POSTERIOR INTERVERTEBRAL DISC INSERTER AND EXPANSION TECHNIQUES

Abstract

Insertion and expansion devices for use in inserting motion discs, and associated methods of use.

Claims

1. A method of inserting a curvilinear motion disc having a first and second legs connected by a pivot, each leg having an endportion, the method comprising the steps of: a) providing the motion disc in a collapsed position, b) providing a motion disc inserter comprising a handle having a longitudinal axis and a first end having a first holder and a deployer, the deployer being axially moveable along the axis of the handle, c) attaching the first endportion of the motion disc to the first holder, d) contacting the second endportion of the motion disc to the deployer, e) arcuately inserting the motion disc into the disc space in the collapsed condition, and f) axially moving the deployer to move the second leg and to expand the motion disc into an open condition.

Description

DESCRIPTION OF THE FIGURES

[0027] FIG. 1 discloses inserting a first motion disc/inserter assembly into the disc space, wherein the motion disc is in a collapsed condition.

[0028] FIG. 2 discloses advancing the motion disc of FIG. 1 further into the disc space to rotate the motion disc.

[0029] FIG. 3 discloses the initial actuation of the deployer to expand the motion disc to a partially expanded condition.

[0030] FIG. 4 discloses the complete actuation of the deployer to expand the motion disc to a final expanded condition.

[0031] FIG. 5 discloses advancing a motion disc up a linear proximal portion of a second motion inserter, wherein the motion disc is in a collapsed condition.

[0032] FIG. 6 discloses further advancing the motion disc of FIG. 5 through a curved intermediate portion of the inserter to rotate the motion disc.

[0033] FIG. 7 discloses further advancing the motion disc of FIG. 6 through a curved distal portion of the inserter to insert the motion disc into the disc space.

[0034] FIG. 8 discloses the final placement of the motion disc of the FIG. 7 in the disc space.

[0035] FIG. 9 discloses advancing an H-type motion disc up a linear proximal portion of a second motion inserter, wherein the motion disc is in a collapsed condition.

[0036] FIG. 10 discloses further advancing the motion disc of FIG. 9 through a curved distal portion of the inserter to rotate the motion disc and insert the motion disc into the disc space.

[0037] FIG. 11 discloses the initial actuation of the motion disc of FIG. 10 to expand a first leg of the motion disc.

[0038] FIG. 12 discloses the final actuation of the motion disc of FIG. 11 to expand a second leg of the motion disc.

DETAILED DESCRIPTION

[0039] Now referring to FIGS. 1-4, there is provided a method of inserting a motion disc having a first and second legs connected by a pivot, each leg having an endportion, the method comprising the steps of:

[0040] a) providing the motion disc 1 in a collapsed position wherein the first 3 and second 5 leg endportions are close together,

[0041] b) providing a motion disc inserter 7 comprising a handle having a longitudinal axis and a first end 11 having first 13 and second holders, the deployer being axially moveable along the axis of the handle,

[0042] c) attaching the first endportion of the motion disc to the first holder,

[0043] d) attaching the second endportion of the motion disc to the deployer,

[0044] e) inserting the motion disc into the disc space in the collapsed condition, and

[0045] f) axially moving the deployer to move the second leg and to expand the motion disc into an open condition.

[0046] In particular, and now referring to FIG. 1, the motion disc inserter secures the proximal portion of the motion disc implant for insertion into the disc space by grasping the top and bottom aspects of the proximal portion of the intradiscal device. Now referring to FIG. 2, the implant is inserted into its desired location in the disc space.

[0047] Now referring to FIG. 3, with the implant in its desired location, the deployment component of the inserter is activated to expand or adjust the implant shape for improved vertebra body contact and balanced load transfer. In particular, the expansion component of the inserter is activated to move the deployer axially and thereby pivot one of the legs of the implant shape. This produces expansion of the implant, improved vertebra body contact and a more balanced load transfer. Means for the axial movement of the deployer (and thereby the second leg) include: a) a rod that is slideably movable within a tube, b) a threaded rod that is threadably movable within a threaded tube, and c) a notched rod that is capable of ratcheted actuation.

[0048] FIG. 4 shows the motion disc in its expanded condition after it has been expanded by activation of the inserter.

[0049] The extent to which the deployer can be axially moved can be monitored via depth markings. In some embodiments, the depth markings are placed on the deployer. In some embodiments, the depth markings are placed on the insertion handle.

[0050] Although the inserter/deployer is shown in FIGS. 1-4 as being utilized in a posterior approach, it can be also used for other angles of approach, including lateral, anterior, and postero/lateral approaches.

[0051] The implant used in conjunction with the first embodiment can be of varying shape and configurations. Typically, it has at least one pivoting leg. In some embodiments, it has a pair of pivoting legs. An X shaped implant is shown in FIG. 1-4. The X-shape can have multiple layers wherein inferior and superior layers are held or deployed individually or simultaneously. Other disc implant geometries can utilizes the inserter holder/deployer of the first embodiment to insert an implant and change the footprint via disclosed the deployment means. An example of an alternate geometry is a T-, Y- or H-shaped implant.

[0052] In some embodiments, the handle portion of the present invention comprises a tube within which the deployer is contained. In some embodiments, the first holder is fixedly attached to the distal end portion of the tube. In other embodiments, the handle portion of the present invention comprises a solid rod, and the holders are attached to the outer surface of the rod.

