Abstract: Disclosed is a dynamically stabilizing intervertebral implant consisting of a stabilizing wedge (1), a blocking pin (2), a locking screw (3), and a flexible link in the form of a strap. The stabilizing wedge includes a cavity (12) into which the strap can be inserted. The blocking pin can engage the wedge by being moved inside the cavity in the direction of the main axis of the body of the wedge in such a way that the longitudinal axis of the blocking pin coincides with the longitudinal axis of the cavity, runs perpendicular to the longitudinal axis of the first portion of the strap inside the cavity and runs parallel to the surface of the first portion of the strap inside the cavity. The strap is immobilized relative to the stabilizing wedge by being clamped between the blocking pin and the inner wall of the cavity.
Technical area
The present invention relates generally to implants used in spinal surgery, and more particularly to an intervertebral implant for dynamic stabilization as well as a surgical kit incorporating.
Background Art
The operations in the field of spine surgery may affect the cervical (neck), the dorsal region or, more frequently, the lumbar region.
When there is an instability, such as a slip of one vertebra relative to the adjacent vertebrae, a spinal stabilization may be accomplished by implanting the metal material in the form of screws interconnected by bars or plates . These implants are a scaffold that acts as a stabilizer of the spine.
According to more recent techniques, the stabilization can be obtained from the column through an intervertebral implant consisting of a stabilizer wedge, a flexible link type textile braid, a movable assembly and a locking member. The stabilizer wedge is intended to be positioned between the spinous processes of two consecutive vertebrae, that is to say adjacent to stabilize. The flexible link (e.g., a textile braid) encloses the apophyses. The moving assembly is adapted to engage with the wedge stabilization so as to lock the flexible link moving relative to the stabilizer wedge. This blocking is achieved by pinching of the flexible link between the mobile assembly and the stabilizer wedge. The locking member (e.g. a screw) is adapted for locking engagement of the movable assembly with the stabilizer wedge, and thus the final locking of the flexible link which follows directly.
Prior art
An intervertebral implant of the aforementioned type is disclosed, for example, in EP 2192863 published by ΟΜΡΙ under publication number WO 2009/040380 and in EP 2303163 published by ΙΌΜΡΙ under publication number WO 2009/141393.
Most lumbar operations are carried out in open hearth rear (channel first posterior), by making an incision in the patient's back in the vertebrae to be stabilized.
The design of the prior art implants involves making gestures by the surgeon require to identify a broad intervention area around the vertebrae to stabilize, particularly for the implementation of flexible links or in the hold, and for tensioning and blocking this or these links.
EP 2138122 describes a stabilization system between the sacrum and lumbar vertebrae. The system comprises at least a textile braid which is anchored in the sacrum by screws. To ensure blocking voltage braids blocker comprises camming pins between the inner walls of an opening provided in the body of the blocker. The direction of movement of such a mobile piece is tangent to the surface of the braid and is parallel to the longitudinal axis of said braid. These provisions are not adapted to an intervertebral implant as one who is the subject of the present invention.
Summary of the Invention
It is important to provide the surgeon with an intervertebral implant of dynamic stabilization that reduces the size of the incision to a minimum to protect the surrounding tissues (including muscle tissue that contribute to the stability of the spine) the stress of the spacing of the surgical wound that can cause severe necrosis. The patient's recovery from surgery is more rapid, and with a result all the more satisfying.
For this purpose, a first aspect of the invention provides an intervertebral implant for dynamic stabilization comprising:
- a stabilizer wedge adapted to stabilize them at least two adjacent vertebrae by the interposition between the spinous processes of the vertebrae, having a substantially parallelepipedal body having a principal axis determined,
- at least one strap forming flexible link for fixing the stabilizer wedge the spinous processes of the vertebrae to be stabilized, said strap having a first and second strap portions comprising each one of the opposite ends of the strap and said strap having a longitudinal direction determined and a specific surface strap,
- at least one movable assembly adapted to engage with the stabilizer wedge, so as to lock the strap moving relative to the stabilizer wedge by pinching the strap between the moving assembly and the stabilizer wedge, and
- a locking member for locking the axial position the movable assembly with the engagement of the stabilizer wedge and thus the locking of the strap.
