INTERVERTEBRAL PROSTHETIC DEVICE FOR SPINAL STABILIZATION AND METHOD OF IMPLANTING SAME

Abstract

A method of implanting a spinal prosthesis comprises inserting a first member between superior and inferior spinous processes associated with respective superior and inferior vertebrae. The superior and inferior vertebrae are separated by an intermediate vertebra. The method further includes inserting a second member through a channel in the first member. After the second member is inserted, the method requires removing the second member from the channel and inserting a third member through the channel. The third member has a different stiffness than the second member. Finally, the method requires anchoring the third member to the intermediate vertebra, while the third member is inserted through the channel. The third member is anchored at first and second locations disposed on respective first and second lateral sides of the intermediate vertebra.

Description

BACKGROUND

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

Spinal discs that extend between adjacent vertebrae in vertebral columns of the human body provide critical support between the adjacent vertebrae while permitting multiple degrees of motion.

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.

In these cases, intervertebral prosthetic devices have been designed that can be implanted between the adjacent vertebrae, both anterior and posterior of the column and are supported by the respective spinous processes of the vertebrae to prevent the collapse of the intervertebral space between the adjacent vertebrae and provide motion stabilization of the spine. Many of these devices are supported between the spinous processes of the adjacent vertebrae.

In some situations it is often necessary to remove the laminae and the spinous process from at least one of the adjacent vertebrae to get proper decompression. In other situations, the defective disc is removed and two vertebral segments are fused together to stop any motion between the segments and thus relieve the pain. When two adjacent vertebrae are fused, the laminae and the spinous process of at least one vertebra are no longer needed and are therefore often removed.

However, in both of the above situations involving removal of a spinous process, it would be impossible to implant an intervertebral prosthetic device of the above type since the device requires support from both processes.

SUMMARY

According to an embodiment of the invention, an intervertebral prosthetic device is provided that is implantable between two adjacent vertebrae, at least one of which is void of a spinous process, to provide motion stabilization.

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.

BRIEF DESCRIPTION OF THE DRAWINGS

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

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

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

FIG. 4 is an enlarged, partial, isometric view of a portion of the column of FIGS. 1 and 2, including the lower three vertebrae of the column, and depicting an intervertebral prosthetic device according to an embodiment of the invention implanted between two adjacent vertebrae.

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

FIG. 6 is a cross-sectional view of the implanted device of FIGS. 4 and 5.

FIG. 7 is an enlarged, isometric, exploded view of an alternate embodiment of the prosthetic device of FIG. 5.

DETAILED DESCRIPTION

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 vertebra 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.

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.

The vertebra V6 includes five fused vertebrae, one of which is a superior vertebra V6 separated from the vertebra 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 vertebra V6 from the coccyx 16 which includes four fused vertebrae (not referenced).

With reference to FIG. 3, the vertebra V5 includes two laminae 20a and 20b extending to either side (as viewed in FIG. 2) of a spinous process 22 that projects posteriorly from the juncture of the two laminae. Two transverse processes 24a and 24b extend laterally from the laminae 20a and 20b, respectively, and two pedicles 26a and 26b extend inferiorly from the processes 24a and 24b to a vertebral body 28. Since the other vertebrae V1-V3 are similar to the vertebra V5 they will not be described in detail. Also, V4 is similar to V5 with the exception that the spinous process 22 of V4 has been removed for one or both of the reasons set forth below.

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. As stated above, it will also be assumed that the spinous process 22 of V4 has been removed.

An intervertebral disc prosthetic device 40 according to an embodiment of the invention is provided which is adapted to be implanted between the spinous processes 22 of the vertebrae V3 and V5. The prosthetic device 40 is shown in detail in FIGS. 5 and 6 and includes a spacer 42 which is substantially rectangular in shape with the exception that two curved notches 42a and 42b are formed in the respective end portions thereof. A laterally extending channel 42c, having a substantially rectangular cross section, extends through the entire width of the spacer 42 approximately midway between the notches 42a and 42b.

