AU2003252848B2 - Device for distracting vertebrae and delivering a flowable material into a disc space - Google Patents

Description

P/00/011 Regulation 3.2

AUSTRALIA

Patents Act 1990 COMPLETE SPECIFICATION FOR A STANDARD PATENT

ORIGINAL

TO BE COMPLETED BY APPLICANT Name of Applicant: Actual Inventors: Address for Service: Invention Title: DEPUY ACROMED, INC.

Hassan Serhan and Michael Slivka CALLINAN LAWRIE, 711 High Street, Kew, Victoria 3101, Australia DEVICE FOR DISTRACTING VERTEBRAE AND DELIVERING A FLOWABLE MATERIAL INTO A DISC

SPACE

The following statement is a full description of this invention, including the best method of performing it known to us:- 07/10/03,eh13644.cov,1 la- DEVICE FOR DISTRACTING VERTEBRAE AND DELIVERING A FLOWABLE MATERIAL INTO A DISC SPACE FIELD OF THE INVENTION This invention relates generally to a device for intervertebral disc augmentation, more particularly to a device for distracting vertebral bodies and simultaneously injecting a flowable material into the disc space for augmentation after performing a discectomy or nucleotomy.

BACKGROUND OF THE INVENTION Spine fusion procedures represent the state of the art treatment for intervertebral disc problems, which generally involve open surgery and the use of interbody fusion cages and spinal fixation systems to stabilize the fusion site. An alternative treatment under evaluation is to replace the disc or nucleus pulposus with a prosthetic device. Examples of some devices currently under investigation include in-situ cured polymers such as polyurethanes and protein polymers, which may have properties varying from a rubbery hydrogel to a rigid plastic. Problems associated with these devices occur during insertion, whereby the pressure required to fill the disc space can cause leakage of the material into sensitive adjacent areas.

A number of devices are available for distracting vertebral bodies or for injecting material into the disc. Some devices are capable of both distraction and injection using the same instrument. These types of devices use a deflated balloon attached to a cannula and inserted between the vertebral bodies. The balloon is inflated with a prosthetic fluid through the cannula to distract the vertebral bodies. This requires high-pressure delivery of the fluid to achieve the pressure needed to distract the vertebral bodies and the balloon and fluid permanently remain in the disc space. Alternatively, a separate device is used 07/10/03,eh13644.spc,l J&J.PATENT LAW Fax:7325242808 Oct 6 2003 12:01 to inject the prosthetic fluid around the balloon and the balloon is used strictly for distraction after which it is deflated and removed. US patent 4,772,287 ("Ray discloses a bladder injected with thixotropic gel.

implanted between two vertebral bodies to restore the disc height. The technique described requires that the vertebral bodies are first distracted and a bore drilled to allow for insertion of the bladder.

US patent 5,562,736 ("Ray II) discloses a method for implanting a prosthetic disc nucleus. Ray II teaches cutting a first and second flap in the annulus, The flaps.

provide access to the nucleus. Ray II then teaches using an inflatable jack to distract the disc space prior to insertion of the prosthetic spinal disc nucleus. The jack has a deflated balloon on its end that is inserted into the nucleus through one of the flaps. The balloon is.inflated with fluid causing the vertebral bodies to distract; Once the vertebral bodies are sufficiently distracted the fluid flow is stopped and the prosthetic spinal disc nucleus is inserted through the other flap. The balloon is then deflated and the second prosthetic spinal disc nucleus is inserted. The flaps are closed and placed in contact with the annulus by.a suture, staple or glue.

U.S. Patent 6,187,048 Milner") discloses an implant for an intervertebral disc nucleus pulposus prosthesis made from a conformable, in-situ curable, material which is S resiliently deformable. Milner teaches removing the nucleus material, then either injecting through the annulus or creating. a opening in the annulus to deliver a curable material under pressure intolthe nucleus space. The pressure is necessary to ensure 2 conformation to the nucleus space and/or to increase the internal pressure of the disc space to distract the vertebral bodies. The amount of pressure needed to distract the disc space is high and may allow the material to flow through cracks or voids in the annulus into the disc space. Milner also describes an embodiment where the curable material is injected into a flexible contaiper that is inserted first into the nucleur space in a deflated state and inflated by the material as the material is injected. This method relies on the pressure of the fluid as it is injected to distract the vertebral bodies. Although this avoids 2 J&J PATENT LAW Fax:7325242808 Oct 6 2003 12:02 .0 P. 06 0.

the problem of the material leaking through the annulus, it imposes certain constraints such as a designing a cover of the correct shape.and size suitable.for safe injection of the curable material and prevention of leakage of the material from the cover once filled.

