INTERVERTEBRAL DEVICES

Abstract

The present invention relates to an intervertebral fusion device (10) comprising a superior component (20), an inferior component (40), and a core component (80) inserted there between. The intervertebral fusion device further comprises first and second retention mechanisms which resist ejection of the core component from between the superior and inferior components. Each of the first and second retention mechanisms comprises first and second portions. One of the first and second portions is unitary with one of the superior and inferior components. The other of the first and second portions is unitary with the core component. The first and second portions each comprise an inter-engaging formation which are urged in an opposite direction. The first inter-engaging formation is urged to inter-engage with the second inter-engaging formation upon insertion of the core component between the superior and inferior components.

Claims

1. An intervertebral fusion device, comprising: a superior component having a superior component top side and a superior component bottom side, the superior component being configured to be received in an intervertebral space between first and second vertebrae whereby the superior component top side abuts against the first vertebra; an inferior component having an inferior component top side and an inferior component bottom side, the inferior component being configured to be received in the intervertebral space between the first and second vertebrae whereby the inferior component bottom side abuts against the second vertebra, the superior component bottom side and the inferior component top side opposing each other when the superior and inferior components are received in the intervertebral space; a core component configured for insertion between the superior and inferior components whereby a separation between the superior and inferior components is determined, the core component having first and second lateral sides which each face in a transverse direction which is orthogonal to a direction of insertion of the core component and to a direction of separation of the inferior and superior components, the first and second lateral sides facing in opposite directions; a first retention mechanism comprising a first finger and a first recess; and a second retention mechanism comprising a second finger and a second recess, wherein a proximal end of each of the first and second fingers is attached to the superior or inferior components at an anterior edge of the inferior or superior component that first receives the core component when the core component is inserted between the superior and inferior components whereby the finger is unitary with the superior or inferior component, and the finger is unsupported and unattached along its length except at its proximal end whereby the finger flexes along its length relative to the inferior or superior component, wherein the proximal end of the first finger is attached at a first lateral side of the inferior or superior component and the first finger extends in the direction of insertion towards a posterior edge of the inferior or superior component, and the proximal end of the second finger is attached at a second lateral side of the inferior or superior component and the second finger extends in the direction of insertion towards a posterior edge of the inferior or superior component whereby the first and second fingers are spaced apart from each other in the transverse direction, wherein the first finger defines a first protrusion at a distal end thereof and the second finger defines a second protrusion at a distal end thereof, the first and second protrusions spaced apart from and facing each other in the transverse direction, wherein the first and second recesses are defined respectively on the first and second lateral sides of the core component, and wherein the first and second lateral sides of the core component are received between the first and second fingers during a first stage of insertion of the core component to thereby guide the core component, a posterior end of the core component bearing against the first and second protrusions at the end of the first stage of insertion to flex the first and second fingers apart in the transverse direction, and during a second stage of insertion following the first stage of insertion the first and second protrusions are received in the first and second recesses respectively under spring bias exerted by the first and second fingers to thereby present resistance to ejection of the core component from between the superior and inferior components.

2. (canceled)

3. The intervertebral fusion device according to claim 1, wherein the first and second fingers are portion is unitary with the inferior component.

4-8. (canceled)

9. The intervertebral fusion device according to claim 3, further comprising third and fourth fingers and third and fourth recesses, the third and fourth fingers unitary with the superior component and the third and fourth recesses defined by the core component, the third and fourth fingers flexing apart in the transverse direction during the first stage of insertion of the core component, a third protrusion defined by the third finger received in the third recess and a fourth protrusion defined by the fourth finger received in the fourth recess during the second stage of insertion of the core component whereby the intervertebral fusion device is configured to provide for resistance to movement of the core component relative to the inferior component and the superior component.

10. The intervertebral fusion device according to claim 1, wherein each of the first and second protrusions is at a location on the inferior or superior component and each of the first and second recesses is at a location on the core component whereby the first and second protrusions are received in the first and second recesses respectively when the core component is substantially fully inserted between the inferior and superior components.

11. The intervertebral fusion device according to claim 1, wherein the core component has an upper side and a lower side, the upper side facing the superior component bottom side and the lower side facing the inferior component top side when the core component is inserted between the inferior and superior components, wherein the first lateral side extends between the upper and lower sides of the core component, and the second lateral side extends between the upper and lower sides of the core component.

