Plate for osteosynthesis device and method of preassembling such device

Abstract

Various methods, devices, and systems are disclosed that facilitate easier and more compact implantation of osteosynthesis devices. In some embodiments, implants are screwed into two vertebrae and a plate is used to hold and displace the spine. In some plate embodiments, at least one longitudinally elongated opening is disposed at one end of the plate and partially opening onto an edge of the plate. In some plate embodiments, at least one longitudinally elongated opening is disposed at one end of the plate having a portion sufficiently large to be inserted without disassembly in the fixation means of an implant already screwed into the spine when the fixation means are already assembled.

Claims

1. An implant for securing a spinal stabilization bar to a vertebra, the implant comprising: a bone screw having a longitudinal screw axis and comprising a bone penetration end disposed at a first end of the longitudinal screw axis and a protrusion end disposed at a second end of the longitudinal screw axis distal from the bone penetration end; a clamping head having a longitudinal clamping head axis and comprising a drive coupler disposed at a second end of the longitudinal clamping head axis and configured for engagement with a drive tool to impart rotation to the bone screw, and a stabilization bar support configured to receive a stabilization bar from the side of the implant; and a universal joint coupling the bone screw and the clamping head.

2. The implant of claim 1, in which the bone screw further comprises a threaded portion disposed along an external surface of the bone screw and configured for screwing into a bone.

3. The implant of claim 1, in which the bone screw further comprises a threaded portion disposed along a hollow core that has a bone-fusion opening.

4. The implant of claim 1, in which the stabilization bar support comprises a partially cylindrical surface complementary to a cylindrical surface of a stabilization bar.

5. The implant of claim 1, in which universal joint is configured for transmission of a rotation of the clamping head around its longitudinal clamping head axis imparted at the drive coupler to a rotation of the bone screw around its longitudinal screw axis while an angle between the longitudinal clamping head axis and the longitudinal screw axis is non-zero, and the stabilization bar support is configured to permit said transmission while the bar is attached to the implant.

6. The implant of claim 1, in which the drive coupler comprises a hexagonal recess.

7. The implant of claim 1, in which the stabilization bar support comprises an opening configured for rotatable disposition of the stabilization bar support about the longitudinal clamping head axis.

8. The implant of claim 1, in which the stabilization bar support and the protrusion end have complementary surfaces configured for support of the stabilization bar support by the protrusion end.

9. The implant of claim 8, in which the complementary surfaces are partially spherical.

10. The implant of claim 1, in which the protrusion end comprises a housing, and the protrusion end has a projection configured to prevent rotation, relative to the bone screw, of the clamping head around its longitudinal clamping head axis.

11. The implant of claim 1, in which the stabilization bar support is rotatable around the longitudinal clamping head axis.

12. A system for spinal stabilization comprising: a spinal stabilization bar; an elongated bone screw having a longitudinal screw axis; a clamping head having a longitudinal clamping head axis; a universal joint coupling the bone screw and the clamping head configured for transmission of a rotation of the clamping head around its longitudinal clamping head axis to a rotation of the bone screw around its longitudinal screw axis while an angle between the longitudinal clamping head axis and the longitudinal screw axis is non-zero; and a rotatable stabilization bar support configured to permit said transmission while the stabilization bar is attached to the implant.

13. The implant of claim 12, in which the stabilization bar support is rotatable around the longitudinal clamping head axis.

14. The implant of claim 13, in which the bone screw further comprises a threaded portion disposed along a hollow core that has a bone-fusion opening.

15. The implant of claim 14, in which the stabilization bar support comprises a partially cylindrical surface complementary to a cylindrical surface of the stabilization bar.

16. The implant of claim 15, in which the stabilization bar support and an end of the bone screw have complementary surfaces configured for support of the stabilization bar support by the end of the bone screw.

