The present invention is directed to an intervertebral implant, its accompanying instrumentation and their method of use. More particularly, the present invention is directed to an intervertebral implant and instrumentation for use in a transforaminal posterior lumbar interbody fusion procedure.
A number of medical conditions such as compression of spinal cord nerve roots, degenerative disc disease, herniated nucleus pulposis, spinal stenosis and spondylolisthesis can cause severe low back pain. Intervertebral fusion is a surgical method of alleviating low back pain. In posterior lumbar interbody fusion (“PLIF”), two adjacent vertebral bodies are fused together by removing the affected disc and inserting one or more implants that would allow for bone to grow between the two vertebral bodies to bridge the gap left by the disc removal.
One variation of the traditional PLIF technique is the transforaminal posterior lumbar interbody fusion (T-PLIF) technique. Pursuant to this procedure, an implant is inserted into the affected disc space via a unilateral (or sometimes bilateral), posterior approach, offset from the midline of the spine, by removing the facet joint of the vertebrae. The T-PLIF approach avoids damage to nerve structures such as the dura and the nerve root, but the resulting transforaminal window available to remove the affected disc, prepare the vertebral endplates, and insert the implant is limited laterally.
A number of different implants typically used for the traditional PLIF procedure have been used for the T-PLIF procedure, with varying success. These include threaded titanium cages, allograft wedges, rings, etc. However, as these devices were not designed specifically for the T-PLIF procedure, they are not shaped to be easily insertable into the affected disc space through the narrow transforaminal window, and may require additional retraction of nerve roots. Such retraction can cause temporary or permanent nerve damage. In addition, some of these implants, such as the threaded titanium cage, suffer from the disadvantage of requiring drilling and tapping of the vertebral endplates for insertion. Further, the incidence of subsidence in long term use is not known for such cages. Finally, restoration of lordosis, i.e., the natural curvature of the lumbar spine is very difficult when a cylindrical titanium cage is used.
As the discussion above illustrates, there is a need for an improved implant and instrumentation for fusing vertebrae via the transforaminal lumbar interbody fusion procedure.
The present invention relates to an intervertebral implant (“T-PLIF implant”) and its use during a transforaminal lumbar interbody fusion procedure. In a preferred embodiment, the T-PLIF implant has an arcuate body with curved, substantially parallel posterior and anterior faces separated by two narrow implant ends, and superior and inferior faces having a plurality of undulating surfaces for contacting upper and lower vertebral endplates. The undulating surfaces may be projections, such as teeth, of a saw-tooth or pyramidal configuration, or ridges which penetrate the vertebral endplates and prevent slippage. The narrow implant ends may be rounded or substantially flat. The arcuate implant configuration facilitates insertion of the implant via a transforaminal window. The implant, which may be formed of allogenic bone, metal, or plastic, may also have at least one depression, such as a channel or groove, at a first end for engagement by an insertion tool, such as an implant holder. In a preferred aspect, the superior and inferior faces are convex, and the thickness of the implant tapers with its greatest thickness in the middle region between the narrow ends of the implant, i.e., at a section parallel to a sagittal plane, and decreasing toward each of the narrow ends.
In another preferred embodiment, the implant is formed of a plurality of interconnecting bodies assembled to form a single unit. In this configuration, the plurality of interconnecting bodies forming the T-PLIF implant may be press-fit together and may include at least one pin or screw extending through an opening in the plurality of bodies to hold the bodies together as a single unit. Adjacent surfaces of the plurality of bodies may also have mating interlocking surfaces that aid in holding the bodies together as a single unit.
In still another preferred embodiment, the present invention relates to a kit for implanting an intervertebral implant into an affected disc space of a patient via a transforaminal window. The kit includes an implant having an arcuate body with curved, substantially parallel posterior and anterior faces separated by two narrow implant ends, superior and inferior faces preferably having a plurality of undulating surfaces, such as projections or teeth, for contacting upper and lower vertebral endplates. The superior and inferior faces may define a thickness. Preferably the implant has at least one depression at a first end for engagement by an insertion tool. The kit may further include at least one trial-fit spacer for determining the appropriate size of the implant needed to fill the affected disc space, an insertion tool having an angled or curved neck for holding and properly positioning the implant during insertion through the transforaminal window, and an impactor having an angled or curved neck for properly positioning the implant within the affected disc space. The face of the impactor may be concavely shaped to mate with the narrow end of the T-PLIF implant during impaction. The kit may further include a lamina spreader for distracting vertebrae adjacent to the affected disc space, an osteotome for removing facets of the vertebrae adjacent to the affected disc space to create a transforaminal window, one or more curettes, angled and/or straight, for removing all disc material from the affected disc space, a bone rasp for preparing endplates of the vertebrae adjacent the affected disc space, and a graft implant tool for implanting bone graft material into the affected disc space. The kit may still further include a curved guide tool to guide the implant into the affected disc space.