U.S Patent 6,248,131 ("Felt') describes distracting and injecting at the same time using a balloon device. The balloon can be used as a shell for containing the injected curable biomaterial and also used as a distraction means as the material is injected.

Another embodiment describes the.balloon as a cylinder shape which when inflated inside the disc space bears against the endplates for the vertebral bodies and distracts them. Then a second device is used to inject the curable biomaterial around the balloon cylinder. The material is allowed to cure and then the balloon is removed.-and a.second curable biomaterial can be injected into the space left where the balloon was. In sui, when Felt discloses injecting material outside of the balloon, Felt discloses using a second device to carry out the injection. Insertion of this second device into the disc s1 should typically require a second breach of the annulus fibrosis.

Therefore, in. general,'in some embodiments, the art describes free injection of material which may lead to uncontrolled leakage. The art also describes injection of the material into a deflated balloon, which requires leaving the balloon inside the disc space.

Lastly, the art describes some of the problems associated with some of these methods' include the need for a first instrument to distract the disc space and another to insert or inject the prosthetic fluid. Also, when two devices are used, two incisions in the annulus are required so that distraction and insertion can be accomplished. As noted above, some methods require insertion .under high pressure, thereby creating a potential for the prosthetic fluid to ooze or seep: out of the disc space intra-operatively.

SUMMARY OF THE INVENTION The present inventors have developed a device that can be used after performing a discectomy or nucleotomy to both distract the disc space and inject material into the disc space without subjecting the injected material to compressive forces. Because this device 3 Sprovides for the distraction of the vertebral bodies through a means separate from the Smeans for injecting the material, it not only provides a way of delivering a flowable Smaterial into the disc space under low pressure, but also allows for the material to cure in-situ without any compressive forces acting upon it. After injection, the device can be removed from the disc space, thereby substantially restoring the 00 nucleus to its original configuration and shape, as well as restoring natural spinal 00 alignment natural lordosis or kyphosis).

tIn Therefore, in accordance with the present invention, there is provided a device for CNi 10 distracting two adjacent vertebral bodies defining a disc space therebetween and delivering a flowable material into the disc space, comprising: a) a body comprising: i) a proximal portion, ii) a distal portion comprising a shape adapted to distract the disc space, wherein the shape adapted to distract has a width and a height, wherein the width is greater than the height, wherein the shape adapted to distract is adapted to distract upon insertion into the disc space and then rotation in the disc space, and wherein the shape adapted to distract has an upper bearing surface and a lower bearing surface, and wherein the upper and lower surfaces define a non-zero angle of between about 5 and about 15 degrees to provide lordosis when inserted posteriorly, and iii) a first longitudinal bore extending through the body and defining a first outlet in the distal portion opening onto the disc space, wherein the bore further defines an injection port in the proximal portion of the body, and b) an injection device filled with a flowable material selected from the group consisting of an in-situ curable liquid and a gel having a port attached to the injection port.

Also in accordance with the present invention, there is provided a method for distracting two vertebral bodies and delivering a flowable material into an intervertebral disc space having an outer annulus, comprising the steps of 12/06/0 7 13644 pgs4-64 a) providing a device for distracting and delivering a flowable material Scomprising, a body having a proximal portion and a distal portion, the distal Sportion having a shape adapted to distract, wherein the shape adapted to distract has a width and a height, wherein the width is greater than the height, wherein the shape adapted to distract is adapted to distract upon insertion into 00 0the disc space and then rotation in the disc space, wherein the shape adapted 00 0, to distract has an upper bearing surface and a lower bearing surface, and wherein the upper and lower surfaces define a non-zero angle of between about 5 and about 15 degrees to provide lordosis when inserted posteriorly, cN 10 and the body also having a longitudinal bore defining a first outlet port in the distal portion, and a first injection port in the proximal portion; b) inserting the distal portion of the device through the outer annulus; c) distracting the vertebral bodies by rotating the shape; and d) introducing the flowable material into the disc space through the injection port.