[0053] The insertion track of the second embodiment of the present invention is curvilinear and has a blade, semi-tubular or tubular construction, thereby allowing negotiation of bony or soft tissues without damaging those tissues. This track provides a fixed route for insertion and rotation of the motion disc. In some embodiments, it has a substantially linear proximal portion and a curved distal portion. In some embodiments, the linear proximal portion is tubular. In some embodiments, the curved distal portion can also be tubular. However, in other embodiments, the curved distal portion can comprise upper and lower rails that mate with the upper and lower aspects of the motion disc. The insertion track also allows insertion of the motion disc via a trajectory more comparable to that of the inner wall of the annulus fibrosus, as compared to line of site linear insertion techniques. This compatible trajectory has the advantage of intruding upon less of the annulus fibrosus during device insertion. In use, the track is inserted into the disc space prior to insertion of the motion disc. Doing so creates an annular shield around the implant so that the implant can be safely inserted into the disc space. The curved feature of the insertion track also creates a guide for turning the device during device placement. It may also provide a method of changing the device footprint by virtue of a guiding pusher for expansion of shape.

[0054] Now referring to FIG. 5, there is provided an insertion track 21 of the present invention following its insertion into the disc space along the annular inner wall.

[0055] Now referring to FIG. 6, a motion disc implant 23 is shown advancing along this insertion track to enter the disc space. Now referring to FIG. 7, the implant is advanced along the track until its final desired central placement is obtained. The placement depth can be limited by a positive stop(s) along the insertion track (proximal tip stop (not shown). The depth to which the implant is inserted into the disc space can be monitored via depth markings provided on the track and referencing off an adjacent vertebral body.

[0056] Several methods of advancing the device along the insertion track can be carried out in accordance with the present invention. These methods include using a pusher instrument that holds and pushes the proximal end of the implant to advance it distally along the track. Another possible method may use a puller comprising a cable wrapped around a pulley located at the distal tip of the track, wherein one free end of the cable is connected to the implant and the other free end extends out of the proximal tubular portion of the insertion track. In this case, providing a tensile or pull force on the cable moves the device distally along the track and into the disc space.

[0057] Various methods of deployment can be used to change the device footprint once the motion disc is placed within the disc space. In one embodiment, the method includes temporarily attaching interconnecting features that connect the insertion track to the implant, and withdrawing the insertion track from the disc space, thereby changing the footprint of the implant via the insertion track extraction forces. In a second embodiment, and now referring to FIG. 8, the method includes placing on the contra-lateral side of the disc space an instrument to create an advancement stop. Instrument 31 has a puller mechanism, activating the puller mechanism and pulling or pushing the motion disc into position In alternate embodiments, the contralateral puller or pusher mechanism may be actuated to change the footprint configuration of the motion disc.

[0058] In some embodiments, the insertion track can be directly connected to the implant, which provides the advantage of controlled trajectory and final position. In other embodiments, the insertion track can be connected to a holder/spacer that is attached to the implant and the insertion track, which provides the advantage of determining the angle of approach and entry for the puller/pusher mechanism.

[0059] The implant used in conjunction with the second embodiment can be of varying shape and configurations. Typically, it has at least one pivoting leg. In some embodiments, it has a pair of pivoting legs. An X-shaped implant is shown in FIGS. 5-8. The X-shape can have multiple layers, wherein various inferior and superior layers are held and/or deployed individually or simultaneously. Other disc implant geometries can exploit the insertion track to insert an implant and change the footprint via disclosed deployment means. In some embodiments, the alternate implant geometry comprises a T-, Y- or H-shaped implant.

[0060] FIGS. 9-12 disclose the insertion and actuation of an H-type motion disc using the insertion track inserter of the present invention. This motion disc has a central body 51 having first 53 and second 55 endportions, wherein a first leg 57 is pivotally attached to the first endportion at a first pivot, and wherein a second leg 61 is pivotally attached to the second endportion at a second pivot. Upon expansion, each of the legs of this device pivots to an orientation perpendicular to the longitudinal axis of the central body, and the device takes on an H shape.

[0061] Now referring to FIG. 9, an H-type motion disc in a collapsed condition is advanced up a linear portion of the insertion track inserter. Now referring to FIG. 10, the H-type motion disc is further advanced through a curved portion of the insertion track inserter to rotate the motion disc and insert the motion disc into the disc space. Now referring to FIG. 11, initial actuation of the motion disc causes the pivoting of first leg of the motion disc and initial expansion of the motion disc. Now referring to FIG. 12, final actuation of the motion disc causes pivoting of the second leg of the motion disc and complete expansion of the motion disc.

[0062] Irrespective of the embodiment selected, if desired, an optional guide 101 (shown in FIG. 8) can be utilized during insertion and deployment to assist the surgeon in any one of disc space distraction, implant positioning, implant expansion, and/or verifying implant placement. This guide is typically placed on a contralateral side of the disc space. When the guide is used as a distractor, it typically has a transverse cross-section having a height and a width, wherein the width is greater than the height. The distractor is inserted into the disc space contralaterally so that its height dimension bears against the endplates. Prior to insertion of the motion disc, the distractor is rotated 90 degrees so that its width dimension now bears against the endplates, thereby increasing the height of the disc space.

[0063] Irrespective of the embodiment selected, in some embodiments, the inserter/deployer (as shown in FIGS. 1-4) or the insertion track (as shown in FIGS. 5-8) is used in a freehand manner. However, in other embodiments, the inserter/insertion track further comprises a docking means to dock onto or reference off nearby stable landmarks such as a vertebral body edge or a pedicle screw. Docking off of these locations provides for enhanced surgical stability and control.

[0064] Irrespective of the embodiment selected, intraoperative imaging techniques (including fluoroscopy) can be used to assist in or verify placement and deployment of the inserter and/or motion disc. Although the primary surgical approach shown is posterior or posterior/lateral, other approaches can be utilized.

[0065] Although the inserter/deployer and insertion track inserters are shown as being utilized posteriorly, they can be also used for other angles of approach including lateral, anterior, and posterior/lateral approaches.