INTERVERTEBRAL DISC PROSTHESIS
20220241087 · 2022-08-04
Inventors
Cpc classification
A61B17/3468
HUMAN NECESSITIES
A61F2/30767
HUMAN NECESSITIES
A61F2002/30367
HUMAN NECESSITIES
A61F2002/30331
HUMAN NECESSITIES
A61F2220/0033
HUMAN NECESSITIES
A61F2002/30365
HUMAN NECESSITIES
A61F2/0095
HUMAN NECESSITIES
A61F2002/30616
HUMAN NECESSITIES
A61F2220/0025
HUMAN NECESSITIES
A61F2002/30369
HUMAN NECESSITIES
A61F2002/443
HUMAN NECESSITIES
A61F2002/30841
HUMAN NECESSITIES
A61F2002/30795
HUMAN NECESSITIES
International classification
Abstract
This disclosure relates to intervertebral disc prostheses which may have an upper plate, a lower plate, and a mobile core, with the upper surface of the core being in contact with at least a part of the lower surface of the upper plate. In some configurations, limit stops reduce friction while limiting or preventing the movements of the core relative to the lower plate, in translation and in rotation, respectively, along an axis substantially parallel to the lower plate and about an axis substantially perpendicular to the lower plate. Instrumentation for insertion of the prostheses into intervertebral spaces is also described.
Claims
1-12. (canceled)
13. A motion preserving disc prosthesis comprising: an upper plate including upper and lower surfaces; a lower plate including upper and lower surfaces; and a core engaging the lower surface of the upper plate and upper surface of the lower plate, wherein an engaging surface of the core comprises at least one dummy hole intersecting a plurality of grooves radiating outwardly from the at least one dummy hole to facilitate engagement of the core with an adjacent portion of the upper or lower plate in response to movement by a patient.
14. The prosthesis of claim 13, wherein the at least one dummy hole passes through only a portion of the core, wherein the engaging surface of the core is a lower surface of the core and the adjacent portion of the upper or lower plate is the upper surface of the lower plate, wherein engaging portions of the lower surface of the core and upper surface of the lower plate are each substantially flat and wherein an angle formed by edges of the at least one dummy hole relative to a substantially flat engaging portion of the lower surface of the core is softened.
15. The prosthesis of claim 13, wherein the at least one dummy hole passes through only a portion of the core, wherein the engaging surface of the core is an upper surface of the core and the adjacent portion of the upper or lower plate is the lower surface of the upper plate, wherein engaging portions of the upper surface of the core and lower surface of the upper plate are each substantially flat and wherein each of the plurality of grooves extends from the at least one dummy hole to a peripheral edge of the engaging portion of the upper surface of the core.
16. The prosthesis of claim 13, wherein the at least one dummy hole and grooves are configured to receive interstitial liquid from surrounding tissue of a patient to lubricate engagement of the core relative to the adjacent portion of the upper or lower plate in response to movement by a patient.
17. The prosthesis of claim 13, wherein the at least one dummy hole passes through only a portion of the core, wherein the engaging surface of the core is an upper surface of the core and the adjacent portion of the upper or lower plate is the lower surface of the upper plate, wherein the at least one dummy hole is centrally located on the upper surface of the core, wherein the core comprises polyethylene, wherein each of the upper surface of the upper plate and lower surface of the lower plate comprise a porous biocompatible coating, and wherein the upper surface of the upper plate and lower surface of the lower plate each comprise plural teeth proximal to opposing edges of the upper plate and lower plate, respectively, and oriented to prevent sliding of the prosthesis prior to adhesion of the porous biocompatible coating to osseous tissue of an adjacent vertebrae of a patient.
18. The prosthesis of claim 13, wherein the at least one dummy hole and plurality of grooves are configured to provide a contact area between the engaging surface of the core and adjacent portion of the upper or lower plate that is substantially equal to a contact area between the lower surface of the core and the upper surface of the lower plate, whereby constraints applied to the prosthesis are absorbed equally by both surfaces of the core.
19. An insertion tool configured to engage the prosthesis of claim 13, wherein a clip of an insertion tool comprises a U-shaped engaging surface that engages a front edge of the prosthesis, each laterally opposed blade of the U-shaped engaging surface gripping opposing sides of the prosthesis, wherein a central edge of the U-shaped engaging surface engages the upper and lower plates of the prosthesis, and wherein a maximum height of the clip is at least substantially equal to a height of the front edge of the prosthesis.
