Vertebral endplate milling device

A milling device having in which opposed distance adjustment elements are slidably coupled with two surfaces of the device's abrading element which face away from the abrading surface of the device's abrading element.

BACKGROUND OF THE INVENTION

Many spinal surgical procedures involve the removal of a problematic intervertebral disc followed by the placement of a prosthetic implant (such as a fusion body, spacer or a motion disk) within the intervertebral disc space.

U.S. Pat. No. 6,083,228 (“Michelson”) discloses abrading elements particularly designed for preparing the intervertebral space in the spine for reception of the implant between adjacent vertebral bodies. FIG. 20 of Michelson discloses an abrading device having a pair of parallel abrading elements connected to a rotary drive mechanism which allows for simultaneous preparation of the adjacent endplates. However, the abrading surfaces of Michelson's devices preferably have a leading edge which removes material along that edge as it is advanced into the disk space. See, e.g., FIGS. 17A and 17B of Michelson. Accordingly, the anterior lips of the opposing vertebrae (which helps retain the implant in its desired space) are undesirably removed by the action of this device as the device enters the disc space. See FIG. 19 of Michelson.

When a variation in the height of the disk space must be accommodated, Michelson teaches using an adjustment screw in conjunction with a pair of wedge-shaped blocks, each having a threaded aperture for receiving the adjustment screw. According to Michelson, as the adjustment screw is turned, the wedged-shaped blocks move relative to one another to change the distance between the abrading surfaces. See col. 12, lines 45-57 of Michelson. The exact placement of these wedged-shaped blocks within the device is not explicitly described by Michelson. However, FIG. 20 also discloses a pair of opposed vertically-disposed frustoconical openings in the center of each abrading element 94 and 96. Accordingly, it appears that Michelson suggests that the wedged-shaped blocks are located in these frustoconcial openings, and that the adjustment screw is vertically-disposed therethrough. Since this vertically-disposed screw must be accessed from either the top or bottom of the device, it does not appear to be accessible to the surgeon once the abrading elements are inserted into the disc space. Accordingly, Michelson's “adjustable screw” device also appears to allow for a height adjustment only before the abrading elements are inserted into the disc space. Since these abrading elements are fixed prior to their entry into the disk space, it is reasonable to conclude that they also remove the anterior lips of the opposing vertebrae as this device is advanced into the disk space.

FIG. 23 of Michelson discloses a vibratory milling device whose abrading elements 218 have rounded working surfaces. Although it appears this device does not remove the anterior lips of the opposing vertebrae, since the device does not provide for in-situ height adjustment, the distance between these elements is fixed during operation, and so these elements must undesirably stretch the ligaments surrounding the disc space as they enter the disc space.

In sum, the devices of FIGS. 17 and 20 of Michelson undesirably eliminate the anterior vertebral lips which help retain the implant, while the device of FIG. 23 undesirably stretches the ligaments surrounding the vertebrae which help retain the implant.

Therefore, there is a need for a milling device which suitably prepare the disc space for the insertion of an implant, while retaining the anterior lips of the opposing vertebrae, but without stretching the vertebral ligaments

During endplate preparation, it is often desirable to increase the pressure upon the endplate being prepared in order to reduce preparation time. Michelson teaches one technique for increasing abrading pressure by using a device having an abrading surface on only one side of the device (as in FIG. 2 of Michelson) and using the non-abrading side as a fulcrum. However, the use of a non-abrading surface allows only for single-sided milling, and so doubles the time required for milling.

Michelson teaches sequentially selecting progressively larger abrading elements to form the desired disk space in a step-wise fashion (4, 45-46). The sequential nature of this activity makes for a time-consuming procedure.

In addition, Michelson does not teach measuring annular tension with the disclosed milling devices.

U.S. Pat. No. 5,865,846 (“Bryan”) teaches forming concave surfaces of predetermined shape in opposing vertebral endplates. However, the milling device used in such a procedure is not disclosed by Bryan.

U.S. Pat. No. 5,514,180 (“Heggeness”) discloses forming spinal prostheses having shapes which conform to the natural contour of the opposing vertebral endplates.

Therefore, there is a need for a milling device suitable for preparing a space in the human spine to receive an insert between adjacent vertebral bodies which can preserve the endplate lips without stretching the ligaments.