17. A system for spinal stabilization comprising: a plurality of implants each comprising: an elongated bone screw having a longitudinal screw axis, a clamping head having a longitudinal clamping head axis, a universal joint coupling the bone screw and the clamping head configured for transmission of a rotation of the clamping head around its longitudinal clamping head axis to a rotation of the bone screw around its longitudinal screw axis while an angle between the longitudinal clamping head axis and the longitudinal screw axis is non-zero, a rotatable stabilization bar support configured to receive a stabilization bar and permit said transmission while the bar is attached to the implant; and an elongated stabilization bar having a first distal end and a second distal end.

18. The system of claim 17, in which the stabilization bar support is configured to allow the stabilization bar to slide laterally across the stabilization bar support.

19. The system of claim 18, in which stabilization bar support is rotatable about the clamping head with the stabilization bar received in the stabilization bar support.

20. The system of claim 19, in which at least one of the implants has a housing in an end of the bone screw in which an end of the clamping head is disposable, and that end of the clamping head has a projection configured to cooperate with a concave portion of the housing to prevent rotation, relative to the bone screw, of the clamping head around the longitudinal clamping head axis.

Description

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

(1) The invention, with its characteristics and advantages, will be seen more clearly upon reading the description with reference to the appended figures wherein:

(2) FIGS. 1a, 1b, and 1c represent an osteosynthesis device according to the invention in an embodiment comprising an H-shaped plate and two polyaxial head implants fitted on an interval vertebra, in three successive phases of the fitting of the plate in the implants;

(3) FIG. 2 represents a longitudinal section view of an implant of a device according to the invention in the implant clamping phase after insertion of the plate, in an embodiment comprising a plate support free to rotate around a rehabitable hollow screw implant and fixed clamping support;

(4) FIG. 3 represents a longitudinal section view of an implant of a device according to the invention in the implant clamping phase after insertion of the plate, in an embodiment comprising a plate support free to rotate around a rehabitable hollow screw implant and inclinable clamping support;

(5) FIG. 3a represents a partial view of an implant according to the invention, in a section along a plane passing through the center of the support head and perpendicular to the support axis;

(6) FIG. 4 represents a longitudinal section view of an implant of a device according to the invention in the plate clamping phase once the implant is in its definitive position, in an embodiment comprising a plate support free to rotate around a rehabitable hollow screw implant and inclinable clamping support;

(7) FIGS. 5a, 5b, 5c and 5d represent a top view of a plate of a device according to the invention, in an embodiment comprising a plate which is respectively H-shaped with two through openings, h-shaped with one through opening, with two non-through openings and with one non-through opening;

(8) FIG. 6 represents a side view of an implant of the preassembled device according to the invention, in an embodiment comprising an inclinable clamping support and a rehabitable hollow screw with two oblong holes;

(9) FIG. 7a represents a perspective view of a longitudinal section of an implant of a device according to the invention, in an embodiment comprising an inclinable clamping support and a rehabitable hollow screw with two oblong holes and according to an alternative embodiment where the screw head housing and the support head interact without being complementary in shape;

(10) FIG. 7b represents a partial perspective view of the support head of an implant of a device according to the invention in the same alternative embodiment;

(11) FIG. 7c represents a partial perspective view of a cross-section along the plane AA (as shown in FIG. 7a) of an implant of a device according to the invention in the same alternative embodiment;

(12) FIG. 8 represents an osteosynthesis device according to the invention in an embodiment comprising an H-shaped plate and two polyaxial head implants according to an alternative embodiment where the implants only comprise a single threaded part, on their outer surface.

DETAILED DESCRIPTION

(13) In an embodiment represented in FIG. 2, the device according to the invention comprises an implant 1 comprising a first end 11 equipped with an outer threading 111, and is illustrated after a first having been screwed in the bone substance of a vertebra 0, after insertion of a plate 2 and during the final approach. Said first end 11 also comprises a cavity or an inner bore, itself equipped with an inner threading 112 wherein the screwing direction is the same as that of the outer threading 111. During the screwing of the implant into the vertebra 0, part of the bone substance tends to fill said cavity and is assisted therein by the action of the inner threading. Preferentially, the inner threading 112 and the outer threading 111 are of the same pitch, so as to minimize the strain exerted on the bone substance at the entry of the bore during screwing.