20. A tool configured to engage the prosthesis of claim 13, wherein a clip of a tool grips and holds opposing sides of the prosthesis and wherein opposing blades mounted on lateral edges of the clip pinch the opposing sides of the prosthesis to maintain the prosthesis in a stationary position in the clip.
21. A motion preserving disc prosthesis comprising: a first endplate including first and second surfaces; a second endplate including first and second surfaces; and a nucleus including first and second surfaces contacting the second surface of the first endplate and first surface of the second endplate, respectively, wherein the first surface of the nucleus comprises at least one central recess intersecting a plurality of grooves radiating outwardly from the at least one central recess to facilitate engagement of the nucleus relative to the second surface of the first endplate in response to movement by a patient, wherein the at least one central recess and plurality of grooves are configured to provide a contact area between the first surface of the nucleus and second surface of the first endplate that is substantially equal to a contact area between the second surface of the nucleus and the first surface of the second endplate, whereby constraints applied to the prosthesis are absorbed equally by both surfaces of the nucleus.
22. The prosthesis of claim 21, wherein contacting portions of the first surface of the nucleus and second surface of the first endplate are each substantially flat and wherein an angle formed by edges of the at least one central recess relative to a substantially flat contacting portion of the first surface of the nucleus is softened.
23. The prosthesis of claim 21, wherein contacting portions of the first surface of the nucleus and second surface of the first endplate are each substantially flat and wherein each of the plurality of grooves extends from the at least one central recess to a peripheral edge of the contacting portion of the first surface of the nucleus.
24. The prosthesis of claim 21, wherein the at least one central recess and grooves are configured to receive interstitial liquid from surrounding tissue of a patient to lubricate engagement of the nucleus relative to the second surface of the first endplate in response to movement by the patient.
25. The prosthesis of claim 21, wherein the at least one central recess is centrally located on the first surface of the nucleus, wherein the nucleus comprises polyethylene, wherein each of the first surface of the first endplate and second surface of the second endplate comprise a porous biocompatible coating, and wherein the first surface of the first endplate and second surface of the second endplate each comprise plural teeth proximal to opposing edges of the first endplate and second endplate, respectively, and oriented to prevent sliding of the prosthesis prior to adhesion of the porous biocompatible coating to osseous tissue of an adjacent vertebrae of the patient.
26. A surgical kit, comprising: a disc prosthesis comprising: a first endplate including first and second surfaces; a second endplate including first and second surfaces; and a nucleus including first and second surfaces engaging the second surface of the first endplate and first surface of the second endplate, respectively, wherein the first surface of the nucleus comprises at least one central recess intersecting a plurality of grooves radiating outwardly from the at least one central recess to facilitate engagement of the nucleus relative to the second surface of the first endplate in response to movement by a patient, wherein the at least one central recess and plurality of grooves are configured to provide a contact area between the first surface of the nucleus and second surface of the first endplate that is substantially equal to a contact area between the second surface of the nucleus and the first surface of the second endplate, whereby constraints applied to the prosthesis are absorbed equally by both surfaces of the nucleus; and a prosthesis insertion tool to position the disc prosthesis between opposing vertebrae of a patient, the prosthesis insertion tool comprising a clip having a U-shaped engaging surface that engages a front edge of the prosthesis, each laterally opposed blade of the U-shaped engaging surface gripping opposing sides of the prosthesis and a center portion of the U-shaped engaging surface engaging the first and second endplates of the prosthesis.
27. The surgical kit of claim 26, wherein a maximum height of the clip is at least substantially equal to a height of the front edge of the prosthesis.
28. The surgical kit of claim 26, wherein engaging portions of the first surface of the nucleus and second surface of the first endplate are each substantially flat and wherein an angle formed by edges of the at least one central recess relative to a substantially flat engaging portion of the first surface of the nucleus is softened.
29. The surgical kit of claim 26, wherein engaging portions of the first surface of the nucleus and second surface of the first endplate are each substantially flat and wherein each of the plurality of grooves extends from the at least one central recess to a peripheral edge of the engaging portion of the first surface of the nucleus.