Also in accordance with the present invention, there is provided a kit for providing a nucleus pulposus replacement material, comprising: a) device for distracting two adjacent vertebral bodies defining a disc space therebetween and delivering a flowable material into the disc space comprising a body comprising: i) a proximal portion, ii) a distal portion comprising a shape adapted to distract the disc space, and wherein the shape adapted to distract has a width and a height, wherein the width is greater than the height, wherein the shape adapted to distract is adapted to distract upon insertion into the disc space and then rotation in the disc space, and wherein the shape adapted to distract has an upper bearing surface and a lower bearing surface, and wherein the upper and lower surfaces define a non-zero angle of between about 5 and about 15 degrees to provide lordosis when inserted posteriorly, and iii) a longitudinal bore extending through the body and defining a first outlet in the distal portion opening onto the disc space, and 12/06 1 0 7 ,rr 136 4 4 pgs4-6.5 b) a flowable material suitable for use as a nucleus pulposus replacement material, wherein the flowable material is selected from the group of consisting of an in-situ curable liquid and a gel.

BRIEF DESCRIPTION OF THE DRAWINGS These and other features of the invention will be understood from the description below, taken together with the Figures which show illustrative embodiments and several variations and details of construction thereof, wherein: FIG.1 shows a top view of the device of the present invention inserted into a disc space.

FIG.2 shows a top view of the device of FIG.l inserted into a disc space after rotating the device 90 degrees to distract the disc space.

FIG.3 shows a top view of an injection of a flowable material into the disc space by the device of FIG.1.

FIG.4 shows the withdrawal of the device from the disc space after injection of flowable material into the disc space.

FIG. 5 shows a distal portion of another embodiment of the device of the present invention having an opening at the distal end of the shape adapted for distraction.

DETAILED DESCRIPTION OF THE INVENTION 12/06/0 7 .rr 1364 4 pgs4-6.4 M PATENT LAW Fax:7325242808 J&J PAENT L~ Fax 732642808Oct 6 2003 12:03 .0 P. 09 0 *For the purposes of the present invention, the "proximal portion" of the body' Is that portion that penetrates the annulus fibrosis, while the "distal portion" of the body Is.

that portion that remains outside the annulus fibrosis.

S Th~Ie present invenltion provides a device far distracting (and preferably alignng two vertbral 'bodies and delivering a flowable material into the d6c space, after .a discectomy or. nucleotomy has been performed. The present invention simplifies and *combines the conventional 'separate methods of distracting two veartebral bodies and *delivering a flowable mateiil i nto the disc space formed after the removal oftbe nucleus in a way that allows for the distraction (and preferably spinal- alignment) and delivery to be pirforhed- bp a singledevice Under -low pressure. Now -referrg to FIGS. 1-2, in preferred embodiments of the invenmtion, there *is provided a device 10 for distracting two vertebral bodies and delivering a flowable is material into a disc space comprising: a) a body 30 comprising: a proximal portion ii) distal portion 32 comprising a shape 17 adapted to distract the disc space,-and iii) -a first. longitudinal bore 3 7 extending through the body and defin-Iig .a first outlot 34 in the distal portion opening onto the disc and a first iNectIon poit 4.

The device of Figures 1-2 further comprises a radially extending flange. or disposed at the distal rklost section of the proximial portion of the body.

The shape~ 17 adapted to distract has a width W is sufficiently large so that, upon, rotation, it cani sufficiently distract the disc space.