12. The intervertebral fusion device according to claim 11, wherein the upper side and the lower side of the core component are inclined to each other whereby the core component has the form of a wedge.

13-14. (canceled)

15. The intervertebral fusion device according to claim 1, wherein each of the first and second fingers is a cantilever spring.

16. (canceled)

17. The intervertebral fusion device according to claim 1, wherein the core component and the inferior or superior component comprise respective inter-engaging anterior formations, the inter-engaging anterior formations configured to draw the superior or inferior component and the core component together in the direction of separation of the inferior and superior components.

18. The intervertebral fusion device according to claim 17, wherein the inter-engaging anterior formations comprise cooperating surface profiles that cooperate to move the superior or inferior component and the core component together in the direction of separation of the inferior and superior components as an extent of insertion of the core component between the superior and inferior components increases.

19. The intervertebral fusion device according to claim 18, wherein at least one of the inter-engaging anterior formation on the core component and the inter-engaging anterior formation on the superior or inferior component is sloped with a direction of the slope being such that the superior or inferior component and the core component are drawn together in the direction of separation of the inferior and superior components.

20. The intervertebral fusion device according to claim 1, wherein the core component and at least one of the inferior component and superior component comprise respective inter-engaging posterior formations, the inter-engaging posterior formations being configured to draw at least one of the superior component and the core component together and inferior component and the core component together in the direction of separation of the inferior and superior components.

21. The intervertebral fusion device according to claim 1, wherein the superior component, the inferior component and the core component are separate components, and wherein the superior component and the inferior component do not engage with each other other than by way of the core component.

22. A method of installing an intervertebral fusion device in an intervertebral space between first and second adjacent vertebrae, the intervertebral fusion device according to claim 1, the method comprising: positioning the superior component and the inferior component relative to each other such that the superior component bottom side and the inferior component top side oppose each other; inserting the core component between the superior and inferior components whereby a separation between the superior and inferior components is determined; and disposing the intervertebral fusion device in the intervertebral space such that the superior component top side abuts against the first vertebra and the inferior component bottom side abuts against the second vertebra, wherein inserting the core component between the superior and inferior components comprises receiving the first and second lateral sides of the core component between the first and second fingers during a first stage of insertion of the core component to thereby guide the core component, wherein a posterior end of the core component bears against the first and second protrusions at the end of the first stage of insertion to flex the first and second fingers apart in the transverse direction, and wherein during a second stage of insertion following the first stage of insertion the first and second protrusions are received in the first and second recesses respectively under spring bias exerted by the first and second fingers to thereby present resistance to ejection of the core component from between the superior and inferior components.

23. The method according to claim 22, wherein the superior component and the inferior component are inserted in the intervertebral space before the core component is inserted between the superior and inferior components.

24. The intervertebral fusion device according to claim 9, wherein the first to fourth fingers flex independently of one another during the first stage of insertion of the core component.

Description

BRIEF DESCRIPTION OF DRAWINGS

[0051] The present invention will now be described by way of example only with reference to the following drawings, of which:

[0052] FIG. 1A shows a superior component of a first embodiment of the present invention;

[0053] FIG. 1B shows an inferior component of the first embodiment of the present invention;

[0054] FIG. 1C shows core component of the first embodiment of the present invention;

[0055] FIG. 2A shows the core component before insertion between the superior and inferior components according to a second embodiment;

[0056] FIG. 2B shows the core component after insertion between the superior and inferior components according to the second embodiment;

[0057] FIG. 3A shows a superior component of a third embodiment of the present invention;

[0058] FIG. 3B shows an inferior component of the third embodiment of the present invention;

[0059] FIG. 3C shows core component of the third embodiment of the present invention;

[0060] FIG. 4A shows the core component before insertion between the superior and inferior components according to the third embodiment; and

[0061] FIG. 4B shows the core component after insertion between the superior and inferior components according to the third embodiment.

DESCRIPTION OF EMBODIMENTS

[0062] A superior component, an inferior component and a core component of a first embodiment of intervertebral fusion device 10 are shown respectively in FIGS. 1A, 1B and 1C. The intervertebral fusion device 10 is an anterior lumbar interbody fusion (ALIF) device. FIG. 2A shows a core component before insertion between the superior and inferior components of FIGS. 1A and 1B according to a second embodiment of intervertebral fusion device with the second embodiment differing from the first embodiment in respect of the greater height of the core component of the second embodiment. FIG. 2B shows the core component of FIG. 2A after insertion between the superior and inferior components.

