Intervertebral prosthetic device for spinal stabilization and method of implanting same

[0001] The present invention relates to an intervertebral prosthetic device for stabilizing the human spine, and a method for implanting same.

[0002] Spinal discs that extend between adjacent vertebrae in vertebral columns of the human body provide critical support between the adjacent vertebrae. These discs can rupture, degenerate, and/or protrude by injury, degradation, disease, or the like to such a degree that the intervertebral space between adjacent vertebrae collapses as the disc loses at least a part of its support function, which can cause impingement of the nerve roots and severe pain.

[0003] In these cases, intervertebral prosthetic devices have been designed that can be implanted between the adjacent vertebrae, both anterior and posterior of the column, to prevent the collapse of the intervertebral space between the adjacent vertebrae and thus stabilize the spine.

[0004] However, many of these devices are relatively difficult to insert, and often do not provide an optimum fit with the anatomy.

[0005] The intervertebral prosthetic device according to an embodiment of the invention overcomes the above deficiencies by providing improved biomechanics and increased strength, in addition to being relatively easy to insert, yet provides an improved fit with the anatomy.

[0006] Various embodiments of the invention may possess one or more of the above features and advantages, or provide one or more solutions to the above problems existing in the prior art.

[0007] FIG. 1 is a side elevational view of an adult human vertebral column.

[0008] FIG. 2 is a posterior elevational view of the column of FIG. 1.

[0009] FIG. 3 is an enlarged, front elevational view of one of the vertebrae of the column of FIGS. 1 and 2

[0010] FIG. 4 is an enlarged, partial, isometric view of a portion of the column of FIGS. 1 and 2, depicting an intervertebral prosthetic device according to an embodiment of the invention inserted between two adjacent vertebrae.

[0011] FIG. 5 is an enlarged, isometric, exploded view of the prosthetic device of FIG. 4.

[0012] FIGS. 6-8, an 9A-9C are views similar to that of FIG. 5, but depicting alternate embodiments.

[0013] FIGS. 10A-10C are views similar to that of FIG. 7 bit depicting an alternate embodiment.

[0014] With reference to FIGS. 1 and 2, the reference numeral 10 refers, in general, to a human vertebral column 10. The lower portion of the vertebral column 10 is shown and includes the lumbar region 12, the vertebrae V6, and the coccyx 16. The flexible, soft portion of the vertebral column 10, which includes the thoracic region and the cervical region, is not shown.

[0015] The lumbar region 12 of the vertebral column 10 includes five vertebrae V1, V2, V3, V4 and V5 separated by intervertebral discs D1, D2, D3, and D4, with the disc D1 extending between the vertebrae V1 and V2, the disc D2 extending between the vertebrae V2 and V3, the disc D3 extending between the vertebrae V3 and V4, and the disc D4 extending between the vertebrae V4 and V5.

[0016] The vertebrae V6 includes five fused vertebrae, one of which is a superior vertebrae V6 separated from the vertebrae V5 by a disc D5. The other four fused vertebrae of the sacrum 14 are referred to collectively as V7. A disc D6 separates the vertebrae V6 from the coccyx 16 which includes four fused vertebrae (not referenced).

[0017] With reference to FIG. 3, the vertebrae V4 includes two laminae 20a and 20b extending to either side (as viewed in FIG. 2) of a spinous process 22 that extends posteriorly from the juncture of the two laminae. Two transverse processes 24a and 24b extend laterally from the laminae 20a and 20b, respectively. Two articular processes 26a and 26b extend superiorly from the laminae 20a and 20b respectively, and two articular processes 28a and 28b extend inferiorly from the laminae 20a and 20b, respectively. The inferior articular processes 28a and 28b rest in the superior articular process of the vertebra V5 to form a facet joint. Since the other vertebrae V1-V3 and V5 are similar to the vertebrae V4 they will not be described in detail.

[0018] Referring to FIG. 4, it will be assumed that, for one or more of the reasons set forth above, the vertebrae V4 and V5 are not being adequately supported by the disc D4 and that it is therefore necessary to provide supplemental support and stabilization of these vertebrae. To this end, an intervertebral prosthetic device 40 according to an embodiment of the invention is implanted between the spinous processes 22 of the vertebrae V4 and V5.

