US20170128223A1 - Spinal facet implants with mating articulating bearing surface and methods of use - Google Patents

Abstract

Superior and/or inferior facets of one or more facet joints may be replaced by superior and/or inferior facet joint prostheses. In one embodiment, a kit of superior or inferior prostheses is provided, in which the prostheses have at least two dimensions that vary among members of the kit independently of each other. Each prosthesis may have a bone engaging surface having a surface that is polyaxially rotatable against a corresponding resection of a vertebra. Each prosthesis may also have an articulating surface shaped such that, after attachment to the spine, the replaced or partially replaced facet joints provide a larger medial-lateral range of motion when the spine is flexed than when the spine is extended. Crosslinks may be used to connect left and right prosthesis together in such a manner that they are stabilized in a position in which they are seated directly against the vertebra.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• This application is a continuation application of U.S. Ser. No. 13/846,034, filed Mar. 18, 2013, which is a continuation application of U.S. Ser. No. 10/860,543, filed Jun. 2, 2004, now U.S. Pat. No. 8,419,770, which claims priority to U.S. Provisional Application 60/528,726, filed Dec. 10, 2003, U.S. Provisional Application 60/545,094, filed Feb. 17, 2004, and U.S. Provisional Application 60/545,101, filed Feb. 17, 2004, all of which are incorporated by reference in their entireties.
BACKGROUND OF THE INVENTION
• 1. Field of the Invention
• The present invention relates to surgical devices and methods to guide instruments that prepare the surface of bones and other tissues for implants that replace a damaged, diseased, or otherwise painful spinal facet joint.
• 2. Description of Related Art
• Traumatic, inflammatory, metabolic, and degenerative disorders of the spine can produce debilitating pain that can have severe socioeconomic and psychological effects. One of the most common surgical interventions today is arthrodesis, or spine fusion, of one or more motion segments, with approximately 300,000 procedures performed annually in the United States. Clinical success varies considerably, depending upon technique and indications, and consideration must be given to the concomitant risks and complications. For example, Tsantrizos and Nibu have shown that spine fusion decreases function by limiting the range of motion for patients in flexion, extension, rotation, and lateral bending. Furthermore, Khoo and Nagata have shown that spine fusion creates increased stresses and, therefore, accelerated degeneration of adjacent non-fused motion segments. Additionally, pseudoarthrosis, as a result of an incomplete or ineffective fusion, may reduce or even eliminate the desired pain relief for the patient. Finally, the fusion device, whether artificial or biological, may migrate out of the fusion site.
• Recently, several attempts have been made to recreate the natural biomechanics of the spine by use of an artificial disc. Artificial discs provide for articulation between vertebral bodies to recreate the full range of motion allowed by the elastic properties of the natural intervertebral disc that directly connects two opposed vertebral bodies.
• However, the artificial discs proposed to date do not fully address the mechanics of motion of the spinal column. In addition to the intervertebral disc, posterior elements called the facet joints help to support axial, torsional and shear loads that act on the spinal column. Furthermore, the facet joints are diarthroidal joints that provide both sliding articulation and load transmission features. The effects of their absence as a result of facetectomy was observed by Goh to produce significant decreases in the stiffness of the spinal column in all planes of motion: flexion and extension, lateral bending, and rotation. Furthermore, contraindications for artificial discs include arthritic facet joints, absent facet joints, severe facet joint tropism or otherwise deformed facet joints, as noted by Lemaire.
• U.S. Pat. No. Re. 36,758 to Fitz discloses an artificial facet joint where the inferior facet, the mating superior facet, or both, are resurfaced.
• U.S. Pat. No. 6,132,464 to Martin discloses a spinal facet joint prosthesis that is supported on the posterior arch of the vertebra. Extending from this support structure are inferior and/or superior blades that replace the cartilage at the facet joint. The Martin prosthesis generally preserves existing bony structures and therefore does not address pathologies that affect the bone of the facets in addition to affecting the associated cartilage. Furthermore, the Martin invention requires a mating condition between the prosthesis and the posterior arch (also known as the lamina) that is a thin base of curved bone that carries all four facets and the spinous process. Since the posterior arch is a very complex and highly variable anatomic surface, it would be very difficult to design a prosthesis that provides reproducible positioning to correctly locate the cartilage-replacing blades for the facet joints.
• Another approach to surgical intervention for spinal facets is provided in WO9848717A1 to Villaret. While Villaret teaches the replacement of spine facets, the replacement is interlocked in a manner to immobilize the joint.
• It would therefore be an improvement in the art to provide a vertebral facet replacement device and method that provides a relatively high degree of mobility in the joint, while effectively removing the source of arthritic, traumatic, or other disease mediated pain with a minimum of patient discomfort.
SUMMARY OF THE INVENTION
• In order to overcome the shortcomings of the prior art, the present invention provides a vertebral facet replacement device and method that replaces a bony portion of the facets so as to remove the source of arthritic, traumatic, or other disease mediated pain. Facet joint replacement in conjunction with artificial disc replacements represent a holistic solution to recreating a fully functional motion segment that is compromised due to disease or trauma. Together, facet joint and disc replacement can eliminate all sources of pain, return full function and range of motion, and completely restore the natural biomechanics of the spinal column. Additionally, degenerative or traumatized facet joints may be replaced in the absence of disc replacement when the natural intervertebral disc is unaffected by the disease or trauma.
• Accordingly, in certain embodiments, the present invention provides an artificial vertebral facet that replaces the cartilage and a portion of the bone of a facet. Furthermore, the invention may provide a method for preparing a vertebra for the installation of an artificial vertebral facet, a method for replacing a spinal facet, and possibly, a total vertebral facet joint replacement.
• The present invention may provide numerous advantages over the prior art. One advantage may be that the quality of attachment of the prosthesis is improved. The present invention may provide a precise press fit into bones, as opposed to relying on prosthetic surfaces mating with highly complex and variable external surfaces of the vertebra, such as the posterior arch or facet. Another advantage may be that the optional porous coating is placed into interior bone spaces where porous coatings have proven to achieve bone ingrowth for excellent long term fixation strength. This ability to achieve bone ingrowth is uncertain for the prior art devices that engage the external bone surfaces of the vertebra. Yet another advantage may lie in the removal of the facet bone structure; where the facet bone is involved in the disease pathology or the trauma that compromised the articular or cartilaginous surface of the facet, resection provides a means for ensuring that all pain associated with the disease or trauma is removed.
• The above, and other features and advantages of the present invention, will become apparent from the following description, which is to be read in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a perspective view of a portion of the spine;
• FIG. 2 is a lateral view of a facet joint reconstructed in accordance with the present invention;
• FIG. 3 is a dorsal view of the facet joint shown inFIG. 2;
• FIG. 4 is a perspective view of the implanted left inferior facet prosthesis shown inFIGS. 2 and 3;
• FIG. 5 is a perspective view of the left inferior facet prosthesis shown inFIGS. 2 and 3;
• FIG. 6 is a cranial view of the implanted left superior facet prosthesis shown inFIGS. 2 and 3;
• FIG. 7 is a perspective view of the left superior facet prosthesis shown inFIGS. 2 and 3;
• FIG. 8 is a perspective view of an alternative implanted left inferior facet prosthesis;
• FIG. 9 is a perspective view of an alternative left inferior facet prosthesis;
• FIG. 10 is a lateral view of an alternative reconstructed facet joint;
• FIG. 11 is a dorsal view of an alternative reconstructed facet joint;
• FIG. 12 is a perspective view of the implanted left inferior facet prosthesis shown inFIGS. 10 and 11;
• FIG. 13 is a perspective view of the alternative left inferior facet prosthesis shown inFIGS. 10 and 11;
• FIG. 14 is a cranial view of the alternative implanted left superior facet prosthesis shown inFIGS. 10 and 11;
• FIG. 15 is a perspective view of the alternative left superior facet prosthesis shown inFIGS. 10 and 11;
• FIG. 16 is a perspective view of an alternative bearing surface for the superior facet prosthesis shown inFIG. 15;
• FIG. 17 is a dorsal view of a single intact vertebra;
• FIG. 18 is a lateral view of the same intact vertebra shown inFIG. 17;
• FIG. 19 is a dorsal view of the same vertebra ofFIG. 17 andFIG. 18, with a portion of the superior facet resected and a portion of the inferior facet resected;
• FIG. 20 is a lateral view of the resected vertebra shown inFIG. 19;
• FIG. 21 is a dorsal view of the same resected vertebra shown inFIG. 18 andFIG. 19 with a fixation element placed through the first superior resection surface and into the pedicle bone;
• FIG. 22 is a dorsal view showing the resected vertebra, the fixation element, and a superior facet prosthesis;
• FIG. 23 is a dorsal view of the vertebra and the implant ofFIG. 23 and also showing the addition of an inferior facet prosthesis;
• FIG. 24 is a dorsal view of the implant and vertebra ofFIG. 23 and also showing the addition of an enlarged head that has the shape of a locking nut;
• FIG. 25 is a perspective view of a vertebra with an assembled implant comprising a fixation element, superior facet prosthesis, and a locking nut;
• FIG. 26 is a perspective, cross-sectioned view of the same vertebra and implant ofFIG. 25 with a cross section aligned with the axis of the fixation element;
• FIG. 27 is a cranial, cross-sectioned view of the vertebra and implant ofFIG. 25, with the section plane positioned as inFIG. 26;
• FIG. 28 is a side view of embodiments A, B, C, D, E, and F of the fixation element, a cross-sectional view of each of embodiments A, B, C, D, E, and F, and a side view of the enlarged head in the shape of a locking nut;
• FIG. 28A is a side view of embodiments G, H, I, J, K, and L of the fixation element with attached enlarged heads, and a cross-sectional view of each of embodiments G, H, I, J, K, and L;
• FIG. 29 is a perspective view of a radially expanding fixation element in its unexpanded state;
• FIG. 30 is a side view and a bottom view of (i) an expanded radially expanding fixation element and (ii) an unexpanded radially expanding fixation element;
• FIG. 31 is a perspective cross-sectional view of a vertebra and a facet implant showing a cross-pin torsionally and axially securing the fixation element;
