The invention relates to an intervertebral disk prosthesis for replacing in full or in part the natural disks that provide the connection between two vertebrae of the vertebral column, regardless of the portion of the spine that is concerned.
Each intervertebral disk of the vertebral column is constituted by a central element referred to as the nucleus pulposus that is enclosed in a winding of fibers referred to as the annulus. The disk provides a connection between two vertebral bodies and it controls the flexing, bending, and turning movements of the vertebral column. Such a disk can become damaged under the effect of time, effort, or certain degenerative diseases, and it then becomes flattened and/or ceases to function properly. This can lead to various types of pathology, leading to multiple more or less intense pains and to handicaps of greater or lesser extent.
Treatment for that type of disorder consists in removing the diseased disk and replacing it either with an element that is movable or deformable, or with an element that readily interconnects the two vertebrae concerned.
Several type of prosthesis have been proposed for replacing an intervertebral disk, however they are satisfactory in part only. They do indeed preserve mobility between vertebrae and restore the distance between the vertebrae to a value close to that provided by a healthy disk. However, in providing such mobility, they impose particular dynamics that are not compatible or that are only partially compatible with the natural relative mobility between two vertebrae. In most circumstances, the prosthesis imposes dynamics that are specific thereto, with its center of rotation and its various plane-on-plane guidances, and that inevitably interfere with the natural joint elements that remain between two vertebrae, in particular the posterior articular facets. In this respect it is important to position the prosthesis with care since any inaccuracy in such placement increases the severity of the conflict between the dynamics of the prosthesis and natural dynamics. This non-physiological mobility can lead to undesirable clinical consequences. It is even possible that a component might migrate or that the prosthesis might become dislocated.
Furthermore, most known prostheses are unsuitable for restoring normal cervical or lumbar lordosis. Restoring the distance between vertebrae does not take account of the inclinations needed from one vertebra to the next in the stack of vertebrae in order to attain such natural lordosis, the existence of which is useful for normal biomechanics of the spine as a whole, and in particular of the adjacent levels.
Furthermore, known prostheses are not adapted to absorb shocks. A consequence of this unsuitability, associated with the conflict between the natural dynamics and the dynamics of the joint, can lead to premature wear both in natural elements and in elements of the prosthesis, thereby running the risk of degrading the patient's clinical state.
The present invention seeks to remedy those drawbacks by a disk prosthesis of simple structure and that is easy to put into place.
To this end, the present invention provides an intervertebral disk prosthesis comprising:
the assembly having the feature of being subdivided in the thickness direction into two units resting one on the other via complementary contact surfaces.
This structure is in the form of a part that does not impose any stressed connection between the two vertebrae it connects together (naturally this applies to amplitudes corresponding to natural relative movements). As a result, the natural guides for guiding such relative movements remain preponderant (in particular the posterior articular facets), and their integrity is preserved. In addition, at these contact surfaces, it is possible, by making an appropriate selection for their shape and their state, to govern the nature and the concentration of the stresses and the deformations that occur at said surfaces.
In a first embodiment of the invention, the complementary contact surfaces are formed in the thickness of the intermediate cushion, and preferably in the form of indentations and projections (teeth), the projections of one of them being complementary to the indentations of the other, so that they come into contact with each other over via least the surfaces of their flanks.
In a preferred embodiment of the invention, the elastically compressible intermediate cushion housed between the two inside surfaces of the plates possesses, in the free state, the general shape of a wedge between said two plates. This wedge shape of the structure enables the lordosis of the spine to be restored, which lordosis will generally have been degraded by the degeneration of the disk.
By way of example, the cushions may be based on high density polyethylenes, on high density polyurethanes, on silicones, or on composites of those various materials.
The prosthesis preferably includes a contention membrane for the cushion, which membrane is secured to the plates. The contention membrane serves to avoid biological invasion and colonization of the prosthesis. It also serves, in spite of all of the materials used being biocompatible, to isolate the cushion completely from the adjacent biological medium, and it forms a barrier to migration into the organism of any particles that might come from the cushion.