An insert 44 is provided that is dimensioned so as to extend in the channel 42c with minimum clearance. Tabs 46a and 46b extend out from the respective ends of the insert 44 and elongated openings 46c and 46d extend through the respective tabs. The length of the insert 44 substantially corresponds to the length of the channel 42c so that when the insert is inserted in the channel, the tabs 46a and 46b project outwardly from the channel.

Two protrusions 48a and 48b extend from the sides of the tab 46a and two protrusions 48c and 48d extend from the sides of the tab 46b. The protrusions are for the purpose of receiving tethers, or the like, to tether the device 40 to the vertebrae V4 and/or V5.

Since the spinous process of the vertebra V4 has been removed, the device 40 is implanted between the spinous process 22 of the vertebra V3 and the spinous process 22 of the vertebra V5. In the implanted position shown in FIGS. 4 and 6, the spinous process 22 of the vertebra V3 extends in the notch 42a of the spacer 42, and the spinous process 22 of the vertebra V5 extends in the notch 42b. The dimensions of the device 40 are such that, when it is implanted in this manner, the elongated openings 46c and 46d extend over the pedicles 26a and 26b (FIG. 3) of the vertebra V4.

Then, two screws, one of which is referred to by the reference numeral 49 in FIGS. 4 and 6, are inserted through the elongated openings 42c and 42d, respectively, of the spacer 42. Torque is applied to the screws 49 so that they are driven into the pedicles 26a and 26b of the vertebra V4. The elongated openings 46c and 46d in the tabs 46a and 46b, respectively, enable the screws 49 to be adjusted laterally and to be angled towards the pedicles 26a and 26b as necessary so that they can be driven into the pedicles.

Although not shown in the drawing, tethers can be tied between the protrusions 46a-46d and the vertebrae V3, V4, and/or V5 to provide additional support and resistance.

As examples of the materials making up the spacer 42 and the insert 44, the spacer can be of a relatively soft material, such as soft plastic, including silicone, while the insert can be of a relatively stiff material, such as hard plastic or rubber. In the latter context, the surgeon could be provided with several inserts 44 that vary in stiffness, and once the condition of the vertebrae V4 and V5 (FIG. 4), and therefore the desired stiffness, is determined, the proper insert 44 can be selected.

When the device 40 is implanted in the manner discussed above, the relatively flexible, soft spacer 42 provides non-rigid connections to the vertebrae V3 and V5 that readily conforms to the spinous processes 22 of the vertebrae V3 and V5 and provides excellent shock absorption, while the insert 44 adds stiffness, compressive strength and durability, and the screws 49 provide a rigid connection to the vertebra V4.

A prosthetic device 50 according to another embodiment is shown in detail in FIG. 7 and includes a spacer 52 which is substantially rectangular in shape with the exception that a curved notch 52a, is formed in one end portion. A tab 52b projects from the other end of the spacer 52 for reasons to be described.

A spacer 54 is also provided which is substantially rectangular in shape with the exception that a curved notch 54a is formed in one end portion and a tab 54b projects from the other end of the spacer 54.

A connector 56 is designed to fit over the tabs 52b and 54b of the spacers 52 and 54, respectively, to connect them. To this end, the connector 56 has a through opening 56a with a cross section slightly greater than the cross sections of the tabs 52b and 54b.

Two tabs 56c and 56b extend out from the respective ends of the connector 56, and elongated openings 56e and 56d extend through the respective tabs for receiving screws, for reasons to be described.

Two protrusions 58a and 58b extend from the sides of the tab 56b and two protrusions 58c and 58d extend from the sides of the tab 56c. The protrusions are for the purpose of receiving tethers, or the like, to tether the device 50 to the vertebrae V4 and/or V5.

To connect the spacers 52 and 54, their respective tabs 52b and 54b are inserted into the opening 56a of the connector 56 from opposite ends of the opening until the corresponding shoulders of the spacers 52 and 54 engage the corresponding ends of the connector 56. The spacers 52 and 54 and the connector are sized so that the tabs 52b and 54b engage the inner wall of the connector 56 in a friction fit so as to retain the spacers 52 and 54 in the connector.