According to embodiments, the body of the stabilizer wedge comprises at least one recess into which can pass at least the first strap portion, the recess having a longitudinal axis parallel to the main axis of the stabilizer wedge, and an inner wall extending parallel to said longitudinal axis of the recess with a predetermined shape;
- the movable assembly comprises at least one locking pin having a given longitudinal axis and a substantially complementary shape of the determined shape of the recess, for engagement with the shift stabilizer wedge in the direction of the main axis the body of said wedge within the recess such that the longitudinal axis of the locking pin:
- first coincides with the longitudinal axis of the recess; - secondly is perpendicular to the longitudinal axis of the first strap portion within the recess; and,
- thirdly is parallel to the surface of the first strap portion inside the recess,
and whereby, moreover, that the strap portion within the recess is prevented from movement relative to the nip stabilizer wedge of said strap portion forming a flexible connection between the locking pin and the wall internal of the recess.
The main axis above coincides with the axis of the posterior approach to the surgical operation to put the implant in place. The slot in the stabilizer wedge being rearwardly open when the wedge is brought into the installation position, its longitudinal axis corresponds to the axis of the posterior approach (as opposed, e.g., to access side, the terms "rear" or "lateral" being those of the vocabulary used in the field of spinal surgery). The latch bolt can thus conveniently and usefully be forcibly inserted into the housing according to the axis of the posterior approach. The area of intervention and insertion (open hearth) can be reduced to a minimum. The invention thus allows a truly minimally invasive procedure and surgical treatment short walking-type.
In one embodiment it can be directly complementary further provided that:
- each of the first and second strap portions can pass through the slot in the stabilizer wedge in order for the strap to form at least one loop in a plane perpendicular to the main axis of the wedge, with a strap adapted to engage with one of the spinous processes of two vertebrae to be stabilized, and so that further
- the latch bolt is engageable with the stabilizer wedge in the direction of the main axis of the body of said shim between each of the first and second strap portions (41a, 42a) within the recess , such that the longitudinal axis of the pin:
- first coincides with the longitudinal axis of the recess;
- DISTINTO summit perpendiculaire to the longitudinal alignment of chacune des deux portions of sangle Inside the évidement; and,
- thirdly is parallel to the surface of each of first and second strap portions within the recess,
and whereby, moreover, that each of the first and second strap portions is locked in movement with respect to the stabilizer wedge nip of said strap portion between the pin and respective portions of the inner wall of the recess facing to each other.
In a directly additional embodiment, the first and second strap portions can pass into the housing provided in the stabilizer wedge in opposite directions so as to intersect in said housing, and in order for the strap to form a loop in a plane perpendicular to the main axis of the wedge, with two loops located respectively on either side of the stabilizer wedge in said plane and adapted to come into engagement with each respective one of the spinous processes of two vertebrae stabilize.
In one embodiment, the recess in the stabilizer wedge has a conical shape, and the locking pin is of conical shape complementary to the shape of the recess.
In one embodiment, the body of the stabilizer wedge comprises passages for the strap extending perpendicularly to the main axis of the body of said shim including at least one passage passing through the recess, into which passages at least strap can slide when it is not locked in movement with respect to the stabilizer wedge.
In one embodiment, the strap is a braid made of textile material nonabsorbable medical use.
In one embodiment, the recess has a threaded opening region of larger diameter than the diameter of the recess behind said opening portion, and the locking member is a screw of the same diameter as the diameter of the recess of the opening area with a thread adapted to cooperate with the internal thread of the opening area, and with a bearing zone adapted to bear against a contact zone of the locking pin into the recess when the screw is screwed into the threaded opening area of the recess.
In a second aspect, the invention also relates to a surgical kit comprising an implant according to the first aspect above, and a tool to the positioning of the wedge of the implant, which is also called implant holder in the following and an insertion stem of the implant locking pin.
Specifically, the kit is such that:
- the implant holder has a tubular body having an inner channel with an inner diameter slightly larger than the largest diameter of the implant locking pin and adapted to be fixed to the body of the spacer of stabilization such that the channel is parallax with the axis of the recess in the body, and
- the insertion rod of the locking pin adapted to slide in the internal channel for the introduction of the locking pin into the recess of the body of the stabilizer wedge.
In one embodiment, the tubular body of the implant holder may be provided at one end with a thread for cooperating with the internal thread of the recess provided in the body of the stabilizer wedge. This allows the mounting of the implant to the implant using the thread provided in addition to the implant locking screw which is set up subsequently during the implantation operation.
