WO2008112404A1

WO2008112404A1 - Deployable segmented tlif device

Info

Publication number: WO2008112404A1
Application number: PCT/US2008/054684
Authority: WO
Inventors: Thomas O. Viker
Original assignee: Zimmer Spine, Inc.
Priority date: 2007-03-08
Filing date: 2008-02-22
Publication date: 2008-09-18
Also published as: US20120004731A1; US8496667B2; US8021429B2; US20080221687A1; EP2129338A1

Abstract

A segmented intervertebral body fusion support (10) includes a plurality of segments (14, 16, 18), the segments including an initial segment (14), a final segment (16) and at least one intermediate segment (18) The intermediate segment (18) has a generally trapezoidal configuration and the initial and final segments include tapered side walls providing triangular gaps between adjacent segments A draw wire (74) is fixed to the first segment and passes through the remaining segments By pulling the draw wire relative to the segments, the segments are drawn together in a generally arcuate configuration The draw wire (74) includes an enlargement that passes through the final segment and engages a piuralsty of fingers (72) on the final segment which prevents the draw wire from retracting, maintaining the arcuate configuration The segmented device (10) can be inserted through a laparoscopic device (100) into the intervertebral space and can be subsequently drawn into the arcuate configuration to establish the desired intervertebral spacing.

Description

DEPLOYABLE SEGMENTED TLIF DEVICE

BACKGROUND OF THE INVENTION fOOOl] Intervertebral discs serve several functions A primary function of the intervertebral disc is to facilitate mobility of the spsne. In addition, the disc provides load bearing, load transferring, and shock absorption between vertebral discs The disc itself is formed of two major components, a gelatinous nucleus pulposus which is surrounded by an annulus fibrosis f0002] The intervertebral disc can be damaged in many ways Mechanical damage can be caused by herniation in which a portion of the nucleus projects through an opening or tear in the annulus Progressive degeneration can be caused by either genetic or biochemical problems In such situations, there may be a decrease in the internal nucleus volume resulting in a decrease m disc height preventing the disc from performing its designed functions

[0003] One way to relieve the symptoms of a ruptured or deteriorated disc is by surgical removaϊ of a portion or al! of the intervertebral disc Removal of the disc decreases disc height, which can cause a number of severe problems Therefore subsequent to removal of the disc, steps must be taken to restore the disc height, or separation, between the adjacent vertebrae Many attempts have been made to insert either mechanical devices or various poiymeπc materials that provide solid support between the vertebrae These devices have had varying degrees of success

[0004] One device that has been utilized to restore disc height is shown in

U S Patent No 6 387,130 The implant includes a C shaped curve and is placed anterior within the disc space This implant has several limitations including the use of a plurality of implants to form the curved implant, lack of a mechanism to keep the plurality of implants in plane during placement in the disc space, and lack of an instrument to effectively deliver the implant Additionally, a number of other implants are available that due to their predetermined C-shaped profile require a significant degree of manipulation during implantation into the disc space This manipulation may require a larger surgical access opening in the patient as well as an increased opening in the annulus of the disc

SUMMARY OF THE INVENTION

[0005j The present invention is premised on the realization that an insert formed from a plurality of generally trapezoidal segments can be inserted between adjacent vertebrae to maintain a desired disc space More particularly, the present invention utilizes a plurality of interconnected trapezoidal segments, which upon insertion into a disc space, can be drawn into a generally arcuate shape within the disc space to maintain disc height The trapezoidal segments are preferably hinged to each other In one embodiment, a continuous strip connects the segments and provides a plurality of interconnected hinges that organize the relationship between the trapezoidal segments allowing the segments to be drawn together and to not move out of plane when creating the finalized implant shape [00061 The segments have a flexible wire that runs from the first or leading segment to the final trailing segment, which can be pulled or moved relative to the trapezoidal segments to draw the segments together into a generally arcuate shape A locking mechanism is provided to prevent the trapezoidal segments from separating from each other, maintaining the generally arcuate shape [00071 The flexible wire preferably includes a breakaway section Force on the wire will first act to bend the insert into an arcuate shape and Sock it into position Additional force will cause the upstream portion of the wire to break away allowing it to be removed

[0008] The objects and advantages of the present invention will be further appreciated in light of the following detailed description and drawings in which

