Source: https://patents.google.com/patent/WO2002080788A1/en
Timestamp: 2018-12-15 05:58:43
Document Index: 572522978

Matched Legal Cases: ['art 21', 'art 310', 'art 31', 'art 21', 'art 22', 'art 21', 'art 22', 'art 22', 'art 21', 'art 22', 'art 33', 'arts 21', 'art 33']

WO2002080788A1 - Spinal osteosynthesis device and preparation method - Google Patents
WO2002080788A1
WO2002080788A1 PCT/IB2002/002827 IB0202827W WO02080788A1 WO 2002080788 A1 WO2002080788 A1 WO 2002080788A1 IB 0202827 W IB0202827 W IB 0202827W WO 02080788 A1 WO02080788 A1 WO 02080788A1
PCT/IB2002/002827
The invention concerns an osteosynthesis device, particularly for the spine by means of internal implantation, comprising firstly one or more bars (2) used to support or move the spine, and secondly at least one implant (3) connecting the bars and the vertebrae (V), said implant comprising firstly bone anchorage means attached to the body of said implant and secondly fixation means for said bars, said fixation being carried out by clamping means (31) clamping said bar against the internal walls (320) of a channel (32) formed in said body of the implant (3), characterised in that said bars comprise a transversal bearing surface (21) on at least part of their length, said transversal bearing surface being produced by a cross-section of said bars comprising at least one flat part or part of lower or opposed convexity in relation to the rest of said cross-section.
SPINAL OSTEOSYNTHES1S DEVICE AND PREPARATION METHOD
For spinal support or correction, a device comprising one or more support bars positioned along the spinal column is used, and fixed to certain vertebrae by implants. Said implants are fixed at one end to the bars and at the other end to the vertebrae by bone anchorage means, composed of a hook supported by a vertebra or of a threaded part screwed inside the vertebra itself, for example at the pedicle. In such devices, it is known to use bars inserted into the body of the implant via an opening, either simply through the implant or in the form of a channel opening onto a side, said channel possibly opening onto the side or rear (on the top of the implant).
In both cases, this assembly of several parts is intended to ensure the reliability of the clamping, but represents a complexity and size liable to render implantation delicate, particularly at the junction of the lumbar and sacral regions where only a small amount of space is available due to anatomical conditions. The presence of small parts to assemble during the operation involves the disadvantage of more delicate manipulations and the risk of said small parts being disseminated in the operative field. The aim of the present operation is to remedy the drawbacks of the prior art by proposing an osteosynthesis device enabling easier adjustment on the operative site and more rapid implantation.
- figure 1 represents a rear view on the spine of an osteosynthesis device according to the invention, in the case of pedicular screw implants;
- figure 2 represents a partial side view of the region comprising the fixation of a bar to an implant, at the stage where the bar is presented at the entry of the opening of the implant and where the clamping screw is pre-f itted in the implant;
- figure 3a and 5 represent a sectional side view of a device according to the invention, at the axis of an implant, in an embodiment using a bar comprising a single flat part and for two different bar thicknesses; - figure 3b represents a sectional side view of a device according to the invention, at the axis of an implant, in an embodiment comprising a polyaxial clamping screw; - figure 4a represents a side view of a device according to the invention, at the axis of an implant, in an embodiment using a bar comprising two flat parts;
- figure 4b represents a side view of a device according to the invention, at the axis of an implant, in an embodiment using a bar comprising one flat part and an implant comprising an inclined plane surface;
- figure 6 represents a side and top view of an implant according to the invention, in an embodiment using a bar comprising an end with no flat part, in the case of a screw implant; - figure 7 represents a sectional side view of a device according to the invention, at the axis of an implant, in an embodiment using a spherical head clamping screw clamping a bar comprising a recess or a circular cross- section groove complementary to the clamping face;
- figure 8 represents a sectional side view of a device according to the invention, at the axis of an implant, in an embodiment using a spherical head clamping screw clamping a bar comprising a recess or a circular cross- section groove of a radius greater than that of the clamping face.
