Technical area
The present invention relates generally to implants used in spinal surgery, and more particularly to a surgical kit comprising an intervertebral implant for dynamic stabilization and positioning tool.
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 2515778 published by ΟΜΡΙ as WO 201 1/077101. More particularly, this document describes a device which includes a wedge body having a first face and a second face, two clamps or bolts positioned on each side and two strips forming flexible links. The wedge body has a tapped hole provided on one face of the wedge body rearwardly facing, which is adapted to receive the attachment of a fixture mount. According to the disclosed teaching, the implant holder is used for gripping the wedge when it is positioned in the treatment area and for clamping the flexible links. Indeed, a clamp guide can be placed over the implant holder for receiving a third tool for tensioning the flexible links.

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.

In recent years, research and development efforts have focused primarily on means and retaining mechanisms of the assembly formed by the shim on the one hand stabilization, and (or) link (s) dissolved ( s) the other. In particular, the surgeons experience shows that the following aspects are taken into account for tensioning and maintaining the tension (or) link (s) Soft (s):

- embodiment of the clamp on the flexible link can be perpendicular posterior tangential, parallel to a longitudinal axis of the link;

- number of fixed or movable components necessary; and,

- how easily the operative implementation by the user surgeon (appreciated especially by the number of steps and the number of instruments, the position in the surgical wound, etc.).

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 for dynamic stabilization and surgical instruments for its implementation in the operating environment, which reduce the incision size to a minimum. Indeed, it should protect the surrounding tissues (including muscle tissue that contribute to the stability of the spine) the stress of separation 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.

To this end, the invention provides a surgical kit including:

- an intervertebral implant with:

- 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 determined major axis, and wherein a recess is provided having a longitudinal axis defined parallel to the main axis of the body of the stabilizer wedge; and,

- at least one strap forming flexible link for fixing the stabilizer wedge the spinous processes of the vertebrae to be stabilized, said strap having first and second portions comprising each one of the opposite ends of said strap; as well as

- an implant holder having an elongated body along a determined longitudinal axis and with a first end and a second end, and having fastening means provided at the first end that are adapted to cooperate with associated means provided at the body the implant stabilizer wedge for fixing the implant holder to the body of the stabilizer wedge such that the elongate body of said implant holder is parallax with said recess.

According to Kit embodiments of the invention:

- the recess in the body of the stabilizer wedge comprises an inner wall extending parallel to the longitudinal axis of the recess and has a defined shape;

- at least the first strap portion may pass through the recess perpendicular to the longitudinal axis of said recess;

- the intervertebral implant further comprises a locking pin having a given longitudinal axis and a substantially complementary shape of the determined shape of the recess provided in the body of the stabilizer wedge, for engaging with said stabilizer wedge by movement in said recess in the direction of the longitudinal axis of said recess, so as to lock the strap moving relative to the stabilizer wedge by pinching the strap portion between the locking pin and the inner wall of the recess ; and further

- the elongate body of the implant holder is tubular with an internal channel extending along the longitudinal axis of the elongate body of the implant holder and having an inner diameter slightly larger than the largest diameter of the locking pin of implant, to allow the insertion and guiding of said internal channel through said locking pin into the recess provided in the body of the stabilizer wedge, in the direction of the axis

said longitudinal recess, when the fixture mount is fixed to the stabilizer wedge.

The main axis above coincides with the axis of the posterior approach to the surgical operation to put the implant in place. The recess provided in the stabilizer wedge being subsequently opened when the wedge is brought into the installation position, its longitudinal axis corresponds to the axis of the posterior approach (as opposed, for example, a lateral access, the terms "rear" or "side" 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.