• FIG. 32 is a dorsal view of a spinal section showing a top, middle, and bottom vertebra with unilateral facet replacements on the right side of the spine section, both between the top and middle vertebra, and between the middle and bottom vertebra;
• FIG. 33 is a dorsal view of a spine section showing a superior hemiarthroplasty facet replacement between the top and the middle vertebra and unilateral replacement between the middle and the bottom vertebra;
• FIG. 34 is a dorsal view of a spinal section showing an inferior facet hemiarthroplasty replacement between the top and the middle vertebra and a unilateral replacement on the right side between the middle and the bottom vertebra;
• FIG. 35 is a dorsal view of a spinal section showing a unilateral replacement between the top and middle vertebrae on the right side, and an inferior facet hemiarthroplasty replacement between the middle and bottom vertebrae on the same side;
• FIG. 36 is a dorsal view of a spinal section showing a unilateral replacement between the top and middle vertebrae on the right side and a superior facet hemiarthroplasty replacement on the right side between the middle and bottom vertebrae on the same side;
• FIG. 37 is a spinal section of two vertebrae showing one inferior facet of the top vertebra and the adjoining superior facet of the bottom vertebra replaced by an articulating facet implant;
• FIG. 38 is a perspective view of a curved superior facet prosthesis;
• FIG. 39 is a perspective view of a superior facet prosthesis with a bone ingrowth surface;
• FIG. 40 is a perspective view of an inferior facet prosthesis;
• FIG. 41 is a perspective view of an inferior facet prosthesis with a bone ingrowth surface;
• FIG. 42 is an exploded, perspective view illustrating the addition of a locking washer to the construction of the implant shown inFIG. 25;
• FIG. 43 is a perspective view illustrating the implant ofFIG. 25 with a locking washer fully installed;
• FIG. 44 is a perspective view of the locking washer shown inFIG. 42;
• FIG. 45 is a perspective view of superior and inferior facet prostheses held against a vertebra by flexible fixation elements;
• FIG. 46 is a dorsal view of a bilateral inferior implant;
• FIG. 47 is perspective view of a vertebra with an alternative embodiment of a superior facet prosthesis fixed to the bone by one embodiment of a fixation element;
• FIG. 48 is a perspective, cross-sectional view of the embodiment of the superior facet prosthesis and fixation element ofFIG. 47 showing the semispherical shape of the resection and the approximately similarly semispherical shape of the apposition side of the superior facet prosthesis, as well as an angled resection and corresponding angled flat on the apposition side of the superior facet prosthesis in combination with the semispherical resection;
• FIG. 49 is a perspective view of the resected vertebra without the superior facet prosthesis attached to the vertebra, in which the fixation element is installed in the vertebra;
• FIG. 50 is a perspective view of the resected vertebra with the superior facet prosthesis attached to the vertebra, with the fixation element installed in the vertebra, but without the locking fastener shown inFIG. 47;
• FIG. 51 is a top view of the superior facet prosthesis showing the semispherical shape of the bone apposition side in combination with the angled flat on the bone apposition side;
• FIG. 52 is a rear view of the superior facet prosthesis showing the semispherical nut engaging surface on the top of the area that is design to connect to the fixation element and the locking nut, or the inferior prosthesis and the fixation element;
• FIG. 53A is a rear view and a perspective view of a plurality of superior facet prostheses of a kit;
• FIG. 53B is a top view of an inferior facet prosthesis according to one embodiment of the invention;
• FIG. 53C is a side view of the inferior facet prosthesis ofFIG. 53B;
• FIG. 53D is a perspective view of a plurality of inferior facet prostheses of a kit;
• FIG. 53E is a perspective view showing how a superior facet prosthesis and an inferior facet prosthesis may fit together;
• FIG. 53F is a dorsal view of an L5 superior facet prosthesis and an inferior facet prosthesis fit on adjacent vertebrae to articulate against each other;
• FIG. 53G is a posteriolateral view of the implants and vertebrae shown inFIG. 53F;
• FIG. 53H is a posteriolateral view showing a cross-section along a first plane cut through the articulation of the implants ofFIG. 53F;
• FIG. 53I is a cephalad view showing a cross-section along a second plane cut through the articulation of the implants shown inFIG. 53F;
• FIG. 54 is a dorsal view of a bilateral inferior facet prosthesis system and a superior facet prosthesis in situ;
• FIG. 55 is a perspective view of the bilateral inferior facet prosthesis system and the superior facet prosthesis ofFIG. 54;
• FIG. 56 is a lateral view of the bilateral inferior facet prosthesis system and superior facet prosthesis in situ;
• FIG. 57 is a cranial view of the bilateral inferior implant system in situ;
• FIG. 58 is a bottom view of the bilateral inferior facet prosthesis system in situ;
• FIG. 59 is rear view of the bilateral inferior facet prosthesis system in isolation;
• FIG. 60 is a top view of the bilateral inferior facet prosthesis system in isolation;
• FIG. 61 is a bottom view of the bilateral inferior facet prosthesis system in isolation;
• FIG. 62 is a perspective view of the right inferior prosthesis;
• FIG. 63 is a perspective view of various ball-shaped members of inferior prostheses, the ball-shaped members having differing surface features, particularly circumferential grooves, longitudinal grooves, and knurling;
• FIG. 64 is an end view of the ball-shaped members ofFIG. 63; and
• FIG. 65 is a dorsal view of the bilateral inferior facet prosthesis system, in which castle nuts are attached to the left and right fixation elements.
DETAILED DESCRIPTION OF THE DRAWINGS
• Referring now toFIG. 1, there is shown a perspective view of asuperior vertebra1 and aninferior vertebra3, with anintervertebral disc2 located in between. Thesuperior vertebra1 hassuperior facets43,inferior facets6, a posterior arch (or lamina)35 and aspinous process46. Theinferior vertebra3 hassuperior facets7, inferior facets44, a posterior arch (or lamina)36 and aspinous process45. Each of thevertebrae1,3 also has a pair ofpedicles11.
• Referring now toFIG. 2, in a lateral view, the leftinferior facet6 of thesuperior vertebra1 shown inFIG. 1 has been resected and an inferior facet prosthesis4 has been attached to thesuperior vertebra1. Similarly, the leftsuperior facet7 of theinferior vertebra3 has been resected and asuperior facet prosthesis5 has been attached to theinferior vertebra3.
• FIG. 3 illustrates a dorsal view of the elements shown inFIG. 2. It can be appreciated that inferior facet prosthesis4 replicates the natural anatomy when compared to the contralateralinferior facet6 ofvertebra1. Similarly, it can be appreciated thatsuperior facet prosthesis5 replicates the natural anatomy when compared to the contralateralsuperior facet7 ofvertebra3. Neither the inferior facet prosthesis4 nor thesuperior facet prosthesis5 rests on thelamina35.
• Turning now toFIG. 4, a perspective view of thesuperior vertebra1 with implanted inferior facet prosthesis4 is provided. A bone resection on the left side of thesuperior vertebra1, shown as aresection31, has removed the naturalinferior facet6 at the bony junction between theinferior facet6 and thelamina35. In this manner, any bone pain associated with a disease, such as osteoarthritis, or trauma of the leftinferior facet6 will be eliminated as the involved bony tissue has been osteotomized.
• FIG. 5 illustrates a perspective view of the inferior facet prosthesis4. A surface8 replicates the natural articular surface of the replacedinferior facet6. A post9 provides a mechanism that can be used to affix the inferior facet prosthesis4 to thesuperior vertebra1. The post9 is implanted into the interior bone space of theleft pedicle11 on thesuperior vertebra1 and may or may not extend into the vertebral body ofsuperior vertebra1 to provide additional stability.
• FIG. 6 illustrates a cranial view of theinferior vertebra3 with the implantedsuperior facet prosthesis5. Aresection surface32 represents the bony junction between the naturalsuperior facet7 and thelamina36.
• FIG. 7 illustrates a perspective view of thesuperior facet prosthesis5. A surface38 replicates the natural articular surface of the replacedsuperior facet7. Thepost37 provides a mechanism usable to affix thesuperior facet prosthesis5 to theinferior vertebra3. Thepost37 is implanted into the interior bone space of the left pedicle11 (FIG. 6) on theinferior vertebra3 and may or may not extend into the vertebral body of theinferior vertebra3 to provide additional stability.
• When the total facet joint is replaced, as shown inFIGS. 2 and 3, then the surface8 (FIG. 5) articulates against the surface38 (FIG. 7) to recreate the natural biomechanics of the spine motion segment made up of thesuperior vertebra1, theinferior vertebra3, and theintervertebral disc2. Neither the inferior facet prosthesis4 nor thesuperior facet prosthesis5 rests on thelamina35 or thelamina36, respectively.
• FIG. 8 illustrates a perspective view of an alternativeinferior facet prosthesis10 that may be implanted into the interior bone space of thelamina35 of thesuperior vertebra1. The interior bone space is accessed from theresection31.
• FIG. 9 shows a perspective view of the alternativeinferior facet prosthesis10, including afin13 that extends into the interior bone space of the35. A surface12 replicates the natural articular surface of the replaced facet.
• The surfaces of the post9 (FIG. 5), the post37 (FIG. 7), and the fin13 (FIG. 9) may or may not include porous coatings to facilitate bone ingrowth to enhance the long-term fixation of the implant. Furthermore, such porous coatings may or may not include osteoinductive or osteoconductive substances to further enhance bone remodeling into the porous coating. In this application, the term “implant” refers to any natural or man-made, fabricated or unfabricated device or group of devices that may be added to a human spine. An implant may include one or more prostheses, one or more fixation devices, and/or other components.
• Referring now toFIG. 10, there is shown a lateral view of a superior vertebra14 and aninferior vertebra16, with anintervertebral disc15 located in between. The left inferior facet of the superior vertebra14 has been resected and aninferior facet prosthesis18 has been attached to superior vertebra14 via ascrew fastener17. Similarly, the left superior facet of theinferior vertebra16 has been resected and asuperior facet prosthesis19 has been attached tovertebra16 via ascrew fastener17.
• FIG. 11 illustrates a dorsal view of the elements ofFIG. 10. It can be appreciated thatinferior facet prosthesis18 replicates the natural anatomy when compared to the contralateral inferior facet22 of the superior vertebra14. Similarly, it can be appreciated thatsuperior facet prosthesis19 replicates the natural anatomy when compared to the contralateralsuperior facet21 of theinferior vertebra16. Neither theinferior facet prosthesis18 nor thesuperior facet prosthesis19 rests on the lamina of thecorresponding vertebra14 or16.
• Turning now toFIG. 12, there is provided a perspective view of the superior vertebra14 with the implantedinferior facet prosthesis18. Aresection34 has removed the natural inferior facet at the bony junction between the inferior facet and the adjoining lamina. In this manner, any bone pain associated with a disease, such as osteoarthritis, or trauma of the natural inferior facet22 will be eliminated inasmuch as the involved bony tissue has been osteotomized.
