 along a section plane in the first orifice and with the first sacral anchoring screw in position, with respectively a zoomed view on the first orifice (FIG. 9a) and an enlarged view showing the permitted angular displacement of the first sacral anchor screw within the first port (Fig. 9b); FIGS. 10a and 10b are schematic views of the implant of FIG. 1 along a section plane in the second orifice with the second sacral anchoring screw in position, with respectively a zoomed view on the second orifice (FIG. 10a). ) and an enlarged view showing the authorized angular displacement of the second sacral anchoring screw inside the second orifice (FIG. 10b); FIGS. 11a and 11b are schematic views of the implant of FIG. 1 along a section plane in the third orifice with the iliac anchor screw in position, with respectively a zoomed view on the third orifice (FIG. 11a) and an enlarged view showing the permitted angular displacement of the iliac anchor screw within the third port (Fig. 11b); FIG. 12 is a schematic view from above of the implant of FIG. 1 illustrating a first line and a second line; FIGS. 13a and 13b are diagrammatic perspective views, according to two distinct angles of view, of the implant of FIG. 1 anchored on the sacrum and on the iliac bone by means of the three anchor screws.
With reference to the figures, a sacroiliac fixation implant 1 comprises an anchoring piece 2 supporting a connection element 3 for an intervertebral connecting bar (not shown).
The anchoring piece 2 is formed of a one-piece piece, in other words made in one piece in a biocompatible material, such as for example a titanium alloy, and optionally with a treatment or surface coating.
The anchoring piece 2 comprises: a main wall 4 in which are formed a first orifice 41 for the passage of a first sacral anchoring screw 61 and a second orifice 42 for the passage of a second anchoring screw sacral 62; and a secondary wall 5 in which a third orifice 50 is provided for the passage of an iliac anchoring screw 63.
The main wall 4 is elongate in a longitudinal direction LG and has a lower face 43 and an opposite upper face 44 and first and second opposite longitudinal edges 45, 46, where the first orifice 41 is formed at a first end 47. of the main wall 4 and the second orifice 42 is formed at a second end 48 of the main wall 4.
The first and second longitudinal edges 45, 46 are substantially parallel to the longitudinal direction of the main wall 4. The first longitudinal edge 45 is provided to extend on the inside of the sacrum SAC, while the second longitudinal edge 46 is provided to extend to the outside of the SAC sacrum (facing the iliac bone OIL).
The main wall 4 has, in the longitudinal direction LG, a length of between 35 and 50 millimeters, preferably between 38 and 42 millimeters, and has a width between its two longitudinal edges 45, 46 between 10 and 15 millimeters.
The first end 47 is intended to be positioned on the upper side of the sacrum SAC (facing the VOC spine), while the second end 48 is intended to be positioned on the underside of the sacrum SAC (coccyx face).
Thus, it is necessary to have two symmetrical implants, with a left implant 1 and a right implant 1; all the figures illustrating by way of example a right implant 1.
The lower face 43 is provided to bear against the sacrum SAC, while the upper face 44 is provided to be opposite the sacrum SAC (opposite the intervertebral link bar). The lower face 43 may be smooth or have attachment elements (teeth or tips) on the sacrum SAC, in other words have a surface state with a controlled roughness to promote bone grip. The connection element 3 is positioned on the upper face 44 of the main wall 4, between the first orifice 41 and the second orifice 42.
This connecting element 3 comprises: a fastener 30 in the general shape of a split ring, in which the slot 31 has at the top a clean internal thread to cooperate with a clamping screw 32 for clamping the connecting bar (not shown) on the fastener 30, where the connecting bar is clamped between the lower bottom of the slot 31 and the clamping screw 32; - A ball 33 (visible in broken lines in Figure 2) integral (including welding) of the upper face 44 of the main wall 4, wherein the fastener 30 is pivotally mounted on the ball 33 so that the fastener 30 has three degrees of freedom in rotation on the ball 33.
The anchoring piece has an overall height HG, taken along a vertical axis Z orthogonal to the lower face 43 of the main wall 4, between 13 and 17 millimeters, preferably between 14 and 16 millimeters; this overall height HG being visible in FIG. 2 and measured between the lower face 43 and the top of the fastener 30.
The main wall 4 has an excess thickness 49 at the second end 48, which thus forms a raised step, and the second orifice 42 is formed in this extra thickness 49. The first orifice 41 and the connecting element 3 are in turn positioned on the part of lesser thickness. By way of example, the part of lesser thickness has a thickness E1 of between 2.5 and 3.5 millimeters, and the thickening 49 has a thickness E2 that is about 1.0 to 2.0 millimeters greater than E1 thickness, and thus the thickness E2 is between 3.5 and 4.5 millimeters.