If a male frustoconical pin has been used to block a textile braid in a blocker as disclosed in in EP 2138122, the use as defined above in the context of a stabilizer wedge intended to be positioned between the spinous processes of two consecutive vertebrae to stabilize is original. The invention is distinguished particularly in terms of the positioning of the movable member constituted by the locking pin, which is obtained by applying a force along the axis of the track first posterior only by means of a single instrument alignment, the guiding and insertion of the locking pin. The invention is also original in the use of a locking pin in combination with a flexible tie strap type or braided flat, perpendicular to the longitudinal axis of the strap and in strict posterior plane of the implant and surgical wound. These provisions allow a truly minimally invasive procedure, and surgical treatment short walking-type.

According to other embodiments, the recess provided in the body of the stabilizer wedge may have a threaded inlet zone, and the tubular body of the implant holder can have at its first end a thread adapted to cooperate with the internal thread of the recess of the inlet region

for fastening by screwing the implant holder in the stabilizer wedge. The internal channel of the implant holder is thus directly parallax with the recess provided in the stabilizer wedge for receiving the locking pin.

According to other embodiments, taken alone or in combination:

- the surgical kit may further comprise an insertion rod of the locking pin having a first end and a second end adapted to slide in the internal channel of the tubular body of the implant holder for inserting and guiding the locking pin through the inner channel of the implant holder into the recess provided in the body of the stabilizer wedge; the engagement of the locking pin in the recess is thus greatly facilitated;

- the surgical kit may further comprise a connecting piece for attaching the releasably locking pin at the second end of the insertion rod; thus avoiding any risk of falling pawn in the wound during the operation; this link is used to manipulate the pin (e.g., rotated about its longitudinal axis) directly via the insertion rod;

- the locking pin may comprise, at the rear, a recess extending in the longitudinal direction of said pin; the second end of the insertion rod may then comprise a threaded recess extending in the longitudinal direction of said rod; and the connecting member may be a cap comprising firstly a first threaded end portion adapted to cooperate with the internal thread of the recess at the second end of the insertion rod, and secondly a second end portion conical adapted to be engaged by force into the recess provided at the rear of the locking pin to achieve the detachable attachment of said locking pin to said insertion rod. The connecting piece can then be disposable, while being securely attached to the end of the insertion rod.

In another embodiment, the implant holder may be provided with an internal thread at its second end, on the side of a free entry of the internal channel when the fixture mount is fixed to the stabilizer wedge and the rod insertion may be provided at its one end with a thread for engaging said

thread so that the insertion and screwing of the insertion stem in the internal channel of the implant holder causes the conical pin within the recess provided in the body of the stabilizer wedge in the direction of the longitudinal axis of said recess. This allows well control the progress of the pin within the recess in the stabilizer wedge.

Furthermore, the strap has a longitudinal direction determined and a specific surface strap, and the locking pin is engageable with the stabilizer wedge by movement within the recess in the body of the stabilizer wedge 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 strap portion within the recess; and,

- thirdly is parallel to the surface of the first strap portion within the recess.

Alternatively, 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 at least a strap adapted to come into engagement with one of the spinous processes of two vertebrae to be stabilized; and the locking pin 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 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 wedge

stabilization by clamping said strap portion between the locking pin and respective portions of the inner wall of the recess facing with each other.

The first and second strap portions may then pass into the housing provided in the body of 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 respectively located 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 adjacent vertebrae to be stabilized.

Finally, the surgical kit may further comprise a screw of the same diameter as the diameter of the entrance area of ​​the recess provided in the body of cast shim with a suitable thread for cooperating with the internal thread of said input area , and with a bearing zone adapted to bear against a rear contact region of the locking pin for locking the axial position of the engagement locking pin into the recess provided in the stabilizer wedge and thus blocking of the strap.

