INTERVERTEBRAL IMPLANT
20200261244 ยท 2020-08-20
Inventors
- Beat Lechmann (Grenchen, CH)
- Dominique BURKARD (Gretzenbach, CH)
- Christopher Marden John Cain (Denver, CO, US)
- Claude Mathieu (Zurich, CH)
Cpc classification
A61B17/86
HUMAN NECESSITIES
A61F2310/00023
HUMAN NECESSITIES
A61F2002/30383
HUMAN NECESSITIES
A61F2/4455
HUMAN NECESSITIES
A61F2220/0025
HUMAN NECESSITIES
A61F2/4465
HUMAN NECESSITIES
International classification
Abstract
An intervertebral implant includes a three-dimensional body and a securing plate. The three-dimensional body includes a front surface and a rear surface. The three-dimensional body further includes a plurality of boreholes for accommodating fixation elements. The intervertebral implant also includes a front plate disposed at the front surface of the three-dimensional body and has a plurality of boreholes. A securing plate can be fastened to the front plate.
Claims
1. (canceled)
2. An intervertebral implant configured to be inserted into an intervertebral space, the intervertebral implant comprising: a one-piece body defining a front body surface, a rear body surface opposite the front body surface along a longitudinal direction, a top surface and a bottom surface opposite the top surface in a vertical direction that is perpendicular to the longitudinal direction, and first and second outer side surfaces that are opposite each other along a lateral direction that is perpendicular to each of the longitudinal direction and the vertical direction, wherein the one-piece body further defines a horizontal middle plane that is oriented along the lateral and longitudinal directions between the upper side and the underside, the one-piece body further defines a vertical middle plane that is oriented along the vertical and longitudinal directions between the side surfaces, and the horizontal middle plane and the vertical middle plane intersect so as to define first and second upper quadrants and first and second lower quadrants, wherein the one-piece body defines a first upper borehole at the first upper quadrant, a second upper borehole at the second upper quadrant, a first lower borehole at the first lower quadrant, and a second lower borehole at the second lower quadrant, such that each of the boreholes extends from a respective first opening in the front body surface to a respective second opening in the top surface, wherein all of the boreholes are circumferentially discontinuous, each of the upper boreholes is configured to receive a respective fixation element that attaches the implant to an upper vertebra, and each of the lower boreholes is configured to receive a respective fixation element that attaches the implant to a lower vertebra.
3. The intervertebral implant of claim 2, wherein the first and second upper boreholes diverge from each other along the lateral direction as they extend rearwardly.
4. The intervertebral implant of claim 3, wherein the first upper borehole and the first lower borehole diverge from each other along the vertical direction as they extend rearwardly.
5. The intervertebral implant of claim 4, wherein the first and second lower boreholes diverge from each other along the lateral direction as they extend rearwardly.
6. The intervertebral implant of claim 5, wherein the second upper borehole and the second lower borehole diverge from each other along the vertical direction as they extend rearwardly.
7. The intervertebral implant of claim 2, wherein the upper boreholes and the lower boreholes diverge from each other along the vertical direction as they extend rearwardly.
8. The intervertebral implant of claim 2, wherein the upper boreholes define a vertical angle with respect to the horizontal middle plane, and the vertical angle is in a range from 20 degrees to 60 degrees.
9. The intervertebral implant of claim 2, wherein the upper boreholes define a lateral angle with respect to the vertical middle plane, and the lateral angle is in a range from 10 degrees to 45 degrees.
10. The intervertebral implant of claim 2, further comprising a front plate that is configured to be secured to the implant, such that boreholes of the front plate are aligned with respective ones of the boreholes of the one-piece body.
11. The intervertebral implant of claim 10, further comprising a securing plate configured to attach to the front plate so as to overlap each of the boreholes of the front plate.
12. The intervertebral implant of claim 11, wherein the plate is inserted into vertically oriented grooves defined by the one-piece body.
13. The intervertebral implant of claim 12, wherein the vertically oriented grooves are open to the top surface of the one-piece body.
14. The intervertebral implant of claim 13, wherein the front plate and one-piece body are made from different materials.
15. The intervertebral implant of claim 2, wherein the one-piece body defines a plurality of apertures that extend through the top surface toward the bottom surface along the vertical direction, wherein the apertures are spaced from each other along the lateral direction.
16. The intervertebral implant of claim 2, wherein the one-piece body has a front height along the vertical direction from the bottom surface to the top surface at the front body surface, and a rear height along the vertical direction from the bottom surface to the top surface at the rear body surface, wherein the front height is greater than the rear height.