[0019] The device 40 is shown in detail in FIG. 5 and includes a solid spacer 42 having a substantially rectangular cross-section with the exception that a longitudinal curved slot 42a is formed in one end portion. The slot 42a is sized so as to receive a process 22 of any of the vertebrae V1-V7, including the vertebrae V4 shown in FIG. 4. Another solid spacer 44 is provided that has a substantially rectangular cross-section with the exception that a longitudinal curved slot 44a is formed in one end portion. The slot 44a receives the process 22 (FIG. 4) from the vertebrae V5. Preferably, the spacers 42 and 44 are fabricated of a relative soft material.

[0020] An adjustable mechanism 50 connects the spacers 42 and 44 while permitting relative axial movement of the members relative to each other. The mechanism 50 consists of a bracket 52 extending from the end 44b of the spacer 44, and connected to the spacer in any conventional manner. The bracket 52 has a substantially U-shaped cross-section that includes a base 52a and two spaced, parallel, legs 52b and 52c extending from, and at right angles to, the base. An internally threaded opening 52d extends through the base 52a.

[0021] The mechanism 50 also includes a plate 56 extending from the end of the spacer 42 and connected to the spacer in any conventional manner. The plate 56 has a rectangular cross section and is sized so as to extend in the bracket 52, that is, in the area of the bracket 52 defined by the base 52a and the two legs 52b and 52c. An elongated slot 56a is formed through the plate 56.

[0022] A set screw 58 is provided that has an externally threaded shank portion that extends through the slot 56a in the plate 56 and threadedly engages the threaded opening 52d in the bracket 52. The screw 58 has a head portion the diameter of which is greater than the width of the slot 56a.

[0023] As an initial set-up prior to the surgical procedure, the plate 56 is positioned in the bracket 52, and the screw 58 is extended through the slot 56a and in threaded engagement with the opening 52d of the bracket 52. Then, the screw 58 is tightened only sufficiently to retain the plate 56 in the bracket 52 while permitting relative axial movement of the spacers 42 and 44, while the slot 56a defines the limits of the axial movement.

[0024] Referring to FIG. 4, the device 40 is inserted between the processes 22 of the vertebrae V4 and the vertebrae V5. The surgeon can then manually adjust the mechanism 50 (FIG. 5) and therefore the spacing between the spacers 42 and 44 intraoperatively in the manner discussed above, until the spinous processes 22 of the vertebrae V4 and V5 extend in the notches 42a and 44a, of the spacers 42 and 44, respectively, with an optimum fit. If needed, a conventional distractor 59, shown by the phantom lines in FIG. 5, can be used to assist in making the above adjustment, with the screw 88 tightened to the extent that it retains the spacers 42′ and 44 in an extended position while permitting relative axial movement as necessary. When the optimum fit is achieved, the set screw 58 is tightened against the plate 56 to lock the plate to the bracket 52 and thus lock the spacers 42 and 44 in the desired position.

[0025] It can be appreciated that after the device 40 has been implanted in the manner discussed above, the device can respond to various movements of the patient that place stress on the vertebral column 10 (FIG. 1) and accommodate these movements by relative movement between the spacers 42 and 44. For example, if the patient bends backwardly, the spacers 42 and 44 would move closer together, and the set screw 58 permitting the relative axial movement. If the patient bends forwardly, then the axial spacing between the spacers 42 and 44 would increase, with the set screw 58 permitting the relative axial movement. In both of the above cases, when the patient returns to a normal position the set screw 58 would permit the spacers 42 and 44 to move back to their original position.

[0026] If the above backward movement is extreme, the spacers 42 and 44 could reach a position in which their corresponding ends abut. In this position, the end of the spacer 42 that abuts the corresponding end of the spacer 44 would compress slightly since the spacer 42 is fabricated of a relative soft material.

[0027] Thus, the device 40 is relatively easy to insert, provides an optimum fit between the processes of two adjacent vertebrae, and is adapted to vary in axial length in response to movements of the patient.

[0028] Referring to FIG. 6, another embodiment of an intervertabral prosthetic device is referred to, in general, by the reference numeral 60 and, is also adapted to be implanted between the spinous processes 22 of the vertebrae V4 and V5.