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 Figures 5A and 5B, respectively, also showing the locking screw engaged in the recess of the entry in the hold;

- Figure 7A and Figure 7B are views identical to those of

5A and 5B, respectively, further illustrating the locking screw in the locking position;

- Figure 8 is a three-dimensional view of an embodiment of the locking pin;

- the Figure 9A, 9B and 9C show a front view, a side view in section and a top view, respectively, of the pin of Figure 8;

- Figure 10 is a three dimensional view of a connecting piece carrying a releasable connection between the locking pin and the end of the rod insert of Figure 4;

- Figure 1 1 is a three dimensions of the insertion rod with the connecting piece of Figure 10 partially engaged in a recess at the rear of the locking pin;

- Figure 12 corresponds to Figure 1 1 when the connecting piece is fully engaged in the recess at the rear of locking pin; the internal channel of the implant holder attached to the stabilizer wedge, during the establishment of the locking pin;

- Figure 13 is a sectional view of an implant holder attached to the stabilizer wedge, with the insertion rod engaged in the channel of the implant carrier and the locking pin secured to the end of the stem bond and partially engaged in the recess provided in the body of the stabilizer wedge; and,

- Figure 14 is a three-dimensional view of the stabilizer wedge with the locking pin engaged in the recess, prior to placement of the locking screw.

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 below 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 said one of the pin.

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 recess of the inlet zone, its 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 the 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.

The flexible link 4 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 spacer. At least one of the passages 3 and 14 1, and preferably two passages 13 and 14 pass through the recess 12. In other words, the passages 13 and 14 open into the recess. 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.

The soft flexible connection link 4 is manually inserted by the surgeon, for example, first through the passage 17. Then the two ends 41 and 42 of the flexible link 4 are round in turn inserted into passages 13 and 14 after having engaged above and below the spinous processes of the upper and lower vertebrae, respectively.

More particularly, the strap 4 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 plan. 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 of the inside of 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 of the cutting plane of the wedge 1 in the 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 form the 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 conical pin 2 has been fully inserted into the threaded portion 1 1 of the 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 secure (axial position) the engagement of the latch bolt 2 into the recess 12.

The method of introduction of the conical locking pin 2 uses an implant holder 5 and a shaft insert 6, which are shown in Figures 3 and 4. The implant holder 5 is for example a hollow tube, c ' is to say that it has a tubular body having an internal channel 52. the channel 52 is 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 may have the form of a splined collar 54 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 may be 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 inner channel 52 aligned 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 through the inner channel 52. This embodiment of the fastening means of the implant holder 5 to the body 1 of the spacer is also illustrated in Figure 13, the description will be completed later.

The grooved flange 54 for gripping the implant holder by the surgeon is preferably close to the end of the tube 5 for the entry of the internal channel 52, that is to say the opposite end to that which carries the fillet 51 by which the fixture mount is fixed to the cleat 1.

For the insertion operation into the recess 12, the locking pin 2 may be fixed in easily detachable manner to one end of the insertion stem 6. The detachable attachment may be achieved, for example, by means of a piece of elastic connection, the detailed description will also be given later.

The other end of the insertion rod 6 is provided with an external thread 61 below gripping means such as a splined head 63 as shown. This thread (not visible in Figure 4) which cooperates with the internal thread 53 of the implant holder 5.

The insertion stem 6 with the conical pin 2 held detachably at its end, are introduced into the channel 52 of the implant holder 5, by its end carrying the internal thread 53. The screwing of the insertion rod 6 in the channel 52 of the implant holder 5 causes the conical pin 2 in the seat 12 of the wedge 1. This screwing is performed by cooperation of the thread 61 of the rod 6 and the internal thread 53 of the implant holder 5. Thus, there is obtained the forcible engagement pin 2 in the conical portion and unthreaded from the recess 12, and was stated above, by the 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. It 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 against the inner wall of the recess provides a certain elasticity, very low, with the engagement of the pin in said 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 detached automatically from the end of the insertion rod 6 remaining in place in the unthreaded conical portion of the recess 12. For this purpose, the bond strength of the pin 2 at 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, and the reaction force at the nip or flexible links.

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 zone 54 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, but also alignment instrument, guiding and inserting the pin through the pin 6 which slides in the internal channel 52 of the implant holder.

Once the implant holder 5 separated from the shim 1 (which is already well vertebrae stabilization situation), 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 inserted according to 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 7A 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 surface of

contact 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 does not increase 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.