(14) The wall between the inner cavity and the outside of the implant has one or more openings, referred to as bone fusion holes 110, in its part which is inside the vertebra after the attachment of the implant. In the time period following the implantation, generally approximately six months, the bone substance present outside and inside the implant tends to fuse. The fusing produced in this way improves the strength of said implantation, both by means of blocking via the bone fusion holes 110, and by means of cooperation of the inner threading 112 with the bone pin formed in this way.

(15) In one alternative embodiment, the inner threading 112 has a greater pitch than that of the outer threading 111. During the screwing of the implant 1, the bone substance present inside the cavity is then attracted slightly more quickly than the implant progresses in the vertebra 0. This effect may make it possible to compensate for a filling defect liable to occur, for example by compression of the bone substance inside the bore. This effect may also make it possible to obtain more complete or more compact filling of said cavity, for example in order to obtain a specific compression or better filling of the cavity or the bone fusion holes 110, and thus favor bone substance fusion.

(16) At its second end, i.e. the end opposite the vertebra, the implant 1 comprises an attachment structure that is used to insert, hold and finally clamp a bar or a plate 2. Said second end also comprises a receptacle for a drive means, using a tool of known type, such as a hexagonal recess 124.

(17) Said structure comprises for example an elongated part 12a of a cross-section less than the central part of the implant, comprising a shoulder. Said elongated part 12a passes through a plate support 3 resting on said shoulder, and comprises at its end a threading 123 to receive a clamping nut 4. In one embodiment, said plate 2, as shown in FIG. 5a, is roughly H-shaped, comprising for example two cylindrical bars joined at their center by a rigid distance sleeve. In an alternative embodiment, the two bars are joined by a non-rigid joint. Because the joint is not rigid, it allows more latitude in the positioning of the plate. Said plate 2 is inserted between the plate support 3 and the nut 4, so as to surround the elongated part 12a of the implant. Once the plate is in position, the nut 4 is fastened, by hand or using a tool of a known type 52, FIG. 4, and cooperates with the threading 123 to clamp the plate 2 against the plate support 3 and thus lock the assembly.

(18) In said embodiment, the plate support 3 comprises a bore 30 with a substantially rectangular insert passing through its center. Said plate support 3, on the side of the plate, has one or more surfaces 2 that are substantially complementary to the surface of the plate 2 resting on them. In said embodiment, the central bore of the plate support 3 is sufficiently larger than the part 12a passing through it to allow a clearance of said support 3 transversally and at an angle with respect to the axis d1 of the implant. Said clearance makes it possible to adjust the relative position of the plate supports of two implants 1, 1a easily, and thus insert the plate 2 easily even if the implants are not well aligned or in the event of a relatively inaccessible anatomical environment. According to an alternative embodiment not shown, the plate support receives a plate 2a, FIG. 5b, comprising a single bar at one of its ends. Said plate support can then comprise an offset bore instead of the central bore 30, without departing from the scope of the invention.

(19) Since the plate support 3 is free to rotate around the part 12a of the implant 1, it is clearly understood that it is possible to continue screwing said implant into the vertebra 0, even when the plate is already in position, provided that the attachment structure is not firmly fastened on said plate 2. In this way, by inserting the plate 2 into said attachment structure before the implant 1 is entirely screwed on, it is possible not to be hindered by the various differences in levels or outgrowths liable to be present in the immediate vicinity of the spine. Once the plate is held in place but not clamped, it is still possible to finish screwing the implant into the vertebra, by rotating it via an opening of the plate support 3. The attachment structure then holds the plate 2 close to the spine, the screwing of the implant providing sufficient force to oblige the plate to come closer to the spine. Therefore, the plate can be positioned and inserted with little effort, while being positioned definitively very close to the surface of the vertebra, which makes it possible to obtain a compact device size once fitted.

(20) In a preferential embodiment of the device according to the invention, represented in FIGS. 3, 3a and 4, the implant 1 comprises a mobile part, referred to as the clamping support 12, at its second end opposite the first end 11 screwing into the vertebra 0. Said clamping support 12 has an elongated first end 121 along a support axis d12. Said elongated end passes through the central bore of the plate support 3 and bears a threading 123 adapted to receive the clamping nut 4.

