AU2003208143A1 - Intervertrebral disc prosthesis with contact studs - Google Patents

Description

P/00/011 Regulation 3.2

AUSTRALIA

Patents Act 1990 COMPLETE SPECIFICATION STANDARD PATENT Invention Title: Intervertebral disc prosthesis with contact studs The following statement is a full description of this invention, including the best method of performing it known to us: Freehills Carter Smith Beadle Melbourne 004324705 INTERVERTEBRAL DISC PROSTHESIS WITH CONTACT STUDS The invention concerns intervertebral disc prostheses.

The document EP-0,356,112, for example, discloses such prostheses comprising two plates and a body of compressible material interposed between the plates and fixed to them. The prosthesis replaces the natural disc after the disc has been ablated, with the plates bearing against the vertebral plates of the adjacent vertebrae. With such prostheses it is possible to a great extent to reproduce the mechanical behaviour of a healthy natural disc, in particular in compression or in torsion about any axis perpendicular to the longitudinal direction of the spine. However, they are not satisfactorily in respect of two other movements: the relative rotation of the two plates about a main axis of the prosthesis: that is to say about the axis of the spine, and the relative displacement of the two plates by shearing, that is to say sliding in a plane perpendicular to this axis. For these two movements, the known prostheses offer an insufficient mechanical reaction or are too rigid for the first movements.

It would be desirable to make available an intervertebral disc prosthesis with which it is possible to come even closer to the behaviour of a healthy natural intervertebral disc.

The invention provides an intervertebral disc Melbourne\004324574 Printed 4 July 2003 (11:44) 2 prosthesis comprising two plates and a deformable body interposed between the plates, where at least one of the plates comprises at least one contact stud which is movable in the body.

Thus, the contact stud offers mechanical resistance when the prosthesis is subjected to a rotational stress about its main axis or a shearing stress in a direction perpendicular to this axis. In addition, this resistance is variable depending on the relative position of the plates, for example depending on how close they are to each other and/or how inclined they are relative to each other. Indeed, the resistance to shearing and to rotation mentioned above will be all the greater the nearer the contact stud is to the opposite plate and thus the more compressed the body is on the axis. Moreover, depending on the position of the contact stud, a relative inclination of the plates will be able to bring the contact stud closer to the opposite plate and thus increase the resistance of the prosthesis locally near the contact stud, or by contrast -move the contact stud away from the opposite plate and thereby reduce this resistance. The prosthesis thus has a mechanical behavior which varies depending on the relative position of the plates, which makes it similar to a healthy natural disc. If its dimensions are sufficiently great, the contact stud or each contact stud can additionally constitute an abutment limiting one of the relative movements of flexion or translation of the plates. Of course, what has just been described above for one contact stud is valid a fortiori when the prosthesis comprises a plurality ,of contact studs.

The contact stud is advantageously offcentered relative to the plate which bears it.

Thus, the resistance behavior of the prosthesis largely depends on the axis of the flexion and on the direction of this flexion.

3 The contact stud advantageously extends at a distance from the plate other than the one which bears it when the prosthesis is not stressed.

The contact stud advantageously has a length of between 0.60 d and 0.90 d, where d is a distance separating the two plates when the prosthesis is not stressed.

Advantageously, for the plate or each plate provided with at least one contact stud, the body is immobilized relative to the plate, in respect of a displacemeht parallel to the plate, only by virtue of the contact stud.

Thus, the body bears, without anchoring, on the plate or each plate comprising a contact stud. Assembly is thus carried out simply by stacking the plates and the body together. The body is in particular able to be separated from the plate under the effect of .a traction causing a displacement in the direction away from the plate, which of course is not conceivable in the normal conditions of use of the prosthesis.

The. contact stud advantageously extends in a recess of the body opening into a lateral face of the body.

The contact stud advantageously has a flattened shape in a plane radial to the main axis of the prosthesis.

Thus, in the event of shearing or torsion about the main axis of the prosthesis, the bearing surface between the contact stud and the body is considerable, resulting in good distribution of the load, although the volume of the contact stud can be relatively small.

The contact stud advantageously has a flattened shape in a plane tangential to ,a direction circumferential to the main axis of the prosthesis.

The contact stud advantageously has a cylindrical lateral face, and the body has a cylindrical face bearing on the cylindrical face of the contact stud.

4 The contact stud advantageously has a lateral face extending outside the body.

Thus, the contact stud encroaches moderately on the volume of the body.

The lateral face of the contact stud advantageously extends in the continuation of an outer lateral face of the body.