SUMMARY OF THE INVENTION

The present invention relates to a milling device in which distance adjustment elements are slidably coupled with two surfaces of the abrading element which face away from the abrading surface. In contrast to the Michelson device (wherein the coupling appears to occur with at least one surface which faces in the same direction as the abrading surface), the distance between the distance adjustment elements of the present invention may be conveniently adjusted from a position lateral to the abrading surface. As that distance is adjusted, the position of the abrading element is correspondingly adjusted to a position higher or lower upon the sliding surfaces of the distance adjustment elements.

Thus, in a device having a pair of abrading surfaces facing opposite directions, the device may be inserted into the disc space in a first closed position having a small profile. Advancement into the disc space with the small profile not only avoids contact with the endplates, but also avoids any stretching of the ligaments. Once the device is safely within the disc space, the distance between the apices of the abrading surfaces may be increased to an open position, thereby creating the desired concave contours upon the endplates without stretching the ligaments.

Therefore, in accordance with the present invention, there is provided a device for preparing a space in the human spine to receive an insert between adjacent vertebral bodies, comprising:a) a first abrading element comprising:i) a first abrading surface shaped to create a first predetermined surface contour in a vertebral body endplate,ii) a first surface portion facing away from the first abrading surface, andiii) a second surface portion facing away from the first abrading surface,b) a first distance adjustment element having a first sliding surface contacting the first inner surface portion for slidable engagement therewith, andc) a second distance adjustment element having a second sliding surface contacting the second inner surface portion for slidable engagement therewith.

DETAILED DESCRIPTION OF THE INVENTION

Now referring toFIG. 1, there is provided a device701for preparing a space in the human spine to receive an insert between adjacent vertebral bodies, comprising:a) a first abrading element703comprising:i) an first abrading surface705shaped to create a first predetermined surface contour in a vertebral body endplate,ii) a first surface portion707facing away from the first abrading surface, andiii) a second surface portion709facing away from the first abrading surface,b) a first distance adjustment element711having a first sliding surface713contacting the first surface portion707for slidable engagement therewith, andc) a second distance adjustment715element having a second sliding surface717contacting the second inner surface portion709for slidable engagement therewith.
The first and second sliding surfaces may be arranged so as to oppose each other, or to face away from each other. For example, inFIG. 1, the first sliding surface713opposes the second sliding surface717. Because these surfaces oppose each other, first abrading element703is moved to a position higher upon the sliding surfaces when the distance adjustment elements are moved together. In other embodiments, the first and second sliding surfaces may be arranged so as to face away from each other (as in FIG.2).

The distance adjustment elements may possess any shape suitable for sliding engagement with a surface portion of an abrading element. For example, the distance adjustment element may have a cross-section of regular geometric shape (such as a parallelogram), or a thin flange. Many embodiments of the distance adjustment elements may conveniently be characterized as a trapezoid possessing parallel inner and outer faces between which reside the sliding surfaces which engage the adjacent abrading elements. For example, inFIG. 1, first distance adjustment element711further comprises a first inner face719, second distance adjustment element715further comprises a second inner face721, and the first inner face opposes the second inner face. First distance adjustment element further comprises a first outer face723, the second distance adjustment element further comprises a second outer face725, and the first outer face faces away from the second outer face.

In some embodiments, and particularly those in which the distance adjustment element has a regular geometric shape, through-holes are provided which traverse the inner and outer faces of the distance adjustment element. These holes may be used to help fix the position of elongate members (whose function will be explained below). For example, inFIG. 1, first distance adjustment element further comprises a first hole741traversing the inner719and outer723faces thereof, while the second distance adjustment element715further comprises a second hole753traversing the inner721and outer725faces thereof Preferably, the first and second holes are co-axial so that an essentially linear elongate member may be easily occupy each hole.

The distance between the distance adjustment elements may be adjusted by an means. In many embodiments, the adjustment is conveniently performed by using at least one elongate member which extends laterally from the device, thereby allowing the surgeon to perform the desired distance adjustment from outside the disc space while the device is located within the disk space. In many embodiments, first and second elongate members are provided which respectively contact first and second distance adjustment elements. Relative movement of the two elongate members results in a relative movement of the distance adjustment members.