For the rest of the description, we will define an orthonormal coordinate system defined by three axes: a so-called longitudinal axis X parallel to the longitudinal direction of the main wall and oriented from the second orifice to the first orifice 41 (in other words, the second end 48 towards the first end 47), this longitudinal axis X being, in an anchored position on a patient, substantially parallel to the vertebral column and therefore to the intervertebral connecting bar and oriented from the bottom of the sacrum SAC to the top of the sacrum SAC ; a so-called transverse axis Y orthogonal to the longitudinal axis X and oriented from the first longitudinal edge 45 to the second longitudinal edge 46, where the longitudinal axis X and the transverse axis Y define a plane (X, Y) substantially parallel to the lower face 43 of the main wall 4, this transverse axis Y extending, in an anchored position on a patient, transversely between the iliac OIL bones of right and left and being oriented on the inside of the sacrum SAC towards the outer side of the sacrum SAC, in other words towards the iliac bone OIL concerned by the anchoring of the implant 1; a so-called vertical axis Z orthogonal to the (X, Y) plane, and therefore substantially orthogonal to the lower face 43 of the main wall 4, and oriented from the lower face 43 to the upper face 44, this vertical axis Z being, in anchoring situation on a patient, substantially perpendicular to the anchoring zone of the implant 1 on the SAC sacrum and oriented sacral sac SAC to the outside of the patient.
The secondary wall 5 protrudes, substantially at right angles, from the second longitudinal edge 46 of the main wall 4, at the second end 48, so that the anchor 2 has a general shape of "L". More specifically, the secondary wall 5 extends transversely, in the transverse direction Y, the extra thickness 49. The secondary wall 5 has a lower face 53 and an opposite upper face 54, where the lower face 53 extends the lower face 43 of the main wall. 4 and the upper face 54 extends the upper face 44 of the main wall 4.
The secondary wall 5 is inclined upwards at an angle M1 with respect to the main wall 4, forming a ramp that protrudes from the upper face 44 of the main wall 4.
More precisely, the lower face 53 of the secondary wall 5 is in continuity with the lower face 43 of the secondary wall 4 with an inclination M1 of between 30 and 60 degrees, preferably between 40 and 50 degrees.
The secondary wall 5 has a thickness E3 substantially equivalent to the thickness E1, being also between 2.5 and 3.5 millimeters.
The secondary wall 5 has a first transverse edge 51 and a second transverse edge 52 opposite and substantially parallel to the transverse axis Y, where the first transverse edge 51 is closer to the first end 47 of the main wall 4 than the second edge. In other words, the first transverse edge 51 is intended to be positioned on the upper side of the sacrum SAC (facing the VOC spine), while the second transverse edge 52 is intended to be positioned on the lower side of the sacrum SAC ( facing the coccyx).
The remainder of the description relates to the conformations of the three orifices 41, 42, 50.
The first orifice 41 is delimited internally and successively from top to bottom (in other words from the upper face 44 in the direction of the lower face 43) by an inlet face 410 in cylindrical or conical portion, extended by a bearing face 411. in spherical portion itself prolonged by a flared face 412 in frustoconical portion (flared in the sense that the flared face widens towards the lower face 43), where these three faces 410, 411, 412 together form a surface of revolution centered around a first central axis G1.
With reference to section A-A of FIG. 8, the angle of conicity AC1 of the flared face 412 of the first orifice 41 is of the order of 20 degrees.
With reference to FIGS. 9A and 9B, the first sacral anchoring screw 61, extending along a main screwing axis AV1, has a threaded rod 611 extended by a head 610 having a bearing surface in a spherical portion, where this bearing surface bears directly and with polyaxiality on the bearing face 411 of the first orifice 41.
Due to the conformity of the bearing face 411 and the flared face 412, the first sacral anchoring screw 61 has, within this first orifice 41, an angular clearance D1 of the order of 30 to 40 degrees between its two extreme positions, in other words the screwing axis AV1 of the first sacral anchoring screw 61 can evolve inside a corner cone D1 centered on the first central axis G1.
The first central axis G1 is oriented, in an orientation direction from the upper face 44 to the lower face 43 of the main wall 4 (in other words, in an orientation direction corresponding to the direction of insertion of the first screw sacral anchorage 61), in the direction of the first longitudinal edge 45 of the main wall 4, as can be seen in FIG.