BRIEF DESCRiPTION OF THE DRAWING

[0009] FIG 1 is a perspective view of the present invention, lOOlO] FlG 2 is a cross sectional depiction of the implant shown in FIG 1 prior to deployment,

[OOllj FIG 3 is a cross sectional view of the implant shown in FIG 1 in a deployed position,

[0012] FIG 4 is a perspective view partially broken away of an apparatus used to apply the insert shown in FIG 1

10013] FIG 5 is a cross sectional view taken at lines 5-5 of FlG 4

[00143 FIG 6 is a cross sectional diagrammatic view showing the implantation of the device shown in FIG 1 ,

[0015] FIG 7 is a diagrammatic cross sectional view of the device shown in

FIG 1 in an implanted state -A-

DETAILEO DESCRIPTION

L0016] The present invention is an intervertebral support 10 that is designed to be implanted within the intervertebral space between adjacent vertebrae The support 10 includes a leading segment 14, a terminal segment 16 and a plurality of intermediate segments 18 In one embodiment, four intermediate segments are included In other embodiments, more or less intermediate segments can be utilized depending on factors such as patient anatomy or smpiant positioning The segments 14, 16 and 18 are connected together by a continuous connective portion 20 along the base of the segments 14, 16 and 18 that following implantation forms an anterior wall 21 of the implant (FIG 7)

[0017] The leading segment 14 includes a rounded leading end 22, radially mner side 24, radially outer side 26, and mirror image top 28 and bottom 30 sides The leading segment 14 can optionally be configured to have a tapered or wedge shaped leading end 22 to facilitate implantation The terms ' radially inward' , "radially outward", "top" and "bottom" reference the implanted support 10 Segment 14 further includes an internal side 34, which is tapered inwardly and includes a notch 32 Segment 14 is connected at a hinge 35 to the next intermediate segment 18

[0018] Each of the intermediate segments 18 are identical As shown the intermediate segments 18 include a radially inner εsde 36, a radially outer side 38, a top surface 40 and a bottom surface 42, and inner walls 44 and 46 Wail 46 connects to the next adjacent intermediate segment by a hinge 48 The inner walls 44 and 46 narrow as they extend from the outer side 38 towards the inner side 36 forming a generally trapezoidal cross section The inner wall 44 further includes a key 50, which is adapted to reside within the notch 32 of the leading segment 14 Inner wall 46 includes a notch 52, which is adapted to receive the key 50 of the next adjacent intermediate segment

[0019] The trailing segment 16 is connected to intermediate segment 18 by a hinge 53, and includes a trailing end 54, a radially inner side 56 and a radially outer side 58, as well as a top surface 60 and a bottom surface 62 The inner wail 64 of segment 16 is tapered inwardly from the outer side 58 towards the inner side 56

This inner wall 64 further includes a key 66 adapted to fit within a notch 52 of intermediate segment 18

[0020] AIi of the segments include a central channel 70 that extends from leading end 22 to trailing end 54 A plurality of inwardly biased fingers 72 surround the terminal end 73 of channel 70

[00211 Draw wire 74 extends through channel 70 and includes a distal knob 76, having a lock πng 80 positioned within a channel in knob 76 This prevents the knob 76 from moving through channel 70 Draw wire 74 extends to a proximal bead 82 and is swedged into a narrow end 84 Bead 82 further includes a larger end 86 A tensioning line 88 ss swedged to this larger end 86

[0022J Bead 82 includes a shoulder 89 between its narrow end 84 and larger diameter end 86 This shoulder 89 is designed to engage the proximal ends of fmgers 72 and prevent the draw wire 74 from retracting into channel 70

[0023] In order to enable the tensioning line to separate from bead 82, the draw wire 74 is swedged more tightly to bead 82 than is tensioning line 88

Preferably the draw wire 74 will be swedged on bead 82 with 90 pounds of force, whereas the tensioning line 88 will be swedged onto end 84 with only about 20-30 pounds of force Thus, increasing force applied to tensioning (me 88 will eventually cause it to separate from bead 82, leaving draw wire 74 in position within device 10 [0024| The support 10 is preferably made from any material that has been approved by the Food and Drug Administration for use sn spsnai applications One preferred material ss a polymeric material, such as polyether ether ketone (PEEK) Any material that has adequate strength and flexibility as well as compatibility for this intended application may be used