For example, the device ofFIG. 1further comprises a first elongate member743having proximal portion745and a distal portion747. The elongate member forms a hollow shaft749, wherein the distal portion747contacts the outer face723of the first distance adjustment element711. The device ofFIG. 1further comprises a second elongate member751extending through the hollow shaft749and the first hole741. In this embodiment, the second elongate member751is slidably disposed in the first hole741and the second hole753.

In thisFIG. 1embodiment, the first distance adjustment element711and the distal portion747of the first elongate member are integral.

Although many embodiments utilize elongate members in a co-axial relationship, there is no requirement that such members must always be co-axial. For example, in other embodiments, as inFIG. 3a, the elongate members901and902are disposed side-by-side parallel relationship, and are held in place by an outer band905. In this embodiment, each elongate member is integral with the corresponding distance adjustment element. In other embodiments, as inFIG. 3b, the elongate members may disposed in a fixed angular relationship fixed by a wedge950having at least one bore952for accommodating at least one elongate member. In this embodiment the distance adjustment member may act as the wedge.

In some embodiments, the device is designed to work upon two opposing endplates at the same time. In these embodiments, the device may conveniently further comprises an additional abrading element whose abrading surface faces in the direction which is opposite that of the first abrading surface. The device may also comprises two additional distance adjustment elements, each comprising a sliding surfaces adapted to slidably engage the surface portions of the abrading element which face away from the second abrading surface. For example, inFIG. 1, First distance adjustment element further comprises a third sliding surface727facing away from the first sliding surface713, and the second distance adjustment element further comprises a fourth sliding surface729facing away from the second sliding surface717. In this embodiment, the third sliding surface opposes the fourth sliding surface.FIG. 1also discloses a second abrading element733comprising:i) a second abrading surface735shaped to create a second predetermined surface contour in a vertebral body endplate, andii) a third surface portion737facing away from the second abrading surface735, andiii) a fourth surface portion739facing away from the second abrading surface735,
wherein the third surface portion737contacts the third sliding surface727for slidable engagement therewith, and wherein the fourth surface portion739contacts the fourth sliding surface729for slidable engagement therewith.

In use, the activation of the device allows the abrading elements to move from a closed position (which is desirable for entering the disc space without unduly streching the surrounding ligaments) to an open position (which is desirable for preparing the endplates. Now referring toFIG. 4a, when the device is outside the disc space and in the closed position, in many embodiments the inner end portion857of the sliding surface contacts the inner end portion of the corresponding surface portion853. In addition, the outer end portion855of the sliding surface contacts the outer end portion of the corresponding surface portion851. Once this device has entered the disc space, it may now be conveniently opened. Now referring toFIG. 4b, the device ofFIG. 4ais activated so as to decrease the distance between the distance adjustment elements. As this occurs, the abrading element is pushed upwards into an open position so that the outer end portion855of the sliding surface contacts the inner end portion of the corresponding surface portion853. The resulting height adjustment causes the abrading surface to contact endplate VE.

When elongate members are used, they are typically provided in a configuration that produces in-situ height adjustment of the abraders upon a change in the relative position of the elongate members. Preferably, the elongate members are disposed so that a change in their relative position along their major axes changes the distance between the distance adjustment elements. The change in distance between the distance adjustment elements will then force the abraders which abut the distance adjustment elements either toward the elongate members (to a more closed position) or away from the elongate members (to a more open position), thereby providing the desired in-situ height adjustment capability.

In some embodiments, there is provided a first elongate member and a second hollow elongate member, wherein the first elongate member is slidably disposed within the second hollow elongate member. In these embodiments, the first elongate member may be either solid or hollow. In addition, C-shape elongate members having an essentially hollow interior are also contemplated.

For example, in some embodiments, the elongate members are selected so that a solid rod (the first elongate member) extends distally from a hollow shaft (the second hollow elongate member), as in FIG.1. In these embodiments, the design and manufacture of the device is relatively simple.

However, in other embodiments, the elongate members are selected so that the solid rod terminates proximally within the hollow shaft, as in FIG.5. In these embodiments likeFIG. 5, the design device typically includes a slot316disposed upon the surface of the hollow shaft from which its distance adjustment element extends and running parallel to the longitudinal axis A of the hollow shaft. When so designed, this slot accommodates the desired axial movement of proximal distance adjustment element. Although these embodiments are more complex, they are nonetheless useful.