[0029] The device includes the same spacers 42 and 44 of the previous embodiment but utilizes a different connecting mechanism, which is referred to, in general, by the reference numeral 62.

[0030] The mechanism 62 includes a plate 64 extending from the end of the spacer 42 and connected to the spacer in any conventional manner, and a plate 66 extending from the end 44b of the spacer 44 and connected to the latter spacer in any conventional manner. The inner facing surfaces of the plates 64 and 66 are provided with teeth. A retainer 69 extends around the plates 64 and 66 and is partially shown in FIG. 6 in the interest of clarity.

[0031] A spur gear 68, having teeth formed on its outer surface, is mounted between the plates 64 and 66 and between the ends of the bracket. The teeth of the gear 68 are in engagement with the teeth of the plates 64 and 68 so that rotation of the gear causes translational movement of the plates relative to each other. Although not shown in the drawings it is understood that a conventional torsion spring can be attached to the gear 68 so that rotation of the gear in one direction cause the spring to coil up and tighten so that, when the rotation ceases the spring will uncoil and cause the gear to rotate in the other direction.

[0032] An opening 68a is provided in the gear 68 that receives a tool, such as an Allen wrench, or the like, to permit the gear to be manually rotated. To this end, and although not shown in the drawings, it is understood that an opening would be provided in one of the end plates of the bracket 69 that would register with a corresponding end of the gear 68 to permit access to the opening 68a gear for this purpose.

[0033] Referring to FIG. 4, the device 60 would be inserted between the processes 22 of the vertebrae V4 and the vertebrae V5 in the same manner as the device 40, as discussed above. The surgeon can then rotate the gear 68 to adjust the spacing between the spacers 42 and 44 until the spinous processes 22 of the vertebrae V4 and V5 extend in the notches 42a and 44a, of the spacers 42 and 44, respectively, with an optimum fit. If needed, the distractor 59, shown in the embodiment of FIG. 5, can be used to make the above adjustment.

[0034] It can be appreciated that after the device 60 has been implanted in the manner discussed above, the device can respond to various movements of the patient that place stress on the vertebral column 10 (FIG. 1) and accommodate these movements by relative movement between the spacers 42 and 44. For example, if the patient bends backwardly, the spacers 42 and 44 would move closer together, with the gear 68 and the above spring permitting the relative axial movement. If the patient bends forwardly, then the axial spacing between the spacers 42 and 44 would increase, with the gear 68 and the spring permitting the relative axial movement. In both of the above cases, when the patient returns to a normal position the spring would rotate the gear 68 in the manner discussed above to move the spacers 42 and 44 back to their original position.

[0035] If the above backward movement is extreme, the spacers 42 and 44 could reach a position in which their corresponding ends abut. In this position, the end of the spacer 42 that abuts the corresponding end of the spacer 44 would compress slightly since the spacer 42 is fabricated of a relative soft material.

[0036] Thus, the device 40 is relatively easy to insert, provides an optimum fit between the processes of two adjacent vertebrae, and is adapted to vary in axial length in response to movements of the patient.

[0037] As a result, the longitudinal, or axial, distance between the spacers 42 and 44 can be adjusted, depending on the distance between the processes 22 of the vertebrae V4 and V5. Thus, the device 60 is relatively easy to insert and provides an optimum fit between the two vertebrae V4 and V5. Thus, the above manual rotation of the gear 68 causes relative axial movement between the plates 64 and 66, and therefore the spacers 42 and 44. As a result, the longitudinal, or axial, distance between the spacers 42 and 44 can be adjusted, depending on the distance between the processes 22 of the vertebrae V4 and V5.

[0038] Another embodiment of an intervertabral prosthetic device is referred to, in general, by the reference numeral 70 in FIG. 7 and is also adapted to be implanted between the spinous processes 22 of the vertebrae V4 and V5.

[0039] The device 70 includes the same spacers 42 and 44 of the previous embodiment but utilizes a different connecting mechanism, which is referred to, in general, by the reference numeral 72.

[0040] The mechanism 72 includes a plate 74 extending downwardly from the end of the spacer 42, as viewed in the drawing, and connected to the spacer in any conventional manner. A plate 76 extends upwardly from the end 44b of the spacer 44 and is connected to the latter spacer in any conventional manner.