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. The pawn moves indeed only along the axis of the posterior approach, which limits the extent of the surgery area.

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 axial displacement of the conical pin 2 in the recess 12. This screw is also introduced and clamped only 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.

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, printing

3D, or any other equivalent technique.

The tapered locking pin 2 is preferably made of titanium alloy, selected for its mechanical strength and biocompatibility. It may for example be obtained by machining from a raw material bar.

The screw 3 of clamping and locking block 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.

Referring to Figure 8 and Figures 9A, 9B and 9C, the pin has a frustoconical general shape. Of the more tapering side, said side "before" that is to say the one in which the pin is inserted into the recess along the axis of the posterior approach, and that is to say also one that is opposite the side said "back" which is provided with the bearing surface 22 already shown, the pin has a rounded end 23. This rounded end facilitates its passage between the strap portions of the strap 4 when they are tensioned in the recess 12 provided in the body 1 of the stabilizer wedge.

In the embodiment here shown, the pin 2 comprises a recess 21 extending along its longitudinal axis 10, for example equal to 2 mm diameter, which is open at the rear end 22 of the pin. This recess is used to receive a connecting piece, which will be discussed further, which has the function of fixing the pin releasably to the end of the insertion rod 6. But this route is not required, the pawn can be simply pushed by means of the insertion rod 6, after its introduction into the internal channel 52 of the implant holder 5, into the recess 12 provided in the body 1 of the spacer.

The central drum of the pin 4 has a larger diameter toward the rear end 22, for example 4.4 mm, and a smaller diameter, for example 3.9 mm from the side of the front end. The dimensions given above

above are purely illustrative of a non-limiting embodiment given for the purposes of this disclosure.

As mentioned above, means may be provided for securing the pin detachably to the insertion rod 6, at the end 62 thereof. This binding is not mandatory, as was previously indicated. But it brings the advantage of avoiding the manipulation of the single counter, which is a small room above the surgical field. This limits the risk related to the possible fall of the pawn in the implantation site or off. Releasably connecting the pin to the rod also allows to control the progression of the pin 2 along the longitudinal axis of the recess 12 provided in the body of the spacer, by the screwing of the insertion rod as discussed further .

The connection of the pin 2 to the insertion rod 6 can be effected by an intermediate connecting part 7, as the tip shown in Figure 10.

The tip 7 here comprises on the one hand, a first portion 71 threaded extremal. This portion 71 is adapted to cooperate with the internal thread of a threaded recess which is provided at the second end 62 of the insertion rod 6 and which extends along the longitudinal direction 10 of the rod 6.

The nozzle 7 comprises on the other hand a second portion extremal 72, which may be slightly conical, without being threaded. This portion 72 is adapted to be forcibly engaged in the recess 21 which is provided at the rear of the locking pin 2 and has been presented above with reference to Figure 8 and to Figures 8, 9B and 9C. The slightly conical shape of the second portion 72 of the tip facilitates this engagement operation force.

In Figure 1 1 the connector 7 is shown with the first part 71 fully screwed into the recess provided at the end 62 of the insertion rod 6. Further, the second portion 72 of the tip n ' here is only partially engaged in the recess 21 provided at the rear 22 of the pin 2.

It is preferable to bring the pin of the rod until the entire portion 72 of the piece 7 is engaged in the recess 21 of the pin, that is to say until the end 62 of the rod comes into contact with the rear face 22 of the pin 2. This operation is performed by the surgeon by entering the pin 2 in one hand and the rod 6 in the other hand. Small rotational movements between the pin and the rod may be exercised simultaneously applying a joining force between these two elements, to facilitate the full engagement of the pin over the portion 72 of the tip.

Figure 12 shows the pin 2 after full completion of its connection to the end 62 of the insertion rod 6. In this figure, the tip 7 is no longer visible, and has been shown in phantom (ie, in dashed lines) to illustrate how the connection of the pin 2 and the shaft 6 is made.