Preferably, when co-axial elongate members are selected, the inner elongate member is axially movable within the hollow portion of the outer elongate member is also slidably movable along axis A within the outer shaft. When the inner rod is axially movable, the surgeon can easily adjust the relative position of the elongate members by simply slidably moving the inner rod either into or out of the outer hollow shaft.

In some embodiments, other types of axial movement, such as ratcheting, are also contemplated as within the scope of the invention.

In some embodiments, means for measuring disc height and tension are contemplated as within the scope of the invention. Now referring toFIG. 6, the proximal end601of the device may comprise co-axial elongate members comprising a hollow outer elongate member603and an inner elongate member605. The proximal end of the outer elongate member may form a handle607for suitable gripping the device. The device may further comprise a trigger609pivotally attached to the handle607by pivot means611. In this embodiment, a proximal end portion613of the trigger may form a ring615which wraps around a portion of the inner elongate member605which extends proximally from the hollow outer elongate member603. In addition, bearing means617is provided at the ring—inner elongate member interface to allow for free rotation of the elongate member. As the surgeon the handle and pulls the distal end619of trigger609towards the handle, inner elongate member is advanced distally.The device ofFIG. 6also includes a pair of measuring means. In particular, trigger609includes first621and second623pointers while handle607includes first625and second627measuring bars having demarcations for measuring the displacement of the inner elongate member. The displacement of pointer621allows the surgeon to measure disc height. A portion628of the handle located proximal to pointer623is relatively narrowed and therefore more susceptible to bending displacement when the trigger is pulled towards the handle. The displacement of this portion is measured by pointer623along bar627, and is a measure of the tension created by the displacement.

In still other embodiments, as inFIG. 7, in-situ height adjustment is provided by using a screw having opposed reversed threads. In particular,FIG. 7discloses an adjustable abrader device401shaped for insertion between adjacent vertebrae. The device401comprises abrading element403whose first and second surfaces portions405,407slidably engage the first409and second411sliding surfaces of distance adjustment elements413,415. Each distance adjustment element further has a hole417,419which is threaded in opposing directions. Lastly, an externally threaded screw450having opposing reversed threads456,458is disposed within the threaded holes. Distance adjustment elements are generally fixed within a housing (not shown) along a track so that they may move along the A axis, but may not rotate about the screw. Accordingly, rotation of the screw brings the distance adjustment elements closer or farther apart, thereby moving the abrading element into an open or closed position.

Alternatively, a device of the present invention incorporating reversed screw thread technology may also use a threaded nut assembly in the manner disclosed in U.S. Pat. No. 5,658,335, the specification of which is incorporated by reference.

These reversed screw thread embodiments can provide advantage in that they may be constructed with only a single elongate member, can provide a stationary setting, and can be used in vibratory embodiments.

In many embodiments, the abrading surface is substantially convex in at least one plane. The convexity of the abrading surface will produce a desirable concave shape in the vertebral endplate which can securely hold in place a convex-shaped implant. In preferred embodiments, the abrading surface is substantially convex in two planes.

In some embodiments, the abrading surface has a contour suitable for producing a contour in an endplate which can securely hold the motion discs disclosed in U.S. Pat. No. 5,824,094 (“Serhan”).

In some embodiments, the abrading surface has at least one feature. When used in conjunction with a non-rotary abrading means (such as a vibratory element), this feature will produce a predetermined relief area in the endplate contour for accommodating a stability-enhancing protrusion present on the surface of the implant.

The abrading element can be driven by any conventional abrading means such as rotary milling means or vibratory milling means. Typically, a device having rotary milling means is preferred when a highly precise contour is desired. However, the utility of rotary milling means is somewhat limited by its ability to produce essentially only circular contours. If a complex contour is desired, then use of a vibratory device is preferred.