J&J PATENT LAW Fax:7325242808 Oct 6 2003 12:04 Thie device* of Figures 1-2 further comprises a second longitudinal, bore 57 extending through the body and defining a second outlet 54 in the distal portion opening onto the disc* and a second injection port The devices of Flgurps 1-2 lrber comprises first and second tubes 61 and'63, each tube having a proximal open and 42, 43 and a dista open end. In this Figure, each tube runs parallel to telongitudinal axis of the body -and enters their respective Injection ports 44,45 of the proximal portion of the body, and temi~nates'within'the body.

at their respective outlets 34*35. The lz)Jeion ports accomnmodate insertion of the tubes io1 such that when flowable material is Injected into the proximal open iends of the tubes, it exits through the distal -end 6f the tube and flows into the disc saethrough the rjrst outlet on the distal portion, of the body.

*The dei~ce of the present invention is typically used immediately afer a is discectomy or a nucleotomy. In performing the disceotomy or a nucleotomy, the sfrgeo typically makes a small(. 5mm) hole in the annulus fibrosis through which the nucleus pulposuis removed.

In -one preferred method of this invention, the surgeon preferably makes a device entry hole In the. annulus fibrosls. The device entry hole is typically made by either i) making a second hole in the: annulus :fibrosis larger than the hole through' which t he -nucleotomy is performed,'or H1) enlargenmng the hole through Which the nucleotomy is perforrmed, Next, the surgeon advances the distal end of the device through an incision in !he annulus In a first orientation 0s shown in FIG. 1 until stopped by the stop. Next, now referring to FIG. 2, the surteoh rotates the device 9bT (as shown by the curved arrow) to a second'orientation' whereby the desired distraction of the vertebral bodies 'is achieved. Now referring to FIG. 3, with a syringe -1 Q attached to injection port 43 by its.

30 port 103, the surgeon then delivers through the Injection port 44 a flowable material that -passes *through the body and exits out the outlet port 35 inothe disc space. The surgeon JU PATENT LAW Fax:7325242808 J&J PTENTLA~ ax: 32522808Oct 6 2003 12:04 P1 P. 11

S

allows the material to begin to cure within the disc space to a point wherethe at least pairtially cured material can withstand the compresaive ibroes of the spine *ithout leaking into the spinal canal. At -this time, and now refering to FIG. 4, the suirgeonM then removes the device from the patient.

In some embodiments, the distraction and injection.=r carried cut a's described above, and then a specified time period Is elapsed bofore the device is withdrawn.. Tbis pause allows the injected material, to partially cure. The partially cured material is *advantageo= because it is less susceptible to leak from the 'annulus fibrdsls -during 10 withdrawl of the device.

in some embodiments, the withdrawl of the device is a gradual withdraw, whereini flowable material is slowly injected into the void distal of the distal port cr~eated. by the withdraw]. ThiS gradual with raw/injection procedure is adyantageous; because it allows is the surgeon to BUl the entire disc apace with flowable material. In these embodiments, It is advantageous to use a devicei in which the outlets are. as distal as possible 1 order. t allow the surgeon to continue 1filling up to the point of withdrawL.

In one prefered use;: a first substantially horizontal incision is. made In the 2o 2 nuls the device is inserte4 itthdscspace and rotated, the flowable material is injected into the disc space, a substantially vertical incision Prefefably orthogonal to and bisecting the first horizontal iiicision) is made in the annulus, and the device, In Its rotated *orientation Is withdrawn through the substantially vertical Incision.

Tlhe body of the device of the present invention may have any shape that accommrodates a distal portion shaped for distracting and injecting.

In another embodimenit of thi -present invention, the device i ntpgraI. Inp p referred embodiirient thereof, the body component of the device is- hollow -and forms.: the longitudinal bore,'is substantialily'cylindrically-shaped, and has an injection port P. 12 J&J PATENT LAW Fax:7325242808 Oct 6 2003 12:05 within proximal portion for injecting a flowable material and an outlet port within its distal portion from which the flowable material exits into the disc space.

More preferably, the body has a length L and a radius R, wherein the length L is at least ten-times the radius R. In these embodimnents, the long length of the body allows the surgeon to easily insert the distal portion of the body into the disc space while keeping the proximal end thereof outside the body. Thus, these embodiments are particularly useful in minimally invasive surgeries requiring access through very small icisions.