In an embodiment represented in figures 2, 3a and 5, the bar 2 has a rounded cross-section comprising a flat part 21. Said flat part forms a transversal bearing surface, i.e. enabling clamping by supporting the clamping means on said surface, in a direction approximately perpendicular to the longitudinal axis of the bar 2. In its part comprising the fixation means to the bar 2, the implant 3 comprises an opening in the form of a channel 32 passing through the implant along the axis of the bar. Said channel is open on one side of the implant and comprises in one of its edges clamping means moving along an axis perpendicular to the axis of the channel and the bar 2. Once inserted into the channel 32 of the implant 3, the bar is held by clamping against an internal wall 320 of the channel using clamping means, said means possibly being a clamping screw 31 co-operating with a threaded hole. In the embodiments illustrated in figures 1 to 6, the clamping screw 31 comprises a plane part 310 at its end pressing on the flat part 31 of the bar. As a general rule, said clamping screw may advantageously be of a set screw type so as to minimise its size while retaining the possibility of a long movement along its axis. Said screw comprises gripping means, such as an upper face comprising a recess 312, figures 7 and 8, capable of co-operating with a manoeuvring or clamping tool, for example a hexagon socket recess.
Due to the plane contact between the clamping screw 31 and the bar 2, it is possible to use several types of bars, of different thicknesses e1 , figure 3; e2, figure 5, in the same implant model, provided that the cross- section of the bar 2 is of a shape capable of co-operating with the lower wall 320 of the implant channel. Indeed, due to the plane nature of the contact surface 21 of the bar, the clamping screw 31 will clamp the bar 2 in the same way, irrespective of its thickness, provided that its travel is sufficient to come into contact with the flat part 21. Therefore, it is possible to have different bar thicknesses, and therefore different rigidities, for the same implant model, which reduces the stock and type of productions required to cover all requirements. It is also possible to modify rigidity by changing the bar during the operation or during a subsequent operation according to the performances obtained, without having to change the implants, which could represent an injury or additional damage to the vertebrae.
In another embodiment represented in figure 4a, the bar 2 comprises a second flat part 22 opposite the first flat part 21 and approximately parallel to said part, said second flat part 22 forming a bearing surface on the bottom face 320 of the channel 32 of the implant 3. In this arrangement, by means of its co-operation with the wall 320 of the channel, the second flat part 22 of the bar helps ensure the stability and centring of said bar in the channel 32 of the implant during clamping to ensure that the clamping screw 31 is indeed resting perpendicularly on the flat part 21 and therefore provides the best clamping possible. Through this increased stability, this arrangement also ensures improved subsequent reliability of the clamping, by preventing the bar 2 from pivoting around its axis under the effect of forces or vibrations, which would be liable to cause the loosening of the assembly.
In one embodiment, the channel 32 receiving the bar 2 in the implant 3 is of a shape enabling the extension of the bar along an outward direction d32 forming a non-null angle a with a plane perpendicular to the axis of the clamping means 31. To prevent any untimely escape of the bar from the implant, said angle a is oriented in the direction where the outward direction d32 of the bar forms an acute angle with the loosening direction d31 of the clamping means. This means that the clamping means 31 must move in the loosening direction d31 for the bar to be able to move d32 to the channel outlet. In one embodiment represented in figure 3b, the clamping screw 31 comprises a plane bearing surface 310 mounted on a ball joint 311 , enabling perfectly flat support on the bar, even if the flat part is not exactly perpendicular to the axis of said clamping screw, in particular when the axes of the different implants are not perfectly parallel. The permissible angle a31 of inclination may for example be of the order of 20°.
The clamping means may be immobilised by any known means, such as glue, the plastic deformation at one or more points of the surfaces cooperating for their movement, or the presence of elastically deformable substances in the threading such as a "Nyl'stop" type locking ring. The only micro-movements remaining possible for the bar are then, at the most, limited to the plane perpendicular to the axis d31 of the clamping means. The movements in this plane, particularly when moving from the base of the channel, are themselves restricted by a part of the bottom edge of the channel, forming an upward nose 321 opposing these movements.
In one embodiment represented in figure 4b, the bar 2 comprises a flat part 22 which co-operates with the inner wall 320 of the channel 32 of the implant forming a plane surface, thus ensuring the stability and centring of said bar in the channel 32 of the implant during the clamping of the clamping screw 31. Said plane surface 320 of the implant forms a non-null angle b with a plane perpendicular to the axis d31 of the clamping means. So as to prevent any untimely escape of the bar from the implant, said angle b is oriented in the direction where the outward direction d32 of the bar forms an acute angle with the loosening direction d31 of the clamping means. This means that the clamping means 31 must move in the loosening direction d31 for the bar to be able to move d32 to the channel outlet.