[0041] The inner surface of the plate 74 is provided with a plurality of ratchet teeth 74a each of which has an angled surface extending downwardly from a horizontal surface. A flexible tab 76a is formed integrally with the plate 76 and projects outwardly from the inner surface of the plate 76. The length of the tab 76a is such that it can extend along the angled surface of a particular tooth 74a and abut the horizontal surface of a tooth immediately above the particular tooth. A retainer 78 extends around the plates 74 and 77 and is shown in cross section in the interest of clarity.

[0042] Thus, the plate 74, and therefore the spacer 42 can be moved manually in an upwardly direction relative to the plate 76, and therefore the spacer 44; and/or the plate 76, and therefore the spacer 44 can be moved in an downwardly direction relative to the plate 74, and therefore the spacer 42. During this movement, the tab 76a rides along the outer surfaces of the teeth 74a and, when the movement is stopped, the tab flexes outwardly to a position along the angled surface of a particular tooth.

[0043] The device 70 is inserted between the processes 22 of the vertebrae V4 and the vertebrae V5 in the same manner as the device 40, as shown in FIG. 4 and discussed above. The surgeon can then adjust the longitudinal spacing between the spacers 42 and 44 in the manner described above until the spinous processes 22 of the vertebrae V4 and V5 extend in the notches 42a and 44a, of the spacers 42 and 44, respectively, with an optimum fit. If needed, the distractor 59, shown in the embodiment of FIG. 5, can be used to assist in making the above insertion.

[0044] An alternate version of the mechanism 72 is shown by the reference numeral 72′ in FIG. 8. The mechanism 72′ is similar to the mechanism 72 of FIG. 7 and includes the plates 74 and 76 and the retainer 78. However the ratchet teeth 74a of the mechanism 72 are eliminated and the outer surface of the plate 74 of the mechanism 72′ is provided with a plurality of axially-spaced indentations that form a plurality of axially-spaced teeth 74b having a rectangular cross-section.

[0045] A flexible tab 76b is bent out from a cut-out portion of the inner surface of the plate 76, with the length of the tab being such that it can ride along the teeth 74b when the plate 74 moves upwardly relative to the plate 76, and/or the plate 76 moves downwardly relative to the plate 74. When this movement is stopped, the tab 76b flexes into an indentation between adjacent teeth 74b to block any axial movement between the plate 74 downwardly relative to the plate 76, and/or movement of the plate 76 upwardly relative to the plate 74.

[0046] The device of FIG. 8 is inserted between the processes 22 of the vertebrae V4 and the vertebrae V5 and the axial distance between the spacers 42 and 44 is adjusted as described above, so that the spinous processes 22 of the vertebrae V4 and V5 extend in the notches 42a and 44a, of the spacers 42 and 44, respectively, with an optimum fit.

[0047] As a result, relative movement between the plates 74 and 76, and therefore the spacers 42 and 44, in a direction away from each other is permitted, while relative movement of the plates and the spacers in a direction towards each other is prevented.

[0048] Thus, the mechanism 72′ of FIG. 8 enjoys the same advantages as the mechanism 72 of the FIG. 7.

[0049] Referring to FIGS. 9A-9C, another embodiment of an intervertebral prosthetic device is shown, in general, by the reference numeral 80 and includes a solid spacer 42′ that is similar to the spacer 42 of the previous embodiments. The spacer 42′ is fabricated from a relatively soft material and has a curved portion 42a′ that receives a process 22 of any of the vertebrae V1-V7, including the vertebrae V4 shown in FIG. 4. According to the embodiment of FIGS. 9A and 9B, a substantially rectangular cut-out 42b′ is provided in the lower end of the spacer 42′. The spacer 44 from the previous embodiments is also provided and, since it is well disclosed above, it will not be described in detail.

[0050] An adjustable mechanism 82 connects the spacers 42′ and 44 while permitting relative axial movement of the members relative to each other. The mechanism 82 consists of a bracket 84 extending from the upper end of the spacer 44, as viewed in the drawings, and connected to the spacer in any conventional manner. The bracket 84 has a substantially U-shaped cross-section that includes a base 84a and two spaced, parallel, legs 84b and 84c extending from, and at right angles to, the base. An internally threaded opening 84d extends through the base 84a.