Part 71 performs the detachable attachment of the locking pin 2 to the insertion stem 6. In fact, once the pin 2 has been placed in the recess 12 provided in the wedge 1 while a voltage was exerted on the or flexible links 4, releasing the tension force which was exerted on the links 4, which are then wedged against the walls of the recess 12 and thus retain their voltage. Is then unscrewed from the implant holder 5 of the stabilizer wedge 1, always with the insertion rod 6 screwed into the internal channel 51 of the implant holder 5. This exerts traction on the insertion stem 6 next the longitudinal direction, rearward. The portion 71 of the nozzle 7 then disengages the pin 2, while the pin remains in engagement in the recess 12 provided in the body of the spacer.

The tip 7 may be made of PE, PET or PEEK, or other, by machining, molding, 3D printing, or the like. Given the distortion it can undergo when inserted forcibly into the back of the locking pin 2, the cap is preferably disposable. It is for this reason that it is in the form of an independent piece which can be screwed to the end 62 of the rod 6. It can in fact be replaced after each intervention, while the implant holder and the insertion rod are made of stainless steel and can be reused.

Preferably the kit is provided to the surgeon with the tip 7 previously screwed into the insertion rod 6. Moreover, the kit may be supplied, in addition, with the pin 2 already coupled to the insertion stem by mouthpiece 7. However, the surgeon may prefer to assemble the pin itself on the portion 72 of the tip, in order to assess the strength of the connection thus achieved. The surgeon can thus

check that this connection is detachable in that the tip is easily disengage the pin upon removal of the implant holder 5 as described in the preceding paragraph.

The connection between the locking pin 2 and the insert rod 6 is also visible in Figure 13 which is a sectional view of the insertion rod screen 2 when introduced into the internal channel of the implant holder 5 the introduction of the pin 2 in the recess 1 1 provided in the body 1 of the stabilizer wedge. It is seen from this figure, in which the same elements as in other figures have the same references, the implant holder 5 is attached to the stabilizer wedge 1 and a flexible link 4 (strap) passes into the recess 12.

In the embodiment shown in Figure 13, the implant holder is provided with an internal thread 53 at the other of its ends, on the side of a free entry of the internal channel 52, that is to say the side opposite to the cleat 1 where the implant holder is secured to said wedge 1. The term "input" is used herein in reference to the fact that the pin is inserted into the internal channel 52 of the implant holder by this threaded end 53 of the stem. The insertion stem 6 is provided with a complementary thread 61 at its end 62 to cooperate with the internal thread 53. In this way, insertion and screwing of the insertion rod 6 in the inner channel 52 of the door -implant 5 advances the conical pin 2 into the recess 12 provided in the body 1 of the stabilizer wedge, in the direction of the longitudinal axis of said recess 10 (which coincides with the longitudinal axis of the inner channel 52) . The progress of the pin in this direction is controlled by controlling the rotation of the insertion rod. This operation can be performed by the surgeon by holding the implant holder 5 in one hand via the gripping portion 54 of said implant holder, and rotating the insertion rod 6 with the other hand using the grip portion 64 of said rod.

Note that it is advantageous for the insertion of the following pin the longitudinal axis of the recess 12 is achieved by rotation of the pin about said axis. Indeed, the helical movement of the peg is thus obtained facilitates insertion into the recess and limit the stress on the flexible links that comes jam against the inner wall of the recess. More particularly, the friction of the pin 2 on the surface of flexible links, or belt surface is divided into a component orthogonal to the longitudinal direction of the strap and a component parallel to said longitudinal direction. This also limits the risk that the strap is not folded on itself along the direction orthogonal to the longitudinal axis of the strap.

This additional advantageous effect is not obtained if the pin 2 is simply pushed longitudinally by the insertion rod 6, that is to say without screwing thereof in the implant holder (e.g. if the rod slides in the inner channel 52 of the implant holder without rotating about its longitudinal axis 10). Similarly, this effect is not obtained without the connection between the pin 2 and the shaft insertion 6.