(21) At a second end opposite its elongated end 121, the clamping support 12 bears a part, referred to as the support head 122, joining said clamping support 12 to the implant by its second end, referred to as the screw head 102, opposite the end 11 screwed into the vertebra 0. Along a plane perpendicular to the support axis d12, said clamping support head 122 has at least one dimension s122; FIG. 3a, greater than at least one cross-section s121 of the elongated end 121 of said clamping support 12. Said support head 122 is retained in a housing provided in the screw head 102 of the implant 1. For this purpose, said housing has an opening of a specified size s102 so as to retain the support head 122 inside said housing, while allowing a clearance of a specified angle a between the support axis d12 and the implant axis d1.

(22) Said angular clearance of the clamping support 12 with respect to the implant enables angular and lateral movements facilitating the insertion of the plate in the fixation means of the implant, as described below. Said angular clearance also makes it possible to compensate for any alignment defects between the different implants 1, 1a; FIG. 1c, of a device according to the invention and therefore renders the positioning of the plate 2 in the attachment structure of said implants less delicate.

(23) In said preferential embodiment, the plate support 3 rests on the screw head 102 of the implant 1, by means of a lower surface 31 that has at least a partially spherical surface for example. Said lower surface 31 of the plate support is in complementary contact with an upper surface 13 of said screw head. Said spherical complementary contact allows freedom of rotation and inclination of the plate support 3 with respect to the implant 1. Said spherical complementary contact of said surfaces 13, 31 also enables a uniform and stable support of said surfaces with respect to each other, after the plate 2 has been clamped onto the plate support, irrespective of the definitive angular position of said plate support 3 or the clamping support 12.

(24) The implant 1 is screwed into the vertebra 0 by means of rotationally driving said implant by rotating the clamping support 12 around its own clamping axis d12. Said clamping support is rotated for example by a tool, of known type, inserted into at least one recess 124 contained in the elongated end 121 of said clamping support. The clamping support 12 preferably rotates the implant 1 by means of a universal type joint, i.e. the rotation of either of the two components around its axis rotates the other component around its own axis, the angle between the two axes possibly being non-null.

(25) Said universal joint is produced by the cooperation of the outer surface 120 of the support head 122 with the inner surface 100 of the housing of the screw head 102 of the implant 1. Along a plane perpendicular to the support axis d12, the support head 12 has a section with a non-circular outline, for example in the shape of a star or cross with rounded corners, as illustrated in FIG. 3a. The housing of the screw head 102 which receives the support head 122, then has an inner surface 100 in substantial complementary contact with the outer surface 120 of said support head 122, said two surfaces 100, 120 cooperating to form the rotational joint between these two components 102, 122. The angular variation is allowed by the fact that the support head 122, and its complementary housing, have a section with a circular outline along at least one plane including the clamping support axis d12, or the implant axis d1, or both.

(26) According to an alternative embodiment illustrated in FIGS. 7a to 7c, the inner surface 100 of the screw head housing receiving the support head simply has one or more projecting parts 100a, for example two. The outer surface 120 of the support head 122 then has one or more concave parts 120a with which the projecting parts 100a of the screw head housing cooperate to prevent the rotation of the clamping support 12 around its axis d12.

(27) In this way, it is clear that it is possible to continue screwing the implant 1 into the vertebra 0, after the plate 2 has already been inserted between the clamping nut 4 and the plate support 3, by adjusting the elongated end 121 of the clamping support 12 that is accessible via the nut 4. Since the plate support 3 is free to rotate with respect to the implant 1, said implant can rotate during screwing while leaving the plate 2 and the plate support 3 immobile.

(28) Once the implant 1 is completely screwed into the vertebra 0, as illustrated in FIG. 4, the plate 2 can then be adjusted and locked in its definitive position, by tightening the clamping nut 4. Said nut may be tightened by hand, for example on a knurled part of its outer surface on the support axis d12, or using a tool 52 of known type, for example by adjusting two inner or outer recesses on the nut.

