US20080046090A1 - Intervertebral allograft spacer - Google Patents

Abstract

An allogenic intervertebral implant for fusing vertebrae is disclosed. The implant is a piece of allogenic bone conforming in size and shape with a portion of an end plate of a vertebra. The implant has a wedge-shaped profile to restore disc height and the natural curvature of the spine. The top and bottom surfaces of the implant have a plurality of teeth to resist expulsion and provide initial stability. The implant according to the present invention provides initial stability need for fusion without stress shielding.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application is a continuation of U.S. patent application Ser. No. 11/150,608, filed Jun. 10, 2005, which is a continuation of U.S. patent application Ser. No. 09/828,625, filed Apr. 9, 2001 (now U.S. Pat. No. 6,986,788), which is a continuation of U.S. patent application Ser. No. 09/363,844, filed Jul. 30, 1999 (now U.S. Pat. No. 6,258,125, and reissued as U.S. Reissue Pat. No. RE38,614), which is a continuation-in-part of U.S. patent application Ser. No. 09/219,439, filed Dec. 23, 1998 (now U.S. Pat. No. 6,143,033), which claims priority to U.S. Provisional Application No. 60/095,425, filed Aug. 5, 1998, U.S. Provisional Application No. 60/095,209, filed Aug. 3, 1998, and U.S. Provisional Application No. 60/073,271, filed Jan. 30, 1998, the contents of all of which are expressly incorporated by reference herein.
FIELD OF THE INVENTION
• The present invention is directed to an allogenic implant and, more particularly, to an allogenic intervertebral implant.
BACKGROUND OF THE INVENTION
• A number of medical conditions such as compression of spinal cord nerve roots, degenerative disc disease, 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 an implant that would allow for bone to grow between the two vertebral bodies to bridge the gap left by the disc removal.
• A number of different implants and implant materials have been used in PLIF with varying success. Current implants used for PLIF include threaded titanium cages and allografts. Threaded titanium cages suffer from the disadvantage of requiring drilling and tapping of the vertebral end plates for insertion. In addition, the incidence of subsidence in long term use is not known. Due to MRI incompatibility of titanium, determining fusion is problematic. Finally, restoration of lordosis, i.e., the natural curvature of the lumbar spine is very difficult when a cylindrical titanium cage is used.
• Allografts are sections of bone taken from a long bone of a donor. A cross section of the bone is taken and processed using known techniques to preserve the allograft until implantation and reduce the risk of an adverse immunological response when implanted. For example, U.S. Pat. No. 4,678,470 discloses a method for processing a bone grafting material which uses glutaraldehyde tanning to produce a non-antigenic, biocompatible material. Allografts have mechanical properties which are similar to the mechanical properties of vertebrae even after processing. This prevents stress shielding that occurs with metallic implants. They are also MRI compatible so that fusion can be more accurately ascertained and promote the formation of bone, i.e., osteoconductive. Although the osteoconductive nature of the allograft provides a biological interlocking between the allograft and the vertebrae for long term mechanical strength, initial and short term mechanical strength of the interface between the allograft and the vertebrae are lacking as evidenced by the possibility of the allograft being expelled after implantation.
• Currently commercially available allografts are simply sections of bone not specifically designed for use in PLIF. As a result, the fusion of the vertebral bodies does not occur in optimal anatomical position. A surgeon may do some minimal intraoperative shaping and sizing to customize the allograft for the patient's spinal anatomy. However, significant shaping and sizing of the allograft is not possible due to the nature of the allograft. Even if extensive shaping and sizing were possible, a surgeon's ability to manually shape and size the allograft to the desired dimensions is severely limited.
• Most PLIF implants, whether threaded cages or allograft, are available in different sizes and have widths that vary with the implant height. For example, the width of a cylindrical cages will be substantially equivalent to the height. Although larger heights may be clinically indicated, wider implants are generally not desirable since increased width requires removal of more of the facet, which can lead to decreases stability, and more retraction of nerve roots, which can lead to temporary or permanent nerve damage.
• As the discussion above illustrates, there is a need for an improved implant for fusing vertebrae.
SUMMARY OF THE INVENTION