In yet another aspect, a method for implanting an intervertebral implant into an affected disc space of a patient via a transforaminal window is described. The transforaminal window is created and bone graft material is inserted into the affected disc space. Using an insertion tool, an implant is inserted into the affected disc space via the transforaminal window, the implant having an arcuate body with curved, substantially parallel posterior and anterior faces separated by two narrow implant ends, superior and inferior faces having a plurality of undulating surfaces for contacting upper and lower vertebral endplates, and preferably at least one depression at a first end for engagement by the insertion tool. In the present method, the arcuate implant configuration facilitates insertion of the implant via the transforaminal window. The method may further comprise impacting the implant with an impactor tool to properly position the implant within the affected disc space. Either or both the insertion tool and the impactor tool may be angled to facilitate insertion, alignment, placement and/or proper seating of the implant.
An implant according to the present invention, referred to herein as a transforaminal posterior lumbar interbody fusion implant (“T-PLIF implant”), is designed for use as an intervertebral spacer in spinal fusion surgery, where an affected disk is removed from between two adjacent vertebrae and replaced with an implant that provides segmental stability and allows for bone to grow between the two vertebrae to bridge the gap created by disk removal. Specifically, the T-PLIF implant is designed for the transforaminal lumbar interbody fusion (T-PLIF) technique, which, as shown in
As shown in
As shown in
As shown in
As in the previous embodiment, the anterior and posterior faces 24, 26 are substantially parallel, and, as shown, may be defined by radii of curvature R1 and R2, where R1, for example, may be in the range of about 28 mm and R2, for example, may be in the range of about 19 mm. The superior and inferior surfaces 28, 30 are arcuate shaped and the implant has a thickness 31, which is preferably greatest at a center portion between narrow ends 25 and gradually tapers becoming thinnest at narrow ends 25. Tapering thickness 31 may be defined by a radius of curvature R3, where R3 for example, may be in the range of about 100 mm. As shown, the component pieces 46, 48 of implant 22 have holes 44 to accommodate pins or screws 42. Holes 44 are preferably drilled after component pieces 38 have been stacked one on top of the other. The multiple pieces 38 are then assembled with screws or pins 42 so that practitioners receive the implant 22 as a single, pre-fabricated unit. The upper component piece 46 has an arcuate superior surface preferably with teeth 32, while its bottom surface is configured with grooves and pallets to interlock with the upper surface of lower component piece 48. The arcuate inferior surface 30 of lower component piece 48 also preferably has teeth 32 for engaging the lower vertebral endplate of the affected disc space. Either or both superior and inferior surfaces 28, 30 may have ridges or some other similar form of engaging projection in place of teeth 32.
Reference is now made to
As shown in
After the discectomy is complete, the superficial layers of the entire cartilaginous endplates are removed with a combination of straight and angled bone rasps. As shown in
Upon identifying and removing the best fitting trial spacer, a T-PLIF implant of appropriate size is selected. At this time, prior to placement of the T-PLIF implant, bone graft material, such as autogenous cancellous bone or a bone substitute, should be placed in the anterior and lateral aspect of the affected disc space. As shown in
While certain preferred embodiments of the implant have been described and explained, it will be appreciated that numerous modifications and other embodiments may be devised by those skilled in the art. Therefore, it will be understood that the appended claims are intended to cover all such modifications and embodiments which come within the spirit and scope of the present invention.
The present application is a divisional of U.S. patent application Ser. No. 09/848,178, filed May 3, 2001, now U.S. Pat. No. 6,719,794, the contents of which is expressly incorporated herein by reference thereto.