More precisely, this first central axis G1 meets the following geometrical conditions: as can be seen in FIG. 2, the first central axis G1 has an angle AX1 with the vertical axis (Z) in the plane (Y, Z) included between +5 and +15 degrees, and especially between +8 and +12 degrees, this angle AX1 being +10 degrees in the example of Figure 2; as can be seen in FIG. 3, the first central axis G1 has an angle AY1 with the vertical axis (Z) in the plane (X, Z) between -5 and +5 degrees, and especially between -2 and +2. degrees, this angle AY1 being 0 degrees in the example of Figure 3, so that this angle AY1 is not referenced; as can be seen in FIG. 4, the first central axis G1 has an angle AZ1 with the transverse axis (Y) in the plane (X, Y) of between -5 and +5 degrees, and especially between -2 and +2. degrees, this angle AZ1 being 0 degrees in the example of Figure 4, so that this angle AZ1 is not referenced.
The second orifice 42 is delimited internally and successively from top to bottom (in other words from the upper face 44 in the direction of the lower face 43) by an inlet face 420 in a cylindrical or conical portion, extended by a support face 421. in spherical portion itself prolonged by a flared face 422 in frustoconical portion (flared in the sense that the flared face widens towards the lower face 43), where these three faces 420, 421, 422 together form a surface of revolution centered around a second central axis G2.
Referring to the section B-B of Figure 8, the taper angle AC2 of the flared face 422 of the second port 42 is of the order of 46 degrees.
With reference to FIGS. 10A and 10B, the second sacral anchoring screw 62, extending along a main axis called screwing axis AV2, has a threaded rod 621 extended by a head 620 having a bearing surface in spherical portion, where this bearing surface bears directly and with polyaxiality on the bearing face 421 of the second orifice 42.
Due to the conformity of the support face 421 and the flared face 422, the second sacral anchoring screw 62 has, inside this second orifice 42, an angular clearance D2 of the order of 35 to 45 degrees between its two extreme positions, in other words the screwing axis AV2 of the second sacral anchoring screw 62 can evolve inside a corner cone D2 centered on the second central axis G2.
The second central axis G2 is oriented, in an orientation direction going from the upper face 44 to the lower face 43 of the main wall 4 (in other words in an orientation direction corresponding to the direction of insertion of the second screw sacral anchorage 62) in the direction of the second longitudinal edge 46 of the main wall 4, as can be seen in FIG. 2, and also in the direction of the first orifice 41, as can be seen in FIG. 4.
More precisely, this second central axis G2 satisfies the following geometrical conditions: as can be seen in FIG. 2, the second central axis G2 has an angle AX2 with the vertical axis (Z) in the plane (Y, Z) included between -15 and -25 degrees, and especially between -18 and -22 degrees, this angle AX1 being -20 degrees in the example of Figure 2; as visible in FIG. 3, the second central axis G2 has an angle AY2 with the vertical axis (Z) in the plane (X, Z) between -18 and -28 degrees, and especially between -21 and -25. degrees, this angle AY2 being -23 degrees in the example of Figure 3; - As shown in Figure 4, the second central axis G2 has an angle AZ2 with the transverse axis (Y) in the plane (X, Y) between + 37 and + 47 degrees, and especially between + 40 and + 44 degrees, this angle AZ2 being + 42 degrees in the example of Figure 4.
Moreover, and as visible in FIG. 12, considering a first point P1 corresponding to the intersection between the first central axis G1 and the plane of the lower face 43 of the main wall 4, a second point P2 corresponding to the intersection between the second central axis G2 and the plane of the lower face 43 of the main wall 4, and a third point P3 corresponding to the intersection between the third central axis G3 and the plane of the lower face 53 of the secondary wall 5 , and considering a first line L12 passing through the first point P1 and the second point P2, and a second line L23 passing through the third point P3 and the second point P2, this first line L12 and this second line L23 intersect each other. on the second point P2 at an angle ANL of the order of 110 degrees.
The third orifice 43 is delimited internally and successively from top to bottom (in other words from the upper face 54 in the direction of the lower face 53) by an inlet face 430 in a cylindrical or conical portion, extended by a support face 431. in spherical portion itself prolonged by a flared face 432 in frustoconical portion (flared in the sense that the flared face widens towards the lower face 53), where these three faces 430, 431, 432 together form a surface of revolution centered around a third central axis G3.
Referring to the section C-C of Figure 8, the taper angle AC3 of the flared face 432 of the third port 42 is of the order of 40 degrees.