• The present invention relates to an allogenic intervertebral implant for use when surgical fusion of vertebral bodies is indicated. The implant comprises a piece of allogenic bone conforming in size and shape with a portion of an end plates of the vertebrae and has a wedge-shaped profile with a plurality of teeth located on top and bottom surfaces. The top and bottom surfaces can be flat planar surfaces or curved surfaces to mimic the topography of the end plates. The implant has a channel on at least one side for receiving a surgical tool. This channel runs in the anterior direction to accommodate a variety of surgical approaches. A threaded hole on the anterior, posterior, posterior-lateral, or lateral side can be provided for receiving a threaded arm of an insertion tool.
• In another embodiment, the implant has an interior space for receiving an osteoconductive material to promote the formation of new bone.
• In another embodiment, the implant is made of a plurality of interconnecting sections with mating sections. Preferably, the implant is made in two halves: a top portion having a top connecting surface and a bottom portion having a bottom connecting surface. The top connecting surface mates with the bottom connecting surface when the top and bottom portions are joined. The top and bottom portions have holes that align for receiving a pin to secure the top and bottom portions together. The pin can be made of allogenic bone.
• In a different embodiment, the medial side of the implant has a scalloped edge such that when a first implant is implanted with a second implant with the medial sides facing each other, the scalloped edges define a cylindrical space.
• The present invention also relates to a discrete spacer used in conjunction with any of the other embodiments of the implant. The spacer comprises a piece of allogenic bone conforming in size and shape with a portion of an end plates of the vertebrae and has a wedge-shaped profile with substantially smooth top and bottom surfaces. The intersecting regions between the top and bottom surfaces and at least one of the lateral sides and the intersecting regions between the anterior and posterior sides and the same lateral side are curved surfaces to facilitate implantation of the spacer. Thus, the spacer can be implanted through an opening on one side of the spinal canal and moved with a surgical instrument to the contralateral side.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a top view of a first embodiment of the implant according to the present invention;
• FIG. 2 is a side view of the implant ofFIG. 1;
• FIG. 3 is a back view of the implant ofFIG. 1;
• FIG. 4 is a top view of a second embodiment of the implant;
• FIG. 5 is a side view of the implant ofFIG. 4;
• FIG. 6 is a top view of a third embodiment of the implant;
• FIG. 7 is a side view of the implant ofFIG. 6;
• FIG. 8A is a top view of a top connecting surface of a top portion of the implant ofFIG. 6;
• FIG. 8B is a top view of a bottom connecting surface of a bottom portion of the implant ofFIG. 6;
• FIG. 9 is a perspective view of a fourth embodiment of the implant;
• FIG. 10A is a side view of one embodiment of the teeth on the implant;
• FIG. 10B is a side view of a second embodiment of the teeth of the implant;
• FIG. 11 is a side view of an embodiment of the implant similar to the embodiment ofFIGS. 6-8;
• FIG. 12 is a top view of a vertebral bone characteristic of those of the cervical, thoracic, and lumbar spine;
• FIG. 13 is a side view of sequentially aligned vertebral bones, such as are found in the cervical, thoracic, or lumbar spine;
• FIG. 14 is a posterior view of a sequence of vertebrae; and
• FIG. 15 is an end view of another embodiment of the implant.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• FIG. 1 shows a top view of a first embodiment of intervertebral allograft spacer orimplant10 according to the present invention.Implant10 conforms in size and shape with a portion of end plates of the vertebrae between which implant10 is to be implanted. Becauseimplant10 is an allograft,implant10 promotes the formation of new bone to fuse the two vertebral bodies together. Althoughimplant10 will probably be predominantly used in the lumbar region of the spine,implant10 can be configured for implantation in any region of the spine.Implant10 has a plurality ofteeth12 on superior andinferior surfaces14,16 which provide a mechanical interlock betweenimplant10 and the end plates.Teeth12 provide the mechanical interlock by penetrating the end plates. The initial mechanical stability afforded byteeth12 minimizes the risk of post-operative expulsion ofimplant10.Teeth12 can be pyramid-shaped (FIG. 10A). Preferably, the angle formed from the tip to the base is approximately 60 degrees. Alternatively,teeth12 have a saw tooth shape with the saw tooth running in the anterior-posterior direction (FIG. 10B).
• As shown inFIG. 2 andFIG. 3, a firstlateral side18 has achannel20 and a secondlateral side22 also has achannel20.Channels20 are sized to receive a surgical instrument such as an inserter for implantation ofimplant10. If the inserter has a threaded arm,implant10 can be provided with a threadedhole24. InFIG. 2,channel20 is shown extended only partially along firstlateral side18.Channel20 can extend along the entire length of firstlateral side18 as shown in the embodiment ofFIG. 5. InFIG. 3,channels20 are shown on both first and second lateral sides18,22. It should be noted thatimplant10 can also have no channels or channels on one lateral side only as shown in the embodiment ofFIG. 9.