In another embodiment, the implant holder may be provided at a second end with an internal thread at the inlet of the channel, and the insertion rod can be provided with a thread for engaging said thread so that the insertion and screwing of the insertion stem in the implant holder of the channel causes the conical pin in the housing provided in the body of the spacer.
Brief Description of Drawings
Other features and advantages of the invention will appear from reading the following description. This is purely illustrative and should be read in conjunction with the accompanying drawings wherein:
- Figure 1 is an exploded three-dimensional view of a portion of the intervertebral implant according to embodiments;
- Figure 2 is a front view, along the axis of the posterior approach, of the assembled implant according to embodiments;
- Figure 3 is an exploded three-dimensional view of a portion of the intervertebral implant and associated implant holder, according to embodiments;
- Figure 4 an exploded three-dimensional view of a portion of the intervertebral implant with the implant holder door mounted on the implant, and an insertion rod of the locking pin according to embodiments;
- Figure 5A and Figure 5B are a sectional view and a sectional view in three dimensions, respectively, of the stabilizer wedge provided with the strap and the locking pin installed, according to embodiments;
- Figure 6A and Figure 6B are views identical to those of
5A and 5B, respectively, also showing the locking screw engaged in the recess of the entry in the hold; and,
- Figure 7A and Figure 7B are views identical to those of Figures 5A and 5B, respectively, further illustrating the locking screw in the locking position.
Detailed description of embodiments
The intervertebral implant is designed to be positioned between the spinous processes of two adjacent vertebrae, that is to say the stack consecutive vertebrae in the lumbar vertebrae, back and neck.
The main elements of the intervertebral implant of dynamic stabilization device according to embodiments of the present invention will be described, firstly with reference to Figures 1 and 2. As shown in these figures, the implant is composed of a stabilizer wedge 1, a locking pin 2, of a locking screw 3, and a flexible link 4.
The stabilizer wedge 1 comprises a generally parallelepipedal body with a main axis which, for the sake of clarity in Figure 1, is coincident axis in this figure the longitudinal axis 10 of a recess 12 provided in the body and on which return later. Figure 2 is a view of the implant along the longitudinal axis 10, when the implant is placed flat against the patient's vertebrae (which is lying on the operating table, on the stomach). The main axis 10 coincides with the axis of the posterior approach, that is to say, it is perpendicular to the spine of the patient and therefore to the axis of the spine corresponding to the direction of stacking of vertebrae from the lumbar vertebrae to the cervical vertebrae.
In terms of the descriptive language, is considered below the viewing direction of the site of implantation by the surgeon according to the axis of the posterior approach, during the implantation and then the operation patient is lying on his stomach against the operating table. Thus, Figure 2 shows a front view along this axis, and a top view in this direction. The words "after", "front" and "rear", "front" and "rear", "front" and "rear", "above" and "below", "upper (e)" and "lower (e) "," high "and" low "," side (e) "and" side "," right (s) "and" left ", especially, are used in the following with reference to this convention. These terms also correspond to the vocabulary used by business people in the field of spine surgery.
The body of the stabilizer wedge 1 comprises, on a lateral side of the parallelepiped, in particular to the right in Figures 1 and 2, an indentation or notch 15 and upper notch or a lower notch 16. These notches are adapted to come into bears against two vertebrae to be stabilized, and more particularly the process of the vertebra from above by the notch 15 and the process of the vertebra from below through the notch 16,
respectively. In other words, in the installed position of the implant for stabilization of two adjacent vertebrae, the spinous processes of these vertebrae are housed in the notches 15 and 16 of the body of the block 1.
As seen in Figure 1, the parallelepiped body of the block 1 has softened angles (ie rounded), at least on the back side intended to be covered by flesh and the patient's back skin. This limits the risk of inflammation or damage to the flesh back into contact with the implant. Also, this reduces the discomfort or pain that the patient can feel if pressed on that part of its back, for example when it is backed against a support (e.g. a seat back) or is lying on his back (e.g. on a hard surface such as the ground).
The locking pin 2 may have a cylindrical and conical shape, that is to say having the shape of a cylinder, the diameter of the section (circular) gradually decreases along its longitudinal axis. In Figure 1, again for clarity of the drawing purposes, the longitudinal axis of the pin coincides with the main axis 10 of the body 1 of the spacer and with the longitudinal axis of the recess 12.