• FIG. 13 illustrates a perspective view of theinferior facet prosthesis18. Asurface23 replicates the natural articular surface of the replaced facet. Aflange25 contacts the pedicle11 (FIG. 12) and ahole24 receives thescrew fastener17 to attach theinferior facet prosthesis18 to the superior vertebra14.
• FIG. 14 illustrates a cranial view of theinferior vertebra16 with the implantedsuperior facet prosthesis19. Aresection surface33 represents the bony junction between the natural superior facet21 (FIG. 11) and the corresponding lamina.
• FIG. 15 illustrates a perspective view of thesuperior facet prosthesis19. A surface27 replicates the natural articular surface of the replaced facet. A flange39 contacts the pedicle11 (FIG. 14) and hole26 receives ascrew fastener17 to attach thesuperior facet prosthesis19 to theinferior vertebra16.
• FIG. 16 provides a perspective view of an alternativesuperior facet prosthesis40 with a bearing surface41 that mounts to substrate42. The bearing surface41 is a biocompatible polymeric material, such as ultra high molecular weight polyethylene. Alternatively, the bearing surface can be ceramic, such as zirconia or alumina. The substrate is a biocompatible metal alloy, such as an alloy of titanium, cobalt, and/or iron.
• The bearing surface41 may be formed separately from the remainder of thesuperior facet prosthesis40, so that the bearing surface41 and the remainder form components that can be assembled as needed. A kit of differently-sized prostheses may include multiple bearing surfaces like the bearing surface41 that may have different thicknesses, articulating surface shapes, material selections, and the like. Such a kit may also include other differently-sized components designed such that some subset of the components can be selected and assembled together to provide a prosthesis having the desired dimensions. Prosthesis kits will be shown and described in greater detail subsequently.
• Referring toFIG. 17 andFIG. 18, a singleintact vertebra100 is shown.FIG. 17 is a dorsal view of thevertebra100.FIG. 18 is a lateral view of thesame vertebra100. Similar to the twovertebrae1,3 shown in the portion of the spine illustrated inFIGS. 1 through 3, thevertebra100 has posterior anatomy comprising left and rightsuperior facets43 on the superior, or top side in this view of thedorsal vertebra100, left and rightinferior facets6 on the inferior or bottom side of theposterior vertebra100, left and righttransverse processes105 extending laterally from the posterior portion ofvertebra100, and left andright pedicles11. Each of thesuperior facets43 has a superior articulatingsurface145. The posterior portion ofvertebra100 also has a posterior arch (or lamina)35, and aspinous process46 that protrudes from thelamina35 posteriorly, out of the page inFIG. 17 and to the left inFIG. 18. InFIG. 17, the bony structure of thesuperior facets43 and theinferior facets6 are intact, as it would be presented in a vertebra without significant tissue degeneration or remodeling resulting from facet joint disease. Although thevertebra100 is shown inFIG. 17 as a generally structurally healthy and intact vertebra, if thevertebra100 were a diseased vertebra, the vertebra could exhibit signs of facet joint disease.
• Consequently, structural pathology related to facet joint disease would likely be visible. For example, the leftsuperior facet43 and the rightsuperior facet43 of thevertebra100 are symmetrical inFIG. 17 andFIG. 18. But in the case of avertebra100 with only one diseased joint, the facet on the diseased side would likely be showing pathological signs of disease such as tissue degeneration or inflammation resulting in an asymmetrical structural comparison between the two facets.
• Also, in more extreme cases the facet disease could progress to a state in which the articular process of the facet is eroded or inflamed resulting in anatomic morphology that is unique to the pathology of a particular facet joint of an individual patient. This could present unusual facet morphology that could be different from what is shown inFIGS. 17 and 18.
• Furthermore, the facet disease could eventually disable the biomechanics of a patient such that the facet joint is essentially non-articulating and immobile. In this case, one superior facet of a first vertebra could essentially be fused to one inferior facet of a second vertebra. Since the structural pathology of the diseased facet is variable, a surgeon may determine that the best bone apposition surface or foundation for securing a facet implant is a resected bone surface.
• Referring toFIG. 19 andFIG. 20 which are dorsal and lateral views of the same vertebra shown inFIG. 17 andFIG. 18 after a portion of the rightsuperior facet43 and a portion of the rightinferior facet6 have been resected. The removal of a portion of thesuperior facet43 by resection results in asuperior facet resection111. In the resection shown inFIG. 19 andFIG. 20, thesuperior resection111 has two resulting faces, afirst resection surface112 and asecond resection surface113. Likewise, the inferior facet resection results in an inferiorfacet resection surface121.
• Tissue removal tools (not shown) such as a bone burr, rasp, reamer, mill, saw, rounger, osteotome or similar tools designed to cut and remove bone tissue can be used to create these resection surfaces. The surgeon uses anatomic landmarks such as thepedicle11 ortransverse process105 to align the tissue removal tools in such a way as to remove the portion of the facet necessary to provide asuperior resection111 that serves as a bone apposition surface or foundation to eventually support asuperior facet prosthesis300, as shown inFIG. 22. The leftsuperior facet43 is shown intact in bothFIG. 19 andFIG. 20, but a portion of the rightsuperior facet43 is resected resulting in thefirst resection surface112 and the adjacent second resection surface113 (FIG. 19). The shape of thesuperior resection111 will vary in accordance with the structure of the tissue removal tool. In the embodiment shown inFIG. 19 andFIG. 20, thefirst resection surface112 and thesecond resection surface113 are on approximately perpendicular planes. However, the geometry of the resection surfaces is a function of the patient anatomy, the pathology of the diseased tissue, the technique of the surgeon, and other factors such as the type of tissue removal tools used to prepare the resection. In general, thefirst resection surface112 will be formed in such a way that it will serve as a foundation to support the superior facet prosthesis300 (FIG. 22). Thesecond resection surface113 or other additional resection surfaces may or may not be present.
• FIG. 19 andFIG. 20 also show that a portion of theinferior facet6 is resected by tissue removal instruments resulting in aninferior resection surface121. Such resection is preferably effected so that resection is confined to the tissue of theinferior facet6 and does not extend into the tissue of the posterior arch (or lamina)35. InFIGS. 19 and 20, the leftinferior facet6 is intact, while a portion of the rightinferior facet6 is resected resulting in theinferior resection surface121 on the right side. The bone surrounding theinferior resection surface121 is contoured by tissue removal tools in a shape designed to cradle and support an inferior facet prosthesis400 (FIG. 23) on the medial side such that when theinferior facet prosthesis400 is loaded on the lateral side it compresses against and is supported by theinferior resection surface121.
• Alternatively, theinferior facet6 can be resected, andinferior facet prosthesis400 sized and shaped, so thatinferior facet prosthesis400 does not engage theinferior resection surface121.
• FIG. 21 is a dorsal view of thevertebra100 with afixation element200 placed through thesuperior resection111 and into the bone of thepedicle11 to receive the superior facet prosthesis300 (FIG. 22). Thefixation element200 is aligned and placed into thepedicle11, similar to how other pedicle screws for posterior stabilization involved with vertebrae fusion are placed in thepedicle11. In one method, a long guide wire (not shown), with a diameter sized to fit freely into a cannulation211 (as also shown inFIG. 26 andFIG. 27) in thefixation element200, is placed through thefirst resection surface112 and into the bone of thepedicle11. The alignment of the long guide wire can be confirmed by x-ray. Thefixation element200 is then guided over the guide wire and driven into thevertebra100 by a driver (not shown) engaged with a drive feature212 (FIG. 21) on aproximal post230 of thefixation element200. Thefixation element200 is driven into thevertebra100 until a connection feature213 (e.g., a screw thread) is just above thefirst resection surface112. Thisconnection feature213 is eventually used to secure thesuperior facet prosthesis300 to thevertebra100.
• In a second method for guiding thefixation element200 into thepedicle11, a long guide wire (not shown), with a diameter sized to fit freely into a cannulation in a bone preparation instrument (not shown) such as a tap, drill, broach or reamer, is placed through thefirst resection surface112 and into the bone of thepedicle11. The alignment of the long guide wire can be confirmed by x-ray. The bone preparation instrument is then guided over the guide wire and driven into the bone of thepedicle11 to prepare a cavity for thefixation element200. The guide wire and bone preparation instrument are then removed and thefixation element200 is guided into the prepared cavity in thepedicle11 by a driver (not shown) engaged with thedrive feature212 on theproximal post230 of thefixation element200. Like in the first method, thefixation element200 is driven into the vertebra until a connection feature213 (e.g., a screw thread) is just above thefirst resection surface112. Thisconnection feature213 is eventually used to secure thesuperior facet prosthesis300 to thevertebra100.
• In yet a third method of placing thefixation element200 in the pedicle, the surgeon aligns thefixation element200 with anatomic landmarks and simply drives thefixation element200 through the first resectedsurface112 and into thepedicle11. As with the first and second methods, thefixation element200 is driven into thevertebra100 until a connection feature213 (e.g., a screw thread) is just above the firstsuperior resection surface112.
• InFIG. 22, a dorsal view illustrates asuperior facet prosthesis300 placed around thefixation element200. Thesuperior facet prosthesis300 has afacet articulating component320 that articulates against the inferior facet articulating surface of the vertebra above it. Thefacet articulating component320 is preferably formed in the general shape of a blade or wing ear. Thesuperior facet prosthesis300 also has abone apposition surface322 that has been placed on thefirst resection surface112 and anopening324 in aflange323 that surrounds thefixation element200. The superiorfacet articulating component320 has an articulatingsurface321 generally adjacent to theflange323 that is oriented in a direction that faces approximately the same direction that the original anatomic superior articulatingsurface145 faced prior to resection.
• This orientation of the articulatingsurface321 allows thesuperior facet prosthesis300 to function as either a hemiarthroplasty implant and articulate against a natural anatomicinferior facet6 or act as a portion of a unilateral prosthesis and articulate against aninferior facet prosthesis400 on the vertebra superior (cephalad) to it. No portion ofsuperior facet prosthesis300 rests on the lamina of thevertebra100. In this application, a “unilateral prosthesis” is a prosthesis in which both facets of only one of the facet joints between adjacent vertebrae are replaced by prostheses. A “hemiarthroplasty” is a type of arthroplasty in which one side of an articulating joint surface is replaced with an artificial implant.