The device may further comprise a stop mechanisin 50-disposed at the distal end of the proximal portion for preventing the body of the device from entering too far into .the disc. space. The stop mechanism may include a flange extending radially from the body. This stop mechanism allows the surgeon to place the distal portion accurately prior Is to injecting the flowable material.

The distal portion of the body includes the shape that. is adapted to distract the adjacent vertebral bodies and restore spinal alignment.

26 In some embodimento, the shape adapted to distract is adapted to distract upon insertion into the disc space. Preferably, this shape includes a tapered portion having a Smaximum height substantiall equal to the desired distraction height and a distally decreasing height that. allows for easier insertion between the vertebral bodies. Once inserted, the device can be advanced until the desired amount of distraction is reached.

In some preferred embodiments, the body has a cylindrical proximal portion, and the distal portion has a symmetric taper (preferably, a bullet).

i.

i j.' .i In another embodiment, the shape adapted to distract is a spreader. In some Sspreader embodiments, the body has a rectangular cross-section, preferably with rounded.

outer edges. The distal porilon has a height less than the disc space and a width about equal to that of a distracted disc space. In use, the distal portion can be inserted between I RJ PATENT LAW Fax:7325242808 J&J PTENTLA~ ax: 32522808Oct 6 2003 12:05 P1 P. 13 th~e vertebral bodies so that the lesser height dimension spans a portion ot the. disc s pace, and then rotated 90 degregs so that the bearing surfaces'71,72 on eithe side of the Oreter width dimension bear .against the opposing endplites and distract the disc spaceto accomplish the necessaly amo unt of distraction.

In* some embodiments, the distal portion may be removable from the body. In these embodiments the surgeon leaves the distal, portion in the disc space as a spacer and iects a. flowable majtial (like bone cement) around and through the distal portion to asece Its position within the disc Space.

In.0 some emi bodiments, the shape adapted to distract has at least one bearing surface havitng a. covex shape adapted to match the contour of the vertebral endplate.

sIn some embodlients, the shape adapted to distract has a leading edge that is curved to prevent fractureof the endplate.

*.in some ebdiments, the. distractor Is shaped to provide an aniterior-posteffor anigle to the distracted disc space. in these embodi ments,:the shape adapted to distract has io an upper bearing surf~ce and a lower- beating surface, wherein the Upper and lower surfaces define a non-zero angle. In some embodiments, the distal portion of the shape is greater than the proximal porion, and produces a non-zero angle of between about 5 and about 15 degrees. This angio prorvides lordois when inserted posteriorly, and kyphsis -when inserted anteriorly. In!I some embodiments, the proximal 'portion of the shape* Is' -greater than the distal potlin and produces a nonzero angle of between about, -5 and about -15 degrees. 'this angle provides Icyphosis when inserted posteriorly and lordoois 'when -inserted, anteriorly.

Now referring to FIG: 5, in some embodiments, the distal portion has'an upper-fin 30 81 extending therefrom, the fin comprising an upper bearing surface 91 having a convex shape, More proferably, the distal portion also has a lower fin 82 extending therefrom, the M& PATENT LAW Fax:7325242808 Oct 6 2003 12:06 P.14 lower fin tomprising lower bearing surface 92 which also has a convex shape, therby producing a football shaped distal portion. This embodiment is uteful when the device is inserted lateirally, as the convexity corresponds to the natural contour of the opposing entdplates.

S

in other emibodinments, the leading and trailing edges of the fns of FIG. 5 are tapered to facillate insertionl and removal from the disc space.

i some embodin qts the shape adpated to distract is a balloon used purely for distraction purposes fluid is Injected into the disc apace through an openig not associated with the balloon>. -it preerre eMbodimcnt thereof, the body comprises: a) an Inflatable balloon having an injection, port,.

b) a first throughboref having a distal portion in fluid connmctio with the balloon injection port, and.

c) 4 second throughbor having a distal portion Opening into. the disc space.

In preferred uses thereof, the surgeon inserts the ditlportion of-the body into the, disc, space, passes. a first fluid ihrough the Enrt. tliroughboie to inflate the. balloon and thereby distract the disc space, and passes a second fluid througb the second throughbore so that the second fluid enters. the distracted disc spice under low pressure.