In one embodiment represented in figure 6, the implant 3 comprises bone anchorage means composed of one part 33 tapered and threaded in a known way, the bar fixation means and clamping means 31 are in this case located in the end opposite the bone anchorage means. In this embodiment, the axis d31 of the clamping means is parallel to the axis d33 of the bone anchorage means, the clamping being carried out by moving closer to the threaded part, referred to here as the lower part of the implant 3. So as to limit the size of the implant, the axis of the clamping means may be offset by moving away from the inlet of the channel 32 to insert the bar 2 in the implant. In the same way, the top edge of the channel comprises a recess r1 in relation to the bottom edge in its projection along the axis d33 of the implant. Said recess r1 could typically be of the order of 2 mm. So as to provide sufficient clamping, the nose 321 formed by the bottom end of the channel 32 protrudes upwards by a determined height r2 in relation to the plane perpendicular to the axis d31 of the clamping means and via the bottom part of the wall 320 which supports the bar 2 during clamping. Said height r2 could typically be of the order of 2 mm. For the implantation of an osteosynthesis device according to the method according to the invention, several types of implants, for example screwed or comprising a hook, may be used.
In the case (represented in figure 1 ) of screwed implants, this implantation may be carried out in the part of the vertebra referred to as the pedicle. This type of surgical intervention comprises in this case a step consisting of fixing by screwing the part of the implant 3 provided with a screw pitch 33 on the vertebrae V, for example two implants on each of five vertebrae, by aligning the directions of their respective channels upwards.
During a surgical intervention, if an osteosynthesis device is implanted using the method according to the invention, the use of bars 2 comprising one or more flat parts 21 , 22 enables said bars to offer a determined flexibility along a direction perpendicular to said plane faces. Said flexibility is important when bending the bars, necessary to adapt the entire device to the patient's conformation and the modifications that need to be made. The presence of said plane faces also enables the bars to comprise a plane surface on part of their length to comprise accurate implant dimensional references or positioning references.
Due to the fact that implants of the same model can accept several bar thicknesses e1 , e2, it will be possible to modify the choice of bar rigidity after fixing the implants, without needing to extract said implants from the vertebrae to insert others, therefore also without damaging the vertebrae further in the case of screwed implants.
In a following step of the method according to the invention (represented in figure 2), the arrangement of the opening of the channel 32 of the implant 3 makes it possible to insert the bar 2 in a simple lateral movement, without requiring a longitudinal movement along the axis of the bar as in the case of a clamp.
In one embodiment represented in figures 7 and 8, the device according to the invention uses one or more bars 2 comprising a transversal bearing surface 21 showing a face of opposed convexity to the rest of the circumference, i.e. concave. In this embodiment, the clamping means, for example the clamping screw 31, comprise a clamping face 310 showing a convexity in the same direction as the bearing surface 21 of the bar 2. Said clamping surface 310 may in particular show a form of revolution around its screwing axis d31 , so that said screwing can be carried out with a progressive approach and a continuous contact on the bar 2.
Depending on the applications, the bar 2 may comprise one or more regions comprising such a transversal bearing surface 21. Said bearing surfaces may be produced in several regions, contiguous or not, distributed along the bar or on only part of this length. Such a bar may in this way comprise one or more spherical recesses, or oblong recesses with a circular cross-section and spherical ends, or in the form of grooves of circular cross-section transversal to the bar. Said bearing surfaces may also be produced in several parts of the same section of the bar, i.e. distributed in several different angular positions around the same point located on the axis of the bar. Such a bar may in this way comprise several grooves along its length in different angular positions.
In the embodiment illustrated in figure 7, the clamping surface 310 and the bearing surface 21 comprise approximately complementary cross- sections, transversal to the bar 2. Therefore, clamping is carried out on large contact surface and ensures a good reliability in itself. In this embodiment, the clamping surface 310 may show for example a spherical portion shape. The channel 32 receiving the bar 2 in the body of the implant 3 may then comprise an arc-shaped internal wall 320 wherein the centre coincides with the centre of the clamping 310 and bearing surfaces 21. In this way, it is possible to modify, around said centre, the angular position of the bar in the channel, for example in a slightly offset position 2', to carry out a rotation or de-rotation to adjust the relative angular position of several implants fixed onto the same bar. Due to the arc shape of the internal wall 320 of the base of the channel 32, said adjustment may be carried out without modifying the distance of the bar to the clamping screw and therefore there is no risk of untimely locking or unlocking.
In this way, the invention relates to an osteosynthesis device, particularly for the spine by means of internal implantation, comprising firstly one or more bars 2 used to support or move the spine, and secondly at least one implant 3 connecting the bars and the vertebrae V, said implant comprising firstly bone anchorage means attached to the body of said implant and secondly fixation means for said bars, said fixation being carried out by clamping means 31 clamping said bar against the internal walls 320 of a channel 32 formed in said body of the implant 3, characterised in that said bars comprise a transversal bearing surface 21 on at least part of their length, said transversal bearing surface being produced by a section of said bars comprising at least one flat part or part of lower or opposed convexity in relation to the rest of said section. According to one embodiment, the transversal bearing surface 21 of the bar is composed of at least one concave shaped face, showing the shape of a concave recess or a groove.