If a rotary milling device is selected, then it is preferred than the two distance adjustment elements and the abrading element be adapted to produce a gear mechanism. In such a case, and now referred toFIGS. 8aand8b, each distance adjustment element comprises a frustoconical gear member7,9having a through-hole41,43for slidable reception along the axis of a distally extending elongate member11. Each frustoconical gear member should also possess gear teeth45,47disposed circumferentially about its tapered surface. Preferably, the gear teeth are present in the form of grooves running radially with the tapered surface. These grooves will enhance the engagement of the distance adjustment elements to portions of the corresponding frustoconical gear member49of the abrading element.

Likewise, the preferred abrading element in a rotary milling device has a frustoconical portion49adapted for engaging both of the frustoconical gear members at the same time. The frustoconical portion of the abrading element should also possess gear teeth51,53disposed circumferentially about its tapered surface. Preferably, these gear teeth are also present in the form of grooves running radially with the tapered surface, as these grooves will enhance the engagement of the frustocone to the frustocone gear members.

If a rotary milling is desired, it is preferred that the angle α formed by the frustocone surface (in relation to the longitudinal axis A of the elongate members) be between 30 and 60 degrees. When rotary milling is desired, one of the frustoconical gear members may preferably be integrally bound to the distally extending elongate member so that rotation of the rod will turn the frustoconical gear member is a desired direction. Accordingly, the distally extending rod will preferably pass through the through-hole of the non-integrated (i.e., free) gear member so that this latter free gear member can freely rotate in the opposite direction of the integrated gear member and move along axis A in response to pull on the rod. The axial movement of this free gear member resulting from the proximal pulling of the inner elongate member brings the gears closer together, thereby forcing the abrading element away from the inner rod due to the frustoconical nature of the engagement surfaces.

In other embodiments, as inFIG. 8b, the proximal gear member7is integrally connected to the inner elongate member11while the distal gear member17is slidably received on the inner elongate member11. When the inner elongate member11is pulled proximally, the proximal gear remains stationary while the distal gears slides proximally along the inner elongate member11, thereby reducing the distance between the gears and causing the abrading surface to rise away from the inner elongate member11. When the inner elongate member11is rotated at milling speed in a clockwise manner, the integrated proximal gear rotates along with the rod while the free distal gear rotates in the opposite direction.

In other embodiments, the proximal gear member may be integrally connected to an outer hollow elongate member (such as a shaft) while the distal gear member is slidably received on an inner elongate member (such as a rod). When the outer shaft is rotated at milling speed in a clockwise manner, the integrated proximal gear rotates along with the shaft while the free distal gear rotates in the opposite direction.

In other embodiments, the distal gear member is integrally connected to the inner elongate member (such as a rod) while the proximal gear member is slidably received on the rod. When the inner rod is pulled proximally, the proximal gear will slide until it abuts the distal end of the outer elongate member (such as a shaft) and thereafter remain stationary, while the distal gear member will move proximally along the proximal movement of the rod, thereby reducing the distance between the gears and causing the abrading surface to rise away from the rod. When the inner rod of this embodiment is rotated at milling speed in a clockwise manner, the integrated distal gear member rotates along with the rod while the free proximal gear rotates in the opposite direction. In this case, the distal end of the inner rod will preferably form hub for preventing distal movement of the distal gear member

Preferably, the device includes a stop means for securably connecting the abrading surface to the distal elongate member. In some embodiments, and now referring toFIG. 8b, the device includes a mounting member71located between the distance adjustment elements7,17along the connecting elongate member15. In some embodiments, the mounting member is a pin which is sized so as to fit within a recess73in the adjacent surface75of the abrading element30. In some embodiments, one end77of the pin has a laterally extending tongue79, and the recess73has a lip77, whereby the lip prevents the tongue from exiting the recess, thereby securably connecting the abrading element to the inner rod.

In some embodiments having a pair of opposed abrading elements, the mounting member can have two opposing ends or be a disc-shaped in order to secure each abrading element.

If a complex shape is desired, then use of a vibratory abrading surface is desirable.

Because rotation of one of the elongate members need not be considered in a vibratory system, a gear system need not be incorporated into the vibratory system. Accordingly, neither of the distance adjustment elements need be a gear member, and neither need be capable of movement independent of a elongate member. Rather, in a vibratory system, it is preferred that each distance adjustment element be integrally connected to its respective elongate member. Because there is no rotation in the vibratory system, the distance adjustment element need not be frustoconical, but rather can have any engagement surface which slidably engages to the adjacent to the abrading element.