(29) According to an alternative embodiment illustrated in FIG. 8, a device according to the invention uses such implants but wherein the end 11 intended to be anchored in the vertebra only comprises one outer threaded part 111. In said alternative embodiment, the implant may comprise a longitudinal bore passing through it from one end to another, to enable positioning by means of sliding around a pin that has previously been implanted in the vertebra.

(30) Several implants according to various alternative embodiments in the same device can of course be combined without departing from the scope of the invention.

(31) Depending on the applications, in order to join two implants 1, 1a; FIG. 1c, it is possible to use a plate of different configurations, for example such as those represented in FIGS. 5a, 5b, 5c and 5d.

(32) In the example of an embodiment illustrated in FIGS. 1a, 1b, and 1c, two implants 1, 1a are screwed into the body of two, respective, vertebrae 0, 0a respectively of the spine, spaced at an interval of one vertebra. These two implants are then fixed together by a plate 2 inserted into their attachment structures around the clamping support and then clamped between the plate support and the nut of each of said implants.

(33) In the preferential embodiment represented in FIG. 5a, the plate 2 is elongated in shape and comprises two roughly parallel bars 201, 202, which are for example cylindrical, joined together in a rigid or flexible manner by a joining part 20. Said joining part joins the two bars at an inner part of the plate, i.e. at a specified non-null distance from each of the ends 21, 22 of the plate. More specifically, said joining part is located at a sufficient distance from each end of the plate so that said end can be inserted into the fixation means of an implant, and possibly slide in said attachment structure. The position of said joining part 20 may be located at the center of the plate, or be offset to allow a greater clearance for sliding during insertion as explained below.

(34) At each end 21, 22 respectively, of the plate 2, the space between the two bars forms an opening 210, 220 respectively, opening out onto the edge of the plate. Said openings have a substantially constant transverse gap s211, s221, enabling longitudinal sliding of the plate in the attachment structure of an implant 1, 1a. This substantially constant transverse gap also makes it possible to clamp said attachment structure in any part of said openings 210, 220. Since said openings open onto the edge of the plate, it is possible to insert each of the ends of the plate into the attachment structure of an implant 1, 1a as illustrated in FIG. 1a, without having to remove the nut 4 if it was preassembled beforehand. At each end, this insertion consists of sliding the end of the two bars between the nut 4 and the plate support 3 of the implant 1, at either side of the clamping support 12.

(35) In another embodiment represented in FIG. 5b, the plate 2a is elongated in shape and comprises a first end 21a comprising a single bar, which is cylindrical for example. Said first end can be inserted into an implant according to the prior art or into an implant as described in the present invention, for example in an alternative embodiment (not shown) where the plate support only comprises a single surface 32 in contact with the plate. The plate 2a also has a second end 22a comprising two substantially parallel bars, which are cylindrical for example. These two bars together form a longitudinally elongated opening 220a, of a roughly constant width s221a. Either of the two ends of said plate 2a can be inserted, or slid, or both, in the attachment structure of an implant according to the invention, in the manner described in the preferential embodiment.

(36) In another embodiment represented in FIG. 5c, the plate 2b is elongated in shape and comprises a first end 21b having at least one opening 210b and a second end 22b having at least one second opening 220b, at least one of these openings not opening onto the edge of the plate 2b. These two openings 210b, 220b have a longitudinally elongated shape, i.e. along the length of the plate, and may be separated by one or more joining parts 20. These two openings have a substantially constant width s211b, s221b, and can be positioned by means of sliding and then be clamped in the attachment structure of the implants. At least one of said openings has a part, referred to as a notch, of a larger size s210b, s220b, of a shape and size able to allow the nut 4 of the attachment structure of an implant to pass through. Therefore, such a bar 2b can also be inserted in the attachment structure of an implant 1 when said attachment structure is already assembled, therefore not requiring handling of small parts, such as the nut 4 or the plate support 3, in the patient's body.

(37) In an alternative embodiment represented in FIG. 5d, the plate 2c has a single opening comprising two notches as described above (see FIG. 5c). In an embodiment not shown, the plate may comprise a sufficient number of openings and notches to be able to assemble the plate to more than two implants.