• FIG. 23 is a dorsal view showing the addition of theinferior facet prosthesis400 to the construct described inFIG. 22. Theinferior facet prosthesis400 generally has a shape similar to a longitudinal rod that is curved to match the contour of the inferior resection121 (FIGS. 19 and 20). Theinferior facet prosthesis400 has anopening410 through itssuperior end420 that is shaped to surround the portion of thefixation element200 that protrudes from thefirst resection surface112. InFIG. 23, theinferior facet prosthesis400 is placed over thesuperior facet prosthesis300. However, the order of the placement of theprostheses300,400 can be reversed such that theinferior prosthesis400 is placed on thefixation element200 first, followed by thesuperior prosthesis300. When only theinferior facet6 or thesuperior facet43 is being replaced, only the appropriate (superior or inferior)facet prosthesis300 or400 is placed on thefixation element200 without the other (inferior or superior)facet prosthesis300 or400.
• Because the various components of the implant are modular, many combinations of configurations and implant size, structure and shapes are feasible. For example, in a patient with unusual anatomy, theinferior facet prosthesis400 may need to be larger than expected to conform to a particularly unusual or exceptionally large morphology of theinferior resection surface121, and thesuperior facet prosthesis300 may need to have an unusual angle to its articulatingsurface321 to conform to particular anatomic constraints. If this is the case, the modularity of the system allows for the surgeon to assemble an implant specifically designed to match the patient's anatomic structures during the surgery. This flexibility of a modular implant design allows the implant manufacturer to accommodate a large variation in anatomic structures with a limited selection of implant component sizes, shapes, and material types.
• The modularity of the implant design also allows different components of the implant to be fabricated from different materials. Traditionally, bone fixation implants such as thefixation element200 are fabricated from biocompatible metals or alloys that provide sufficient strength and fatigue properties, such as cobalt chrome alloys, titanium and titanium alloys, and stainless steels. However, thefixation element200 may be fabricated from ceramics, polymers, or biological materials such as allograft bone, composites, or other biocompatible structural materials. Likewise thesuperior facet prosthesis300 and theinferior facet prosthesis400 may be fabricated from metals, alloys, ceramics, polymers, biological materials, composites, or other biocompatible structural materials.
• InFIG. 24, a dorsal view illustrates the addition of anenlarged head500 to thefixation element200. Theenlarged head500 is tightened down to force theprostheses300,400 against the bone to stabilize them. Theenlarged head500 shown inFIG. 24 has a hexagonal geometry on its external surface that is shaped to accept a driver (not shown) that is used to force an internal connection feature520 (e.g., a screw thread) of theenlarged head500 onto theconnection feature213 of thefixation element200. In the case of the threaded embodiment of theconnection feature213, theenlarged head500 is provided with a threaded connection feature520 and is driven onto thefixation element200 by turning theenlarged head500 and allowing the threads to drive all components of the implant between theenlarged head500 and thefirst resection surface112 against the bone at or near theresection surface112.
• FIG. 25 is a perspective posterior view of the assembly of thefixation element200, thesuperior facet prosthesis300, and theenlarged head500. Theenlarged head500 has been placed on thefirst resection surface112.
• FIG. 26 is a perspective, cross-sectioned view of the same construct shown inFIG. 25. Thesuperior facet prosthesis300, theenlarged head500, thefixation element200, and thevertebra100 have been cut by across-sectioning plane150 placed along an axis that passes through the center of thefixation element200. Thecross-section plane150 is shown for visualization purposes to illustrate, using a cross-sectioned view, how thevertebra100,fixation element200,superior facet prosthesis300 and theenlarged head500 engage each other. In actual surgery, it is highly unlikely that a surgeon would make a cut as illustrated by thecross-section150 shown inFIG. 26.
• FIG. 27 is a cranial, section view of thevertebra100 and the implant, wherein thecross-section plane150 is oriented to face the viewer. InFIG. 27, thefixation element200 is in thevertebra100. The embodiment of thefixation element200 inFIG. 27 comprises adistal end220 that is shaped to guide thefixation element200 into bone tissue, abone stabilizing portion210 adjacent to the distal end, ashaft portion240 adjacent to thebone stabilizing portion210, aconnection feature213 adjacent to theshaft portion240, and adrive feature212.
• Thedistal end220 shown inFIG. 27 has a frusto-conical shape that allows thefixation element200 to be driven or guided into thevertebra100. Thedistal end220 could be shaped in the form of a spade tip, trochar tip, or twist drill tip to assist in the guidance of thefixation element200 in thevertebra100. Thefixation element200 may also have a cutting flute (not shown) formed in thedistal end220 to help remove bone tissue and accommodate the guidance of thefixation element200 in thevertebra100. Thebone stabilizing portion210 helps to secure thefixation element200 to thevertebra100. Thebone stabilizing portion210 can include various features designed to anchor into bone such as threads, ribs, grooves, slots, fins, barbs, splines, bone ingrowth surfaces, roughened surfaces, or any geometric feature that helps to engage thefixation element200 with the bone tissue to help stabilize thefixation element200. InFIG. 27, thebone stabilizing portion210 has a unitarycontinuous bone thread231. However, other types of threads such as multiple lead threads, variable pitched thread, non-uniform pitch thread, buttress thread, or other thread forms used on bone screws may be used. BecauseFIG. 27 is a cross-sectional view, the full length of thecannulation211 is seen passing from thedistal end220 of thefixation element200 to theproximal post230 of thefixation element200.
• Thedrive feature212 in the embodiment shown inFIG. 27 is an internal hex. However, any shape ofdrive feature212 that transmits the loads necessary to drive thefixation element200 into thevertebra100 can be formed on theproximal post230 of thefixation element200. The depth of thedrive feature212 formed in theproximal post230 of thefixation element200 is seen in the cross-sectional view ofFIG. 27. Thedrive feature212 may be an internal drive feature such as the hex socket shown in this embodiment, or an external drive feature with geometry on the periphery of theproximal post230 of thefixation element200 that engages with a corresponding internal drive feature on a driver tool (not shown). In this embodiment the depth of thedrive feature212 is slightly longer than its cross-section is wide. This depth can be adjusted based on the material properties of thefixation element200 and the drive tool (not shown).
• Thefixation element200 is fabricated from biocompatible base materials that provide the necessary structural rigidity and strength. Examples of base materials that may be used in the construction of thefixation element200 include titanium, titanium alloys, cobalt-chrome alloys, stainless steel alloys, zirconium alloys, other biocompatible metal materials, biocompatible ceramics, biocompatible composites, and biocompatible polymers. Thefixation element200 may also have surface materials formed on the base material that provide material properties specific to a particular portion of thefixation element200. For example, thebone stabilization portion210 could be coated with materials that allow for improved bone ingrowth into the implant surface such as a hydroxylapatite, bioceramic, Bioglass®, or other calcium phosphate derived material. The tribological bearing properties of the material in the areas that thefixation element200 interfaces with other artificial elements may be improved by applying surface hardening techniques to the material of thefixation element200 in these areas. Surface hardening techniques known in the materials science and materials engineering arts such as anodizing, ion implantation, and other techniques could be applied to these isolated areas.
• As mentioned previously, theconnection feature213 is formed on the portion of thefixation element200 that protrudes from thefirst resection surface112. Thisconnection feature213 is designed to connect theenlarged head500 to thefixation element200. In the embodiment of theconnection feature213 shown inFIG. 21,threads260 are on the external surface of this proximal section of thefixation element200. Thesethreads260 engage with the threads of the internal connection feature520 (FIG. 27) of theenlarged head500. Although theconnection feature213 in this embodiment is threaded, other mechanical locking features (not shown) capable of locking thefixation element200 and theenlarged head500 together, such as press fit, taper fit, bonding fit by cement or glue, interference fit, expansion fit and mechanical interlocking fit such as a bayonet connection, can be used as theconnection feature213. A corresponding construction may then be used as connection feature520 of theenlarged head500.
• Also shown inFIG. 27 is a cross-sectional view of thesuperior facet prosthesis300. This embodiment of thesuperior facet prosthesis300 has aflange323 that has anopening324 that receives thefixation element200. In the assembled and implanted configuration of this embodiment, theflange323 is positioned such that itsbone apposition surface322 makes contact with thefirst resection surface112. Although not shown in this embodiment, other embodiments of thesuperior facet prosthesis300 have structures (e.g., spikes) that protrude into thefirst resection surface112 to help resist torsion and other anatomic loads. Protruding from theflange323 at a given angle α, and a given distance X from theopening324, is the articulatingcomponent320. The articulatingsurface321 of thefacet articulating component320 replicates the natural articular surface of the replaced facet. Once the surgeon assesses the anatomy of thesuperior facet43 that is being replaced, a particularsuperior facet prosthesis300 is selected that has the angle α and the distance X that best fits the anatomy of the level of vertebra, the left or right side, and the size of the patient's anatomy being replaced. Thus a kit containing various sizes and shapes ofsuperior facet prostheses300 is provided to the surgeon and the surgeon selects thesuperior facet prosthesis300 that best suits the situation.
• After thefixation element200 and thesuperior facet prosthesis300 are selected and placed, they are locked to thevertebra100 by theenlarged head500. As shown inFIG. 24, theenlarged head500 in this embodiment has an internal connection feature520 and a hexagonal shaped external drive feature510 that is used to drive theenlarged head500 over thefixation element200 and against thesuperior facet prosthesis300. The specific shape of the external drive feature510 is dependent on the mating shape of the driver (not shown).
• Referring toFIG. 28, side and cross-sectional views illustrate six different embodiments of fixation elements, which are labeled A, B, C, D, E, and F. The figure shows a side view of each fixation element embodiment and a cross-sectional view of each embodiment to the right of the respective side view. To the left of the six embodiments is a representativeenlarged head500. Embodiment A is the threadedfixation element200 embodiment shown inFIGS. 26 and 27 and described above. Embodiments B through E are various designs of fixation elements with non-circular cross-sections. Embodiment B is a four rib cruciate design with fourlongitudinal fins285 configured to resist torsion when thefixation element200 is in thevertebra100. Embodiment C is an oval shaped cross-section design that is wider in thefirst direction286 than thesecond direction287 to resist torsion. If the width in thefirst direction286 is equal to the width in thesecond direction287, the cross-section shape becomes more of a circle andbone stabilization portion210 becomes more of a press-fit peg. Embodiment D is a square cross-section design with four approximatelyperpendicular sides288. Thecorners289 of thesides288 help to resist torsion. Embodiment E is a triangular cross-section design with threesides291 to resist torsion. Embodiment F is an anchor-like design that is driven into the vertebra, with the wire arches orbarbs290 being compressed against the host bone and applying a radial expansion force so as to lock the structure to the bone.