• The dimensions ofimplant10 can be varied to accommodate a patient's anatomy. Typically,implant10 would have a width between 6-15 mm (in the medial-lateral direction), a length between 15-30 mm (in the anterior-posterior direction), and a height between 4-30 mm (maximum height in the superior-inferior direction). The size ofimplant10 allowsimplant10 to be implanted using conventional open surgical procedures or minimally invasive procedures, such as laparoscopic surgery. Additionally, because the width is kept to a restricted size range and does not necessarily increase with implant height, taller implants can be used without requiring wider implants. Thus, facet removal and retraction of nerve roots can remain minimal.
• In order to restore the natural curvature of the spine after the affected disc has been removed,implant10 has a wedge-shaped profile. As shown inFIG. 2, this wedge shape results from a gradual decrease in height from ananterior side26 to aposterior side28. In anatomical terms, the natural curvature of the lumbar spine is referred to as lordosis. Whenimplant10 is to be used in the lumbar region, the angle formed by the wedge should be approximately between 4.20 and 150 so that the wedge shape is a lordotic shape which mimics the anatomy of the lumbar spine.
• In order to facilitate insertion ofimplant10,anterior side26 transitions to superior andinferior surfaces14,16 with roundededges30. Rounded edges30 enableimplant10 to slide between the end plates while minimizing the necessary distraction of the end plates.
• Althoughimplant10 is typically a solid piece of allogenic bone,implant10 can be provided with a hollow interior to form an interior space. This interior space can be filled with bone chips or any other osteoconductive material to further promote the formation of new bone.
• FIG. 4 shows a top view of a second embodiment of animplant40 according to the present invention. In general, most of the structure ofimplant40 is like or comparable to the structure ofimplant10. Accordingly, discussion of the like components is not believed necessary. The superior andinferior surfaces14,16 ofimplant10 are flat planar surfaces. As seen best inFIG. 5, superior andinferior surfaces14,16 ofimplant40 are curved surfaces which still retain the wedge-shaped profile. The curved surfaces of superior andinferior surfaces14,16 ofimplant40 are a mirror-image of the topography of the vertebral end plates. Thus, the curved surfaces conform to the contours of the end plates.
• FIG. 6 shows a top view of a third embodiment of animplant50 according to the present invention. In general, most of the structure ofimplant50 is like or comparable to the structure ofimplants10,40. Accordingly, discussion of the like components is not believed necessary. As best seen inFIG. 7,implant50 comprises atop portion52 joined to abottom portion54. As it may be difficult to obtain a single section of allogenic bone from which implant50 is to be made, fabricatingimplant50 in two pieces, i.e. top andbottom portions52,54, allows smaller sections of allogenic bone to be used. A top connectingsurface56 and abottom connecting surface58 define the interface between top andbottom portions52,54. As shown inFIGS. 8A and 8B, top andbottom surfaces56,58 haveridges60 that mate withgrooves62 to interlock top andbottom portions52,54. Preferably,ridges60 andgrooves62 are formed by milling top andbottom surfaces56,58 in a first direction and then milling a second time with top andbottom surfaces56,58 oriented 90 degrees. with respect to the first direction.
• Apin64 passing through alignedholes66 in top andbottom portions52,54 serves to retain top andbottom portions52,54 together. Althoughpin64 can be made of any biocompatible material,pin64 is preferably made of allogenic bone. The number and orientation ofpins64 can be varied.
• FIG. 11 shows an embodiment of animplant80 which, likeimplant50, is made in multiple pieces. In general, most of the structure ofimplant80 is like or comparable to the structure ofimplants10,40,50. Accordingly, discussion of the like components is not believed necessary.Implant80 has atop portion82, amiddle portion84, and abottom portion86. As was the case forimplant80, the surfaces between the portions are mating surfaces with interlocking surface features, such as ridges and grooves. One or more pins preferably hold top, middle, andbottom portions82,84,86 together.
• FIG. 9 shows a perspective view of a fourth embodiment of afirst implant70 according to the present invention. Asecond implant70′, which is substantially similar tofirst implant70, is also shown. In general, most of the structure of first andsecond implants70,70′ is like or comparable to the structure ofimplants10,40,50. Accordingly, discussion of the like components is not believed necessary. Firstlateral sides18 of first andsecond implants70,70′ are scalloped to have a C-shape. When first andsecond implants70,70′ are placed side by side with the firstlateral sides18 facing each other, acylindrical space72 is formed. When first andsecond implants70,70′ are implanted together,cylindrical space72 can be filled with osteoconductive material to help promote the formation of new bone. First andsecond implants70,70′ can be provided with lockingpins74 which engageapertures76 to maintain the spatial relationship between first andsecond implants70,70′.