The pin 2 is adapted to cooperate with the recess 12 provided in the body of the block 1, for example on the lateral side of the parallelepiped opposite to that where the recesses 15 and 16 are located (ie, to the left in Figures 1 and 2 ). For this purpose, the pin 2 and the recess 12 have complementary shapes to each other. In the example shown, the pin has the shape of a tapered cylinder, and the recess 12 also has a shape of hollow conical cylinder with an opening angle equal to that of the pin and an opening diameter slightly greater than that of the peg.
The recess opens out (open) at least on the side of the rear face of the wedge 1, and preferably on the side of each of the front and rear faces of the wedge, as shown in Figures 5A-5B, 6A-6B and 7A-7B. The diameter of the opening is substantially larger than the largest diameter of the pin, and is constant in a recess inlet area on the side of the rear face, by which the pin 2 is intended to enter with its end tapered. In this inlet region of the recess, the walls
have an internal thread (screw thread) 1 1 for the locking screw which will be discussed further. The length of the inlet zone, along the longitudinal axis is at least equal to the thickness of the locking screw 3. In front of the inlet zone, the shape of the recess is conical, without thread (smooth wall) and substantially corresponds to the complementary shape of the pin, that is to say that the shape is conical with the same aperture angle as that of the pin but with a slightly larger diameter in order to receive the pin and the braid as will be explained later. In other words, in front of the recess of the inlet region which is threaded, the diameter of the recess progressively decreases along its longitudinal axis 10 towards the front. In particular, the length of the conical part of the recess following the longitudinal axis of the recess is substantially equal to the length of the locking pin 2 in its longitudinal direction.
The locking screw 3 is also shown in Figure 1 parallax with the main axis 10 of the body 1 of the spacer and the longitudinal axis of the recess 12. The screw 3 has a greater diameter than the largest diameter pion. This diameter corresponds to that of the threaded opening area of the recess 12. The screw 3 has an external thread (thread) 31, adapted to cooperate with the internal thread 1 1 There the recess 12.
The screw 3 also has a bearing zone 32, faces downwards in Figure 1, capable of abutting against a contact area 22 at the rear of the pin 2. In an embodiment the bearing region 32 of the screw 3 and / or the contact area 22 of pin 2 are circular planar surfaces.
The function of the screw 3 is to lock the position of the pin 2 engaged in the recess 12. Another function of the screw is, according to embodiments, to adjust the axial position of the pin in the recess: by turning the screw 3 engaged in the recess 12 via their respective threads, the screw rests with its surface 32 against a contact surface 22 on the rear side of the pin 2, so that it progresses in the recess 12 along its longitudinal axis from the rear face of the wedge to its front face. Details of the setting position will be given later with reference to Figures 5A-5B, 6A-6B and 7A-7B.
The flexible link 4 may be a braid made of a textile material for medical use (non-resorbable), for example Polyethylene Terephthalate (PET) or polyethylene (PE). These materials can be chosen for their biocompatibility and their high chemical inertness. In the installed position of the implant, the flexible link 4 encloses the processes in a similar manner to that described in EP 2192863, particularly as shown in Figures 3, 10 and 1 1 of the publication of this document.
4 the flexible link preferably has the form of a strap (eg, tape), with a longitudinal axis and a strap surface extending along said longitudinal direction. It can pass into a passage 17 of the body of the wedge provided in the caudal end of the body of the block on the right side thereof, that is to say the side notches 15 and 16 which is opposite to the recess 12. the portion 17 passes through the body of the block 1 perpendicular to the main axis 10 of the body 1 of the spacer. When not locked in movement with respect to the hold, the flexible link 4 can slide in the passage 17.
4 the flexible link may also pass into the recess 12. For this purpose, the body of the spacer may have two other passages 13 and 14 passing through the body 1 from side to side perpendicularly to the main axis 10 of the body 1 of the down. The passages 13 and 14 thus extend perpendicularly to the main axis 10 of the body 1 of the spacer. At least one of the passages 13 and 14, and preferably two passages 13 and 14 pass through the recess 12. In other words, the grooves 13 and 14 open into the recess, each of the front side and by the back side. In the embodiment shown, the two passages 13 and 14 and pass through the recess 12, but this is not mandatory, and it would be possible that only one of passages 13 and 14 only through the recess 12. When it is not locked in movement with respect to the cleat 1, the flexible link 4 can slide in the passages 13 and 14.
4 the flexible link is inserted manually by the surgeon, for example, first through the passage 17. Then the two ends 41 and 42 of the flexible link 4 are alternately inserted into the grooves 13 and 14 having the engaged par- above and below the spinous processes of the upper and lower vertebrae, respectively.