Int some embodimnents, the. shape adapted to distract includes upper and lowe* jaws mounted on a pivot. In Wse, the shape adapted to distract enters the disc space in a' closed position. Then, the surgeon activates the -device so that the upper and lower jawvs 25 separate from each other to ui open position. The outer surfaces of each jaw press agairpt the op~osing endplates to provide the desired distraction.

The injection port. Includes an opening located along the proximal portion of the.

:.surface'of the body. The flbwable -material can be'injected tl~rough this port Into the body. There may be more than one Injection port located along the proximal portion of the body. Ihe port can include a connection means to an injection device. The matdrijkl J&J PATENT LAW~ Fax:7325242808 Oct 6 2003 12:07 *can be injected into the Port through any means- including, syringe and a Pump.

Preferbly, the Injection means Is asyringe. In some eimbodiments, the injcction moans comprises two syringes.

s The outlet port includes an opening located on the distal portion. of the sirface'of the body. It allows the flow~able material to exit'the body and enter into the disc space.

in some embodiments, there may be more than one outlet port on the.distal portion. The outlet port may be located at the distal end of the body or anywhere along the disial portion of the body, ~In some embodiments, as in FIG. 1, the device comprises two distal outlet ports.

l rferibly, -each outlet port 'opens onto the disc space thirough a non-bearing surface of the distal portion of the devipe. This allows the surgeon to fill each side of the disc apace.

when the distractor Is in place.

Generally, the more distally disposed the outlet port, the longer the surgeon can continue filling the disc sac as the districtor is withdrawn from the disc space. In some embodiments, the device comprises a outlet port opening onto the disc space fom the distal half of the distractor; component, preferably the distal most quarter of the disc 2o space. Now referring to FIG. 5, the device comprises a outlet port 20 'opening onto the disc space 'from the distal exid of the distractor component. This embodiment allows the surgeon to continue filling hedisc space until the distractor. component Is essentially removed from the disc .spaC1:.. The device of FIG. 5 fturtLhr comprises a outlet port 24 opening onto the disc spac from a non-bearing surface 22 within the distal end of the *2s distractor component. A se~dnd. outlet port (not shown)'may be provided opposite. of outlet port 24.

The -device may be -made of materials typically selected -for uso in. surgSical.

instruments. Preferably, the ntire device is serile..

12 SWhen placed in-situ (and in some instances, after curing), the flowable Smaterial preferably replaces as least a portion of the natural function of the nucleus Sfibrosis. Accordingly, in preferred embodiments, the flowable material is a nucleus pulposus replacement. The flowable materials are preferably selected from the group conistsing of liquids, gels (such as hydrogels, such as PVA-based hydrogels), and 00 solid materials that are sufficiently morselized to flow under pressure. Typically, the 00 Sliquid flowable material cures in-situ. The flowable material may cure in-situ to C create a stiff material (such as polyurethane), or a relatively pliant material (such as silicone).

C The present invention relates to a surgical device for distracting two vertebral bodies and delivering a flowable material into the disc space. The invention being thus disclosed and illustrative embodiments depicted herein, further variations and modifications of the invention, will occur to those skilled in the art, and all such variations and modifications are considered to be within the scope of the invention, as defined by the claims appended hereto and equivalents thereof.

Throughout this specification and the claims which follow, unless the context requires otherwise, the word "comprise", and variations such as "comprises" and "comprising", will be understood to imply the inclusion ofa stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps.

The reference to any prior art in this specification is not, and should not be taken as, an acknowledgment or any form or suggestion that the prior art forms part of the common general knowledge in Australia.