According to one embodiment, the clamping means 31 comprise a joint 311 , for example a ball joint, between their main body and the plane surface 310 supported on the flat surface 21 of the bar 2, enabling a plane support even if the flat part of the bar forms a non-null angle a31 with a plane perpendicular to the axis d31 of the clamping means.
According to one embodiment, the plane surface 320 of the channel
32 of the implant can form a non-null angle b with a plane perpendicular to the axis d31 of the clamping means, said angle b being oriented in the direction where the clamping means are to be loosened d31 to enable the bar to come out d32 of the base of the channel. According to one embodiment, the approach distance of the clamping means 31 and the dimensions of the channel 32 of the implant are sufficiently large to receive bars of different thicknesses e1 , e2 with the same implant model 3, it being possible to compensate for said differences in thickness with a variation in the position of the clamping means in relation to the opposite wall 320 of the channel.
According to one embodiment, the edge of the channel opposite the clamping means forms a nose 321 which prevents the bar 2 from coming out of the channel 32 perpendicular to the axis of the clamping means 31 , for example under the effect of vibrations, wear or crushing of the different surfaces in contact.
According to one embodiment, the clamping means 31 are composed of a clamping screw mounted into a threaded hole passing through one of the edges of the channel 32 receiving the bar 2 in the implant 3. According to one embodiment, the bone anchorage means of the implant are composed of a tapered and threaded part 33 that can be screwed into a vertebra V, for example into a pedicle.
According to one embodiment, the top edge of the channel 32 comprising the clamping screw 31 is retracted at the symmetrical axis d33 of the implant in relation to the bottom edge of the channel, limiting the size of the implant in the part opposite the bone anchorage means.
It should be clear to those skilled in the art that the present invention allows embodiments in numerous other specific forms without leaving the scope of the invention as claimed. As a result, the present embodiments rnust be considered as illustrations, but may be modified in the field defined by the scope of the claims attached and the invention must not be limited to the details given above.
1. Osteosynthesis device, particularly for the spine by means of internal implantation, comprising firstly one or more bars (2) used to support or move the spine, and secondly at least one implant (3) connecting the bars and the vertebrae (V), said implant comprising firstly bone anchorage means
5 attached to the body of said implant and secondly fixation means for said bars, said fixation being carried out by clamping means (31) clamping said bar against the internal walls (320) of a channel (32) formed in said body of the implant (3), characterised in that said bars comprise a transversal bearing surface (21 ) on at least part of their length, said transversal bearing surface 0 being produced by a cross-section of said bars comprising at least one flat part or part of lower or opposed convexity in relation to the rest of said cross- section.
2. Device according to claim 1 , characterised in that the transversal 5 bearing surface (21) of the bar is composed of at least one concave shaped face, showing the shape of a concave recess or a groove.
3. Device according to any of claims 1 to 2, characterised in that the clamping means comprise a convex surface (310) which is supported on the o recess or groove of the bar (2), thus ensuring good clamping reliability.
4. Device according to claim 1 , characterised in that the transversal bearing surface of the bar is composed of at least one face in the form of a flat part (21).
5 5. Device according to claim 4, characterised in that the clamping means comprise a plane surface (310) which is supported on the flat part (21) of the bar (2), thus ensuring good clamping reliability.
6. Device according to any of claims 4 to 5, characterised in that the 0 clamping means (31) comprise a joint (311 ), for example a ball joint, between their main body and the plane surface (310) supported on the flat part (21 ) of the bar (2), enabling a plane support even if the flat part of the bar forms a non-null angle (a31) with a plane perpendicular to the axis (d31) of the clamping means.
7. Device according to any of claims 1 to 6, characterised in that the bars (2) comprise at at least one of their ends a part with no flat part or transversal bearing surface over a determined length, said part with no flat part forming a shoulder (23) capable of co-operating with the shape of the implant or clamping means to act as a longitudinal stop on the bars, thus making it possible to reduce the length protruding from the implants (3) located at their ends and therefore to reduce the size of the device.
8. Device according to any of claims 1 to 7, characterised in that the support bars (2) comprise on a part of their length a plane face (22) cooperating with an internal wall (320) of the channel of the implant forming a plane surface to carry out positioning and stable centring of the bar in said opening.
9- Device according to claim 8, characterised in that the plane surface
(320) of the channel (32) of the implant can form a non-null angle (b) with a plane perpendicular to the axis (d31) of the clamping means, said angle (b) being oriented in the direction where the clamping means are to be loosened (d31 ) to enable the bar to come out (d32) of the base of the channel.