• The use of the implant according to the present invention will now be described with reference toFIGS. 12-14 and using posterior lumbar interbody fusion as an example. As the implant according to the present invention conforms in size and shape to a portion ofend plates100, preoperative planning is recommended for proper sizing. Determine the appropriate implant height by measuring adjacentintervertebral discs102 on a lateral radiograph. The implant must be seated firmly with a tight fit betweenend plates100 when the segment is fully distracted. The tallest possible implant should be used to maximize segmental stability. Due to variability in degrees of magnification from radiographs, the measurements are only an estimate.
• With the patient in a prone position on a lumbar frame, radiographic equipment can assist in confirming the precise intraoperative position of the implant. The surgeon incises and dissects the skin from the midline laterally and locatesspinous process104,lamina106,dura108, and nerve roots of the appropriate level(s). As much asfacets110 as possible should be preserved to provide stability to the intervertebral segment. The surgeon performs a laminotomy to the medial aspect offacet110 and reflectsdura108 to expose an approximately 13 mm window to the disc space.Disc102 is removed through the window until only anterior112 and lateral114 annulus remain. The superficial layers of the entirecartilaginous end plates100 are also removed to expose bleeding bone. Excessive removal of the subchondral bone may weaken the anterior column. Furthermore, if the entire end plate is removed, this may result in subsidence and a loss of segmental stability.
• Distraction can be done with either a surgical distractor or a trial spacer implant. In the first method, the distractor blades are placed into the disc space lateral todura108. The curve on the neck of the distractor should be oriented toward the midline. The distractor blades should be completely inserted into the disc space so that the ridges at the end of the blades rest onvertebral body116. Fluoroscopy can assist in confirming that the distractor blades are parallel to endplates100. Correct placement will angle the handles of the distractor cranially. particularly at L5-S1. The handle of the distractor is squeezed to distract the innerspace. The distraction is secured by tightening the speed nut on the handle.
• Using the preoperatively determined size, a trial spacer is inserted in the contralateral disc space with gentle impaction. Fluoroscopy and tactile judgment can assist in confirming the fit of the trial spacer until a secure fit is achieved. Using either the slots or threader hole on the implant, the selected implant is inserted in the contralateral disc space. Alternatively, the channels on the implant allow distraction and insertion to occur on the same side. Regardless of the side the implant is inserted in, autogenous cancellous bone or a bone substitute should be placed in the anterior and medial aspect of the vertebral disc space prior to placement of the second implant. The distractor is removed and a second implant of the same height as the first implant is inserted into the space, using gentle impaction as before. Preferably, the implants are recessed 2-4 mm beyond the posterior rim of the vertebral body.
• As previously noted, the implant according to the present invention can be inserted using minimally invasive procedures. In some of these procedures, only one side of the spinal cord needs to be approached. This minimizes muscle stripping, scar tissue in the canal, and nerve root retraction and handling. In clinical situations in which bilateral implant placement is required, proper implantation on the side opposite the incision can be difficult.FIG. 15 shows abeveled spacer120 that facilitates placement on the side contralateral to the incision. In general and unless otherwise described, most of the structure ofbeveled spacer120 is like or comparable to the structure ofimplants10,40,50, and80. Accordingly, discussion of the like components is not believed necessary. Firstlateral side18 transitions to superior andinferior surfaces14,16 with roundededges30. Firstlateral side18 also transitions to anterior andposterior sides26,28 with roundededges30. Additionally,spacer120 has no teeth. The lack of teeth and roundededges30 enablespacer120 to slide between the end plate and across the evacuated disc space (from one lateral annulus to the other) to the contralateral side. As firstlateral side18 is the side that must promote movement ofspacer120, the use of roundededges30 on secondlateral side22 is optionally. Oncespacer120 has been placed on the side contralateral to the single incision using a surgical instrument to pushspacer120, bone graft or other osteoconductive material is packed in the disc space. Finally, an implant (any ofimplant10,40,50,70, or70′ can be used) is implanted in the side proximal to the incision.
• While it is apparent that the illustrative embodiments of the invention herein disclosed fulfill the objectives stated above, 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.