With reference to FIGS. 11A and 11B, the iliac anchoring screw 63, extending along a principal axis called screwing axis AV3, has a threaded rod 631 extended by a head 630 having a bearing surface in spherical portion, where this bearing surface bears directly and with polyaxiality on the bearing face 431 of the third orifice 43.
Due to the conformity of the bearing face 431 and the flared face 432, the iliac anchoring screw 63 has, within this third orifice 43, an angular clearance D3 of the order of 35 to 45 degrees between its two extreme positions, in other words the screwing axis AV3 of the iliac anchor screw 63 can evolve inside a corner cone D3 centered on the third central axis G3.
More precisely, this third central axis G3 satisfies the following geometrical conditions: as can be seen in FIG. 2, the third central axis G3 has an angle AX3 with the vertical axis (Z) in the plane (Y, Z) included between -40 and -50 degrees, and especially between -43 and -47 degrees, this angle AX3 being -45 degrees in the example of Figure 2; as can be seen in FIG. 3, the third central axis G3 has an angle AY3 with the vertical axis (Z) in the plane (X, Z) of between -5 and +5 degrees, and especially between -2 and +2. degrees, this angle AY3 being 0 degrees in the example of Figure 3, so that this angle AY3 is not referenced; as shown in FIG. 4, the third central axis G3 has an angle AZ3 with the transverse axis (Y) in the plane (X, Y) of between -5 and +5 degrees, and especially between -2 and +2. degrees, this angle AZ3 being 0 degrees in the example of Figure 4, so that this angle AZ3 is not referenced.
Thus, the first central axis G1 and the third central axis G3 both extend in planes parallel to each other and parallel to the (Y, Z) plane, as can be seen in FIGS. 3 and 4.
With reference to FIGS. 5 to 7, thanks to the orientations of the three central axes G1, G2, G3 and thanks to the geometrical conformations of the three orifices 41, 42, 43, the three anchoring screws 61, 62, 63 can, in situation, present a particularly advantageous configuration with a provision of their screwing axes AV1, AV2, AV3 according to a tri-orthogonal trihedron, where more precisely: - as shown in Figure 5, the screwing axis AV1 of the first anchor screw sacral 61 is orthogonal to the screw axis AV3 of the iliac anchoring screw 63; - As shown in Figure 7, the screwing axis AV1 of the first sacral anchoring screw 61 is orthogonal to the screwing axis AV2 of the second sacral anchoring screw 62; and - as visible in FIGS. 6 and 7, at the screwing axis AV2 of the second sacral anchoring screw 62 is orthogonal to the screwing axis AV3 of the iliac anchoring screw 63.
Of course, because of the angular deflections D1, D2, D3 of the anchoring screws 61, 62, 63 in the holes 41, 42, 43 corresponding, this configuration is not the only possible.
权利要求:
Claims (10)
[1" id="c-fr-0001]
1. sacroiliac fixation implant (1) for an intervertebral connecting bar, said implant (1) comprising a one-piece anchoring piece (2) supporting a connection element (3) of the connecting bar and provided with three orifices (41, 42, 43) including a first orifice (41) for the passage of a first sacral anchoring screw (61), a second orifice (42) for the passage of a second sacral anchoring screw ( 62), and a third port (43) for the passage of an iliac anchor screw (63), said implant (1) being characterized in that the anchor (2) comprises: - a main wall ( 4) elongated in a longitudinal direction (LG) and having a lower face (43) and an opposite upper face (44) and a first and a second longitudinal edge (45, 46) opposite, where the first orifice (41) is provided at a first end (47) of said main wall (4) and the second opening (42) is provided at a second end (48) of said main wall (4), and wherein the connecting element (3) is mounted protruding and integral with the upper face (44) of the main wall (4) and is interposed between the first port ( 41) and the second port (42); and a secondary wall (5) projecting from the second longitudinal edge (46) of the main wall (4) at its second end (48), so that the anchor piece (2) has a general shape of "L", said secondary wall (5) having a lower face (53) and an opposite upper face (54), wherein the third orifice (43) is provided on said secondary wall (5); in that each orifice (41; 42; 43) is at least internally delimited by a bearing face (411; 421; 431) in a spherical portion extended by a flared face (412; 422; 432) in a frustoconical portion of predefined taper angle (AC1; AC2; AC3), wherein the bearing face (411; 421; 431) and the tapered face (412; 422; 432) together form a surface of revolution centered around a common central axis , a first central axis (G1) associated with the first orifice (41), a second central axis (G2) associated with the second orifice (42) and a third central axis (G3) associated with the third orifice (43), and in that that the orientations of said three central axes (G1, G2, G3) and the taper angles (AC1, AC2, AC3) of said three flared faces (412, 422, 432) are shaped to allow an arrangement of the screw pins (AV1, AV2, AV3) of the three anchoring screws (61, 62, 63) according to a tri-orthogonal trihedron, with the screwing axis (AV1) of the first e sacral anchoring screw (61) orthogonal to the screw axis (AV2) of the second sacral anchoring screw (62) and to the screwing axis (AV3) of the iliac anchoring screw (63) and with the screwing axis (AV2) of the second sacral anchoring screw (62) orthogonal to the screwing axis (AV3) of the iliac anchoring screw (63).
