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METHOD OF LUMBAR INTERVERTEBRAL
DISK STABILIZATION

This application is a divisional of co-pending application Ser. No. 08/210,229, filed Mar. 18, 1994.

BACKGROUND OF THE INVENTION

The present invention relates to an intervertebral disk stabilizing implant and a method of lumbar intervertebral disk stabilization ("LIDS"). More specifically, the present invention relates to cylindrically shaped disk implants which are expanded in the middle portion which are used for spinal fusion.

The spine is a flexible structure comprised of thirty-three vertebrae separated and cushioned from each other by fibrous intervertebral disks. If the spine is injured or becomes diseased, surgical intervention involving removal of one or more disks, and fusion of the adjacent vertebrae, may be indicated. The more frequent injuries are in the lower lumbar and in the lower cervical regions.

Treatment of a herniated disk in the neck and in the lumbar region continues to be a challenging field of medicine. The classical treatment for a ruptured disk continues to be diskectomy, i.e., removal of the disk from between the vertebrae. In this process, all or a portion of the intervertebral disk is removed, leaving a defect which continues to bother the patients throughout the rest of their lives. An additional procedure is to replace the disk space with a bone graft, usually bone chips cut from the patient's iliac crest, bringing about fusion of the vertebrae above and below the disk, eliminating the empty space between the vertebrae.

Theoretically, a diskectomy with fusion is a satisfactory procedure, though not ideal because the replaced bone does not have any of the functions of the cartilaginous tissue of the disk, i.e. no cushioning effect, and has complications because of several factors. First, conventional bone plugs used to pack the disk space do not conform to the shape of the disk because the disk bulges niaximaily in the center. The disk space is wider in the middle and narrower at its anterior and posterior ends. For this reason, the various bone plugs which are currently available commercially have only four contact points, i.e. at the front and back of the disk space. Secondly, access to the disk is from one side or the other of the dorsal spine of the adjacent vertebrae, leaving a space that is "off-center" relative to the bodies of the adjacent vertebrae. An implant inserted into that off-center space, therefore, replaces only a portion of the disk and consequently contacts only a portion of the bodies of the adjacent vertebrae such that the stability of the implant is even more problematical than might be apparent from the limited contact resulting from the shape of the intervertebral space in the first place. Another complication is the possibility of infection or other conditions which may require the removal of the implant Also, if the bone pieces do not fuse, they may eventually extrude out of the disk space, causing pressure on the nerve roots.

Various prosthetic disk plugs, or implants, are disclosed in the art, but all are characterized by limitations of not conforming to the shape of the disk space, lack of stability when inserted off-center, inability to be removed, or other disadvantages. For instance, U.S. Pat. No. 4,863,476 describes an elongated body divided longitudinally into two portions having a cam device movable therebetween for increasing the space between the two body portions once inserted into the disk space. However, that device is generally cylindrical in shape such that the only contact points between the device and the vertebral,bodies are at the front and back of the disk space, creating increased likelihood of instability and generally rendering that device unsuitable for

use after partial diskectomy. The art also discloses intervertebral disk prostheses (e.g., U.S. Pat. Nos. 3,867,728,4309, 777,4,863,477 and 4,932,969 andFrench Patent Application No. 8816184) which may have more general contact with

5 the adjacent disks, but which are not intended for use in fusion of the disks. The art also includes spinal joint prostheses such as is described in U.S. Pat. No. 4,759,769, which is again not indicated for use when fusion is the preferred surgical intervention.

10 There is, therefore, a need for a device capable of stabilizing the vertebrae adjacent an intervertebral disk, but which is also removable, for use in spinal fusion. There is also a need for a method of implanting such a stabilizer.

20

SUMMARY OF THE INVENTION

15

These needs are met in the present invention by providing a vertebral disk stabilizer comprised of a generally cylindrical, elongate implant having end and middle portions, the middle portion having a diameter larger than the diameter of the end portion, threads formed on the outside surface of the implant for bearing against the bodies of the adjacent vertebrae when the implant is inserted into the anatomical region from which a portion of the intervertebral disk has been removed, and an applicator. The applicator is mounted to the implant for (1) facilitating the 25 insertion of the implant into the region between the adjacent vertebrae from which the portion of the disk has been removed and (2) rotating the implant so as to cause the implant to move in an anterior-posterior direction as the threads bear against the bodies of the adjacent vertebrae to 30 a position in which both the middle and end portions of the implant engage the bodies of the adjacent vertebrae so as to more completely support the upper vertebrae, thereby stabilizing the adjacent vertebrae, and is subsequently detached therefrom.