More particularly, the strap then forms a loop in a plane perpendicular to the main axis 10 of the wedge 1, with at least one and preferably two loops 4a and 4b respectively located on either side of the wedge in said plane . These loops 4a and 4b of the textile braid are adapted to come into engagement with each respective one of the spinous processes of two vertebrae to be stabilized.
The locking pin 2 is engageable with the stabilizer wedge in the direction of the main axis 10 of the body 1 of the spacer between each of the strap portions within the recess, such that the longitudinal axis of the pin:
- first coincides with the longitudinal axis 10 of the recess;
- DISTINTO summit perpendiculaire to the longitudinal alignment of 40 chacune des deux portions of sangle Inside the évidement; and,
- thirdly is parallel to the surface of each of the two strap portions within the recess (ie, the strap portions at the ends 41 and 42 respectively, of the strap).
In addition, each of the portions of the strap on the side of its ends 41 and 42 respectively, is then locked in movement with respect to the cleat 1. This locking is obtained by pinching said strap portions between the pin and respective portions of the inner wall of the recess 12 facing with each other.
To illustrate the locking of the two portions of the strap 4 with the pin 2, the central portion of Figures 5A, 6A and 7A corresponding to the internal space of the recess (which receives the pin 2) is shown along a plane of cut at 90 degrees relative to the body 1 of the cutting plane of the wedge on these same figures. Thus, these Figures 5A, 6A and 7A show in their center a sectional view of the portions 41a and 42a of the side strap 40 of the ends 41 and 42 of said strap, respectively.
In one embodiment, these two extreme portions of the strap 41a and 42a can pass into the housing 12 provided in the wedge 1 in opposite directions so as to intersect in said housing and for forming
loops 4a and 4b. This embodiment is shown in FIGS. It is however not exclusive. Indeed, the two portions extremal 41a and 41b of the strap may move parallel to each other in the passages 13 and 14, and therefore in the recess 12, with another form of engagement with the processes spiny vertebrae to be stabilized, and also through another form of the stabilizer wedge. In particular, in such embodiment, the strap would form a strap, so that two straps are used, namely one for each of the vertebrae, with the same hold.
To facilitate the insertion operation into the passages 13 and 14, the ends 41 and 42 of the strap may be reinforced, for example by treatment with an ultrasonic welder, by adding material or by a titanium piece, or any other suitable material, or by any other equivalent means.
Advantageously, the locking means and locking of the flexible link 4, which includes the pin 2 and the screw 3 are set up by the rear face of the stabilizer wedge 1. This provision allows the surgeon to reduce the incision size to a minimum, and thus maintain the integrity of the surrounding body tissues, especially the back muscles.
After the establishment of the flexible link 4 and its tensioning with the aid of a suitable tool (operation not described in the context of the present description), the locking pin 2 is inserted into the housing 12, between the two extreme portions of the flexible link 4. the insertion of the pin causes the two clamping portions of the flexible connection 4 between the outer circumferential surface of the pin 2 and the inner wall opposite the recess 12, and stabilizes the flexible link 4. because of this compression of the flexible link 4, it can no longer slide in the passages 13, 14 and 17. the locking screw 3 is then engaged in the recess 12, for example by hand (using or not a tool), once the pin 2 has been fully inserted into the threaded portion 1 1 of recess 12 as shown in Figures 5A and 5B. This operation is illustrated by Figures 6A and 6B. The function of the screw 3 is to lock (axial position) the engagement of the latch bolt 2 into the recess 12.
The method of introduction of the locking pin 2 uses an implant holder 5 and an insertion rod 6, which are shown in Figures 3 and 4. The implant holder 5 is for example a hollow tube, it is -to say, it has a tubular body having an inner channel 52, for example of constant circular section with an inner diameter slightly larger than the largest diameter of the locking pin 2.
At one end of the tube 5, there may be provided a female thread 53 at the canal entrance 52. Also, the gripping means 54 may have the form of a fluted flange surrounding the tube 5 as shown, may be provided on the side of the inlet end of the tube 5.
At the other end thereof, the tube 5 is provided with an external thread 51 which cooperates with the internal thread 1 1 of the stabilizer wedge 1. The implant holder 5 can thus be screwed into the stabilizer wedge 1, with the internal channel 52 in alignment with the longitudinal axis 10 of the recess 2, that is to say parallax with the recess 12 in for insertion of the locking pin 2 in said recess 12.