[2" id="c-fr-0002]
2. Implant (1) according to claim 1, wherein the connecting element (3) comprises a fastener (30) cooperating with a clamping member (32) for clamping the connecting bar on said fastener (30) , wherein said fastener (30) is pivotally mounted on a ball joint (33) integral with the anchor (2) so that said fastener (30) has three degrees of freedom in rotation on said ball (33).
[3" id="c-fr-0003]
3. Implant (1) according to claims 1 or 2, wherein the secondary wall (5) is inclined upwards relative to the main wall (4) with an inclination (M1) of between 30 and 60 degrees, preferably between 40 and 50 degrees.
[4" id="c-fr-0004]
4. Implant (1) according to any one of the preceding claims, wherein, considering a first point (P1) corresponding to the intersection between the first central axis (G1) and the plane of the lower face (43) of the main wall (4), a second point (P2) corresponding to the intersection between the second central axis (G2) and the plane of the lower face (43) of the main wall (4), and a third point (P3 ) corresponding to the intersection between the third central axis (G3) and the plane of the lower face (43) of the secondary wall (5), and considering a first line (L12) passing through the first point (P1) and by the second point (P2), and a second line (L23) passing through the third point (P3) and the second point (P2), said first line (L12) and said second line (L23) intersect on the second point (P2) at an angle (ANL) between 100 and 120 degrees, and preferably between 105 and 115 degrees.
[5" id="c-fr-0005]
5. Implant (1) according to any one of the preceding claims, wherein, considering an orthonormal reference consisting of a longitudinal axis (X) parallel to the longitudinal direction (LG) and oriented from the second orifice (42) to the first orifice (41), of a transverse axis (Y) orthogonal to the longitudinal axis (X) where the longitudinal axis (X) and the transverse axis (Y) define a plane (X, Y) parallel to the lower face (43) of the main wall (4) and wherein said transverse axis (Y) is oriented from the first longitudinal edge (45) towards the second longitudinal edge (46), and from a vertical axis (Z) orthogonal to the lower face (43) of the main wall (4) and oriented from the lower face (43) to the upper face (44), at least one of the following geometrical conditions is fulfilled: the first central axis (G1) presents an angle (AX1) with the vertical axis (Z) in the plane (Y, Z) between +5 and +15 degrees, and in particular between e + 8 and + 12 degrees; the first central axis (G1) has an angle (AY1) with the vertical axis (Z) in the plane (X, Z) of between -5 and +5 degrees, and in particular between -2 and +2 degrees; the first central axis (G1) has an angle (AZ1) with the transverse axis (Y) in the plane (X, Y) of between -5 and +5 degrees, and in particular between -2 and +2 degrees; the second central axis (G2) has an angle (AX2) with the vertical axis (Z) in the plane (Y, Z) between -15 and -25 degrees, and in particular between -18 and -22 degrees; the second central axis (G2) has an angle (AY2) with the vertical axis (Z) in the plane (X, Z) between -18 and -28 degrees, and in particular between -21 and -25 degrees; - The second central axis (G2) has an angle (AZ2) with the transverse axis (Y) in the plane (X, Y) between + 37 and + 47 degrees, and especially between + 40 and + 44 degrees; the third central axis (G3) has an angle (AX3) with the vertical axis (Z) in the plane (Y, Z) between -40 and -50 degrees, and in particular between -43 and -47 degrees; the third central axis (G3) has an angle (AY3) with the vertical axis (Z) in the plane (X, Z) of between -5 and +5 degrees, and in particular between -2 and +2 degrees; the third central axis (G3) has an angle (AZ3) with the transverse axis (Y) in the plane (Y, Z) of between -5 and +5 degrees, and in particular between -2 and +2 degrees.