35 Also provided is a method of stabilizing adjacent vertebrae, particularly lumbar vertebrae, Comprising the steps of spreading two adjacent vertebrae and removing a portion of the intervertebral disk from therebetween, followed by insertion of an elongate, generally cylindrically

40 shaped implant having middle and end portions, the middle portion being of larger diameter than the end portion, into the space between the adjacent vertebrae from which the disk has been removed. The implant is then rotated to cause threads formed on the outside surface thereof to bear against the bodies of the adjacent vertebrae to move the implant in

45 an anterior-posterior direction until positioned at a point between the adjacent vertebrae at which both the larger diameter middle portion and the smaller diameter end portion of the implant engage the vertebrae to stabilize the adjacent vertebrae relative to each other.

50

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plan view of a preferred embodiment of a vertebral disk stabilizer constructed in accordance with the present invention. 55 FIG. 2 is a projected view of the applicator of the stabilizer of FIG. 1 after being detached from the implant.

FIG. 3 is a projected view of the implant of the stabilizer of FIG. 1 after being detached from the applicator.

FIG. 4 is a plan view of a spreader which is used to 60 advantage in connection with the insertion of the implant of the stabilizer of FIG. 1 between two adjacent vertebrae of a patient's spinal column.

FIG. 5 is a lateral view of a portion of a human spinal column having the implant of the stabilizer of FIG. 1 65 inserted therein and having a portion of the bodies of the vertebrae adjacent the implant cut away to show the engagement of the vertebral bodies by the implant

3 4

FIG. 6 is a plan view of a second embodiment of a out below. Implant 14 is preferably constructed of any

stabilizer constructed in accordance with the present inven- durable, relatively biologically inert substance such as car

tion. bon fiber, titanium, several medical grade hard plastics, and

FIG. 7 is a projected view of the applicator of the such other materials as are known in the art for use in such

stabilizer of FIG. 6 after detaching the implant therefrom. 5 implants.

FIG. 8 is a projected view of the implant of the stabilizer Referring now to FIGS. 4 and 5, there is shown a spreader,

of FIG. 6 after being detached from the applicator. indicated generally at reference numeral 48, having integral

FIG. 9 is a longitudinal, sectional view of a portion of the handle 50 and ^^nt 52 portions sized and generally

stabilizer of FIG. 6, taken along the lines 9—9 in FIG. 6. shaPed in tile same size md dimensions as the stabilizer 10.

Xtt/" 1 n •„ „• ,„ „f „r o„ m The use of the stabilizer 10 of the present invention in, for

FIG. 10 is a projected view or another embodiment of an iu . x ^j^i i_ • * ^uij-i

i * * J • j vwi. *• instance, a method of lumbar intervertebral disk

implant constructed in accordance with the present invention ..... ..' ,„_.„„ . .„ ..... = c

o^i ,„uivh io „«.»h ;„ ~io„„ „f jTM„io.,t%,f iTM- i stabilization, or LIDS . is illustrated in FIG. 5. Surgery is

and which is used in place oi the implant or rIG. 3. . . , , . iU . ^ ° ; ,

__ v . . - ,. , „. performed as in a simple diskectomy and the intervertebral

FIG. 11 is an exploded, projected view of a third embodi- 54 is exposed through a small laminotomy. The disk

ment of a stabilizer constructed in accordance with the materfal is removed md any nerve root compression is

present invention. 15 corrected The posterior longitudinal ligament and disk

FIG. 12 is a plan view of a spreader which is used to cartilage are removed until the surfaces of the bodies 60 and

advantage in connection with the insertion of the implant of $2 0f adjacent vertebrae 56 and 58, respectively, are exposed

the stabilizer of FIG. 11 between two adjacent vertebrae of above and below the disk space.

a patient's spinal column. Using ^ spreader 48; the vertebrae 56 and 58 are

DFTATT ,FD DESQilPTION OF THE 20 distracted to open the disk space, and once the desired