For this purpose, the pin 2 can be attached easily releasably to the end of the insertion rod 6 by means for example of a resilient adapter, not shown, and the detailed description is not necessary for the good understanding of the operating principle.
The insertion stem 6 with taper pin 2 and maintained in a detachable manner at its end, are introduced into the channel 52 of the implant holder 5. The insertion rod 6 is provided with an external thread below gripping means such as a splined head 61 as shown. This thread (not shown) cooperates with the internal thread 53 of the implant holder 5. In this way, insertion and screwing of the insertion rod 6 into the channel 52 of the implant holder 5 causes the conical pin 2 in the housing 12 of the wedge 1. One can thus engage the pin 2 in the conical portion and unthreaded from the recess 12, as has been indicated above by screwing of the insertion stem in the implant holder. After complete screwing of the insertion stem in the implant holder, the pin 2 is fully engaged in the tapered portion of the recess 12.11 then comes into engagement with the inner wall of the recess by pinching the flexible link 4 against this wall. The crushing of the braid which follows from the nip gives a certain elasticity, very low, with the engagement of the pin against the inner wall of the recess.
The implant holder 5 can then be unscrewed from the cleat 1, optionally after unscrewing of the insertion rod of the implant holder (not mandatory). The pin 2 is automatically detached from the end of the insertion rod 6 remaining in place in the unthreaded conical portion of the recess 12. For this purpose, the force of the resilient connection of the pin 2 to the end 62 of the insertion rod 2 is calibrated so as to be lower than the clamping pressure applied to the pin 2 by the inner wall of the unthreaded conical portion of the recess 12 when the pin is fully engaged there.
When the pin 2 insertion operation into the recess 12, the one stabilizer wedge may be held by the surgeon, in position with the straps 4a and 4b of the belt 4 engaged around the spinous processes of the vertebrae to stabilize , thanks to the gripping area of the implant holder 5. the implant holder thus simultaneously serves to maintain the stabilizer wedge in position against the vertebrae in the critical step of inserting the locking pin of the flexible link 4 and a guide for the insertion of the pin through the pin 6 which slides in the internal channel 52 of the implant holder and is screwed thereon.
Once the implant holder 5 separated from the wedge 1 which is thus already experiencing stabilization of the vertebrae, the locking screw 3 can be engaged in the threaded portion 1 1 of the recess 12 provided in the wedge, as shown in Figure 6A and Figure 6B. Note that, at this stage, the flexible link is already blocked by the pin 2 by pinching extremal portions 41a and 42a against the opposing portions of the inner wall of the recess 12, as shown in Figure 5A and Figure 5B.
The screw 3 and the taper pin 2 are used to control the clamping pressure exerted on the flexible link 4 without using a device for measuring the force or torque.
For this purpose, the length of the taper pin 2 in its longitudinal direction is calibrated so that its flat contact surface 22 is flush slightly above the countersink of the threaded hole 1. 1 of the stabilizer wedge
1 when it is inserted according to the technique described above. The planar support face 32 of the screw 3 then abuts against the countersink of the threaded hole 1. 1 and in support on the flat contact surface 22 of the conical pin 2, the rear side, as shown in Figure 7 A and Figure 7B.
Screwing the screw 3 into the threaded hole 1. 1 shall be for example by hand, using a screwdriver, for example a hexagonal head. When the flat surface 32 of the clamping screw comes in contact with the contact surface 22 of the locking bolt, the locking screw causes the locking pin
2 further into the recess 12, until the planar surface 32 of the clamping screw match the countersink of the threaded hole 1. 1 which forms a shoulder. The axial advancement of the conical pin 2 is then blocked by said shoulder, ensuring that the pressure exerted by the conical pin 2 of the flexible link 4 will not increase anymore even if the surgeon continues to exert a torque on the clamping screw 3 using the screwdriver.
In this position, the screw 3 prevents any movement of the pin 2 which would tend to make it stand out from the recess 12, for example under the effect of tension exerted on the flexible link 4 by the patient's movements in the life of gestures common. This is the locking feature of the screw 3 according to the principle of the embodiments of the invention. As we have understood, this function is exercised radically manner different from that of the screw described in EP 2192863 and EP 2303163. Documents It is exercised in cooperation with the conical pin 2 which is functionally and structurally radically different from the movable part of the implant described in these documents. The originality of the function of the locking pin according to embodiments of the invention lies in the pin movement direction which is orthogonal to the direction of the pressing force of the pin against the surface of the strap 4 and against the inner wall of the recess 12 provided in the wedge.