30. The surgical kit of claim 26, wherein the at least one central recess and grooves are configured to receive interstitial liquid from surrounding tissue of a patient to lubricate engagement of the nucleus relative to the second surface of the first endplate in response to movement by the patient.
31. The surgical kit of claim 26, wherein the at least one central recess is centrally located on the first surface of the nucleus.
32. The surgical kit of claim 26, wherein the nucleus comprises polyethylene, wherein each of the first surface of the first endplate and second surface of the second endplate comprise a porous biocompatible coating, and wherein the first surface of the first endplate and second surface of the second endplate each comprise plural teeth proximal to opposing edges of the first endplate and second endplate, respectively, and oriented to prevent sliding of the prosthesis prior to adhesion of the porous biocompatible coating to osseous tissue of an adjacent vertebrae of the patient.
Description
BRIEF DESCRIPTION OF FIGURES
[0038] Other particular features and advantages of the embodiments of present invention will emerge more clearly from the description hereinbelow, given in reference to the attached drawings, in which:
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DESCRIPTION OF PREFERRED EMBODIMENTS
[0056] The intervertebral disc prosthesis according to an embodiment of the present invention is comprised of a first plate (1) articulated relative to a second plate (2) by means of a core (3), as evident in particular in
[0057] The core (3) is of less thickness (for example 3 mm in a preferred embodiment) for a cervical prosthesis or thicker (for example 15 mm in a preferred embodiment) for a lumbar prosthesis.
[0058] In another embodiment, a part of the upper surface of the upper plate (1) is bulged, as shown in
[0059] In the embodiment of
[0060] In another embodiment, the lower surface of the core (3) is enclosed by a protective shell (4) of the core. This protective shell (4) is, for example, drilled, in the centre of its lower surface, with at least one hole (41), for example a dummy, which improves sliding on the upper surface of the lower plate (2). In a simpler variant embodiment, in the absence of this protective shell (4), it is the lower surface of the core (3) which, for example, will be pierced by a dummy hole in its centre. The core alone will then have substantially the same appearance as the ensemble made up by the core (3) and its protective shell (4), such as in the embodiment described hereinafter and illustrated in
[0061] In a variant embodiment the dummy hole (41) present at least on the lower surface of the core (3) or of the protective shell (4) of the core is prolonged by grooves (410) which extend as far as the periphery of this lower surface. These grooves (410) thus form channels via which interstitial liquid from surrounding tissue can slide between the lower surface of the core (3) or of the protective shell (4) and play a lubricating role to improve sliding of the core (3) on the upper surface of the lower plate (2).
[0062] The hole (41) and the eventual grooves (410) may be such that the area of contact between the lower surface of the core (3) and the upper surface of the lower plate (2) is substantially equal to the area of contact between the upper surface of the core (3) and the lower surface of the upper plate (1). The constraints applied to the prosthesis will thus be absorbed equally by both surfaces of the core (3) in this embodiment, which will allow reducing frictions and improving the life duration of the core by optimizing the displacement of the core (3) relative to the plates (1, 2).
[0063] In the embodiment where the lower surface of the core (3) is enclosed by a protective shell (4), the lower part of the core may be narrower than its upper part, such that once the protective shell (4) is mounted on the lower part, the core has substantially homogeneous dimensions, as shown in
[0064] The core (3) in this embodiment has, on at least one part of its upper surface, a convex part (32), evident particularly in
[0065] According to an embodiment of the invention, the lower surface of a core (3) made of compressible material could be enclosed by a metallic protective shell (4), permitting better sliding on the lower metallic plate (2) and reduction in creep of the compressible material. The sliding of the core will be improved by a hole (41), for example a dummy, bored in the lower surface of the protective shell (4).
[0066] In the embodiment of
[0067] In the embodiment where a core (3) made of compressible material is provided with a protective metallic shell (4) sliding on a lower metallic plate, the protective shell could be in an adapted form so that it is not in contact with a metallic limit stop of the lower plate. Such a result can be obtained, for example, thanks to the fact that the edges of the protective shell (4) are slightly offset from the limit stops of the core. This variant embodiment can prove necessary since, in a living organism, it is preferable to avoid the shocks between two metallic materials, which risk projecting metallic particles into the surrounding tissue and causing complications.