Claims (25)

1. An intervertebral allograft implant for implantation between adjacent first and second vertebrae, each of the first and second vertebrae including an end-plate, the implant comprising:

a superior surface sized and configured to contact at least a portion of the end-plate of the first vertebra,

an inferior surface sized and configured to contact at least a portion of the end-plate of the second vertebrae,

a front surface extending from the superior surface to the inferior surface;

a back surface extending from the superior surface to the inferior surface, and

a pair of lateral surfaces extending from the superior surface to the inferior surface and extending from the front surface to the back surface;

wherein the implant is formed from at least two pieces of bone joined together to form a single body.

2. The implant ofclaim 1, wherein the plurality of bone pieces have mating interlocking surfaces that aid in holding the pieces together.

3. The implant ofclaim 1, further comprising at least one pin extending through an opening formed in the plurality of bone pieces to hold the pieces together.

4. The implant ofclaim 1, wherein the pin intersects the superior and inferior surfaces at an oblique angle.

5. The implant ofclaim 1, wherein the implant includes a top piece joined to a bottom piece, the top piece including the superior surface for contacting the first vertebra and a first connecting surface, the bottom piece including the inferior surface for contacting the second vertebra and a second connecting surface, the first connecting surface being sized and configured to contact the second connecting surface so that the top and bottom pieces are stacked one on top of the other.

6. The implant ofclaim 5, wherein the first and second connecting surfaces include a plurality of interconnecting ridges and grooves to interlock the top and bottom pieces.

7. The implant ofclaim 5, wherein the top and bottom pieces each include at least one bore formed at least partially therein, the at least one bore being sized and configured to receive at least one pin for further securing the top piece to the bottom piece.

8. The implant ofclaim 1, wherein the implant includes a first lateral piece and a second lateral piece, each of the first and second lateral pieces including at least a portion of the superior and inferior surfaces for contacting the first and second vertebra respectively, the first lateral piece further including a first connecting surface and the second lateral piece further including a second connecting surface, the first connecting surface being sized and configured to contact the second connecting surface so that the first and second lateral pieces are arranged in a side by side configuration.

9. The implant ofclaim 1, wherein the implant comprises a first lateral piece joined to a second lateral piece, wherein the first and second lateral pieces are substantially C-shaped so that when joined side by side they define a central bore.

10. The implant ofclaim 1, wherein the implant is formed by at least three pieces of bone.

11. The implant ofclaim 1, wherein the pair of lateral surfaces each have a length extending from the front surface to the back surface and wherein the front and back surfaces each have a length extending between the pair of lateral surfaces, the length of the lateral surfaces being at least approximately twice as long as the length of the front and back surfaces.

12. The implant ofclaim 1, wherein the pair of lateral surfaces each have a length extending from the front surface to the back surface and wherein the front and back surfaces each have a length extending between the pair of lateral surfaces, the length of the lateral surfaces being at least approximately half as long as the length of the front and back surfaces.