1 the stabilizer wedge may be made of a polymer, such as polyether ether ketone (PEEK). It can be obtained by machining from a bar or block of raw material, by injection molding, 3D printing, or by any other equivalent technique.
The tapered locking pin 2 is preferably made of titanium alloy, selected for its mechanical strength and biocompatibility. It is provided with a rounded end of the more tapering side to facilitate its passage between the tensioning strap portions of the flexible link. It may for example be obtained by machining from a raw material bar.
The screw 3 of clamping and locking can also be a titanium alloy, for the same reasons and with the same advantages. It can be obtained by machining from a raw material bar.
4 the flexible link is made, preferably woven textile. As already mentioned above, the ends of the flexible link may be stiffened so as to facilitate gripping and guiding them through the passages 13, 14 and 17 provided in the body of the stabilizer wedge 1.
The present invention differs from the invention described in EP 2192863 in particular due to that the dynamic stabilizer wedge has no part set in motion perpendicular to the surface of the strap, so in a lateral direction. On the contrary, the pin moves only along the axis of the posterior approach. The solution described herein also allows to install a locking screw 3 which provides a safety device (locking position) of the locking pin 2 of the strap 4, and allows exerted pressure control due to the control the axial displacement of the pin 2 in the recess 12. This screw is also introduced and clamped in the direction of the axis of the posterior approach.
In other words, and following the main advantage of the embodiments described, no action surgeon and no moving parts movement is performed in a lateral direction. Everything is going along the axis of the posterior approach.
The invention has been described and illustrated in this detailed description and in the Figures, in particularly advantageous embodiments. It is not limited, however, to the embodiments presented. Other variants and embodiments can be derived and implemented by the skilled person reading this description and the accompanying drawings.
In the claims, the terms "comprises" or "comprises" do not exclude other elements or other steps. The various features disclosed and / or claimed may be advantageously combined. Their presence in the description or in different dependent claims does not exclude this possibility. Reference signs should not be understood as limiting the scope of the invention.
CLAIMS
1. An intervertebral implant comprising:
- a stabilizer wedge (1) adapted to stabilize them at least two adjacent vertebrae by the interposition between the spinous processes of said vertebrae, having a substantially parallelepipedal body having a principal axis determined,
- at least one strap (4) forming flexible link for fixing the stabilizer wedge the spinous processes of the vertebrae to be stabilized, said strap having a first and second strap portions (41a, 42a) each comprising one of opposite ends (41, 42) of the strap, and said strap having a longitudinal direction determined and a specific surface strap,
- at least one mobile assembly (2) adapted to come into engagement with stabilizer wedge, so as to lock the strap moving relative to the stabilizer wedge nip of said strap between said movable assembly and said stabilizer wedge, and
- a locking member (3) for locking the axial position of engagement of the movable assembly with the stabilizer wedge and thus the locking of the strap,
characterized in that
- the body of the stabilizer wedge comprises at least one recess (12) into which can pass at least the first strap portion, the recess having a longitudinal axis parallel to the main axis of the stabilizer wedge and a wall internal extending parallel to said longitudinal axis of the recess with a predetermined shape;
- the mobile assembly (2) comprises at least one locking pin having a given longitudinal axis and a substantially complementary shape of the determined shape of the recess, for engagement with the shift stabilizer wedge in the direction of the main axis of the body of said shim within the recess such that the longitudinal axis of the locking pin:
- first coincides with the longitudinal axis of the recess;
- secondly is perpendicular to the longitudinal axis of the first strap portion within the recess; and,
- thirdly is parallel to the surface of the first strap portion inside the recess,
and whereby, furthermore, the portion of the strap within the recess is prevented from movement relative to the stabilizer wedge by clamping said portion of the webbing between the locking pin and the inner wall of recess.
2. An intervertebral implant according to claim 1, wherein:
- each of the first and second strap portions can pass through the slot in the stabilizer wedge in order for the strap to form at least one loop in a plane perpendicular to the main axis of the wedge, with a strap adapted to engage with one of the spinous processes of two vertebrae to be stabilized, and wherein further
- the latch bolt is engageable with the stabilizer wedge in the direction of the main axis of the body of said shim between each of the first and second strap portions (41a, 42a) within the recess , such that the longitudinal axis of the pin:
- first coincides with the longitudinal axis of the recess;
- DISTINTO summit perpendiculaire to the longitudinal alignment of chacune des deux portions of sangle Inside the évidement; and,
- thirdly is parallel to the surface of each of first and second strap portions within the recess,
and whereby, moreover, that each of the first and second strap portions is locked in movement with respect to the stabilizer wedge nip of said strap portion between the pin and respective portions of the inner wall of the recess facing to each other.