The membrane may be an annulus that is to be fastened to the plates (leaving direct contact between the cushion and each plate), or it may be a hermetically-sealed bag, enclosing the cushion, and for example bonded to the plates by adhesive, or indeed it may be a membrane that is sandwiched between each plate and a backing plate that is riveted thereto, the other face of the backing plate being in contact with the cushion.
Other structural arrangements appear on reading the description below. Particular mention can be made of the existence of a tie between the two plates of the prosthesis that enables the prosthesis to be kept in a compressed state so as to make it easier to put into place. One of the advantages of the prosthesis lies in that it is easy to put into place, and that this does not require great accuracy since there is no need to “match” its degrees of freedom with the natural degrees of freedom that exist between two vertebrae.
Other characteristics and advantages of the invention appear from the description given below of a few embodiments thereof.
Reference is made to the accompanying drawings, in which:
The end plates 5 and 6 of the prosthesis are in contact with the vertebral bodies 1a and 2a via surfaces of said bodies that have received prior preparation after removal of the damaged natural disk. The outside surfaces of these plates may include anchor means, e.g. portions in relief, in order to improve bone fixing; they may also make use of screws or any other equivalent element. The spine is shown presenting lordosis through an angle A that imposes on the prosthesis the relative orientation of these two vertebrae.
In
In this figure, it can be seen that the plates 5 and 6 are of dimensions such that, in the posterior portion of the prosthesis, they are set back from the cushion which projects beyond the plates via a portion 9 beside the tip of the wedge.
In
In a variant (not shown) the indentations are curved, e.g. in circular arcs centered beside the hinge.
In another variant (not shown) the two portions 11a and 11b can be separate (the hinge being omitted) and merely superposed with their indentations interleaved.
In
Finally,
Advantageously, at least one of the plates 5 and 6, and preferably both of them, is dimensioned in such a manner that the prosthesis has a cushion that projects beyond the plates, behind them, so as to leave a space adjacent to the posterior portion of the spine in which there is no metal element, with this being done for two purposes:
Finally, it should be mentioned that the above-described prosthesis corresponds to a single-piece prosthesis that is put into place using an anterior approach. In an embodiment adapted to be put into place via a posterior approach, it would comprise two half-prostheses that are put into place via lateral approaches so as to be placed on either side of the remaining portion (nucleus pulposus) of the natural disk. The shape of each half-prosthesis should then be adapted to the morphology that is encountered, e.g. by being kidney-bean shaped, when seen from above. Each half-prosthesis should be subdivided into two units using the various above-described variants.
Number | Date | Country | Kind |
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05 11596 | Nov 2005 | FR | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/FR2006/002515 | 11/14/2006 | WO | 00 | 3/4/2009 |
Publishing Document | Publishing Date | Country | Kind |
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WO2007/057555 | 5/24/2007 | WO | A |
Number | Name | Date | Kind |
---|---|---|---|
6093205 | McLeod et al. | Jul 2000 | A |
6582466 | Gauchet | Jun 2003 | B1 |
7250060 | Trieu | Jul 2007 | B2 |
7905922 | Bergeron | Mar 2011 | B2 |
20030187506 | Ross et al. | Oct 2003 | A1 |
20040049279 | Sevrain | Mar 2004 | A1 |
20040059418 | McKay et al. | Mar 2004 | A1 |
20050165485 | Trieu | Jul 2005 | A1 |
20060069436 | Sutton et al. | Mar 2006 | A1 |
20060089721 | Muhanna et al. | Apr 2006 | A1 |
Number | Date | Country |
---|---|---|
HEI2307494 | Dec 1990 | JP |
2008504892 | Feb 2008 | JP |
2005072660 | Aug 2005 | WO |
2006004848 | Jan 2006 | WO |
Number | Date | Country | |
---|---|---|---|
20090228109 A1 | Sep 2009 | US |