Advantageously, for the contact stud or each contact stud, the plate other than the one bearing the contact stud has a recessed zone constituting the part facing the contact stud when the prosthesis is at rest.

Thus, in the event of flexion or of the plates coming extremely close to each other, the contact stud or each contact stud does not come into abutment against the opposite plate, so that the deformable body taking up the stresses continues to impose the mechanical behavior of the prosthesis.

The plate advantageously comprises at least two contact studs arranged symmetrically about a center of the plate.

Each plate advantageously comprises at least one contact stud, the contact studs overlapping in a direction parallel to the main axis of the prosthesis when the prosthesis is not stressed.

The anti-shearing effect is increased in this way.

The contact studs advantageously overlap by a length of between 0.35 d and 0.65 d, where d is a distance separating the two plates when the prosthesis is not stressed.

Advantageously, when the prosthesis is not stressed, the contact studs overlap by a length of between 0.45 h and 0.85 h, where h is a height of the contact studs parallel to the main axis of the prosthesis.

Each plate advantageously comprises at least two contact studs, the contact studs being arranged alternatingly around the main axis of the prosthesis.

5 Other characteristics and advantages of the invention will also become apparent from the following description of two preferred embodiments given as nonhimiting examples. In the attached drawings: Figure 1 is an exploded perspective view of a prosthesis according to a first preferred embodiment, without its bellows; Figure 2 is a side view of the prosthesis from Figure 1, partially cut away in the area of the bellows; Figure 3 is a perspective view of an alternative to the prosthesis of the first embodiment; Figures 4 and 5 are perspective views of a prosthesis according to a second preferred embodiment, in the assembled state and in an exploded representation, respectively; and Figures 6 and 7 are perspective and plan views, respectively, of the body of the prosthesis in Figure 4.

Referring to Figures 1 and 2, in the present embodiment (and in the second one) the intervertebral disc prosthesis 2 is intended for the lumbar region of the spine.

It comprises two plates 4 which are identical to each other. Each plate 4 has a generally planar disc shape. In the present case, each plate has a slightly raised peripheral edge 6 projecting from a plane central inner face 8 of the disc, thus giving it the appearance of a saucer.

Each plate comprises contact studs 10, in this case two in number and identical to each other. Each contact stud 10 has the general shape of a rectangular parallelepiped whose edges, except for its base in contact with the plate, would have been rounded. The contact stud is almost as high as it is wide, but it is flattened in its third dimension corresponding to its thickness. The contact studs 10 project from the inner face 8, perpendicular to the plane thereof. The two contact studs .10 are arranged symmetrically with 6 respect to a main axis 12 of the prosthesis passing through the center of this face and perpendicular to its plane when the prosthesis is not stressed. The thickness of the contact studs 10 extends in a plane radial to the axis 12 'so that the two contact studs are substantially in the same radial plane, either side of the axis 12. On a plane outer face 14, the plate has reliefs making it easier to fix the plate 4 to a vertebral plate, in particular by means of a hydroxyapatite covering. The plates can be made of metal or composite material.

The prosthesis comprises a body 16 of general cylindrical shape, having a cylindrical outer face 18 and two opposite plane end faces 20. The body 16 is here made of an elastic material such as an elastomer.

The body has channels or recesses 22, here four in number. The channels are profiled in a direction parallel to the axis 12 of the body 16. Their profile is identical to the profile of the contact studs 10 in a plane transverse to their height, that is to say to the axis 12. Each channel 22 thus has a generally plane shape and extends in a radial plane to the axis 12.

Each channel 22 extends at a distance from the axis 12 and opens out on the cylindrical face 18 across its entire height and on each of the two end faces Viewed from the end, the body thus has a cross or cloverleaf shape.

For assembly, the body 16 is arranged between the two plates 4 which have their inner faces 8 and their contact studs 10 facing each other, the two plates being mutually offset by a quarter turn about the axis' 12, the four channels 22 being in line with the four contact studs. The two plates 4 are moved toward each other until their inner faces 8 come into surface contact with the end faces 20 of the body, the four contact studs 10 'penetrating the four respective channels 22. The four contact studs thus belong to the two plates alternately about the axis 12. The plates 4 bear on the body 16 without any anchoring other than 7 the contact studs. The body 16 is immobilized by bearing on the inner faces 8 and the contact studs the latter by themselves prohibiting its displacement in translation in a plane perpendicular to the axis 12.

The prosthesis comprises a compressible bellows 26 in the form of a sleeve which has a corrugated profile and is fixed to the edges 6 of the twoplates in order to isolate the space to the inside of the bellows, including the body 16, from the outside. In this case, the bellows has ten convolutions, which creates nine crests in addition to the crests fixed to the edges 6. The bellows and the plates can be made of titanium or titanium alloy.