[0063] As mentioned above, the intervertebral fusion device 10 of FIGS. 1A to 2B comprises a superior component 20, an inferior component 40 and a core component 60, 80. Each of the superior component 20 and the inferior component 40 is generally of the form of a plate, albeit a plate having structures thereon and a large aperture through the centre thereof. The core component 60, 80 has the form of a frustum of a wedge. As can be seen from comparison of FIG. 1C with FIGS. 2A and 2B, the core component of FIG. 1C is thinner than the core component of FIGS. 2A and 2B. What is shown in FIGS. 2A and 2B therefore constitutes a second embodiment. Use of core components of different thicknesses and/or different extents of tapering wedge and with the same superior component 20 and inferior component 40 provides for different heights and angles of intervertebral fusion device 10. When the intervertebral fusion device 10 is being brought into use, the superior component 20 and the inferior component 40 are placed in the intervertebral space. It should be noted that the superior component 20 is shown in FIG. 1A upside down so that the features of the underside of the superior component can be seen. In use, the superior component 20 of FIG. 1A is turned upside down when inserted into the intervertebral space. The core component 60, 80 is positioned relative to the superior component 20 and the inferior component 40 as shown in FIG. 2A. Then the core component 60, 80 is positioned between edges of the superior component 20 and the inferior component 40 with the thin edge of the wedge shape of the core component foremost before the core component is progressively inserted between the superior component and the inferior component until fully received between the superior component and the inferior component. FIG. 2B shows the intervertebral fusion device 10 when the core component 60, 80 is fully received between the superior component 20 and the inferior component 40. When in the disposition shown in FIG. 2B, the superior component top side abuts against a first vertebra defining the intervertebral space in part and the inferior component bottom side abuts against a second vertebra defining the intervertebral space in part.

[0064] According to an alternative approach to use of the intervertebral fusion device 10, the intervertebral fusion device 10 is assembled outside the intervertebral space, as described above, before the assembled intervertebral fusion device is inserted into the intervertebral space.

[0065] The superior component 20 will now be described further with reference to FIG. 1A. The superior component 20 has a superior component bottom side 22, a superior component top side 24, a first lateral side 26 and a second lateral side 28. The superior component 20 comprises various formations 30, 31, 72, 78 on the superior component bottom side 22 which inter-engage with formations on the core component and provide for guided alignment and engagement between core component and superior component during progressive insertion of the core component. The formations 30, 31, 72, 78 also provide for secure attachment of core component and superior component to each other when the core component is fully received in the superior component. The superior component 20 defines a circular aperture 31 towards its anterior edge. The circular aperture 31 allows for reception therethrough of a screw which is driven into the adjacent vertebra. The superior component 20 further comprises two first portions 32 which are integrally formed with the superior component. One of the first portions 32 is located towards the first lateral side 26 and the other of the first portions 32 is located towards the second lateral side 28. Each of the first portions 32 comprises a main body in the form of a finger which extends from a proximal end of the finger at an anterior edge of the superior component across the superior component towards the posterior edge of the superior component. The first portion 32 therefore extends in a direction of insertion of the core component. The first portion 32 is unsupported and attached along its length with the exception of its proximal end. The superior component and hence the first portion 32 are formed of a material of sufficient yield strength that the first portion functions as a cantilever spring. Although not shown in FIG. 1A, the finger is tapered in certain forms to determine stiffness and hence extent of deflection. Furthermore, a radius of the interface between the finger and the part of the superior component from which the finger extents is determined to control stiffness of the finger. The main body of the first portion 32 defines a protrusion 34 (which constitutes a first inter-engaging formation) at its distal end with the protrusion 34 extending in a transverse direction of the superior component. The two first portions 32 are mirror images of each other whereby their two protrusions 34 oppose each other and extend towards each other. In view of the cantilever sprung nature of each first portion 32, application of a load to the protrusion 34 in a transverse direction towards a respective lateral side deflects the main body to thus store energy in the first portion to provide for urging of the protrusion 34 in the opposite direction. As described below, the main body of the finger is deflected by a leading edge of the core component bearing against the protrusion 34.