17. The intervertebral implant of claim 2, wherein the one-piece body defines teeth that extend vertically away from each of the top surface and the bottom surface.
18. A bone stabilizing system comprising: the intervertebral implant of claim 2; and a plurality of bone screws each configured to be driven through respective ones of the boreholes and into bone.
19. The bone stabilizing system of claim 18, further comprising a front plate that is configured to be secured to the implant, such that boreholes of the front plate are aligned with respective ones of the boreholes of the one-piece body, and the bone screws are configured to be driven through both the boreholes of the front plate and the boreholes of the one-piece body.
20. The bone stabilizing system of claim 19, further comprising a securing plate configured to attach to the front plate so as to overlap each of the boreholes of the front plate.
21. The bone stabilizing system of claim 20, wherein the first opening is disposed in a recessed portion of the front body surface. and the front plate is spaced from the front body surface when the front plate is attached to the one-piece body.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0011]
[0012]
[0013]
[0014]
[0015]
[0016]
[0017]
DESCRIPTION OF PREFERRED EMBODIMENTS
[0018] The intervertebral implant, shown in
[0019] As shown in
[0020] At the front surface of the three-dimensional body 10, a front plate 8 may be mounted, which is disposed perpendicular to the horizontal central plane of the intervertebral implant and through which four boreholes 9 pass and in which the longitudinal fixation elements 20 can be anchored. The front plate 8, as shown in
[0021] In one embodiment, at least one of the boreholes 9 in the front plate is constructed so that a longitudinal fixation element 20, accommodated therein, can be connected rigidly with the front plate. A rigid connection may be accomplished, for example, owing to the fact that at least one of the boreholes 9 of the front plate 8 has an internal thread. A corresponding longitudinal fixation element 20, bone screw, with a threaded end can then be screwed together rigidly with the implant. In an alternative embodiment, the four boreholes 9 in the front plate may have an internal thread 11, so that longitudinal fixation elements 20 can be connected rigidly with the front plate 8.
[0022] As discussed, the front plate 8 may be disposed, preferably vertically to the horizontal central plane, so that it can be displaced vertically with respect to the three-dimensional body 10. By these means, stress shielding (protection and neutralization of mechanical stresses) is attained, which permits the end plates to be adapted to the intervertebral implant during the healing process.
[0023] The intervertebral implant may have a securing plate 18, which can be fastened by means of a screw connection parallel to the front plate 8 at the front plate 8 in such a manner that the boreholes 9 of the front plate 8 are partly covered by the securing plate 18. The securing plate 18 may have a central borehole 17 provided, preferably, with an internal thread. Corresponding thereto, the front plate 8 has a central borehole 15 for accommodating fastening means 16. Preferably, the central borehole 15 has an internal thread 14 for accommodating a fastening means 16 in the form of a screw. The securing plate 18 may also be fastened by a bayonet catch or a click catch. By fastening the securing plate 18 to the front plate 8, the heads 21 of the longitudinal fixation elements 20 (discussed later) are contacted by the securing plate 18, so that they are secured against being ejected or screwed out.
[0024] Preferably, the boreholes 9a of the three-dimensional body 10 do not pass either through the left side surface 3 or the right side surface 4 or completely through the front surface 5. The front surface 5, preferably, is also not crossed by the boreholes 9a. Further, the horizontal middle plane 7 is not pierced by the boreholes 9a. Only the axes 24 of the longitudinal fixation elements 20, introduced therein, intersect the horizontal middle plane 7 of the body 10. As seen from the front surface 5, the boreholes of the three-dimensional body 10 and the front plate diverge. The axes 24 of the boreholes of the three-dimensional plate 10 and the front plate 8 enclose an angle ranging from 20 to 60, specifically from 36 to 48, and more preferably an angle of 42 with the horizontal middle plane 7 (
[0025] In one embodiment, at least one of the boreholes 9 of the front plate 8 may taper conically towards the underside 2, so that a bone screw, with a corresponding conical head, can be anchored rigidly therein. The conical borehole preferably has a conical angle, which is smaller than the resulting frictional angle. Advisably, the conicity of the conical borehole is 1:3.75 to 1:20.00 and preferably 1:5 to 1:15.