[6" id="c-fr-0006]
6. Implant (1) according to any one of the preceding claims, wherein the main wall (4) has, in the longitudinal direction (LG), a length of between 35 and 50 millimeters, preferably between 38 and 42 millimeters, a width between its two longitudinal edges (45, 46) of between 10 and 15 millimeters, and a thickness between its lower face (43) and its upper face (44) of between 2.5 and 4.5 millimeters, preferably between 3.2 and 3.8 millimeters.
[7" id="c-fr-0007]
7. Implant (1) according to any one of the preceding claims, wherein the anchor (2) has an overall height (HG), taken along a vertical axis (Z) orthogonal to the underside (43) of the main wall (4), between 13 and 17 millimeters, preferably between 14 and 16 millimeters.
[8" id="c-fr-0008]
8. Implant (1) according to any one of the preceding claims, wherein the flared face (412; 422; 432) frustoconical portion of each orifice (41; 42; 43) has a taper angle (AC1; AC2; AC3) between 20 and 50 degrees.
[9" id="c-fr-0009]
9. Implant (1) according to any preceding claim, wherein the main wall (4) has an extra thickness (49) at the second end (48), which forms a raised step, and the second orifice (48), 42) is formed in this extra thickness (49), and the secondary wall (5) extends transversely, in a transverse direction (Y) orthogonal to the longitudinal direction (LG) of the main wall (4), said overthickness (49).
[10" id="c-fr-0010]
A sacroiliac fixation system for an intervertebral connecting bar, said system comprising an implant (1) according to any one of the preceding claims, and three anchoring screws including a first sacral anchoring screw (61). engaged in the first orifice (41) of the anchor piece (2), a second anchor screw engaged in the second orifice (42) of the anchor piece (2) and an anchoring screw (63). ) engaged in the third hole (43) of the anchor (2), each anchor screw (61; 62; 63) having a threaded rod (611; 621; 631) extended by a head (610; 620; 630) having a bearing surface in spherical portion, wherein said bearing surface bears directly and with polyaxiality on the bearing face (411; 421; 431) of the orifice (41; 42; 43); corresponding, where the orientations of the three central axes (G1, G2, G3) and the taper angles (AC1, AC2, AC3) of the faces 4, 422, 432) of the three orifices (41, 42, 43) permit the provision of the screwing pins (AV1, AV2, AV3) of the three anchoring screws (61, 62, 63) according to a trihedral trihedron. orthogonal, with the screwing axis (AV1) of the first sacral anchoring screw (61) orthogonal to the screwing axis (AV2) of the second sacral anchoring screw (62) and to the screwing axis (AV3) of the iliac anchoring screw (63), and with the screwing axis (AV2) of the second sacral anchoring screw (62) orthogonal to the screwing axis (AV3) of the screw iliac anchorage (63).
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同族专利:
公开号 | 公开日
FR3038218B1|2017-07-21|
WO2017006028A1|2017-01-12|
US20180177535A1|2018-06-28|
US10531898B2|2020-01-14|
引用文献:
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FR2657774B1|1990-02-08|1992-05-22|Sofamor|SACRED TAKING SHOE FOR A SPINAL OSTEOSYNTHESIS DEVICE.|EP3484387A4|2016-07-18|2020-03-25|Sail Fusion, LLC|Implant and method for posterior sacroiliac fusion|
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法律状态:
2016-05-12| PLFP| Fee payment|Year of fee payment: 2 |
2017-01-06| PLSC| Search report ready|Effective date: 20170106 |
2017-05-31| PLFP| Fee payment|Year of fee payment: 3 |
2018-06-07| PLFP| Fee payment|Year of fee payment: 4 |
2020-06-02| PLFP| Fee payment|Year of fee payment: 6 |
2021-06-30| PLFP| Fee payment|Year of fee payment: 7 |
优先权:
申请号 | 申请日 | 专利标题
FR1556338A|FR3038218B1|2015-07-03|2015-07-03|SACRO-ILIAC FIXING IMPLANT FOR INTERVERTEBRAL CONNECTION BAR|FR1556338A| FR3038218B1|2015-07-03|2015-07-03|SACRO-ILIAC FIXING IMPLANT FOR INTERVERTEBRAL CONNECTION BAR|
PCT/FR2016/051649| WO2017006028A1|2015-07-03|2016-06-30|Sacroiliac fixation implant for an intervertebral linking rod|
US15/738,818| US10531898B2|2015-07-03|2016-06-30|Sacroiliac fixation implantat for an intervertebral linking rod|
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