Number | Name | Date | Kind |
---|---|---|---|
3875595 | Froning | Apr 1975 | A |
4349921 | Kuntz | Sep 1982 | A |
4535485 | Ashman et al. | Aug 1985 | A |
4636217 | Ogilvie et al. | Jan 1987 | A |
4743256 | Brantigan | May 1988 | A |
4772287 | Ray et al. | Sep 1988 | A |
4790297 | Luque | Dec 1988 | A |
4820305 | Harms et al. | Apr 1989 | A |
4834757 | Brantigan | May 1989 | A |
4878915 | Brantigan | Nov 1989 | A |
4917704 | Frey et al. | Apr 1990 | A |
4961740 | Ray et al. | Oct 1990 | A |
4969888 | Scholten et al. | Nov 1990 | A |
5026373 | Ray et al. | Jun 1991 | A |
5055104 | Ray | Oct 1991 | A |
5059193 | Kuslich | Oct 1991 | A |
5071437 | Steffee | Dec 1991 | A |
5123926 | Pisharodi | Jun 1992 | A |
5192327 | Brantigan | Mar 1993 | A |
5222987 | Jones | Jun 1993 | A |
5261913 | Marnay | Nov 1993 | A |
5282862 | Baker et al. | Feb 1994 | A |
5294391 | McMillin | Mar 1994 | A |
5306309 | Wagner et al. | Apr 1994 | A |
5336699 | Cooke et al. | Aug 1994 | A |
5395317 | Kambin | Mar 1995 | A |
5397364 | Kozak et al. | Mar 1995 | A |
5405402 | Dye et al. | Apr 1995 | A |
5407445 | Tautvydas et al. | Apr 1995 | A |
5423825 | Levine | Jun 1995 | A |
5425772 | Brantigan | Jun 1995 | A |
5429863 | McMillin | Jul 1995 | A |
5443514 | Steffee | Aug 1995 | A |
5458638 | Kuslich et al. | Oct 1995 | A |
5458642 | Beer et al. | Oct 1995 | A |
5474555 | Puno et al. | Dec 1995 | A |
5476880 | Cooke et al. | Dec 1995 | A |
5480442 | Bertagnoli | Jan 1996 | A |
5489307 | Kuslich et al. | Feb 1996 | A |
5489308 | Kuslich et al. | Feb 1996 | A |
5514180 | Heggeness et al. | May 1996 | A |
5522899 | Michelson | Jun 1996 | A |
5562736 | Ray et al. | Oct 1996 | A |
5571103 | Bailey | Nov 1996 | A |
5609635 | Michelson | Mar 1997 | A |
5609636 | Kohrs et al. | Mar 1997 | A |
5618286 | Brinker | Apr 1997 | A |
5645596 | Kim et al. | Jul 1997 | A |
5658335 | Allen | Aug 1997 | A |
5669909 | Zdeblick et al. | Sep 1997 | A |
5674295 | Ray et al. | Oct 1997 | A |
5676146 | Scarborough | Oct 1997 | A |
5683463 | Godefroy et al. | Nov 1997 | A |
5683464 | Wagner et al. | Nov 1997 | A |
5709685 | Dombrowski et al. | Jan 1998 | A |
5716415 | Steffee | Feb 1998 | A |
5741261 | Moskovitz et al. | Apr 1998 | A |
5755797 | Baumgartner | May 1998 | A |
5766252 | Henry et al. | Jun 1998 | A |
5782919 | Zdeblick et al. | Jul 1998 | A |
5820918 | Ronan et al. | Oct 1998 | A |
5824077 | Mayer | Oct 1998 | A |
5824094 | Serhan et al. | Oct 1998 | A |
5860973 | Michelson | Jan 1999 | A |
5865845 | Thalgott | Feb 1999 | A |
5865846 | Bryan et al. | Feb 1999 | A |
5868745 | Alleyne | Feb 1999 | A |
5876457 | Picha et al. | Mar 1999 | A |
5885300 | Tokuhashi et al. | Mar 1999 | A |
5888224 | Beckers et al. | Mar 1999 | A |
5888227 | Cottle | Mar 1999 | A |
5897593 | Kohrs et al. | Apr 1999 | A |
5904719 | Errico et al. | May 1999 | A |
5913896 | Boyle et al. | Jun 1999 | A |
5919235 | Husson et al. | Jul 1999 | A |
5954724 | Davidson | Sep 1999 | A |
5961554 | Janson et al. | Oct 1999 | A |
5984922 | McKay | Nov 1999 | A |
5989289 | Coates et al. | Nov 1999 | A |
6019793 | Perren et al. | Feb 2000 | A |
6025538 | Yaccarino, III | Feb 2000 | A |