PREFERRED EMBODIMENT "spread" has been achieved, the middle portion of the disk

space is packed with cancellous bone chips (not shown). As

Referring now to the figures, multiple embodiments of the described below, a kit of several spreaders, each having present invention will be illustrated and described in more progressively larger diameter implant portions, is used to detail. Specifically with regard to the embodiment shown in 25 achieve the desired spread. Because the posterior longituFIG. 1, the stabilizer is indicated generally at reference dinal ligament is left intact to the opposite side and to the numeral 10, and is comprised of two parts, an applicator 12 center of the disk space, the bone chips are held in place in and an implant 14. Applicator 12 is shown with a handle 16 the disk space. The appropriately-sized implant 14 of stain the shape of a "T", but it will be recognized from this bilizer 10 is then inserted into the disk space using the disclosure by those skilled in the art that the handle 16 may 30 applicator 12 until the threads 46 formed on the outside take the form of any convenient hand grip or other structure surface of implant 14 engage the bodies 60 and 62 of the which facilitates the handling of the stabilizer 10 and adjacent vertebrae 56 and 58, respectively. Piston 22 is then subsequent rotation of the stabilizer 10 once the implant 14 wedged into the bore 20 to cause the applicator 12 to has been inserted into the space between two adjacent frictionally engage implant 14 to prevent relative rotational vertebrae as more particularly described below. movement therebetween and the stabilizer 10 is rotated.

As shown more clearly when FIG. 1 is viewed in con- Rotation of the implant 14 in the disk space causes the

junction with FIGS. 2 and 3, applicator 12 is comprised of threads 46 to bear against the bodies 60 and 62 to move the

an elongate mandrel 18 having a longitudinal bore 20 implant further into (or back out of, depending upon the

therethrough, the bore 20 terminating in a point, with an direction of rotation) the disk space in an anterior-posterior

elongate piston 22 disposed therein. Piston 22 is provided direction so as to enable the implant 14 to be positioned in

with a wedge-shaped, or pointed, end 24 which is sized to 40 the disk space at a position in which the expanded, or larger

approximate the shape of the pointed end of the bore 20 in diameter portion 44 and the smaller diameter ends 40 and 42

mandrel 18 at one end and a handle 26 formed at the other of implant 14 contact the respective lower and upper sur

end. As best shown in FIG. 2, the end 28 of mandrel 18 is faces of the bodies 60 and 62 of the adjacent vertebrae 56

provided with screw threads 30 which mate with the threads and 58. The respective lower and upper surfaces of the

32 (see FIG. 3) formed in the interior wall of the bore 34 in 45 vertebral bodies 60 and 62 are slightly concave such that the

implant 14. In this manner, the end 28 of mandrel 18 is expanded middle portion 44 of implant 14 allows the

received in and affirmatively engages the implant 14 to implant 14 to engage substantially more of the respective

detachably mount implant 14 to applicator 12. Applicator 12 surfaces of the vertebral bodies 60 and 62 than conventional

is provided with means for preventing relative rotational prosthetic devices, thereby providing increased stability to

movement between the implant 14 and applicator 12 50 the fusion.

comprised, in the preferred embodiment shown, of a plu- Once positioned in the disk space so as to provide

rality of radially spaced, longitudinal slots 36 in the end 28 maximum stabilization, pressure on the piston 22 is released

of mandrel 18 communicating with the longitudinal bore 20 and the piston 22 is backed out of the bore 34 so as to allow

therethrough and the wedge-shaped end 24 of piston 22. the applicator 12 to be rotated without rotating the implant

When piston 22 is forced down into the bore 20 in mandrel J5 14. The applicator is then detached from the implant 14 by

18, the pointed end 24 of piston 22 acts to spread, or force unscrewing and backed out of the incision in the patient If

the portions 38.of the threaded end of mandrel 18 between necessary, a small amount of a physiologically compatible

slots 36 outwardly into increasingly tighter frictional adhesive of a type known in the art is applied over the

engagement with the interior wall of the bore 34 of implant cancellous bone chips just medial to the implant to close off

34, thereby preventing relative rotational movement of the the remaining portion of the opening into the disk space. The

implant 14 and applicator 12. 60 patient should be able to ambulate soon after the LIDS

Implant 14 is formed in the shape of a generally elongate procedure because of the stability imparted to the spinal

cylinder with a blunt, or rounded end 40 and the end 42 column by the implant of the present invention. Before

having the aforementioned bore 34 opening therein. The narrowing of the disk space occurs, the cancellous bone

diameter of the ends 40 and 42 is smaller than the diameter chips will have started the fusion process,

of the middle portion 44 of the implant for a purpose to be 65 The stabilizer 10 is also used to advantage to perform, for

explained below. The outside surface of implant 14 is instance, a posterior lateral intertransverse fusion. The

provided with threads 46, the function of which are also set implant 14 is inserted into the region of the disk space from

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