[0026] In another configuration, at least two of the boreholes 9 of the front plate 8 extend parallel to each other. This makes insertion of the intervertebral implant easier. In another embodiment, at least two of the boreholes 9 of the front plate 8 diverge when viewed from the front side. By these means, a region of the vertebral body, which has a better bone quality than does the center of the vertebral body, is reached by the bone screws.
[0027] To improve the anchoring of the bone screw in a plastic body of the intervertebral implant (discussed later), a metal sleeve with an internal thread (not shown) may be inserted in the boreholes of the front plate and three-dimensional body. The intervertebral implant may also consist only partially of an x-ray transparent plastic and, in the region of the boreholes consist of a metal, such as titanium or a titanium alloy. Improved guidance and anchoring of the bone screws in the intervertebral implant may be achieved. Further, the boreholes 9 may have a smooth internal wall, into which the threaded head of a metallic, longitudinal fixation element may cut or be molded.
[0028] Depending on circumstances, two, three, four or more longitudinal fixation elements may be connected rigidly with the intervertebral implant. Preferably, at least one fixation element should pierce the upper side and at least one fixation element the underside of the intervertebral implant. The longitudinal fixation elements 20 may have either a smooth head, so that there will not be a rigid connection with the implant or a threaded, conical or expendable end, so that there will be a rigid connection with the implant. In both cases, however, the longitudinal fixation elements 20 are secured by the securing plate against rotating out, being ejected out or falling out at a later time.
[0029] The longitudinal fixation elements 20 are preferably constructed as bone screws. As shown in
[0030] In the case of a second, possibly rigid type of connection, a longitudinal fixation element 20, bone screw, may preferably be used, the head of which tapers conically towards the shaft, the conicity of the head corresponding to the conicity of the borehole of the intervertebral implant. The longitudinal fixation elements may also be constructed as threadless cylindrical pins, which are provided with a drilling tip, preferably in the form of a trocar. A further variation consist therein that the longitudinal fixation elements are constructed as spiral springs. Finally, the longitudinal fixation elements may also be constructed as single-vaned or multi-vaned spiral blades.
[0031] As shown in
[0032] The intervertebral implant may be produced from any material which is compatible with the body. Preferably, the three-dimensional body 10 may consist of a body-compatible plastic which has not been reinforced and which may be transparent to x-rays. The advantage over fiber-reinforced plastics, which are already known in implant technology, is that no reinforcing fibers are exposed. Such exposure may be disadvantageous clinically. In such a three-dimensional body 10 constructed of a plastic that has not been reinforced, the use bone screws may be preferable. As discussed previously, the external thread of the bone screw(s) may have a load thread angle range of 11 to 14, and preferably between 12 to 13. A comparatively slight inclination of the load flank brings about a high clamping force. As a result, radial expansion and the danger of forming cracks in the plastic are reduced. Furthermore, the external thread of the bone screw(s) may preferably have a pitch angle between 6 and 10 and preferably between 7 and 9.
[0033] The front plate 8 may be made from materials different than the three-dimensional body 10. The front plate 8 is preferably made from a metallic material. Titanium or titanium alloys are particularly suitable as metallic materials. The complete tension chord arrangement (front plate and screws) may also be made from implant steel or highly alloyed metallic materials, such as CoCrMo or CoCrMoC. The advantage of titanium lies in that there is good tissue compatibility and the good ingrowing behavior of bones. The advantage of highly alloyed metallic materials lies in their high-strength values, which permit filigree constructions.
[0034] A brief description of a surgical procedure follows in order to explain the invention further.
[0035] The intervertebral implant, in the form of a three-dimensional body 10, is introduced between two adjacent vertebral bodies by means of a suitable instrument. Longitudinal fixation elements 20, in the form of bone screws, securing the three-dimensional body 10 are screwed/inserted by means of a suitable aiming device through the boreholes 9 of the front plate 8 into the vertebral bodies. The front plate 8 may be displaced vertically with respect to the three-dimensional body 10, such that the openings of the boreholes 9a of the three-dimensional plate 10 and the boreholes 9 of the front plate 8 overlap, to obtain stress shielding. The securing plate 18 is fastened by means of the fastening agent 16 in the form of a screw over the heads 21 of the longitudinal fixation elements 20 at the front plate 8, so that the heads 21 of the longitudinal fixation elements 20 and, with that, the screws themselves, are captured between the front plate 8 and the securing plate 18 and secured against being shifted relative to the three-dimensional body 10 (for example, by falling out or by turning out). The fastening agent 16, in the form of a screw, preferably is provided with a thread, which is distinguished by a large self-retardation.