[0025] As shown more particularly in FIGS 5, 6 and 7, the support 10 is inserted into the intervertebral space through an opening created in the annulus of the intervertebral disk using an applicator 100 Applicator 100 includes a rectangular barrel 102 fixed to a handle member 104 Applicator 100 further includes a rod 106 having a plunger 108 at one end and a knob 1 10 at the opposite end Rod 106 can be advanced down the barrel 102 by pressing trigger 111 of handle 1 12 The tensioning line 88 extends through the barrel 102, around a tensioning spool 114 to maintain the desired tension on draw wire 74 A sufficient length of line 88 is on spool 1 14 to allow the support 10 to be inserted into the intervertebral space The end of line 88 (not shown) ss fixed to the spool 114 Tensioning spool 1 14 either has a preset resistance to inhibit rotation, or a screw type mechanism 122 to tighten spool 1 14 A tensioning spring can also be employed

[0026] As shown in FIG 5, the barrel 102 further includes inner ridges 116

The upper and lower walls of the segments 14, 16 and 18 include channels 1 18 and 120, which are adapted to ride on ridges 1 16 in barrel 102 maintaining the support in a Smear position while in barrel 102

[0027] To insert the support 10 of the present invention, the intervertebral space in the cervical, thoracic, or lumbar region of the spine is accessed by way of an incision through the patient's tissue that leads to the vertebral column Preferably, the vertebral column is accessed from a transforaminal approach S] '.

Alternatively, the vertebral column can be accessed through a lateral, anterior anterior-lateral, posterior or posterior-lateral approach. The vertebral space is surgically prepared as desired removing all or some of the nucleus or annulus fibrosis to provide any necessary spacing for the support 10 Proper incisions are performed to allow the support to pass to and through the annuSus fibrosis to the intervertebral space

[0028J Support 10 is then placed into the disc space It can be advanced using the handle 1 1 1 to move tab 128, rod 106 and plunger 108 through barrel 104 This moves support 10 out barrel 104 into the intervertebral space Alternateiy, rear knob 1 10 can be struck with a hammer or similar instrument to provide the necessary force to move the support 10 into the disc space Spring biased tab 124 prevents the rod 106 from moving in the opposite direction [0029 j As the support 10 is inserted into the space tension is applied in the direction of arrow 120, which causes the support 10 to rotate into a generally arcuate or arched position The radial continuity of the arch, as well as the degree of curvature can vary as desired Generally, the support 10 will assume a general curved shape The support 10 can be predisposed to have the general curved shape prior to loading into the applicator 100 Alternatively, the support 10 can be linear pπor to loading into the application 100 and the generally curved shape can be achieved through actuation of the applicator 100

[003Oj Once the support 10 is properly inserted, tensioning isne 88 is fixed and increased force is applied by plunger 108 against the rear surface 54 of the support 10 The applied force wiii exceed the force holding the tensioning line 88 to the rear portion of bead 82, separating the tensioning wire 88 from bead 82 and allowing the tensioning line 88 to be withdrawn [0031] More particularly, as the support 10 ss inserted into the disc space, the tension on line 88 will cause the adjacent segments to rotate about the hinges and close the gap 113 between the adjacent segments in one embodiment, the gap 1 13 has a generally triangular shape Alternatively, the gap can be of any shape to accommodate movement of the segments in a manner that creates a desired implantation shape of the implantation shape of the implant, such as an arcuate shaped implant (C-shaped or V-shaped) This will continue until the support transforms from a linear shape and assumes the configuration shown in F!G 3 As the support 10 changes to this final shape the enlarged portion of bead 82 will pass through channel 70 and through the fingers 72 The fingers 72 expand as the enlarged portion 86 of bead 82 passes through The fingers 72 then retract engaging the shoulder 89 between the narrow inner portion 84 of bead 82 and the larger end 86 (see FiG 3) This will prevent the wire 74 from moving in a direction opposite arrow 120 and permanently lock the support 10 in a generally arcuate position

[0032] The implanted support 10 provfdes needed support between adjacent vertebrae The interlocking notch and key configuration of the different segments prevents the adjacent segments from rotating relative to each other providing vertical stability