[0051] The mechanism 82 also includes a plate 86 that extends from the base of the cut-out 42b′ of the spacer 42′ and is connected to the spacer in any conventional manner.

[0052] The plate 86 has a rectangular cross section and is sized so as to extend in the area of the bracket 84 defined by the base 84a and the two legs 84b and 84c. An elongated slot 86a is formed through the plate 86.

[0053] A set screw 88 is provided that has an externally threaded shank portion that extends through the slot 86a in the plate 86 and threadedly engages the threaded opening 84d in the bracket 84. The screw 88 has a head portion the diameter of which is greater than the width of the slot 86a.

[0054] As an initial set-up prior to the surgical procedure, the plate 86 is positioned in the bracket 84, and the screw 88 is extended through the slot 86a and in threaded engagement with the opening 84d of the bracket 84. Then, the screw 88 is tightened only sufficiently to retain the plate 86 in the bracket 84 while permitting relative axial movement of the spacers 42′ and 44, while the slot 86a defines the limits of the axial movement.

[0055] FIG. 9B shows the spacers 42′ and 44 in an assembled, slightly-extended position with the amount of the extension depending, of course, on the distance between the adjacent processes. In this context, and referring to FIG. 4, during the surgical procedure, the device 40 is inserted between the processes 22 of the vertebrae V4 and the vertebrae V5. The surgeon can then manually adjust the mechanism 82, and therefore the spacing between the spacers 42′ and 44, intraoperatively in the manner discussed above, until the spinous processes 22 of the vertebrae V4 and V5 extend in the notches 42a′ and 44a, of the spacers 42′ and 44, respectively, with an optimum fit.

[0056] If needed, the distractor 59 shown by the phantom lines in FIG. 9A, and discussed above, can be used to assist in making the above adjustment. The screw 88 is then tightened to the extent that it permits relative axial movement of the spacers 42′ and 44 between an extended position, such as that shown in FIG. 9B, and the completely retracted position of FIG. 9C, as necessary, with the length of the slot 86a limiting this movement.

[0057] It can be appreciated that after the device 80 has been implanted in the manner discussed above, the device can respond to various movements of the patient that place stress on the vertebral column 10 (FIG. 1) and accommodate these movements by relative movement between the spacers 42′ and 44. For example, if the patient bends backwardly, the spacers 42′ and 44 would move closer together, and the set screw 88 would permit the relative axial movement. If the patient bends forwardly, then the axial spacing between the spacers 42′ and 44 would increase, with the set screw 58 permitting the relative axial movement. In both of the above cases, when the patient returns to a normal position the set screw would permit the spacers 42′ and 44 to move back to their original position.

[0058] If the above backward movement is extreme, the spacers 42′ and 44 could reach a position in which their corresponding ends abut as shown in FIG. 9C. In this position, the end of the spacer 42′ that abuts the corresponding end of the spacer 44 would compress slightly since the spacer 42′ is fabricated of a relative soft material.

[0059] Thus, the device 80 is relatively easy to insert, provides an optimum fit between the processes of two adjacent vertebrae, and is adapted to vary in axial length in response to movements of the patient.

[0060] Another embodiment of an intervertabral prosthetic device is referred to, in general, by the reference numeral 90 in FIGS. 10A-10C and is also adapted to be implanted between the spinous processes 22 of the vertebrae V4 and V5.

[0061] The device 90 includes the same spacers 42 and 44 of the previous embodiment but utilizes a different connecting mechanism, which is referred to, in general, by the reference numeral 92.

[0062] Referring to FIG. 10A, the mechanism 92 includes a plate 94 extending downwardly from the lower end of the spacer 42, as viewed in the drawing, and connected to the spacer in any conventional manner. The inner surface of the plate 94 is provided with a plurality of ratchet teeth 94a each of which has an angled surface extending downwardly from a horizontal surface. A plate 96 extends upwardly from the upper end of the spacer 44 and is connected to the latter spacer in any conventional manner. The inner surface of the plate 96 is provided with a plurality of ratchet teeth 96a each of which has an angled surface extending up from a horizontal surface. The teeth 96a are adapted to mesh with the teeth 94a.