• Referring toFIG. 28A, side and cross-sectional views illustrate six more different embodiments of fixation elements, which are labeled G, H, I, J, K, and L.FIG. 28A shows a side view of each fixation element embodiment and a cross-sectional view of each embodiment to the right of the respective side view. Each embodiment has an attached or integrally formedenlarged head500′. Embodiment G is similar to the threadedfixation element200 embodiment shown inFIGS. 10, 11, 12 and 24 and described above. Embodiments H through K are various designs of fixation elements with non-circular cross-sections. Embodiment H is a four rib cruciate design with fourlongitudinal fins285 configured to resist torsion when the fixation element is in thevertebra100. Embodiment I is an oval shaped cross-section design that is wider in afirst direction286 than in asecond direction287 to resist torsion. If the width in thefirst direction286 is equal to the width in thesecond direction287, the cross-section shape becomes more of a circle and thebone stabilization portion210 becomes more of a press-fit peg. Embodiment J is a square cross-section design with four approximatelyperpendicular sides288. Thecorners289 of thesides288 help to resist torsion. Embodiment K is a triangular cross-section design with threesides291 to resist torsion.
• Embodiment L is an anchor-like design that is similar to Embodiment F inFIG. 28, but with an attached or integrally formedenlarged head500′. As embodiment L is driven into the vertebra, wire arches orbarbs290 are compressed and apply radial expansion force against the wall of the prepared bone and into thepedicle11, resulting in a locking anchor.
• FIG. 29 is a perspective view of a radially expandingfixation element600. The radially expandingfixation element600 comprises two main elements, anexpansion sleeve620 and acentral element610 that is inside of theexpansion sleeve620. The radially expandingfixation element600 is placed into thevertebra100 and then thecentral element610 is drawn outward relative to theexpansion sleeve620 resulting in radial expansion of thefixation element600. This is shown inFIG. 30.
• Referring toFIG. 30, side and bottom views illustrate thefixation element600 ofFIG. 29. As aproximal post630 of thecentral element610 is pulled axially along its longitudinal axis, and the expansion sleeve is held axially in the bone by compression fit,talons621 on theexpansion sleeve620 are radially expanded outward by amandrel660 on thecentral element610. The talons orfingers621 provide both torsional and axial stability to the radially expandingfixation element600. This provides a secure fixation element for fixation of the remaining implant components. Furthermore, expansion of thefixation element600 may cause thefixation element600 to center itself within thepedicle11.
• FIG. 31 is a perspective, cross-sectional view of across-pin element700 engaged with thefixation element200 to help secure thefixation element200 both torsionally and axially. Thecross-pin element700 is columnar in shape having adistal end710, a midsection730 (with a length along its longitudinal axis that is longer than its transverse cross-sectional width), and a proximal post720. Thedistal end710 is shaped to penetrate through bone tissue and into a cross hole280 formed in thefixation element200. Instrumentation (not shown) is used to align thecross-pin element700 with the cross-hole280 via fixation of the instrumentation to thedrive feature212 or thecannulation211 on thefixation element200 and alignment of the direction of insertion of thecross-pin element700 with the cross-hole280. Once thecross-pin element700 is in place in the bone and through thefixation element200, the torsional and axial stability of thefixation element200 is improved.
• The various embodiments of thefixation element200 described above and shown inFIG. 28 throughFIG. 31 function in conjunction with theenlarged head500 to hold theinferior facet prosthesis400 and/or thesuperior facet prosthesis300 to their respective resection surfaces112,113, and/or121. Various combinations of this modular implant will be described below and shown inFIGS. 32 through 37. Although these figures illustrate the use of thefixation element200 and theenlarged head500 as the mechanism for securing theprostheses300,400 to thevertebra100, other clamping devices such as the screw fastener17 (FIG. 10) may be used to mount theprostheses300,400 to the bone. For example, thescrew prostheses17 shown inFIGS. 10 through 12 may pass through either the opening324 (FIG. 22) in thesuperior facet prosthesis300 or the opening410 (FIG. 23) in theinferior facet prosthesis400 or through both of theseopenings324,410. The head of thescrew fastener17 acts as the securing mechanism by pressing theinferior facet prosthesis400 and thesuperior facet prosthesis300 against their respective resection surfaces112,113, and/or121.
• FIGS. 32 through 37 demonstrate different combinations of assemblies of facet replacement prostheses. The basic components of the prosthesis are thefixation element200, thesuperior facet prosthesis300, theinferior facet prosthesis400, and theenlarged head500. However, as described above, ascrew fastener17 can replace thefixation element200 and theenlarged head500.
• Referring toFIG. 32, a dorsal view illustrates three sequential layers of vertebrae. Atop vertebra101 is above amiddle vertebra102, and themiddle vertebra102 is above abottom vertebra103. Portions of some of the facets on the right side of the vertebrae are replaced by prostheses. With regard to the facet joint between thetop vertebra101 and themiddle vertebra102, aninferior facet prosthesis401 is articulating against asuperior facet prosthesis302 to form an artificial unilateral joint. The inferior facet of themiddle vertebra102 is replaced by aninferior facet prosthesis402 and the superior facet of thebottom vertebra103 is replaced bysuperior facet prosthesis303. Thus, a second unilateral prosthetic joint is formed that is also on the right side and is located at the level between themiddle vertebra102 and thebottom vertebra103.FIG. 32 demonstrates the difference in shape of theinferior facet prosthesis401 that is implanted around thefixation element201 without asuperior facet prosthesis300 and aninferior facet prosthesis402 that is implanted around afixation element202 and over asuperior facet prosthesis302. The opening410 (not visible) of theinferior facet prosthesis401 on thetop vertebra101 in this assembly is offset more laterally than the opening410 (not visible) in theinferior facet prosthesis402 for themiddle vertebra102. This is because thefixation element201 is implanted more laterally on thetop vertebra101 to preserve more of the superior facet since it is not replaced by a prosthesis at this level.
• Referring toFIG. 33, a dorsal view illustrates thetop vertebra101 in intact form, without resection of the facets. Portions of both the superior and inferior facets on the right side of themiddle vertebra102 are replaced by asuperior facet prosthesis302 and aninferior facet prosthesis402. Only the right superior facet of thebottom vertebra103 is replaced (i.e., by a superior facet prosthesis303) inFIG. 33. Thus, a hemiarthroplasty replacement has been performed on the right facet joint between thetop vertebra101 and themiddle vertebra102 and a unilateral replacement has been performed between themiddle vertebra102 and thebottom vertebra103. The assembly shown inFIG. 33 demonstrates how thesuperior facet prosthesis302 can articulate against the naturalinferior facet6 and thesuperior facet prosthesis303 can articulate against theinferior facet prosthesis402.
• FIG. 34 is a dorsal view illustrating how theinferior facet prosthesis401 can articulate against the naturalsuperior facet43, or theinferior facet prosthesis402 can articulate against thesuperior facet prosthesis303. The right facet joint between thetop vertebra101 and themiddle vertebra102 is a hemiarthroplasty replacement with the inferior facet replaced by theinferior facet prosthesis401. The right facet joint between themiddle vertebra102 and thebottom vertebra103 is a unilateral replacement with the inferior facet replaced by theinferior facet prosthesis402 and the superior facet of thebottom vertebra103 replaced by thesuperior facet prosthesis303.
• Referring toFIG. 35, a dorsal view shows another example of how thesuperior facet prosthesis303 can articulate against the naturalinferior facet6 or thesuperior facet prosthesis302 can articulate against theinferior facet prosthesis401. In this assembly of the implant, the right side between thetop vertebra101 and themiddle vertebra102 is a unilateral replacement and the right side between themiddle vertebra102 and thebottom vertebra103 is a hemiarthroplasty replacement.
• Referring toFIG. 36, a dorsal view shows another example of how theinferior facet prosthesis402 can articulate against the naturalsuperior facet43, or theinferior facet prosthesis401 can articulate against thesuperior facet prosthesis302. The right facet joint between thetop vertebra101 and themiddle vertebra102 is a unilateral replacement with the inferior facet of thetop vertebra101 replaced by theinferior facet prosthesis401 and the superior facet of themiddle vertebra102 replaced by thesuperior facet prosthesis302. The right facet joint between themiddle vertebra102 and thebottom vertebra103 is a hemiarthroplasty replacement with the inferior facet replaced by theinferior facet prosthesis402.
• Referring toFIG. 37, a dorsal view illustrates only one level, that between themiddle vertebra102 and thebottom vertebra103, being replaced on the right side. The right facet joint between themiddle vertebra102 and thebottom vertebra103 is a unilateral replacement with the inferior facet of themiddle vertebra102 replaced by theinferior facet prosthesis402 and the superior facet of thebottom vertebra103 replaced by thesuperior facet prosthesis303.
• FIG. 38 andFIG. 39 show two embodiments of the superior facet prosthesis. InFIG. 38, a perspective view illustrates an embodiment in which a curvedsuperior facet prosthesis305 with a curved articulatingcomponent330 has a curved articulatingsurface331. This curved articulatingsurface331 allows for a more distributed contact load between an inferior facet prosthesis, such as theinferior facet prosthesis400 ofFIG. 23, and the curved articulatingsurface331. This allows slightly more flexibility in the position that the surgeon places the curvedsuperior facet prosthesis305 than thesuperior facet prosthesis300 previously described. The articulatingsurface321 of thesuperior facet prosthesis300 previously described is relatively flat. The articulatingsurface331 of the curvedsuperior facet prosthesis305 is curved. Since the bearing portion of theinferior facet prosthesis400 is columnar, the two prosthesis can be aligned on a slight mismatch and make more of an anatomic contact if the articulated surface is curved as inFIG. 38.
• Referring toFIG. 39 a perspective view illustrates a bone ingrowth feature390 on asuperior facet prosthesis306. The bone ingrowth feature390 can be any surface that allows bone to grow into the implant between thefirst resection surface112 of thevertebra100 and theapposition surface322 of the implant. Examples of bone ingrowth features390 include porous coating of beads or meshes, electrochemically etched shapes and porous pads pressed onto the implant surface made from tantalum, titanium, cobalt chrome alloys and/or other biocompatible material such as hydroxylapatite or calcium phosphate ceramics.
• Referring toFIG. 40, a perspective view shows theinferior facet prosthesis400, which is formed in the general shape of a finger or talon. More particularly, theinferior facet prosthesis400 is formed with aflange420 on its superior side shaped to fit between theenlarged head500 and either thesuperior facet prosthesis300 or thefirst resection surface112. Theflange420 has anopening410 that is dimensioned to allow theinferior facet prosthesis400 to fit over theproximal post230 of thefixation element200 and around theshaft portion240 of thefixation element200. Theinferior facet prosthesis400 also has aninferior portion450 on the opposite side of theflange420 that has abone apposition side440 that is shaped to contact the surface of the inferior facet resection surface121 (FIG. 19) and ajoint articulation side430 that is shaped to articulate against a natural or prosthetic superior facet.