In Figure 2, the prosthesis is illustrated in the unstressed state. Each contact stud 10 has, on the axis 12, a height h of between 0.60 d and 0.90 d, where d is a distance, taken between the edges 6, separating the two plates when the prosthesis is in the unstresed state. In the present case, h is equal to 0.75 d.

In the present embodiment, the contact studs of one of the plates partially overlap those of the other plate in the situation in Figure 2. This means that any cut through the prosthesis transverse to the axis 12 intercepts two contact studs 10 of the same plate 4 in the vicinity of the end faces 20, and the four contact studs in a median portion of the body. The length of overlap r, measured parallel to the axis 12, can be between 0.35 d and 0.65 d or between 0.45 h and 0.85 h. Here, r is equal to 0.66 h and 0.5 d.

Once fitted, the prosthesis behaves as follows.

If the prosthesis is subjected to rotation about the axis 12, the contact studs 10 cooperate with the body 16 in order to take up a large part of the generated stresses, which locally are shearing stresses.

If the prosthesis is compressed on its axis 12, the four contact studs 10 each penetrate further into their channel 22, moving in the direction of the opposite plate. The resistance of the prosthesis to 8 shearing perpendicular to the axis 12 or to rotation about this axis is therefore greater.

If the prosthesis is subjected to flexion about an axis perpendicular to the axis 12, the two plates 4 incline relative to each other, which corresponds locally to a compression on certain parts of the body 16 and to a traction on other parts of the body. The resistance to shearing is thus increased in the former and reduced in the latter.

Although the body 16 is deformable, the movement of each contact stud 10 in its channel 22 is on the whole similar to a sliding movement.

Referring to Figure 3, it is possible for each plate 4 to have two lugs 30 projecting from the outer face 14 of the plate 4 perpendicular to the plane of the plate. Each lug 30 has an orifice 32 passing right through it in the direction of the center of the plate and, on a face of the lug directed away from the plate, an indentation of spherical shape. The orifices 32 can receive a bone screw 34 having a head whose lower face has a male spherical shape interacting with the female indentation of the lug 30 in order to permit free orientation of the screw relative to the associated lug.

For short-term anchoring of the disc prosthesis in the column, the screws 34 can be anchored in -the body of the vertebrae adjacent to the disc which is to be replaced.

However, it will be possible to. provide for long-term anchoring in which, in addition, the surfaces 14 of the plates 4 in contact with the adjacent vertebrae are covered with hydroxyapatite or any other substance known per se for stimulating bone growth.

Before being covered, said surfaces can be treated to obtain a more or less porous surface condition, with anchoring points for the bone tissue, so as to ensure a better interface with said bone tissue. In Figure 3, the plates have the shape of a bean with a posterior hilum.

9 Figures 4 to 7 illustrate a second embodiment in which the elements analogous to those of the first embodiment bear reference numbers increased by one hundred.

In this prosthesis 102, each of the two plates 104 here bears three contact studs 110. Each contact stud 110 is contiguous with the edge 106 of the plate and has a flat shape parallel to this edge, that is to say substantially in a plane tangential to a direction circumferential to the axis 112. As the edge 106 has, at the location of the contact studs 110, a plane of substantially circular convex shape, each contact stud has an outer lateral face 111 intended to be set opposite the body 116 and with a convex cylindrical shape, extending in the continuation of the edge 106.

Each contact stud 110 additionally has an inner lateral face 113, also of convex cylindrical shape. The two cylindrical faces 111, 113 of each contact stud form two ridges parallel to the axis 112. The ridges are in fact not very pronounced and are very rounded (in a plane perpendicular to the main axis) in order to ensure that they do not cut into the body. The same is true of the ridges forming the free end face of the contact studs. Here once again, the contact studs of the two plates are intended to partially overlap parallel to the axis 112 so that the contact studs of the two plates mesh.

The body 116 has a lateral face 118 of generally cylindrical shape, except that its plane once again has the shape of a bean with posterior hilum.

This is also the shape of the plane of the -overall prosthesis. The six channels or seats 122 for contact studs on the body 116 are here delimited by cylindrical and concave faces, respectively, with axes parallel to the axis 112 and opening in the lateral face 118. The body 116 thus has laterally an alternating sequence of concave cylindrical, faces 122 and convex cylindrical faces 118. Each face 122 has the same radius and the same length as the inner lateral face 113 of the 10 corresponding contact stud in order to ensure surface contact of one with the other. However, the cylindrical face 122 of the body is higher, parallel to the axis 112, than the contact stud.