(38) It is clear that these different types of openings, which are either through apertures or have a wider part, can be combined in various ways without departing from the scope of the invention.

(39) In the same way, the position of the joining part 20 can vary and be offset along the length of the plate, so as to leave the clearance required for the plate to slide during positioning. In a preferential embodiment, said position is slightly offset with respect to the center of the plate, so as to be able to slide the plate sufficiently in the first implant 1; FIG. 1b, to be able to have the second implant 1a inserted into it.

(40) It is necessary to understand here that the device described can equally well comprise any other combination of different alternative embodiments of plates and alternative embodiments of implants without departing from the scope of the invention.

(41) FIGS. 1a, 1b, and 1c illustrate different steps in the positioning of the plate 2 in two implants 1, 1a, in the preferential embodiment. This positioning is carried out after the implants have already been screwed into the spine, and where the attachment structures, in this case the plate support 3 and the nut 4 have already been assembled on the implant but not yet fully clamped.

(42) In this way, in FIG. 1a, a first end 21 of the plate 2 is first mated with the attachment structure of the first implant 1, on the plate support 3 and under the nut 4, straddled around the clamping support 12.

(43) Once this first end 21 has been inserted, due to the fact that the bars have a substantially constant gap, it is possible to slide the plate in the attachment structure of the first implant 1 until the second end 22 of the plate can be aligned (FIG. 1b) in front of the attachment structure of the second implant 1a.

(44) By sliding the plate in the opposite direction, it is then possible to insert (FIG. 1c) said second end 22 in a similar manner in the structure of the second implant 1a. It is them possible to adjust the definitive position of the plate 2 and tighten the nut of the attachment structure of each of the two implants, and thus stiffen the assembly.

(45) In this way, it is clear that it is possible to prepare the osteosynthesis device in advance using the preassembly method, comprising the following steps: assembly of the plate support 3 around the clamping support; and assembly of the nut 4 on the threading 123 of the clamping support.

(46) Once it has been preassembled using this method, an implant 1 of the device according to the invention can be used directly during the surgical operation, as represented in FIG. 6.

(47) The osteosynthesis device can then be positioned using the following steps: the implants are screwed into the spine, without inserting them to their final depth. This approach position makes it possible not to be hindered by any osteophytes when positioning the plate 2. The plate 2 is inserted via a first end 21 into a first implant 1. It is then slid into said first implant to be presented in front of the attachment structure of the second implant 1a. The second end 22 is then inserted into the second implant. This positioning is illustrated in FIGS. 1a, 1b, and 1c.

(48) At this stage and subsequently, the clearance of the plate support 3 around the clamping support 12 allows the angular and lateral movements required for insertion. This clearance also makes it possible to compensate for any alignment defects between the two implants 1, 1a, and thus renders the positioning of the plate 2 less delicate. The screwing of the two implants into the spine is then completed until they are clamped in their final desired position. This screwing is performed (FIG. 3) using a tool of known type, such as, for example, drive tool 51 shown in FIGS. 2 and 3, rotating the implant by means of a rotation of the clamping support 12. Since the plate 2 is already in position and held in place by the attachment structure of the implants, this additional screwing of the implants drives the plate to its desired final position close to the spine. Therefore, this driving obtained by screwing the implants makes it possible to reduce the size determined by said plate, by tightening or inlaying said plate firmly and easily on the surface of the spine. Once the implants have been completely screwed on, the plate is locked in the attachment structure of the implants, by clamping (FIG. 4) their nut 4 on the plate 2 itself resting on the plate support 3 which rests on the shoulder or on the screw head 102 of the implant. Naturally, said clamping may be carried out using other parts not mentioned, such as washers or locking devices of known types.

(49) It must be clear to those skilled in the art that the present invention enables other embodiments in numerous other specific forms without leaving the scope of the invention as claimed. As a result, the present embodiments must be considered as illustrations, but may be modified in the field defined by the scope of the fixed claims, and the invention must not be restricted to the details given above.