[0068] In a variant embodiment not shown, the dimensions of each recess (31) of the core (3) are substantially the same as those of each nib (22) of the lower plate (2), so as to avoid any clearance of the core (3) relative to the lower plate (2), both in translation and in rotation. In the latter case, the only permitted movement of the prosthesis is that of the upper plate (1) relative to the core (3).
[0069] In a variant embodiment not shown, the contact plates (22) are replaced by nibs curved towards the interior of the prosthesis, above the edges of the core (3), so as to prevent the core from being raised. In another variant, one of the nibs is replaced by a contact plate (or pin) equipped with a hole in which, for example, a dowel fixes a plate (or hasp). The ensemble made up by the hasp fixed on the contact plate will have the same form as the nib of the opposite side and will fulfil the same function with the added advantage of facilitating mounting of the different pieces of the prosthesis. In a variant embodiment, the two nibs are each replaced by a contact plate to which a hasp is fixed.
[0070] In another variant embodiment not shown, the contact plates (22) of the lower plate (2) are replaced by half dog points. The core (3), by way of complement, does not comprise recesses (31), but two wells under its lower surface. The dimensions of the half dog points of the lower plate (2) and of the wells of the core (3) will be adapted according to the desired result, by choice, of slight clearance of the core in translation and in rotation or any clearance.
[0071] In another embodiment not shown, the contact plates (22) of the lower plate (2) are replaced by walls, positioned opposite one another, in the vicinity of two substantially parallel edges of the lower plate, but more towards the interior of the prosthesis than the contact plates (22). The core (3) comprises recesses complementary to the walls. The dimensions of each recess of the core of this embodiment are, either slightly greater, or substantially the same as those of each wall of the lower plate, so as to allow or not slight clearance in translation and in rotation.
[0072] In yet another embodiment not shown, the female cooperation means are situated on the lower plate (2) and the male cooperation means on the core (3).
[0073] An intervertebral disc prosthesis according to many embodiments of the present invention help to correct the defects of lordosis. The presence of an acute angle, for example of between 0° and 15°, in the postero-anterior direction, between the upper plate (1) and the lower plate (2) of the prosthesis could be desired. To adjust the angle necessary as a function of the patient, it suffices to select a core (3) with an appropriate angle between the average plane representing its upper surface and the plane passing through its lower surface. Such an angle could likewise be obtained by making an upper plate, including the plane means representing its lower and upper surfaces forming an angle. Another possibility involves the lower plate whereof the plane means representing its lower and upper surfaces form an angle. Another possibility consists of a position of the core slightly offset to the rear or the front relative to the centre of the prosthesis including the plates which will then form an angle. This slightly offset position of the core can, for example, be maintained due to adjustable positioning of the male and female limit stops.
[0074] In the event where the male structure or stop in the vicinity of the edges of the core (i.e., near the periphery of the core) and the female structure or stops are situated in the vicinity of the edges of the lower plate (i.e., near the periphery of the lower plate), a lordosis core (by the fact that if forms an acute angle in the postero-anterior direction) can then be made solid with the plate by a projection penetrating a cavity or opening in the lower plate. If the surgeon wants lordosis determined for a patient, he will select a core (3) which cannot have any clearance relative to the lower plate (2). However, if he only wants the lordosis to remain within a range of values, he will select a core which can have slight clearance in translation and in rotation relative to the lower plate (2), but about a position imposing slight permanent inclination of at least one of the plates.
[0075] The intervertebral disc prosthesis according to a variety of embodiments of the present invention can, in variant embodiments, be anchored solidly, from when implanted, in the vertebral column to prevent the prosthesis from migrating under the effect of the resulting transversal of the force exerted by the vertebral column on the prosthesis in place, an important consideration in lordosis. In this case, the lower plate (2) comprises one or more openings situated in the vicinity of the rear side of the prosthesis, receiving anchors of a variety of types.
[0076] Therefore, in a variant embodiment, the openings in the lower plate (2) are circular and the anchors preferably have the shape of studs, with a head having a size greater than that of the openings to allow the lower plate (2) to be sandwiched between the head of the anchors and the vertebra on which the prosthesis is anchored. For greater security, the openings could be made such that the anchors and the lower plate form an angle of less than or equal to 90°.