In some vibratory embodiments, as inFIG. 9, the proximal distance adjustment element207is integrally connected to distal end of the outer elongate member205while the distal distance adjustment element217is integrally connected to the distal end215of the inner elongate member211. In other vibratory embodiments, as inFIG. 5, the proximal distance adjustment element307is integrally connected to distal end305of the inner elongate member305while the distal distance adjustment element317is integrally connected to the distal end315of the outer elongate member311.

The vibratory system can possess a stop means similar to the pin-recess means disclosed above for the rotary system. In other embodiments, the stop means in the vibratory system can be accomplished by providing a tongue-and-groove system upon the engagement surfaces of the gear and the abrading element.

Because the vibratory abrading element need not accommodate rotary motion, its abrading surface may possess any shape which forms the desired relief in the opposing endplate.

Generally, the vibratory abrading element will comprises an abrading surface and an angled engagement surface which functions as a sliding surface portion. The angled engagement portion may be continuous around the periphery of the abrading element (as inFIGS. 8aand8b), or discontinuous (such as the two sliding surfaces portions provided in FIGS.5and9). In many embodiments, the abrading surface is substantially convex. In some embodiment, the vibratory abrading element may further possess a securement surface having a recess therein for providing secure attachment to the distally extending elongate member.

Since each of the opposing vertebral endplates should be contoured, in preferred embodiments, the device comprises a pair of abrading elements for simultaneous contouring of the opposed endplates.

In some rotary embodiments having a mounting member, the second abrading element may comprise:i) a mounting member receiving surface having a recess therein for slidable reception of the second end of the mounting member,ii) an abrading surface selected to create a predetermined surface contour in one of the adjacent vertebral bodies as the abrading element is moved by the drive mechanism, andiii) a gear engagement surface adapted to engage both the first and second frustoconical gears.

In rotary embodiments, the required rotation of one of the elongate members may be accomplished by a drive mechanism including a motor. Preferably, the motor and rotating elongate member are connected by a gear mechanism.

In vibratory embodiments, the required vibration of one of the elongate members may be accomplished by a conventional vibration mechanism including a vibrator. Preferably, the vibrator and vibrating elongate member are integrally connected.

In some embodiments wherein the elongate members comprise an inner rod and an outer shaft, when the outer shaft is connected to either a drive mechanism or a vibration system, a handle may be provided at the proximal end of the inner rod in order to facilitate handling of the device in surgery. In other embodiments, when the inner rod is connected to either a drive mechanism or a vibration system, a handle is provided at the proximal end of the outer shaft for the same purpose.

Now referring toFIGS. 8aand8b, there is provided a rotary device for preparing a space in the human spine to receive an insert between adjacent vertebral bodies, comprising:a) a hollow shaft1having a bore2, a proximal end3and a distal end5defining a first axis A;b) a first frustoconical gear7disposed at the distal end of the hollow shaft and forming a first slidable engagement surface9which tapers distally at an angle α and has a plurality of teeth10formed thereon;c) an elongate rod11having a proximal end13and a distal end15, the rod being slidably movable within the hollow shaft along the first axis A;d) a second frustoconical gear17disposed at the distal end15of the rod11and forming a second slidable engagement surface19which tapers proximally at the angle α and has a plurality of teeth20formed thereon; ande) a first abrading element30comprising:i) an abrading surface31selected to create a predetermined surface contour in a vertebral body, andii) a frustoconical surface33comprising first 34 and second 36 surface portions, each surface portion facing away from the abrading surface31and forming the angle α for slidable engagement with each of the gear engagement surfaces, and having teeth35formed thereon for geared engagement with the teeth of the gear engagement surfaces.
In use, the device ofFIGS. 8aand8bis first inserted into the disk space in its closed form. Because it is sized appropriately and is closed, its entrance does not destroy the lip of the vertebral endplate nor does it unduly stretch the ligaments. Next, the handle of the inner rod is pulled proximally, thereby bringing the distal gear to a more proximal position, and forcing the rotary abrading surface to a position farther from the inner rod. Inner rod is pulled proximally until the abrading surfaces reach the predetermined height which corresponds to the height of the implant. Next, the device is locked in order to fix the desired spacing and the power for the motor is turned on. The drive mechanism now forces the rotary abrading surfaces to turn at high speed, thereby creating a milling surface.