13. The implant ofclaim 1, wherein the superior and inferior surfaces include a plurality of teeth.

14. The implant ofclaim 13, wherein the teeth have a pyramidal-shape.

15. The implant ofclaim 13, wherein the teeth have a saw tooth shape.

16. The implant ofclaim 1, wherein each of the lateral surfaces includes a channel for engaging a surgical instrument.

17. The implant ofclaim 1, further comprising a threaded hole formed in one of the front, back or lateral surfaces for receiving a surgical instrument.

18. The implant ofclaim 1, wherein the superior and inferior surfaces include a wedge-shaped profile so that the body has a gradual decreasing height.

19. The implant ofclaim 1, wherein the superior and inferior surfaces are curved to substantially match the contours of the end-plates.

20. The implant ofclaim 1, wherein the implant includes at least one rounded edge along a perimeter of the superior and inferior faces for facilitating insertion of the implant in-between the first and second vertebrae.

21. The implant ofclaim 1, wherein the implant includes a hollow bore extending from the superior surface to the inferior surface.

22. An intervertebral allograft implant for implantation between adjacent first and second vertebrae, each of the first and second vertebrae including an end-plate, the implant comprising:

a superior surface sized and configured to contact at least a portion of the end-plate of the first vertebra,

an inferior surface sized and configured to contact at least a portion of the end-plate of the second vertebrae,

a front surface extending from the superior surface to the inferior surface;

a back surface extending from the superior surface to the inferior surface, and

a pair of lateral surfaces extending from the superior surface to the inferior surface and extending from the front surface to the back surface;

wherein the implant is formed from at least a first lateral piece joined to a second lateral piece to form a single body, the first and second lateral pieces being sized and configured so that when joined side by side they define a central bore, the central bore extending from the superior surface to the inferior surface.

23. An intervertebral allograft implant for implantation between adjacent first and second vertebrae, each of the first and second vertebrae including an end-plate, the implant comprising:

a superior surface sized and configured to contact at least a portion of the end-plate of the first vertebra,

an inferior surface sized and configured to contact at least a portion of the end-plate of the second vertebrae,

a front surface extending from the superior surface to the inferior surface;

a back surface extending from the superior surface to the inferior surface, and

a pair of lateral surfaces extending from the superior surface to the inferior surface and extending from the front surface to the back surface;

wherein the implant is formed from at least a top piece joined to a bottom piece to form a single body, the top piece including the superior surface for contacting the first vertebra and a first connecting surface, the bottom piece including the inferior surface for contacting the second vertebra and a second connecting surface, the first connecting surface being sized and configured to contact the second connecting surface so that the top and bottom pieces are stacked one on top of the other.

24. An intervertebral allograft implant for implantation between adjacent first and second vertebrae, each of the first and second vertebrae including an end-plate, the implant comprising:

a superior surface sized and configured to contact at least a portion of the end-plate of the first vertebra,

an inferior surface sized and configured to contact at least a portion of the end-plate of the second vertebrae,

a front surface extending from the superior surface to the inferior surface;

a back surface extending from the superior surface to the inferior surface, and

a pair of lateral surfaces extending from the superior surface to the inferior surface and extending from the front surface to the back surface;

wherein the pair of lateral surfaces each have a length extending from the front surface to the back surface and wherein the front and back surfaces each have a length extending between the pair of lateral surfaces, the length of the lateral surfaces being at least approximately twice as long as the length of the front and back surfaces.

25. An intervertebral allograft implant for implantation between adjacent first and second vertebrae, each of the first and second vertebrae including an end-plate, the implant comprising:

a superior surface sized and configured to contact at least a portion of the end-plate of the first vertebra,

an inferior surface sized and configured to contact at least a portion of the end-plate of the second vertebrae,

a front surface extending from the superior surface to the inferior surface;

a back surface extending from the superior surface to the inferior surface, and

a pair of lateral surfaces extending from the superior surface to the inferior surface and extending from the front surface to the back surface;

wherein the superior and inferior surfaces include a plurality of teeth.

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