Since the spinous process of the vertebra V4 has been removed, the device 50 is implanted between the spinous process 22 of the vertebra V3 and the spinous process 22 of the vertebra V5. In the implanted position, the spinous process 22 of the vertebra V3 extends in the notch 52a of the spacer 42, and the spinous process 22 of the vertebra V5 extends in the notch 54a. The dimensions of the device 50 are such that, when it is implanted in this manner, the elongated openings 56d and 56e extend over the pedicles 26a and 26b (FIG. 3) of the vertebra V4.

Although not shown in the drawing, tethers can be tied between the protrusions 58a-58d and the vertebrae V3, V4, and/or V5 to provide additional support and resistance.

The spacers 52 and 54 could be fabricated from a relatively soft material, such as soft plastic, including silicone, while the connector 56 could be fabricated from a relatively stiff material, such as hard plastic or rubber. In the latter context, the surgeon could be provided with several connectors 56 that vary in stiffness. Thus, once the surgeon ascertains the condition of the vertebrae V3, V4, and V5 (FIG. 3) and determines the particular stiffness that is needed, the proper connector 56 can be selected.

Thus, when the device 50 is implanted between the spinous processes 22 of the vertebrae V3 and V5 in the manner discussed above, the relatively flexible, soft spacers 52 and 54 provide a non-rigid connection to the vertebrae V3 and V5 that readily conforms to the spinous processes 22 of the vertebrae V3 and V5, and provides excellent shock absorption. Also, the connector 56 adds stiffness, compressive strength and durability, and the screws 49 provide a rigid connection to the vertebra V4.

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

Any conventional substance that promotes bone growth, such as HA coating, BMP, or the like, can be incorporated in the prosthetic device of the above embodiments.

One or more of the components of the above devices may have through holes formed therein to improve integration of the bone growth.

The surfaces of the body member defining the notch can be treated, such as by providing teeth, ridges, knurling, etc., to better grip the spinous processes and the adapters.

The body member can be fabricated of a permanently deformable material thus providing a clamping action against the spinous process.

The spacers and associated components of one or more of the above embodiments may vary in shape, size, composition, and physical properties.

Through openings can be provided through one or more components of each of the above prosthetic devices to receive tethers for attaching the devices to a vertebra or to a spinous process.

The prosthetic device of each of the above embodiments can be placed between two vertebrae in the vertebral column 10 other than the ones described above.

The prosthetic device of each of the above embodiments can be fabricated from materials other than those described above.

The relative stiff components described above could be made of a resorbable material so that their stiffness would change over time.

The prosthesis of the above embodiments can be implanted between body portions other than vertebrae.

In the embodiment of FIG. 7, the spacers 52 and 54 can be fabricated from a relatively stiff material and the connector 56 from a relatively soft, flexible material.

The prostheses of the above embodiments can be inserted between two vertebrae following a discectomy in which a disc between the adjacent vertebrae is removed, or a corpectomy in which at least one vertebra is removed.

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.

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.

Claims

1. A method of implanting a spinal prosthesis comprising: inserting a first relatively flexible member between superior and inferior spinous processes associated with respective superior and inferior vertebrae; the superior vertebra and inferior vertebra separated by an intermediate vertebra; the first member having a channel that extends, after insertion, laterally through the first member;inserting a second relatively stiff member through the channel such that the second member is operatively connected to the first member;removing the second member from the channel and inserting a third relatively stiff member through the channel such that the third member is operatively connected to the first member; wherein the third member has a different stiffness than the second member;anchoring the third member to the intermediate vertebra, while inserted through the channel, at first and second locations disposed on respective first and second lateral sides of the intermediate vertebra.

2. The method of claim 1 wherein the first member comprises first and second notches and wherein inserting the first member further comprises engaging the first notch with the superior spinous process and engaging the second notch with the inferior spinous process.

3. The method of claim 1 wherein the third member includes first and second tabs extending from opposite ends thereof and wherein anchoring the third member to the intermediate vertebra comprises connecting tethers to the first and second tabs and tethering the third member to the intermediate vertebra.

4. The method of claim 1 wherein the third member includes first and second tabs extending from opposite ends thereof; wherein said inserting the third member comprises disposing the third member such that the first and second tabs extend over the pedicles of the intermediate vertebra; and wherein anchoring the third member to the intermediate vertebra comprises inserting screws through the first and second tabs such that the screws are driven into the pedicles of the intermediate vertebra.