[0066] The inferior component 40 will now be described further with reference to FIG. 1B. The inferior component 40 has an inferior component top side 42, an inferior component bottom side 44, a first lateral side 46 and a second lateral side 48. Like the superior component 20, the inferior component 40 comprises various formations 50 on the inferior component top side 42 which inter-engage with formations on the core component and provide for engagement between core component and inferior component during progressive insertion of the core component. The formations 50 also provide for secure attachment of core component and inferior component to each other when the core component is fully received in the inferior component. However, the form and disposition of the formation 50 at the posterior of the inferior component 40 differs from the form and disposition of the formation 78 at the posterior of the superior component 20. The inferior component 40 defines two circular apertures 51 towards its anterior edge which are spaced apart from each other in the transverse direction. Each circular aperture 51 allows for reception therethrough of a screw which is driven into the adjacent vertebra. The inferior component 40 further comprises two first portions 52 which are integrally formed with the inferior component. One of the first portions 52 is located towards the first lateral side 46 and the other of the first portions 52 is located towards the second lateral side 48. The first portion 52 at the first lateral side 46 of the inferior component is of the same form and function as the first portion 32 at the first lateral side 26 of the superior component. The first portion 52 at the second lateral side 48 of the inferior component is of the same form and function as the first portion 32 at the second lateral side 28 of the superior component. The reader's attention is therefore directed to the preceding description of the two first portions 32 of the superior component 20.

[0067] The core component 60 will now be described further with reference to FIG. 1C. As described above, the core component 60 has the form of a frustum of a wedge. The core component 60 has an upper side 62 and a lower side 64, the core component 60 being configured to be inserted between the superior and inferior components 20, 40 such that the upper side 62 faces the superior component bottom side 22 and the lower side 64 faces the inferior component top side 42. This orientation of core component 60 in relation to superior and inferior components 20, 40 is obtained by various formations 66, 67, 74, 76 on the upper and lower sides 62, 64 with the formations on the upper side being of different form and disposition to the formations on the lower side. Furthermore, the formations 66, 67, 74, 76 on each side of the core component correspond to and provide for engagement with a respective one of the formations 30, 31, 72, 78 on the superior component and the formations 50 on the inferior component. The core component 60 defines four recesses 68 having sloping sides (each recess constitutes a second inter-engaging formation). Two of the recesses are located towards the upper side and two of the recesses are located towards the lower side. Furthermore, the recesses are located towards the thin edge of the wedge. Each of the recesses 68 faces in a transverse direction away from the core component.

[0068] As described above, the superior and inferior components 20, 40 are placed in the intervertebral space and the core component 60, 80 is positioned relative to the superior and inferior components as shown in FIG. 2A before the core component is inserted between the superior and inferior components. As the leading edge of the core component 60, 80 reaches the protrusions 34 of the superior and inferior components 20, 40 during insertion, the leading edge of the core component bears against each of the protrusions causing deflection of each of the four first portions 32, 52. The part of the leading edge that bears against a respective protrusion is bevelled to provide for increasing deflection as the extent of insertion of the core component is increased. Upon further insertion the protrusions 34 and the recesses 68 come into registration and each of the protrusions is urged under spring bias into a corresponding one of the recesses. Reception of the protrusions in their respective recesses produces an audible click which indicates to the surgeon that the core component is fully inserted. Inter-engagement between protrusions 34 and recesses 68 contributes to holding the core component 60, 80, and superior and inferior components 20, 40 together and more importantly presents resistance to ejection of the core component from between the superior and inferior components during use of the intervertebral fusion device 10.

[0069] As mentioned above, each of the recesses 68 on the core component 60 has sloping sides. When the core component is inserted to the extent that a protrusion 34 reaches its respective recess, the spring bias of the finger causes the protrusion to ride down the sloped side of the recess and thereby exert force to draw the core component further between the superior and inferior components. Further to this, the protrusion 34 is at a first distance from an anterior edge of the inferior or superior component and the recess 68 is at a second distance from an anterior edge of the core component with the first distance being slightly greater than the second distance. These relative distances in combination with the spring bias pull the core component fully between the superior and inferior components.