12/06/07.rr 13644pg 1313

Claims (17)

1. A device for distracting two adjacent vertebral bodies defining a disc space C therebetween and delivering a flowable material into the disc space, comprising: a) a body comprising: 00 i) a proximal portion, 00 ii) a distal portion comprising a shape adapted to distract the disc space, (N In wherein the shape adapted to distract has a width and a height, wherein the Swidth is greater than the height, wherein the shape adapted to distract is adapted to distract upon insertion into the disc space and then rotation in the disc space, and wherein the shape adapted to distract has an upper bearing surface and a lower bearing surface, and wherein the upper and lower surfaces define a non-zero angle of between about 5 and about 15 degrees to provide lordosis when inserted posteriorly, and iii) a first longitudinal bore extending through the body and defining a first outlet in the distal portion opening onto the disc space, wherein the bore further defines an injection port in the proximal portion of the body, and b) an injection device filled with a flowable material selected from the group consisting of an in-situ curable liquid and a gel having a port attached to the injection port.

2. The device of claim 1 wherein the injection device is a syringe.

3. The device of claim 1 wherein the shape adapted to distract is removable.

4. The device of claim 1 further comprising a stop means extending radially from a longitudinal axis of the proximal portion of the body.

The device of claim 1 wherein the shape adapted to distract has a convex upper bearing surface. 12/06/07.r 13644.claims. 14

6. The device of claim 5 wherein the shape adapted to distract has a convex lower bearing surface.

7. The device of claim 1 further comprising: c) a tube having an open distal end adapted for insertion in the injection port.

8. The device of claim 1 wherein the body further comprises: iv) a second longitudinal bore extending through the body and defining a second outlet in the distal portion opening onto the disc space.

9. The device of claim 1 wherein the first outlet opening onto the disc space is located within a distal half of the shape adapted to distract.

The device of claim 1 wherein the first outlet opening onto the disc space is located within a distal quarter of the shape adapted to distract.

11. The device of claim 1 wherein the first outlet opening onto the disc space is located at the distal end of the shape adapted to distract.

12. A method for distracting two vertebral bodies and delivering a flowable material into an intervertebral disc space having an outer annulus, comprising the steps of a) providing a device for distracting and delivering a flowable material comprising, a body having a proximal portion and a distal portion, the distal portion having a shape adapted to distract, wherein the shape adapted to distract has a width and a height, wherein the width is greater than the height, wherein the shape adapted to distract is adapted to distract upon insertion into the disc space and then rotation in the disc space, wherein the shape adapted to distract has an upper bearing surface and a lower bearing surface, and wherein the upper and lower surfaces detine a non-zero angle of between about 5 and about 15 degrees to provide lordosis when inserted posteriorly, and the body also having a longitudinal bore defining a first outlet port in the distal portion, and a first injection port in the proximal portion; 12/0610 7 ,r 13644claims. b) inserting the distal portion of the device through the outer annulus; c distracting the vertebral bodies by rotating the shape; and d) introducing the flowable material into the disc space through the injection port. 00

13. The method of claim 12 further comprising the step of: 00 C e) removing the device after step d). tIn

14. The method of claim 12 wherein the step of inserting is accomplished C1 10 through a single incision in the outer annulus.

A kit for providing a nucleus pulposus replacement material, comprising: a) device for distracting two adjacent vertebral bodies defining a disc space therebetween and delivering a flowable material into the disc space comprising a body comprising: i) a proximal portion, ii) a distal portion comprising a shape adapted to distract the disc space, and wherein the shape adapted to distract has a width and a height, wherein the width is greater than the height, wherein the shape adapted to distract is adapted to distract upon insertion into the disc space and then rotation in the disc space, and wherein the shape adapted to distract has an upper bearing surface and a lower bearing surface, and wherein the upper and lower surfaces define a non-zero angle of between about 5 and about 15 degrees to provide lordosis when inserted posteriorly, and iii) a longitudinal bore extending through the body and defining a first outlet in the distal portion opening onto the disc space, and b) a flowable material suitable for use as a nucleus pulposus replacement material, wherein the flowable material is selected from the group of consisting of an in-situ curable liquid and a gel. 1 2/06/07.rT 13644.claims, 16

16. A device or method for distracting two adjacent vertebral bodies and delivering a flowable material into an intervertebral disc space substantially as hereinbefore described with reference to the accompanying drawings.

17. A kit for providing a nucleus pulposus replacement material, substantially as hereinbefore described with reference to the accompanying drawings. 12/06/07.rr136 4 4 claims.l17