5. A method of implanting a spinal prosthesis comprising: providing a main body member and a plurality of inserts, each having different stiffness from the other; the main body member being more flexible than the inserts;inserting the main body member between superior and inferior spinous processes associated with respective superior and inferior vertebrae; the superior vertebra and inferior vertebra separated by an intermediate vertebra; the main body member having, after said inserting: an upwardly facing concave notch engaging the superior spinous process;a downwardly facing concave notch engaging the inferior spinous process;a channel that extends laterally through the main body member;selecting one of the inserts based on its relative stiffness;coupling the selected insert to the main body by inserting the selected insert through the channel;anchoring the selected insert to the intermediate vertebra, while inserted through the channel, at first and second locations disposed on respective first and second lateral sides of the intermediate vertebra.

6. The method of claim 5 wherein the selected insert includes first and second tabs extending from opposite ends thereof and wherein anchoring the selected insert to the intermediate vertebra comprises inserting screws through the tabs and driving the screws into the intermediate vertebra.

7. The method of claim 5 wherein the selected insert includes first and second tabs extending from opposite ends thereof and wherein anchoring the selected insert to the intermediate vertebra comprises connecting tethers to the tabs and tethering the selected insert to the intermediate vertebra.

8. The method of claim 5 wherein the selected insert is a second insert; and, prior to inserting the second insert, the method further comprises inserting a first insert through channel and thereafter removing the first insert from the channel; wherein the second insert has a different stiffness than the first insert.

9. A method of implanting a spinal prosthesis comprising: providing a first body member and a plurality of second body members, each having different stiffness from the other; the first body member being more flexible than the second body members;selecting a first of the second body members;inserting the first body member between superior and inferior spinous processes associated with respective superior and inferior vertebrae; the superior vertebra and inferior vertebra separated by an intermediate vertebra; the first body member, after said inserting: coupled to the first of the second body members; andhaving an upwardly facing concave notch engaging the superior spinous process;selecting a second of the second body members based on its relative stiffness;decoupling the first of the second body members from the first body member and thereafter engaging the second of the second body members with the first body member;thereafter, anchoring the second of the second body members to the intermediate vertebra, while engaged with the first body member and disposed so as to extend through a sagittal plane defined by the first and second vertebrae, at first and second locations disposed on respective first and second lateral sides of the intermediate vertebra.

10. The method of claim 9 wherein the first body member includes a first tab extending downwardly therefrom and wherein engaging the second of the second body members with the first body member comprises inserting the first tab into a recess on a superior side of the second of the second body members.

11. The method of claim 10 further comprising: engaging the second of the second body members with a third body member; the third body member: being more flexible than the second body members;having a downwardly facing concave notch for engaging the inferior spinous process;having a second upwardly extending tab extending into the second of the second body members;inserting the second of the second body members between the superior and inferior spinous processes, while engaged with said first and third body members, so the second of the second body members extends through the sagittal plane and the concave notch of the third body member engages the inferior spinous process while the concave notch of the first body member engages the superior spinous process.

12. The method of claim 9 wherein the second of the second body members includes first and second tabs extending from opposite ends thereof; and wherein anchoring the second of the second body members to the intermediate vertebra comprises connecting tethers to the first and second tabs and tethering the second of the second body members to the intermediate vertebra.

13. The method of claim 9: wherein the second of the second body members includes first and second tabs extending from opposite ends thereof;further comprising inserting the second of the second body members between the superior and inferior spinous processes, while engaged with the first body member, so the second of the second body members extends through the sagittal plane and the first and second tabs extend over the pedicles of the intermediate vertebra; andwherein anchoring the second of the second body members to the intermediate vertebra comprises inserting screws through the first and second tabs such that the screws are driven into the pedicles of the intermediate vertebra.

14. The method of claim 9: wherein inserting the first body member between superior and inferior spinous processes comprises receiving the superior and inferior spinous processes in first and second concave notches on the first body member, respectively;wherein the decoupling the first of the second body members from the first body member comprises disengaging the first and second concave notches from the superior and inferior spinous processes, respectively, and removing both the first body member and the first of the second body members from between the superior and inferior spinous processes.