[0077] Intervertebral disc prostheses are typically not easy to implant in the patient. This difficulty is exacerbated by the fact of the relative mobility of the pieces of the prostheses. It is thus preferred to associate these prostheses with a device allowing it to be held and inserted between the vertebrae. Such a device according to an embodiment of the present invention is made up of a clip (7) whereof the front surface (71) has a shape provided to fit the form of the front edge of the prosthesis. This clip (7) has a fitting on its front that grips (72) the prosthesis. These gripping means (72) can, for example, be two (72) flexible blades mounted on the lateral edges of the clip and can hold the prosthesis by pinching the lateral edges of the upper and lower plates of the prosthesis. The front surface (71) of the clip (7) has preferably, for example, a height at least substantially equal to the height of the prosthesis, so as to come into contact with the front edges of each of the plates of the prosthesis.
[0078] In an embodiment of the invention, a groove (711) is present in the median part of the front surface (71) of the clip (7) so as to come into contact with the front edge of the core, slightly set back relative to the front edges of the plates. There can of course be several grooves fitting the shape of the prosthesis. The front surface (71) of the clip (7) provided with the groove (711) thus fits the form of the front edge of the prosthesis when in contact with the three elements making up the prosthesis. The clip thus helps hold the prosthesis and push it homogeneously towards its opening between two vertebrae. This clip (7) is provided to hold the prosthesis and to be inserted into a charger (6) (or loader). This charger (6) has a head (62) in which a space is arranged to receive the clip holding the prosthesis and a body (61) provided to slide about a rod, called a guide (5). The rear surface of the clip (7) can be provided with a hole in its centre, provided to insert an end (54) of the guide (5) so that the guide (5) can hold and push the clip (7). The guide (5) is equipped with a pusher (52) at its other end, which will help push the clip and the prosthesis out of the head (62) of the charger (6) by having the guide (5) slide in the body (61) of the charger (6). An adjustable stop is mounted on the guide (5). For example, a threaded ring (53) is screwed around the guide. This ring serves as a stop (53) to the guide when it slides in the body (61) of the charger (6). The position of the stop (53) will be adjusted, as a function of the size of the vertebra, so that when the stop (53) of the guide (5) comes into contact with the body (61) of the charger (6), the end (54) of the guide (5) will have pushed the clip (7) as far as a position where the prosthesis, held by the flexible blades (72) of the clip, is now out of the head (62) of the charger (6) and centred relative to the axis of the vertebral column.
[0079] In an embodiment of the prosthesis according to the invention, as described earlier, the upper (1) and lower (2) plates are provided with anchors as such teeth or notches (11 and 21) for example, on their surface in contact with the vertebrae. These anchors or notches (11, 21) are oriented so as to oppose displacement of the prosthesis in the direction of withdrawal of the clip (7), once the prosthesis is entered in its opening between two vertebrae, made in advance by the surgeon. These notches (11, 21) are thus oriented so as to allow the prosthesis to return to its opening but not come out when the surgeon pulls back the clip (7) holding the prosthesis. On the other hand, the front end of the gripping means (72) of the prosthesis is larger (thicker) than their back end. The width of the clip at its back end is substantially equal to (or slightly smaller than) the width of the space in the head (62) of the charger (6). Thanks to these substantially equal dimensions of the space inside the head (62) of the charger (6) and of the prosthesis and the clip (7), when both the latter are in the head (62) of the charger (6), the prosthesis is solidly held by the flexible blades (72) of the clip (7) whereof the front ends are compressed between the prosthesis and the internal wall of the space made in the head (62) of the charger (6). When the surgeon presses on or strikes the pusher (52) of the guide, the prosthesis exits from the head (62) of the charger and it is held less firmly by the clip (7) since the back ends of the flexible blades (72) are less compressed than were the front ends. The prosthesis could then be released from the clip by pulling back the insertion device, owing to the presence of the notches on the lower and upper plates, allowing the prosthesis to remain in its opening between the two vertebrae.
[0080] The present invention allows embodiments in numerous other specific forms without departing from the spirit of the invention. As a consequence, the present embodiments must be considered by way of illustration only, and can be modified within the scope defined by the range of the attached claims, and thus, the invention should be.
[0081] Although the present invention has been described in detail, it will be apparent to those skilled in the art that many embodiments taking a variety of specific forms and reflecting changes, substitutions and alterations can be made without departing from the spirit and scope of the invention. Therefore, the described embodiments illustrate but do not restrict the scope of the claims.