3. An intervertebral implant according to claim 2, wherein the first and second strap portions can pass into the housing provided in the stabilizer wedge in opposite directions so as to intersect in said
housing, and so for the strap to form a loop in a plane perpendicular to the main axis of the wedge, with two loops located respectively on either side of the stabilizer wedge in said plane and adapted to come into engagement each with a respective one of the spinous processes of two vertebrae to be stabilized.
4. An intervertebral implant according to any one of claims 1 to 3, wherein the recess in the stabilizer wedge is tapered, and wherein the locking pin is of conical shape complementary to the shape of the recess .
5. An intervertebral implant according to any one of claims 1 to 4, wherein the body of the stabilizer wedge comprises passages (13,14) for the strap (4) extending perpendicularly to the main axis (10) the body (1) of said shim including at least one passage passing through the recess (12) in which passages at least the strap is displaceable when it is not locked in movement with respect to the stabilizer wedge.
6. An intervertebral implant according to any one of claims 1 to 5, wherein the strap (4) is a braid made of textile material nonabsorbable medical use.
7. An intervertebral implant according to any one of claims 1 to 6, wherein the recess has a threaded opening area (1 1) of larger diameter than the diameter of the recess behind said opening area and wherein the locking member is a screw of the same diameter as the diameter of the opening area of the recess with a thread adapted to cooperate with the internal thread of said opening area, and with an area of support (32) adapted to bear against a contact zone (22) of the locking pin (2) into the recess (12) when the screw is screwed into the threaded opening area of the recess.
8. Surgical Kit including:
- an intervertebral implant according to any one of the preceding claims,
- an implant holder (5) with a tubular body having an internal channel (52) with an inner diameter slightly larger than the largest diameter of the locking pin (2) of the implant and adapted to be fixed to the body of bilge stabilization such that the channel is in parallax with the axis of the recess (12) in said body, and
- a rod (6) of insertion of the locking pin adapted to slide in the internal channel for the introduction of the locking pin into the recess of the body of the stabilizer wedge.
9. A surgical kit according to claim 8, limited in that it corresponds to an intervertebral implant according to claim 7, wherein the tubular body of the implant holder (5) is provided at one end with a thread (51) for cooperate with the thread (1 1) of the recess (12) provided in the body of the stabilizer wedge (1).
10. A surgical kit according to any of claims 8 or 9, wherein said implant holder is provided at a second end with an internal thread (53) at the channel inlet (52), and wherein the insertion stem (6) is provided with a thread (61) for engaging said thread so that the insertion and screwing of the insertion pin (6) in the channel (52) of the implant carrier (5) causes the pin conical (2) in the housing (12) provided in the body of the wedge (1).
| # | Name | Date |
|---|---|---|
| 1 | 201817034153-TRANSLATIOIN OF PRIOIRTY DOCUMENTS ETC. [11-09-2018(online)].pdf | 2018-09-11 |
| 2 | 201817034153-STATEMENT OF UNDERTAKING (FORM 3) [11-09-2018(online)].pdf | 2018-09-11 |
| 3 | 201817034153-PRIORITY DOCUMENTS [11-09-2018(online)].pdf | 2018-09-11 |
| 4 | 201817034153-FORM 1 [11-09-2018(online)].pdf | 2018-09-11 |
| 5 | 201817034153-DRAWINGS [11-09-2018(online)].pdf | 2018-09-11 |
| 6 | 201817034153-DECLARATION OF INVENTORSHIP (FORM 5) [11-09-2018(online)].pdf | 2018-09-11 |
| 7 | 201817034153-COMPLETE SPECIFICATION [11-09-2018(online)].pdf | 2018-09-11 |
| 8 | 201817034153.pdf | 2018-09-25 |
| 9 | abstract.jpg | 2018-10-09 |
| 10 | 201817034153-FORM 3 [27-03-2019(online)].pdf | 2019-03-27 |
| 11 | 201817034153-Verified English translation (MANDATORY) [06-09-2019(online)].pdf | 2019-09-06 |