[0063] FIG. 10B depicts an operative position of the device 90 in which two of the lower teeth 94a mesh with two of the upper teeth 96a to lock the spacers 42 and 44 in an extended position. FIG. 10C depicts another operative position of the device 90 in which all of the teeth 94a mesh with all of the teeth 96a to lock the spacers 42 and 44 in another extended position. In the positions of FIGS. 10B and 10C, a retainer 98, shown in cross-section, extends around the plates 94 and 96 and retains the plates, and therefore the spacer 42 and 44 in the position shown. It can be appreciated that the spacers 42 and 44 can be locked in relative axial positions other than those discussed above, depending on the number of the teeth 94a and 96a that engage.

[0064] The device 90 is inserted between the processes 22 of the vertebrae V4 and the vertebrae V5 in the same manner as the device 40, as shown in FIG. 4 and discussed above. The surgeon can then adjust the longitudinal spacing between the spacers 42 and 44 in the manner described above until the spinous processes 22 of the vertebrae V4 and V5 extend in the notches 42a and 44a, of the spacers 42 and 44, respectively, with an optimum fit. If needed, the distractor 59, shown in the embodiment of FIG. 5, can be used to assist in making the above insertion.

[0065] It is understood that variations may be made in the foregoing without departing from the invention and examples of some variations are as follows:

• [0066] Any conventional substance that promotes bone growth, such as HA coating, BMP, or the like, can be incorporated in the prosthetic device of one or both of the above embodiments;
• [0067] The surfaces of the spacers 42, 42′, and 44 spacer defining the notches 42a, 42a′ and 44b can be treated, such as by providing teeth, ridges, knurling, etc., to better grip the spinous processes and the adapters.
• [0068] The spacer can be fabricated of a permanently deformable material thus providing a clamping action against the spinous process.
• [0069] One or both of the spacers 42, 42′, and 44 may have through openings formed therein to improve integration of bone growth;
• [0070] The spacers 42, 42′, and 44 and their associated mechanisms 50, 62, 82, and 92 can vary in shape, size, composition, and physical properties;
• [0071] In the embodiments of FIG. 5 and 9A-9C, the brackets can be connected to the spacers 42 and 42′ and the plates 56 and 86 can be connected to the spacer 44.
• [0072] One or both of the spacers 42, 42′ and 44 may have through openings formed therein to receive tethers for attaching the spacer to a vertebrae or to a spinous process;
• [0073] In the embodiment of FIGS. 5 and 9A-9C, the bracket 52 can be locked to the plate 56 in manners other than by the set screw 58;
• [0074] In the embodiment of FIG. 6, only one of the plates 64 or 66 can have teeth formed thereon;
• [0075] The shape, number, and spacing of the teeth in the embodiments of FIGS. 7, 8, and 10A-10C, as well as the shape of the tabs in FIGS. 7 and 8, can be varied.
• [0076] The prosthesis of the above embodiments can be placed between two vertebrae in the vertebral column other than the ones described above;
• [0077] Bilateral extrusions, or the like, can be provided on one or more of the devices f the above embodiments to enable a tethering device to be attached;
• [0078] The prostheses of the above embodiments can be inserted between two vertebrae following a discectemy in which a disc between the adjacent vertebrae is removed, or a corpectomy in which at least one vertebrae is removed.
• [0079] The prostheses of the above embodiments can be inserted between the facets of adjacent vertebrae, rather than the spinous processes; and
• [0080] The spatial references made above, such as “under”, “over”, “between”, “flexible, soft”, “lower”, “top”, “bottom”, etc. are for the purpose of illustration only and do not limit the specific orientation or location of the structure described above.

[0081] The preceding specific embodiments are illustrative of the practice of the invention. It is to be understood, therefore, that other expedients known to those skilled in the art or disclosed herein, may be employed without departing from the invention or the scope of the appended claims, as detailed above. In the claims, means-plus-function clauses are intended to cover the structures described herein as performing the recited function and not only structural equivalents but also equivalent structures. Thus, although a nail and a screw may not be structural equivalents in that a nail employs a cylindrical surface to secure wooden parts together, whereas a screw employs a helical surface, in the environment of fastening wooden parts a nail and a screw are equivalent structures.