• Referring toFIG. 41, a perspective view shows aninferior facet prosthesis460 also formed in the general shape of a finger or talon. Theinferior facet prosthesis460 is formed with asuperior end420 having anopening410 that is dimensioned and shaped to accept thefixation element200. Theinferior facet prosthesis460 is generally columnar in shape, having a curved length designed to conform to the prepared anatomy of thevertebra100. Theinferior facet prosthesis460 ofFIG. 41 has aninferior portion470, which is shown opposite thesuperior end420, and slightly medially offset from thesuperior end420. This medial offset of theopening410 relative to theinferior portion470 allows theinferior facet prosthesis400 to be anchored to the bone by thefixation element200 and secured to the bone by theenlarged head500, or thesuperior facet prosthesis300 in combination with theenlarged head500, at an anatomical position that allows optimal bone fixation. Theinferior facet prosthesis460 ofFIG. 41 has abone ingrowth surface441 and a joint articulatingside430 on itsinferior end470. In this embodiment, thebone ingrowth surface441 is a textured structure that permits bone cells to grow into the implant surface. The shape of thebone ingrowth surface441 can be a uniform textured surface as shown inFIG. 41, or can be a non-uniform randomized structure such as a open cell foam structure, a porous beaded structure, a wire mesh structure, an electrochemical etched structure, or other bone ingrowth structures known in the design of orthopedic implants. Thebone ingrowth surface441 is shaped to mate with the inferior resectedbone surface121 shown inFIG. 19 andFIG. 20.
• FIG. 42 shows an exploded, perspective view of thevertebra100 with thesuperior facet prosthesis300 installed. Anadditional locking washer800 is used to assist in stabilizing the attachment of thesuperior facet prosthesis300 to thefirst resection surface112. The construction of the implant assembly shown inFIG. 42 is similar to that of the assembly shown inFIG. 25 with the addition of the lockingwasher800 that is placed over and around theproximal post230 of thefixation element200.
• Referring toFIG. 43, a perspective view shows the same implant ofFIG. 42 with theenlarged head500 locked onto thefixation element200 and pushing the lockingwasher800 against thesuperior facet prosthesis300 and into the bone tissue. This added bone penetration of the lockingwasher800 helps to fix thesuperior prosthesis300 such that the entire assembly is more mechanically stable with respect to thevertebra100.
• FIG. 43 shows a further step in, the assembly of the implant construct described inFIG. 42. InFIG. 43, the lockingwasher800 is secured over thefixation element200 and into the bone tissue by theenlarged head500. Although this embodiment of the lockingwasher800 is only shown with thesuperior facet prosthesis300, the lockingwasher800 can alternatively be used to mechanically secure theinferior facet prosthesis400, or the combination of theinferior facet prosthesis400 and thesuperior facet prosthesis300. In the embodiment of the lockingwasher800 shown inFIG. 42 andFIG. 43, the lockingwasher800 is placed over thesuperior facet prosthesis300. However, the lockingwasher800 may be placed under thesuperior facet prosthesis300, under theinferior facet prosthesis400 and thesuperior facet prosthesis300, or between thesuperior facet prosthesis300 and theinferior facet prosthesis400 to stabilize the implant construct.
• FIG. 44 shows a perspective view of the lockingwasher800. The lockingwasher800 has abody805 with anopening810 that is dimensioned to fit over theproximal post230 of thefixation element200. The lockingwasher800 also has ananti-rotation feature820 that mates with either thesuperior facet prosthesis300 or theinferior facet prosthesis400 or a combination of both theinferior facet prosthesis400 and thesuperior facet prosthesis400. Theanti-rotation feature820 shown in this embodiment is a flat surface, however, any feature that would rotationally constrain the lockingwasher800 to the other components of the implant (such as a tab, groove, taper or other geometric shape) can be formed on the lockingwasher800 as an anti-rotation feature. The lockingwasher800 also hasprongs830 that pass into the bone tissue of thevertebra100 to help stabilize the implant construct. Theprongs830 in this embodiment of the lockingwasher800 are elongated protrusions that taper to atissue penetration tip840. The prongs havesidewalls850 that provide a surface to resist torsion once the lockingwasher800 penetrates the bone tissue. Theprongs830 may also be simple spikes that are either symmetrical or asymmetrical in cross-section that protrude from the lockingwasher body805. The shape and length of the lockingwasher prongs830 are dependent on how the lockingwasher800 is used. Theprongs830 of the lockingwasher800 that holds only one of theinferior facet prosthesis400 or thesuperior facet prosthesis300 to thevertebra100 may be shorter than prongs of a locking washer that holds both theinferior facet prosthesis400 and thesuperior facet prosthesis300 to thevertebra100.
• FIG. 45 shows a perspective view of thesuperior facet prosthesis300 andinferior facet prosthesis400 held to thevertebra100 by an adjunctive flexible fixation element900 and a secondaryflexible fixation element910. These flexible fixation elements900 and/or910 may be made from such constructs as suture, braided cable, wire, ribbon, and/or other constructs that have longer lengths than cross-sections and withstand larger loads in tension than in compression. The flexible fixation elements900 and/or910 may be manufactured from biocompatible metals, alloys such as cobalt chrome alloys, titanium alloys, stainless steel alloys, polymers, bioabsorbable materials, composites, or other materials that are biocompatible and can be formed into a flexible element structure900 and/or910 such as those shown inFIG. 45. The adjunctive flexible element900 shown inFIG. 45 is shown attached to and securing theelongated head500. A flexible element attachment portion580 (e.g., including an opening) mates the flexible element900 to the elongated head. However, the adjunctive flexible fixation element900 may alternatively or additionally be attached to thefixation element200, thesuperior facet prosthesis300, theinferior facet prosthesis400 or any combination of the above listed elements. A flexible fixation attachment portion480 (e.g., including an opening) in theinferior facet prosthesis400 allows the secondaryflexible fixation element910 to secure theinferior facet prostheses400 to thevertebra100. The flexible fixation elements900 and/or910 may be secured to thevertebra100 by physically wrapping them around anatomic features such as theposterior arch35, thespinous process46,transverse process105, or a combination of these anatomic features. The flexible element900 and the secondaryflexible element910 may also be secured to thevertebra100 by bone anchors such as anchors designed to anchor flexible fixation elements (such as suture, not shown) to bone. Suture anchors such as threaded suture anchors, barbed suture anchors, toggle suture anchors or any other means of anchoring a flexible fixation element to bone may be used to anchor the flexible fixation element900 and/or the secondaryflexible fixation element910 to thevertebra100.
• FIG. 46 is a dorsal view of a bilateralinferior facet prosthesis1000. The bilateralinferior facet prosthesis1000 is a one-piece inferior facet prosthesis that has both a rightinferior side1040 and a leftinferior side1020 connected by a stabilizingbar1010. Both the rightinferior side1040 and the leftinferior side1020 are designed to fix to thetop vertebra101 at the respective inferior resection surface121 (FIG. 19) and at thefirst resection surface112. The bilateralinferior facet prosthesis1000 allows replacement of both the left and the right inferior facets. In this embodiment, the bilateralinferior facet prosthesis1000 is placed over the left andright fixation elements200 which extend into the bone of thetop vertebra101. In the embodiment shown inFIG. 46, the rightinferior side1040 is articulating against the rightsuperior facet prosthesis300 attached to thebottom vertebra102. Also in this embodiment, the leftinferior side1020 is articulating against the left naturalsuperior facet43 of thebottom vertebra102. The stabilizingbar1010 of the bilateralinferior prosthesis1000 is designed to stabilize theleft side1020 and theright side1040 so that they are secure.
• FIG. 47 illustrates a perspective view of asuperior facet prosthesis1100 coupled to thevertebra3. Thesuperior facet prosthesis1100 has a bone apposition surface (not shown) that has been placed on afirst resection surface1112 and an opening (not shown) in aflange1116 that surrounds afixation element1110, and coupled thereto by a locking fastener such as acastle nut1114 or the like. Thesuperior facet prosthesis1100 has a superiorfacet articulating component1120 with an articulatingsurface1122 generally adjacent to theflange1116. The articulatingsurface1122 is oriented in a direction that faces approximately the same direction that the original anatomic superior articulating surface faced prior to resection. This orientation of the articulatingsurface1122 allows thesuperior facet prosthesis1100 to function as either a hemiarthroplasty implant by articulating against a natural anatomicinferior facet6 or as a unilateral prosthesis by articulating against an inferior facet prosthesis on the vertebra superior (cephalad) to it, such as the inferior facet prosthesis4 shown inFIG. 5, theinferior facet prostheses10 shown inFIGS. 8 and 9, and theinferior facet prosthesis400 shown inFIG. 40, as well as those described below.
• Thefacet articulating component1120 is preferably formed in the general shape of a blade or wing ear, wherein the articulatingsurface1122 has a concave shape. In the embodiment shown, the articulatingsurface1122 curves from an orientation generally perpendicular to theflange1116 towards an orientation generally parallel to theflange1116 from adistal end1124 thereof to aproximal end1126 thereof.
• The concave shape of the articulatingsurface1122 provides more tolerance for a miss-match with the natural anatomicinferior facet6 or with the inferior facet prosthesis4 on the vertebra superior to it. Functionally, the clearance between the concave shape of the articulatingsurface1122 and the adjacentinferior facet6 or inferior facet prosthesis4 increases as the patient bends forward (flexion) and decreases as the patient bends backward (extension). Thus in flexion the patient has more facet movement allowing for more torsion (twisting) and lateral bending (side to side movement) than in a neutral stance. As the patient extends, the articulating members are more constrained in torsion and lateral bending. This mimics the natural anatomic constraints of the spinal facets.
• FIG. 48 is a perspective view of the same construct shown inFIG. 47, but with the implants and thevertebra3 cut by across-sectioning plane1130 placed along an axis that passes through the center of thefixation element1110. Thecross-section plane1130 shown cutting through thevertebra3 and the implant ofFIG. 47 is shown for visualization purposes to illustrate, using a cross-sectioned view, how thevertebra3,fixation element1110, andsuperior facet prosthesis1100 engage each other.