[0033] The present invention can be modified in a number of ways, as desired. In particular, the connection portion 20 can be removed, and the indivioual segments connected by a hinge pin mechanism so that the individual segments are formed separately but attached together prior to implantation Additionally, surfaces of the implant can be modified to have projections or teelh that provide friction between the implant and patient anatomy Further, the support can be formed from any material that is suitable for implantation and possesses the required strength [0034] This support structure of the present invention provides many different advantages It enables a support to be located into the intervertebral area utilizing a minimally invasive surgicai procedure This is particularly beneficial because of the limited space available in such a surgical procedure Further, forcing the device into the intervertebral space as tension is applied causes the structure to bend as it passes into the intervertebral space, again allowing a longer support device to be inserted into the space Further, the draw wire with the locking bead mechanism maintains this in a permanently arcuate condition Finally, the interlocking notch and key structure of the adjacent segments prevent relative rotation of the segments about their central axis

[00351 This has been a description of the present invention along with the preferred method of practicing the present invention However, the invention itself should only be defined by the appended claims WHEREIN I CLAIM

Claims

1 . A deployable segmented interbody fusion support comprising a plurality o! segments said segments including a first leading segment, a final trailing segment, and at least one intermediate segment, said support having a gap between said first segment and said intermediate segment and between said final segment and said intermediate segment, the support including a connection portion coupling the segments together, a draw member coupled to said first segment and extending through said intermediate segment and said final segment and effective to pull said segments together into a generally arcuate configuration, and a locking mechanism comprising an enlargement on said draw member and an aperture on said final segment for receiving the enlargement the enlargement and the aperture configured to maintain said segments in said generally arcuate position.

2. The device claimed in claim 1 wherein the connection portion comprises a plurality of hinges.

3. The device claimed in claim 1 wherein the gap between said first segment and said intermediate segment and between said final segment and said intermediate segment has a generally triangular shape

4 The device claimed in claim 1 wherein said locking mechanism comprises a plurality of flexible fmgers on said final segment and a bead on said draw member

5 The device ciairned in claim 4 wherein said draw member comprises a

6 The device claimed in claim 5 wherein said segments each include upper and lower surfaces said surfaces having a groove

7 The device claimed in claim 1 wherein said segments have sides adapted to engage adjacent sides of adjacent segments wherein a first side has a key portion and a second adjacent side has a notch portion

8 The device claimed in ciaim 1 wherein said segments are connected by hinges

9 The device claimed in claim 1 wherein said first segment has a leading first side and a second side, said second side facing a first side of said intermed ate segment wherein said second side is angled relative to said first side

10 The device claimed in claim 9 wherein said final segment has a first back side and a second lateral side facing a side of said intermediate segment wherein said second side is tapered

1 1 The device claimed in claim 1 having a plurality of intermediate segments

12 A depioyabte segmented intervertebral fusion support comprising a plurality of segments wherein said segments include a first segment, at least one intermediate segment and a final segment wherein said segments are hinged together along a back wall with a gap between the segments, a draw wire fixed to said first segment and extended through said at least one intermediate segment and said final segment, said final segment including a plurality of inwardly biased fingers and said draw wire including an enlargement wherein when said draw wire SS pulled in a first direction relative to said segments said draw wire draws said segments together to form a generally curved shape and wherein safd enlargement extends through said fingers and said fingers prevent said wire from moving in an opposite second direction

13. The device claimed in claim 12 wherein the gap between said first segment and said intermediate segment and between said final segment and said intermediate segment has a generally triangular shape

14. A method of applying an arcuate support having a plurality of segments into an intervertebral space, the method comprising moving said support through a surgical opening mto said space while applying a constant curling force on said insert forcing said insert to curl into a genera! arcuate position as sasd insert enters εa^d intervertebral space

15. The method claimed in claim 14 wherein said insert is iinear prior to passing through said surgica! opening.

16. The method claimed in claim 14 further comprtsing the step of maintaining a planar connection between the segments when applying the constant curling force the support

17. The method claimed in claim 16 further comprising the step of providing a key and notch relationship between segments to maintain the planar connection between segments.

18. The method claimed in claim 16 further comprising the step of providing a connection portion on the support to maintain the planar connection between segments

19 Apparatus for inserting a support having a draw wire through a foramen into a intervertebral space comprising a generally linear barrel adapted to receive said insert; a plunger effective to force said insert in a first direction; a tensioner acting in a second direction on said draw wire as said wire moves in said first direction.