When the insertion rod has been screwed completely into the internal channel 52 of the implant holder, the locking pin is fully inserted into the recess 12 provided in the stabilizer wedge. This result is guaranteed by the design of the various elements of the kit, in particular the axial length of the pin and that of the insertion rod, and the axial length of the threads 1 1 and 53.

The implant holder can then be separated from the stabilizer wedge, by unscrewing it from the threaded Portion 1 1 of recess 12 provided in said wedge, leaving the stud 2 in place in said recess, as was said above.

Figure 14 is a three-dimensional view of the stabilizer wedge with the latch bolt 2 engaged in the recess after removal of the implant holder 5 of the stabilizer wedge 1, and before introduction of the locking screw 3. Note again that the locking of the flexible link 4 is effective with the conical pin 2 alone, the locking screws 3 being merely an additional safety measure.

Advantageously, the same threaded Part 1 1 to the inlet of the recess 12 in the stabilizer wedge, is used again, this time to the introduction of the locking screw 3. In other words, the tapping January 1 serves successively to the temporary fixing of the implant holder 5 of the wedge 1 during the operation, then the introduction of the locking screw 3 which

permanently secures the position of the pin 2 in the recess 12. The design of the block according to the embodiments described modes is therefore particularly simple. A reduced number of parts and components allow the establishment of the locking pin by manual operations carried out by the surgeon according to the axis of the posterior approach only.

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 particular, the fixing of implant holder 5 on the spacer 1 can be made in a different way of screwing described above. For example, this fixation can be achieved through a mechanism of "bayonet" or any other form of snap.

In addition, the connection between the pin 2 and the insert rod 6 can be achieved by a connecting piece 7, which may differ in its embodiment of the connector described above with reference to Figure 10. the part 7 may for example be a resilient connecting piece. This may be for example a cylinder or sleeve of a deformable elastic material, for example elastomeric material. This part 7 cooperating with the recess 21 made at the rear 22 of the locking pin 2, and with a non-threaded recess provided at the first end 62 of the insertion rod 6. When a first end portion of the sleeve is pressed into the first recess above, and the second end portion of the sleeve is pressed into the second recess above, the sleeve carries the releasable securing said locking pin to the insertion stem.

To this end, the diameter of the sleeve 7 is slightly greater than the diameter of the recess 21 which is provided in the pin 2. Thus, the sleeve 7 can be forced into the channel 21 from the rear end 22 of the pin 2 , playing its elasticity. A portion of the sleeve is left outside the channel 21, and protrudes from the end 22 of the pin rearwardly. The surgeon then pushes the free end of the sleeve 7, whose other end is and remains engaged in the pin 2 inside the recess at the end 62 of the insertion rod. The diameter of this recess is slightly less than the diameter of the part 7. In other words, the rod 6 is thus pressed over the sleeve 7, and this until the edge of the end 62 of the rod enter into contact with the rear edge 22 of the locking pin 2. the order of the above two operations may be reversed.

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. A surgical kit comprising:
- an intervertebral implant with:
- a stabilizer wedge (1) 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 main axis (10) determined and wherein is provided a recess (12 ) having a longitudinal axis defined parallel to the main axis of the body of the stabilizer wedge; and,

- 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 a second portions (41a, 42a) each comprising one of the opposite ends (41, 42) of said strap; as well as

- an implant holder (5) having an elongated body along a determined longitudinal axis and with a first end (51) and a second end (53) and having fastening means provided at the first end (51) which are adapted to cooperate with associated means provided at the body of the implant stabilizer wedge for fixing the implant holder to the body of the heel stabilization such that the elongate body of said implant holder is parallax with said recess (12);

in which :

- the recess in the body of the stabilizer wedge comprises an inner wall extending parallel to the longitudinal axis of the recess and has a defined shape;

- at least the first strap portion may pass through the recess perpendicular to the longitudinal axis of said recess;