[0070] The core component 60 has two anterior formations 74 on its upper side 62 in the form of protrusions which are spaced apart from each other in the transverse direction along the anterior edge of the core component. Each anterior formation 74 has a side oriented towards the posterior edge of the core component which slopes away from a distal surface of the anterior formation towards the anterior edge. The superior component 20 has two recesses 72 which are spaced apart from each other in the transverse direction and which are defined in the anterior edge of the superior component. When the core component is nearly fully inserted between the inferior and superior components, a base of each recess 72 bears against the sloping side of its respective anterior formation 74 with further insertion causing the base to ride along the sloping side. As the base rides along the sloping side, the superior component is drawn down onto the core component. The pulling of the core component fully between the superior and inferior components by the spring bias, as described above, also causes the base to ride along the sloping side whereby the spring bias also draws the superior component down at its anterior edge onto the core component. The first distance being slightly greater than the second distance, as described above, causes the superior component to be drawn closely against the core component.

[0071] The core component 60 has a posterior formation 76 in the form of a protrusion which extends from the posterior edge of the core component adjacent the upper side 62 of the core component. An upper surface of the posterior formation 76 is defined by the upper side 62 of the core component. A distal edge of the posterior formation 76 slopes downwards from a distal edge 77 at the upper surface of the posterior formation and towards the posterior edge of the core component to define a slope. The superior component 20 has a posterior formation 78 in the form of a protrusion which extends from the posterior edge of the superior component in a direction opposite the direction of insertion of the core component over the superior component bottom side 22. The posterior formation 78 defines a distal surface which faces towards the inferior component when the inferior and superior components are aligned. A side of the posterior formation 78 oriented towards the anterior edge of the superior component slopes from an edge of the distal surface furthest from the posterior edge upwards and towards the posterior edge. When the core component is nearly fully inserted between the inferior and superior components, the slope defined by the posterior formation 76 of the core component and the slope defined by the posterior formation 78 of the superior component ride over each other to draw the superior component down onto the core component. The pulling of the core component fully between the superior and inferior components by the spring bias, as described above, also causes the slopes defined by the two posterior formations 76, 78 to ride over each other whereby the spring bias also draws the superior component down at its posterior edge onto the core component. The distal edge 77 at the upper surface of the posterior formation 76 of the core component is configured by virtue of the thinness of the distal edge having regard to the material properties of the core component to deflect when cooperating with the posterior formation 78 of the superior component. Inherent spring bias of the material of the posterior formation 76 adjacent the distal edge 77 exerts force to draw the superior component and the core component together to thereby provide a further means of drawing the superior component down at its posterior edge onto the core component.

[0072] Referring to FIG. 1C, the core component 60 further comprises in its lower side 64 a living hinge which defines a protrusion 67 thereon. Inherent spring bias of the living hinge urges the protrusion 67 towards the inferior component 40 when the core component 60 is received between the superior and inferior components 20, 40. When the core component 60 is at full insertion, the protrusion 67 on the living hinge at the lower side 64 of the core component is urged by the inherent spring bias of the living hinge into an elongate aperture 53 in the inferior component near the anterior edge of the inferior component. Reception of the protrusion 67 in the elongate aperture 53 presents a barrier to ejection of the core component from between the inferior and superior components.

[0073] A third embodiment of intervertebral fusion device 100 is shown in FIGS. 3A to 4B. The intervertebral fusion device 100 according to the third embodiment is an oblique lateral interbody fusion device. A superior component 120, an inferior component 140, and a core component 160 of the third embodiment are shown respectively in FIGS. 3A, 3B and 3C. FIG. 4A shows the core component 160 of the third embodiment before insertion between the superior and inferior components 120, 140 of FIGS. 3A and 3B. FIG. 4B shows the core component 160 of the third embodiment after insertion between the superior and inferior components 120, 140 of FIGS. 3A and 3B. The superior component 120, the inferior component 140, and the core component 160 of the third embodiment are of different shape and dimensions to the first and second embodiments when viewed in plan whereby the third embodiment is configured for insertion into an intervertebral space from an oblique lateral direction. Otherwise, and except as described below, the third embodiment is configured in respect of key features in the same fashion as the first and second embodiments. Such key features are therefore indicated in FIGS. 3A to 4B by the same reference numerals as for the first and second embodiments and the reader's attention is directed to the preceding description for a description of such key features. In respect of differences, as can be seen from FIG. 3C, the core component 160 has one anterior formation 74 on its upper side instead of the two anterior formations 74 of the first and second embodiments. Correspondingly, the superior component 120 of the third embodiment has one recess 72 at its anterior edge instead of the two recesses of the first and second embodiments. Furthermore, the third embodiment lacks the first and second embodiments' combination of the protrusion 67 on the living hinge in the core component and the elongate aperture 53 in the inferior component.