Given the bean shape of the prosthesis, and since each contact stud is intended to be received between two contact studs of the other plate, the two plates are not strictly identical.

The prosthesis is assembled as before by bringing the two plates 104 toward one another with their contact studs 110 facing each other, and interposing the body 116 between these. Each contact stud 110 thus penetrates into its seat 122, the lateral inner face 113 of the contact stud coming into contact with the face 122 of the channel. Once assembly has been completed, as in Figure 4, each plate has its plane inner face bearing on the respective plane end face of the body.

The curvatures of the outer lateral faces 111 of the contact studs and of the lateral face 118 of the body (that is to say of each portion of this face) are chosen in such a way that these faces extend in the continuation of each other without any protruding or recessed ridge, giving the plane of the prosthesis a bean shape.

Each plate 104 has in a plane three recesses 115 in the edge 106, each delimited by a concave circular edge of greater radius than that of the associated face 122, as will be seen. Each recess 115 extends between two of the contact studs 110 of the plate so that said recess itself lies opposite a.

contact stud of the other plate.

Thus, in the assembled position, and at rest, as is shown in Figure 4, each contact stud 110 extends opposite a part of the other plate formed by the recess 115. Thus, in the event of considerable stress displacing at least one of the contact studs 110 in the direction of the other plate, the contact stud ,can extend into the recess 115 without coming into abutment 11 against the plate. The radius or the depth of the recess 115 is greater than that of the associated channel 122, which gives the assembly a step-shaped configuration locally and prevents any abutment of the contact stud against the opposite plate. This substantial depth of the recess increases the flexibility of the prosthesis in the event of torsion about an axis perpendicular to the main axis.

The characteristics concerning the dimensions r, h and d again apply in this embodiment. Also in this embodiment, it will be possible to provide a bellows or a screw attachment as in Figure 3.

Here once again, each contact stud 110 is movable relative to the body and is able to stress the body in a direction not parallel to the axis 112, this stress being variable depending on the position of the contact stud in the body in the radial direction and the direction parallel to the axis 112. Although the contact studs penetrate less deeply into the body than in the preceding embodiment, they still ensure the transmission of the forces from the plates to the body.

The torisonal flexibility of the prosthesis can be regulated in particular by modifying the thickness of the three contact studs 110. This is because thicker contact studs make the.prosthesis more rigid in torsion about the axis 112. Moreover, since there is no attachment between the body 116 and each of the plates 104, the latter can slide to a certain extent on the body during torsion. The body 116 arranged between the opposed contact studs 110 is compressed and pushed radially inward during torsion on account of the overall movement of the contact studs.

The axial rigidity of the prosthesis can be regulated in particular in the area of the contact zone between the body 116 and each plate 104. The inner face of each plate and the associated end face of the body can in fact be configured in such a way that the contact between these faces is established over a zone which becomes ever greater as the compression stress on 12 the axis 112 increases. It will be possible, for example, to retain the plane shape of the end face of the body and give the inner face of the opposite plate a slightly spherical convex shape. The axial rigidity is in particular a function of the radius of the spherical face.

In order to ensure a long-term fixation between the plates and the body, it will be possible to arrange matters so that the body is to a large extent fitted into the plates between the contact studs thereof. The fact that the plates are not rigidly fixed to the body facilitates production and also the regulation of the height of the prosthesis in advance of the intervention or during it. It suffices in fact to modify the height of the body on the axis 112, for example by changing body, in order to modify the height of the prosthesis itself.

When the prosthesis is subjected to torsion about its main axis, the zones of the body situated between two succesive contact studs are compressed in a circumferential direction. Since there are three contact studs here on each plate, there are three zones of compression. The torsional rigidity thus depends on the shape of the contact studs, the distance between them, and the extent of the axial overlap between the contact studs.

Each of the plates and also the body will be made separately by injection molding.

The prosthesis tolerates prolonged cyclic loading without modification of its shape.

In some known prostheses, the join between the plates and the body is fragile and risks rupturing. The prosthesis according to the invention eliminates this risk since the plates are designed to be movable by sliding on the body.

The contact studs limit the extension of the body beyond the contour of the plates, particularly during axial compression.

13 The body can have a spatially variable modulus of elasticity.

The body can be made of a number of materials.