The device may be designed so as to be suitable for use in any or all of the cervical, thoracic or lumbar spine areas.

Now referring toFIG. 9, a vibratory device for preparing a space in the human spine to receive an insert between adjacent vertebral bodies, comprising:a) a hollow shaft201having a bore202, a proximal end203and a distal end205defining a first axis A;b) a proximal distance adjustment element207extending from the distal end of the shaft and forming a first engagement surface209which tapers distally at an angle α;c) an elongate rod211having a proximal end213and a distal end215, the rod being slidably movable within the hollow shaft along the first axis A;d) a distal distance adjustment element217extending from the distal end of the rod and forming a second surface219which tapers proximally at the angle α;e) a mounting member225having a hole227for slidable reception upon elongate rod211and located upon elongate rod211between the first and distal distance adjustment elements, the mounting member225having an end228from which tongue229laterally extends, andf) a first abrading element230comprising:i) an abrading surface231selected to create a predetermined surface contour in a vertebral body, andii) a proximal surface portion233disposed at the angle a for slidable engagement with the first engagement surface of the proximal distance adjustment element,iii) a distal surface portion234disposed at the angle α for slidable engagement with the second engagement surface of the distal distance adjustment element, andiv) a surface236disposed between the first and second engagement surfaces and having a recess235for the slidable reception of mounting member, and further having a lip237around recess235for retaining tongue229within the recess.

Now referring toFIG. 5, a vibratory device for preparing a space in the human spine to receive an insert between adjacent vertebral bodies, comprising:a) an elongate rod301having a proximal end303and a distal end305defining a first axis A;b) a proximal distance adjustment element307extending from the distal end of the shaft and forming a first slidable engagement surface309which tapers distally at an angle α, the first slidable engagement surface having a first groove310therein disposed at the angle α;c) a hollow shaft311having a bore302, a proximal end313, a distal end315, and a elongate slot316along axis A, the rod301being movable within the hollow shaft along the first axis A and proximal distance adjustment element307being movable within slot316along the first axis A;d) a distal distance adjustment element317extending from the distal end of the shaft311and forming a second slidable engagement surface319which tapers proximally at an angle α, the second slidable engagement surface having a second groove318therein disposed at the angle α; ande) a first abrading element330comprising:i) an abrading surface331selected to create a predetermined surface contour in a vertebral body,ii) a proximal surface portion333disposed between the abrading surface and the proximal distance adjustment element at the angle α for slidable engagement with the first slidable engagement surface of the proximal distance adjustment element and having a first stop335extending from the proximal surface portion for slidable reception within first groove310,iii) a distal distance adjustment element engagement surface334disposed between the abrading surface and the distal distance adjustment element at the angle α for slidable engagement with the second slidable engagement surface of the distal distance adjustment element and having a second stop337extending from the second surface for slidable reception within second groove318.

Typically, the elongate members, distance adjustment elements and mounting members can be made out of any material commonly used in instruments used spinal fusion operations, including hardened stainless steel alloys, such as Custom 455 Stainless, available from Carpenter Specialty Alloys of Wyomissing, Pa. Each of these components should be sterilizable. The abrading surfaces can be made from metals such as stainless steel (preferably for rotary devices) or conventional abrasives composites (preferably for rotary devices or vibratory devices).

As noted above, the tension on ligaments produced by the extension of the opposing vertebrae is often an important factor in interbody devices. However, present methods for determining this tension appear to be limited to merely inserting an instrument between the opposing bodies and manually appreciating the feeling of tightness. There appears to be no objective measure for measuring tension.

Because the height of the device of the present invention is changeable in situ, and the device may also be used to measure the tension produced in the ligaments surrounding disc space when the height is so increased.

Therefore, in accordance with the present invention, there is provided a method of measuring a tension in a disc space, comprising the steps of:a) removing at least a portion of an intervertebral disc to create a disc space having an endplate,b) inserting into the disc space a device comprising a first abrading element so that the first abrading element faces but does not contact the endplate,c) contacting the first abrading surface with the endplate, andd) measuring a force required to maintain the contact between the abrading surface and the endplate.