6033438 | Bianchi et al. | Mar 2000 | A |
6039762 | McKay | Mar 2000 | A |
6042582 | Ray | Mar 2000 | A |
6059790 | Sand et al. | May 2000 | A |
6059829 | Schläpfer et al. | May 2000 | A |
6074423 | Lawson | Jun 2000 | A |
6080158 | Lin | Jun 2000 | A |
6086613 | Camino et al. | Jul 2000 | A |
6113602 | Sand | Sep 2000 | A |
6113638 | Williams et al. | Sep 2000 | A |
6136031 | Middleton | Oct 2000 | A |
6143032 | Schafer et al. | Nov 2000 | A |
6143033 | Paul et al. | Nov 2000 | A |
6156040 | Yonemura et al. | Dec 2000 | A |
6159211 | Boriani et al. | Dec 2000 | A |
6159212 | Schoedinger et al. | Dec 2000 | A |
6174311 | Branch et al. | Jan 2001 | B1 |
6200347 | Anderson et al. | Mar 2001 | B1 |
6241769 | Nicholson et al. | Jun 2001 | B1 |
6245108 | Biscup | Jun 2001 | B1 |
6261586 | McKay | Jul 2001 | B1 |
6296664 | Middleton | Oct 2001 | B1 |
6315797 | Middleton | Nov 2001 | B1 |
6342074 | Simpson | Jan 2002 | B1 |
6350283 | Michelson | Feb 2002 | B1 |
6371988 | Pafford et al. | Apr 2002 | B1 |
6387130 | Stone et al. | May 2002 | B1 |
6395035 | Bresina et al. | May 2002 | B2 |
6423095 | Van Hoeck et al. | Jul 2002 | B1 |
6432106 | Fraser | Aug 2002 | B1 |
6447544 | Michelson | Sep 2002 | B1 |
6454805 | Baccelli et al. | Sep 2002 | B1 |
6458159 | Thalgott | Oct 2002 | B1 |
6575899 | Foley et al. | Jun 2003 | B1 |
6830570 | Frey et al. | Dec 2004 | B1 |
20010008980 | Gresser et al. | Jul 2001 | A1 |
20010012966 | Studer et al. | Aug 2001 | A1 |
20010016774 | Bresina et al. | Aug 2001 | A1 |
20010016777 | Biscup | Aug 2001 | A1 |
20010031967 | Nicholson et al. | Oct 2001 | A1 |
20020004683 | Michelson | Jan 2002 | A1 |
20020013624 | Michelson | Jan 2002 | A1 |
20020019637 | Frey et al. | Feb 2002 | A1 |
20020022886 | Fuss et al. | Feb 2002 | A1 |
20020026243 | Lin | Feb 2002 | A1 |
20020055781 | Sazy | May 2002 | A1 |
20020065558 | Varga et al. | May 2002 | A1 |
20020065560 | Varga et al. | May 2002 | A1 |
20020077700 | Varga et al. | Jun 2002 | A1 |
20020082597 | Fraser | Jun 2002 | A1 |
20020087212 | James et al. | Jul 2002 | A1 |
20020091447 | Shimp et al. | Jul 2002 | A1 |
20020099376 | Michelson | Jul 2002 | A1 |
20020099444 | Boyd et al. | Jul 2002 | A1 |
20020107573 | Steinberg | Aug 2002 | A1 |
Number | Date | Country |
---|---|---|
0 307 241 | Mar 1989 | EP |
0 551 574 | Jul 1993 | EP |
0 599 419 | Dec 1993 | EP |
0 834 295 | Apr 1998 | EP |
0 916 323 | May 1999 | EP |
2 736 537 | Dec 1995 | FR |
2 724 312 | Mar 1996 | FR |
2 727 003 | May 1996 | FR |
2 727 004 | May 1996 | FR |
2 727 005 | May 1996 | FR |
2 736 538 | Jan 1997 | FR |
8010275 | Jan 1996 | JP |
8010276 | Jan 1996 | JP |
2001170092 | Jun 2001 | JP |
WO 8909035 | Oct 1989 | WO |
WO 9625086 | Aug 1996 | WO |
WO 9640014 | Dec 1996 | WO |
WO 9715248 | May 1997 | WO |
WO 9909914 | Mar 1999 | WO |
WO 9937255 | Jul 1999 | WO |
WO 0007527 | Feb 2000 | WO |
WO 0074608 | Dec 2000 | WO |
WO 0128469 | Apr 2001 | WO |
WO 0128469 | Apr 2001 | WO |
WO 0170144 | Sep 2001 | WO |
WO 0195838 | Dec 2001 | WO |
Number | Date | Country | |
---|---|---|---|
20040167538 A1 | Aug 2004 | US |
Number | Date | Country | |
---|---|---|---|
Parent | 09848178 | May 2001 | US |
Child | 10788015 | US |