When a homogeneous elastomer is used for the body, that is to say an elastomer having the same modulus of elasticity everywhere, the ratio of the axial compression rigidity to the torsional rigidity is generally too high. To reduce the axial rigidity without reducing too much the torsional rigidity, one of the two following alternatives can be applied. In a first alternative, the center of the body can be made of an elastomer which is less rigid than that of the periphery of the body. This reduces the compression rigidity without too much affecting the torsional rigidity since the latter is governed mainly by the periphery of the body. In a second alternative, a cavity can be formed in the inner surface of the plates in contact with the body, in order to reduce the surface of contact of the plates with the body. This reduces the volume of elastomer which is compressed in the event of axial compression, thereby diminishing the axial rigidity, but once again without too much affecting the torsional rigidity.

Many modifications can of course be made to the invention without departing from the scope thereof.

The contact stud 10, if there is only one per plate, can be at the center of the plate which bears it.

The contact stud or each contact stud 10, 110 can be in contact with the opposite plate 4, 104 when the prosthesis is not stressed or only when the compression of the prosthesis in the area of the contact stud exceeds a certain limit: the contact stud thus forms a stop limiting certain types of movements.

It is conceivable that only one of the plates 4, 104 will have one or more contact studs 10,110.

The body 16, 116 can be made of a viscoelastic material such as silicone.

14 The contact studs will be able to have another shape, for example a cylindrical shape with an axis parallel to the axis 12, 112.

The contact stud will be able to extend in the Sbody within a seat which does not open out on a lateral face of the body.

Claims (15)

1. 2. Prosthesis according to claim i, wherein the contact stud is off-centered relative to the plate which bears it.
2. 3. Prosthesis according to either one of claims 1 or 2, wherein the contact stud extends at a distance from the plate other than the one which bears it when the prosthesis is not stressed.
3. 4. Prosthesis according to any one of claims 1 to 3, wherein the contact stud has a length of between about 0.60 d and 0.90 d, where d is a distance separating the two plates when the prosthesis is not stressed. Prosthesis according to any one of claims 1 to 4, wherein for the plate or each plate provided with at least one contact stud, the body is immobilized relative to the plate, in respect of a displacement parallel to the plate, only by virtue of the contact stud. Melbourne\004324574 Printed 4 July 2003 (11:44) -16-
4. 6. Prosthesis according to any one of claims 1 to wherein the contact stud extends in a recess of the body opening into a lateral face of the body.
5. 7. Prosthesis according to any one of claims 1 to 6, wherein the contact stud has a flattened shape in a plane radial to the main axis of the prosthesis.
6. 8. Prosthesis according to any one of claim 1 to 6, wherein the contact stud has a flattened shape in a plane tangential to a direction circumferential to the main axis of the prosthesis.
7. 9. Prosthesis according to any one of claims 1 to 8, wherein the contact stud has a cylindrical lateral face, and the body has a cylindrical face bearing on the cylindrical face of the contact stud. Prosthesis according to any one of claims 1 to 9, wherein the contact stud has a lateral face extending outside the body.
8. 11. Prosthesis according to any one of claims 1 to wherein the lateral face of the contact stud extends in the continuation of an outer lateral face of the body.
9. 12. Prosthesis according to any one of claims 1 to 11, wherein for the contact stud or each contact stud, the plate other than the one bearing the contact stud Melbourne\004324574 Printed 4 July 2003 (1 1:44) -17- has a recessed zone constituting the part facing the contact stud when the prosthesis is at rest.
10. 13. Prosthesis according to any one of claims 1 to 12, wherein the plate comprises at least two contact studs arranged symmetrically about a centre of the plate.
11. 14. Prosthesis according to any one of claims 1 to 13, wherein each plate comprises at least one contact. stud, the contact studs overlapping in a direction parallel to the main axis of the prosthesis when the prosthesis is not stressed.
12. 15. Prosthesis according to claim 14, wherein the contact studs overlap by a length of between 0.35 d, and 0.65 d, where d is a distance separating the two plates when the prosthesis is not stressed.
13. 16. Prosthesis according to claim 14 or 15, wherein when the prosthesis is not stressed, the contact studs overlap by a length of between 0.45 h and 0.85 h, where h is a height of the contact studs parallel to the main axis of the prosthesis.
14. 17. Prosthesis according to any one of claims 1 to 16, wherein each plate comprises at least two contact studs, the contact studs being arranged alternatingly around the main axis of the prosthesis. Melbourne\004324574 Printed 4 July 2003 (1 1:44) -18-
15. 18. Intervertebral disc hereinbefore described accompanying drawings. prosthesis substantially as with reference to the DATED this 4 July 2003 FREEHILLS CARTER SMITH BEADLE Patent Attorneys for the Applicant DIMSO (Distribution Medicale du Sud-Ouest) Melbourne\004324574 Printed 4 July 2003 (11:44)