• Thefixation element1110 provides a mechanism that affixes thesuperior facet prosthesis1100 tovertebra3.Fixation element1110 is implanted into the interior bone space of the left pedicle11 (FIG. 6) on thevertebra3 and may or may not extend into the vertebral body ofvertebra3 to provide additional stability. Thefixation element1110 can take the form of a screw (as shown), or any of the devices shown inFIGS. 28-30. Thefixation element1110 has adrive feature1140, which is an internal hex in the embodiment shown inFIG. 48. However, any shape of drive feature that transmits the loads necessary to drive thefixation element1110 into thevertebra3 can be formed on aproximal post1142 of thefixation element1110.
• The depth of thedrive feature1140 formed in theproximal post1142 of thefixation element1110 is seen in the cross-sectional view ofFIG. 48. Thedrive feature1140 may be an internal drive feature such as the hex socket shown in this embodiment, or an external drive feature with geometry on the periphery of theproximal post1142 of thefixation element1110 that engages with a corresponding internal drive feature on a driver tool (not shown). Theflange1116 of thesuperior facet prosthesis1100 is secured to thefixation element1110 by thecastle nut1114 or the like.
• Theflange1116 of thesuperior facet prosthesis1100 includes acoupling portion1144 having a generally semisphericalbone engaging surface1150 on the apposition side of thesuperior facet prosthesis1100 that engages a correspondingsemispherical resection1146 in the bone bed of the pedicle ofvertebra3. The term “semispherical” relates to a surface that includes some sectorial portion of a sphere, which may be less than a hemisphere. A semispherical surface may be concave or convex. A surface that is semispherical or generally semispherical may have some deviations from a precise semispherical shape.
• Thesemispherical resection1146 may be said to be “inversely shaped” with respect to the coupling portion because thesemispherical resection1146 has a generally concave surface that matches the generally convex surface of thecoupling portion1144. Although thecoupling portion1144 and thesemispherical resection1146 are semispherical in the embodiment ofFIGS. 47 and 48, in alternative embodiments, they may have a variety of other matched shapes, including three-dimensional parabolas, ellipsoids, and other regularly or irregularly curved or flat-sided shapes. Furthermore, although thecoupling portion1144 is convex and thesemispherical resection1146 is concave in the embodiment ofFIGS. 47 and 48, in alternative embodiments, the shapes may be reversed so that a coupling portion is concave and a resection is convex.
• In the embodiment ofFIGS. 47 and 48, thecoupling portion1144 is integrally formed with the articulatingsurface1122 of the superiorfacet articulating component1120. Thecoupling portion1144 may be said to be “attached to” the articulatingsurface1122 because in this application, the term “attached” is used broadly to include parts that are integrally formed with each other as well as parts that are formed separately and subsequently coupled together.
• Thesemispherical resection1146 in the bone bed allows for less transverse process to be resected (vs. a flat bone bed resection). Thesemipherical resection1146 in the bone bed also allows for more stable support of thesuperior facet prosthesis1100, than does a flat bone bed resection, as thesuperior facet prosthesis1100 is polyaxially supported in such a way as to resist any shear forces applied between thesemispherical resection1146 and thecoupling portion1144. In this application, “polyaxial” refers to a linear or angular force or motion acting with respect to at least two perpendicular axes. Thecoupling portion1144 may seat directly against thesemispherical resection1146. In this application, an item that “seats directly against” another is positioned to abut the other item so that surfaces of the two items are in contact with each other.
• Thecoupling portion1144 has a fixationelement receiving aperture1148 that can be made slightly larger than a circumferential diameter of thefixation element1110 taken in a direction perpendicular to a longitudinal axis thereof to provide accurate polyaxial seating of theimplant1100 in relation to the resected bone bed andfixation element1110, as well as to provide increased tolerance for miss-match. An implant engaging end1154 of the castle nut1114 (or other fastener) also has a semispherical shape for engaging a semispherical nut engaging side of thecoupling portion1144 of thesuperior facet prosthesis1100 at the final position of thesuperior facet prosthesis1100.
• The semispherical shape of thecoupling portion1144 enables thecoupling portion1144 to move polyaxially against thesemispherical resection1146. Movement “against” the semispherical resection refers to movement in which thecoupling portion1144 remains substantially continuously in contact with thesemispherical resection1146 so as to slide against thesemispherical resection1146. Accordingly, during installation, a surgeon can position thecoupling portion1144 against thesemispherical resection1146 and then pivot thecoupling portion1144 along three perpendicular axes, without removing thecoupling portion1144 from thesemispherical resection1146. Thecoupling portion1144 simply rotates against thesemispherical resection1146.
• The phrase “polyaxial motion” refers to any combination of translation and/or rotation along at least two perpendicular axes. Since thecoupling portion1144 is pivotable with respect to thesemispherical resection1146 along three perpendicular axes, thecoupling portion1144 is “tri-axially pivotable” with respect to thesemispherical resection1146.
• When thesuperior facet prosthesis1100 has been rotated to the proper orientation, the articulatingsurface1122 is positioned for proper articulation against the corresponding inferior facet or inferior facet prosthesis. The orientation of thecoupling portion1144 may then be fixed with respect to thesemispherical resection1146 by tightening the castle nut1114 (or another fastener) on thefixation element1110, thereby firmly gripping thecoupling portion1144 against thesemispherical resection1146. Accordingly, thecoupling portion1144 is “selectively polyaxially movable” with respect to thesemispherical resection1146 because thecoupling portion1144 is movable with respect to thesemispherical resection1146 along multiple perpendicular axes until the surgeon decides to fix its disposition.
• In alternative embodiments (not shown) of the invention, tri-axial pivotal movement need not be provided. Rather, a coupling portion and a corresponding resection surface may have a cylindrical, flat-sided, splined, or other shape designed to enable relative translation in addition to or in place of rotation. In place of the fixationelement receiving aperture1148, an elongated fixation element receiving aperture may be used to accommodate relative translation between the coupling portion and a fixation element. Alternatively, a coupling portion and a resection surface may be shaped to provide relative pivotal motion along only one or two axes.
• In an alternative embodiment the implant engaging end1154 of the castle nut1114 (or other fastener) can be deformable such that the implant engaging end1154 conforms under pressure to the adjacent surface of thecoupling portion1144 regardless of the angle of the surface with respect to the axis of thecastle nut1114. The deformable end can be formed of a plastic such as polyethylene attached to the metal body of thecastle nut1114, but is preferably formed of a substance that hardens over time, such as a fast-curing and biocompatible resin or a material that is heated prior to insertion into the patient and hardens upon cooling to the patient's body temperature. The material that hardens over time provides more stability than the deformable material, though both provide acceptable results.
• FIG. 48 also shows anangled resection1112 and corresponding angled flat1156 on the apposition side of thesuperior facet prosthesis1100 in combination with thesemispherical resection1148.
• The surfaces of the apposition side of thecoupling portion1144 and flat1156, as well asfixation element1110, may or may not include porous coatings to facilitate bone ingrowth to enhance the long-term fixation of the implant. Furthermore, such porous coatings may or may not include osteoinductive or osteoconductive substances to further enhance the bone remodeling into the porous coating.
• FIG. 49 shows a perspective view of thevertebra3 with afixation element1110 portion implant placed through thesemispherical resection1146 in theresection surface1112 and into the bone of thepedicle11. Thefixation element1110 is aligned and placed into thepedicle11 in a manner similar to that of other pedicle screws for posterior stabilization vertebrae fusion procedures.
• InFIG. 50, a perspective view illustrates thesuperior facet prosthesis1100 in place around thefixation element1110. Thecastle nut1114 has not yet been installed. As shown, thecoupling portion1144 has a semisphericalnut engaging surface1152.
• FIG. 51 is a top view of thesuperior facet prosthesis1100, particularly showing the curved shape of the articulatingsurface1122 and the semisphericalbone engaging surface1150 of thecoupling portion1144. Additionally,FIG. 51 more clearly illustrates the angled flat1156 on the apposition side of thesuperior facet prosthesis1100.
• FIG. 52 is an illustration of a rear view of thesuperior facet prosthesis1100. In this context, “rear” means as viewed from along the axis of the fixationelement receiving aperture1148.FIG. 52 particularly shows the curved shape of the articulatingsurface1122 and the semisphericalnut engaging surface1152 of thecoupling portion1144.
• FIG. 53A shows a kit including a plurality of differently configuredsuperior facet prostheses1100,1162,1164,1166,1168. View A is a rear view of thesuperior facet prostheses1100,1162,1164,1166,1168, while View B illustrates a perspective view of the laterallyadjacent prosthesis1100,1162,1164,1166,1168 rotated 90°. As shown, thesuperior facet prostheses1100,1162,1164,1166,1168 have differing physical dimensions.
• Referring again toFIG. 51, which shows a singlesuperior facet prosthesis1100, some of the physical dimensions that change between the differently sizessuperior facet prostheses1100,1162,1164,1166,1168 in the kit (FIG. 53A) are a resection angle (α), an x offset (X₁), a y offset (Y₁), a facet angle (β), and a facet articulation radius (R). Exemplary values for the foregoing will be provided below. Although the exemplary values relate primarily to L5 superior and L4 inferior, they may apply to other combinations of vertebrae in the lower back and/or the sacrum. One or more of these variables can change between the different superior facet prosthesis sizes.
• P1 is the most medial and anterior point on the articulatingsurface1122. Thesuperior pedicle axis1170 is the axis that is colinear with the longitudinal axis of thefixation element1110 that is positioned through thepedicle11 nearest to the resected superior facet (not shown). Thesuperior pedicle axis1170 extends through a saddle point S1, which is offset as shown, by an offset1176, which may be about 2 mm, from the fixationelement receiving aperture1148. Thesuperior pedicle axis1170 is parallel with the direction of the y offset (Y₁). The direction of the x offset (X₁) is perpendicular to the direction of the y offset (Y₁). The direction of the x offset (X₁) is generally, but not precisely, lateral to medial with respect to the central axis of the patient's spine.
• P4 is the most posterior point on the articulatingsurface1122. As shown, P4 is displaced from the saddle point S1 by an x offset (X₄) and a y offset (Y₄). The direction of the X₄offset is parallel to that of the X₁offset, and the direction of the Y₄offset is parallel to that of the Y₁offset.
• The resection angle (α) for thesuperior facet prostheses1100 can range from 5° to 85°. However, the optimal range of the resection angle (α) for the majority of patients will range from 30° to 70°. Thus, by way of example, a family containing nine sets ofsuperior facet prostheses1100 can be provided with the resection angles (α) varying in increments of 5°. Sets ofsuperior facet prostheses1100 would be provided with resection angles (α) at 30°, 35°. 40°, 45°, 50°, 55°, 60°, 65° and 70°.