10. Device according to any of claims 1 to 9, characterised in that the approach distance of the clamping means (31) and the dimensions of the channel (32) of the implant are sufficiently large to receive bars of different thicknesses (e1 , e2) with the same implant model (3), it being possible to compensate for said differences in thickness with a variation in the position of the clamping means in relation to the opposite wall (320) of the channel.
12. Device according to any of claims 1 to 11 , characterised in that the implant (3) receives the bar (2) in a channel (32) wherein the opening comprises an extension direction (d32) forming a non-null angle (a) with a plane perpendicular to the axis (d31 ) of the clamping means, said angle (a) being oriented in the direction where the clamping means are to be loosened (d31) to enable the bar to come out (d32) of the base of the channel.
14. Device according to any of claims 1 to 13, characterised in that the clamping means (31 ) are composed of a clamping screw mounted into a threaded hole passing through one of the edges of the channel (32) receiving the bar (2) in the implant (3).
16. Device according to claim 15, characterised in that the axis (d31 ) of the clamping screw is approximately parallel to the symmetrical axis (d33) of the bone anchorage means of the implant.
17. Device according to any of claims 15 to 16, characterised in that the top edge of the channel (32) comprising the clamping screw (31) is retracted toward the symmetrical axis (d33) of the implant in relation to the bottom edge of the channel, limiting the size of the implant in the part opposite the bone anchorage means.
18. Device according to any of claims 15 to 17, characterised in that the nose (321 ) formed by the bottom edge of the channel (32) protrudes by a determined distance (r1) in relation to the top edge moving from the axis (d33) of the implant and protrudes by a determined distance (r2) in relation to the base (320) of the channel, along the axis of the clamping screw and in the loosening direction (d31 ).
19. Device according to any of claims 1 to 14, characterised in that the bone anchorage means of the implant are composed of a curved part that can be attached to a shape disorder present on a spinal component.
20. Device according to any of claims 1 to 19, characterised in that it can be used to perform spinal osteosynthesis in exclusively internal implantation.
21. Method to prepare an osteosynthesis device according to any of the above claims, characterised in that it comprises a step consisting of inserting the clamping means (31) into the implants (3), said step being carried out prior to the surgical intervention.
PCT/IB2002/002827 2001-04-06 2002-04-03 Spinal osteosynthesis device and preparation method WO2002080788A1 (en)
DK05292783T DK1656898T3 (en) 2001-04-06 2002-04-03 Device for osteosynthesis
CA 2443215 CA2443215C (en) 2001-04-06 2002-04-03 Spinal osteosynthesis device and preparation method
DE2002609732 DE60209732T2 (en) 2001-04-06 2002-04-03 System for spinal osteosynthesis and process for its manufacturing
EP20020745729 EP1372503B1 (en) 2001-04-06 2002-04-03 Spinal osteosynthesis device and preparation method
JP2002578827A JP4245352B2 (en) 2001-04-06 2002-04-03 Spinal osteosynthesis device and method of forming
US10473999 US7507248B2 (en) 2001-04-06 2002-04-03 Spinal osteosynthesis device and preparation method
BR0208659A BR0208659B1 (en) 2001-04-06 2002-04-03 Osteosynthesis device.
MXPA03009106A MXPA03009106A (en) 2001-04-06 2002-04-03 Spinal osteosynthesis device and preparation method.
KR20037012914A KR100879046B1 (en) 2001-04-06 2002-04-03 Spinal osteosynthesis device and preparation method
US10473999 A-371-Of-International 2002-04-03
US10473999 A-371-Of-International US7507248B2 (en) 2001-04-06 2002-04-03 Spinal osteosynthesis device and preparation method
WO2002080788A1 true true WO2002080788A1 (en) 2002-10-17
WO2007045895A1 (en) * 2005-10-22 2007-04-26 Depuy International Limited A spinal support rod kit
KR101173964B1 (en) 2006-12-14 2012-08-16 프리아덴트 게엠베하 Apparatus for inserting implants
FR2545350A1 (en) 1983-05-04 1984-11-09 Cotrel Yves Apparatus for shoring spine
US7507248B2 (en) 2009-03-24 grant
Ref document number: 2002745729
Ref document number: 2002318541
Ref document number: 200307583
Ref document number: 2003/07583
Ref document number: 2443215
Ref document number: 2002578827
Ref document number: PA/a/2003/009106
Ref document number: 028091566
Ref document number: 2003132460
Ref document number: 10473999