- the intervertebral implant further comprises a locking pin (2) having a given longitudinal axis and a substantially complementary shape determined from the shape of the recess provided in the body of the wedge

stabilization, for engagement with said displacement stabilizer wedge into said recess in the direction of the longitudinal axis of said recess, so as to lock the strap moving relative to the stabilizer wedge by pinching the strap portion between the locking pin and the inner wall of the recess; and,

- the elongate body of the implant holder is tubular with an inner channel (52) extending along the longitudinal axis of the elongate body of the implant holder and having an inner diameter slightly larger than the largest diameter of the pin blocking (2) of the implant, to allow the insertion and guiding of said internal channel through said locking pin into the recess (12) provided in the body of the stabilizer wedge, in the direction of the longitudinal axis of said recess when the fixture mount is fixed to the stabilizer wedge.

2. A surgical kit according to claim 1, wherein:

- the recess in the body of the stabilizer wedge has an inlet zone (1 1) threaded, and

- the tubular body of the implant holder has at its first end (51) a thread adapted to cooperate with the internal thread of the recess inlet area for attachment by screwing the implant holder in the stabilizer wedge (1 ).

3. A surgical kit according to claim 1 or claim 2, further comprising:

- a rod (6) of insertion of the locking pin (2) having a first end (61) and a second end (62) adapted to slide in the internal channel (52) of the tubular body of the implant holder (5 ) for inserting and guiding the locking pin (2) through the internal channel (52) of the implant holder (5) into the recess (12) provided in the body of the stabilizer wedge.

4. A surgical kit according to claim 3, further comprising a connecting piece (7) for fixing the locking pin (2) detachably to the second end (62) of the insertion pin (6).

5. A surgical kit according to claim 4, wherein:

- the locking pin (2) has at the rear (22) a recess (21) extending in the longitudinal direction (10) of said peg,

- the second end (62) of the insertion rod (6) comprises a threaded recess extending in the longitudinal direction of said rod (10), and

- the connecting piece (7) is a cap comprising firstly a first end portion (71) threaded adapted to cooperate with the internal thread of the recess provided at the second end (62) of the insertion rod, and on the other hand, a second end portion (72) tapered adapted to be engaged by force into the recess provided at the rear of the locking pin (2) to achieve the detachable attachment of said locking pin to said insertion rod.

6. A surgical kit according to any of claims 1 to 5, wherein the implant carrier (5) is provided with an internal thread at its second end (53) of the side of a free entry of the internal channel (52) when the fixture mount is fixed to the stabilizer wedge, and wherein the insertion rod (6) is provided at its first end (61) with a thread for engaging said thread so that the insertion and the screwing of the insertion pin (6) in the inner channel (52) of the implant carrier (5) causes the conical pin (2) within the recess (12) provided in the body of the stabilizer wedge in the direction of the longitudinal axis of said recess.

7. A surgical kit according to any one of claims 1 to 6, wherein the strap has a longitudinal direction determined and a specific surface strap, and wherein the latch bolt is engageable with the stabilizer wedge by displacement inside the recess provided in the body of the spacer of stabilization 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 strap portion within the recess; and,

- thirdly is parallel to the surface of the first strap portion within the recess.

8. A surgical kit according to any one of claims 1 to 6, wherein:

- the strap has a longitudinal direction determined and a specific strap surface;

- 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 at least one strap adapted to come into engagement with one of the spinous processes of two vertebrae to be stabilized; and

- 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 by pinching said strap portion between the locking pin and respective portions of the inner wall of recess facing to each other.

9. A surgical kit according to claim 8, wherein the first and second strap portions can pass into the housing provided in the body of 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 spinous processes of two adjacent vertebrae to be stabilized.

10. A surgical kit according to any preceding claim, further comprising a screw of the same diameter as the diameter of the entrance area of ​​the recess provided in the body of cast shim with a suitable thread for cooperating with the internal thread of said input area, and with a bearing zone (32) adapted to bear against a contact zone at the rear (22) of the locking pin (2) for locking the axial position of the engagement locking pin into the recess (12) provided in the stabilizer wedge and thus the locking of the strap.