• The x offset (X₁) for thesuperior facet prosthesis1100 can range from 5 mm to 30 mm. However, for the majority of patients, the x offset (X₁) will range from 10 mm to 20 mm. Therefore a family ofsuperior facet prostheses1100 can be provided with the x offset (X₁) varying in increments of 5 mm. Thus, sets ofsuperior facet prostheses1100 would be provided with x offset (X₁) at 10 mm, 12 mm, 14 mm, 16 mm, 18 mm, and 20 mm to providesuperior facet prostheses1100 that cover the statistical range for the majority of the population of patients needingsuperior facet prostheses1100.
• The y offset (Y₁) for thesuperior facet prosthesis1100 can range from 2 mm to 20 mm. However, for the majority of patients, the y offset (Y₁) will range from 5 mm to 15 mm. Therefore a family ofsuperior facet prostheses1100 can be provided with the y offset (Y₁) varying in increments of 2 mm. Thus, sets ofsuperior facet prostheses1100 would be provided with y offset (Y₁) at 5 mm, 7 mm, 9 mm, 11 mm, 13 mm, and 15 mm to providesuperior facet prostheses1100 that cover the statistical range for the majority of the population of patients needingsuperior facet prostheses1100.
• The x offset (X₄) for thesuperior facet prosthesis1100 can range from about 5 mm to about 25 mm. However, for the majority of patients, X₄will range from about 8 mm to about 20 mm. A family of superior facet prostheses may be provided with X₄values varying in increments of 2 mm. Thus, sets ofsuperior facet prostheses1100 would be provided with X₄values of 8 mm, 10 mm, 12 mm, 14 mm, 16 mm, 18 mm, and 20 mm to providesuperior facet prostheses1100 that cover the statistical range for the majority of the population of patients needingsuperior facet prostheses1100.
• The y offset (Y₄) for thesuperior facet prosthesis1100 can range from about −5 to about 15 mm. However, for the majority of patients, Y₄will range from about −2 mm to about 10 mm. A family of superior facet prostheses may be provided with Y₄values varying in increments of 2 mm. Thus, sets ofsuperior facet prostheses1100 would be provided with Y₄values of −2 mm, 0 mm, 2 mm, 4 mm, 6 mm, 8 mm, and 10 mm to providesuperior facet prostheses1100 that cover the statistical range for the majority of the population of patients needingsuperior facet prostheses1100.
• The facet angle (β) for thesuperior facet prosthesis1100 can range from 50° to 120°. However, for the majority of patients, the facet angle (β) will range from 60° to 100°. Therefore a family ofsuperior facet prostheses1100 can be provided with the facet angle (β) varying in increments of 5°. Thus, sets ofsuperior facet prostheses1100 would be provided with the angle (β) at 60°, 65°, 70°, 75°, 80°, 85°, 90°, 95°, and 100° to providesuperior facet prostheses1100 that cover the statistical range for the majority of the population of patients needingsuperior facet prostheses1100.
• Once the surgeon assesses the anatomy of the superior facet that is being replaced, a particularsuperior facet prosthesis1100 is selected that has the curvature and overall angle of the articulatingsurface1122, with respect to theflange1116 that best fits the anatomy of the level of vertebra, the left or right side, and the size of the patient's anatomy being replaced. Thus a kit containing various sizes and shapes ofsuperior facet prostheses1100 is provided to the surgeon and the surgeon selects thesuperior facet prosthesis1100 that best suits the situation.
• According to one example, such a kit may contain nine prostheses, which may be dimensioned to provide a variety of combinations of values for α, X₁, Y₁, β, X₄, Y₄, and R, within the ranges listed above. If desired, one or more of the above-listed variables may remain constant over the entire kit. For example, R may have a constant value, such as 11.5 mm, for all members of the kit.
• Theprostheses1100,1162,1164,1166,1168 of the kit ofFIG. 53A are not simply scaled up or down, but are varied according to a number of carefully selected parameters to cover the vast majority of morphologies occurring in the L5 vertebra. In a similar manner, a plurality of inferior facet prostheses adapted to replace inferior facets can be provided either as a separate kit, or in combination with the kit ofFIG. 53A. Such a kit will be shown and described in connection withFIG. 53D.
• FIGS. 53B and 53C illustrate top and side views, respectively, of an exemplary inferior facet prosthesis1172. The inferior facet prosthesis1172 has an x offset (X), a y offset (Y), and a z offset (Z), which are illustrated inFIGS. 53B and 53C. As shown, the offsets X, Y, and Z run between a saddle point S1 of the inferior facet prosthesis1172 and a center point C1 of thearticulation surface1174. The saddle point S1 ofFIGS. 53B and 53C is defined in a manner similar to that of thesuperior facet prosthesis1100 ofFIG. 51.
• As shown inFIGS. 53B and 53C, the inferior facet prosthesis1172 has a semispherical coupling portion similar to thecoupling portion1144 of thesuperior facet prosthesis1100 introduced in the description ofFIG. 47. Accordingly, the inferior facet prosthesis1172 provides the same type of tri-axial pivotal motion during installation as thecoupling portion1144, as described previously. The coupling portion of the inferior facet prosthesis1172 may also be nested in thecoupling portion1144 of thesuperior facet prosthesis1100, or vice versa, to enable independent polyaxial adjustment of theprostheses1100,1170 when positioned in engagement with a singlesemispherical resection1146.
• Referring toFIG. 53D, a perspective view illustrates a kit ofinferior facet prostheses1180,1182,1184,1186,1188,1190. Again, the physical dimensions can vary between the variousinferior facet prostheses1180 in the kit ofFIG. 53D. These dimensions may include an inferior resection angle (Iα), an inferior x offset (X), an inferior y offset (Y), an inferior facet angle (Iβ), an inferior facet articulation radius (IR), and an inferior z offset (Z, from the center of fixation to the center of the articulation radius).
• The inferior resection angle Iα is the angle of the flat resection to be made in the vertebra, for example, thevertebra101 illustrated in some of the preceding drawings, to serve as a backing for the articulating surface of the selectedinferior facet prosthesis1180,1182,1184,1186,1188, or1190. When measured according to the coordinate system established for thesuperior facet prosthesis1100, as illustrated inFIG. 51, the inferior resection angle Iα may be approximately the same as the facet angle β for thesuperior prosthesis1100 because the articulation surfaces1122,1174 are to be positioned generally parallel to each other. Due to the clearance between the articulatingsurfaces1122,1174 and the generally concave and convex shapes thereof, as long as the selectedinferior facet prosthesis1180,1182,1184,1186,1188, or1190 is placed so that the articulatingsurfaces1122,1174 are generally parallel to each other, proper articulation may be expected to occur.
• Thus, theinferior facet prosthesis1180,1182,1184,1186,1188, or1190 may be dimensioned such that Iα is nearly the same as β, and the orientation of the articulatingsurface1174 may be adjusted as needed to permit theinferior facet prosthesis1180,1182,1184,1186,1188, or1190 to be attached to thecorresponding vertebra101. Accordingly, Iα need not be determined based on measurement of thevertebra101, but may instead be inferred based on the selection of thesuperior facet prosthesis1100,1162,1164,1166, or1168 and adjusted during installation.
• The inferior facet angle Iβ may be defined as the angle of the surface to which the articulatingsurface1174 is most nearly parallel. Due to the shape of theinferior facet prostheses1180,1182,1184,1186,1188, or1190, this angle is the same as the inferior resection angle Iα, when measured according to the coordinate system of thesuperior facet prosthesis1100 ofFIG. 51.
• Theinferior pedicle axis1170 is the axis that is collinear with the longitudinal axis of thefixation element1110 that is positioned through thepedicle11 nearest to the resected inferior facet (not shown). This axis is parallel with the direction of the inferior y offset (Y). The direction of the inferior x offset (X) is perpendicular to the direction of the inferior y offset (Y). The direction of the inferior x offset (X) is generally lateral to medial with respect to the central axis of the patient's spine. The direction of the inferior y offset (Y) is generally anterior to posterior. The direction of the inferior z offset (Z) is generally cephalad to caudal.
• The inferior x offset (X) for theinferior facet prosthesis1180 can range from 0 mm to 20 mm. However, for the majority of patients, the inferior x offset (X) will range from 2 mm to 16 mm. Therefore a family ofinferior facet prostheses1180 can be provided with the inferior x offset (X) varying in increments of 2 mm. Thus, sets ofinferior facet prostheses1180 would be provided with inferior x offset (X) at 2 mm, 4 mm, 6 mm, 8 mm, 10 mm, 12 mm, 14 mm, and 16 mm to provideinferior facet prostheses1180 that cover the statistical range for the majority of the population of patients needinginferior facet prostheses1180.
• The inferior y offset (Y) for theinferior facet prosthesis1180 can range from −15 mm to 5 mm. However, for the majority of patients, the inferior y offset (Y) will range from −12 mm to 4 mm. Therefore a family ofinferior facet prostheses1180 can be provided with the inferior y offset (Y) varying in increments of 2 mm. Thus, sets ofinferior facet prostheses1180 would be provided with inferior y offset (Y) at −12 mm, −10 mm, −8 mm, −6 mm, −4 mm, −2 mm, 0 mm, 2 mm, and 4 mm to provideinferior facet prostheses1180 that cover the statistical range for the majority of the population of patients needinginferior facet prostheses1180.
• The inferior facet articulation radius (IR) for theinferior facet prosthesis1180 can range from 5 mm to 30 mm. However, for the majority of patients, the inferior facet articulation radius (IR) will range from 10 mm to 15 mm. A family of incremented inferior prostheses may be provided to cover the aforementioned range. Alternatively, the inferior facet articulation radius (IR) may be set at a given value, for example, 12 mm, and such a value may be used in substantially all cases.
• The inferior z offset (Z) for theinferior facet prosthesis1180 can range from 20 mm to 40 mm. However, for the majority of patients, the inferior z offset (Z) will range from 25 mm to 31 mm. Therefore a family ofinferior facet prostheses1180 can be provided with the inferior z offset (Z) varying in increments of 1 mm. Thus, sets ofinferior facet prostheses1180 would be provided with inferior z offset (Z) at 25 mm, 26 mm, 27 mm, 28 mm, 29 mm, 30 mm, and 31 mm to provideinferior facet prostheses1180 that cover the statistical range for the majority of the population of patients needinginferior facet prostheses1180.
• If desired, a kit having ten inferior facet prostheses may be assembled. Like theprostheses1100,1162,1164,1166,1168 of the kit ofFIG. 53A, theprostheses1180,1182,1184,1186,1188,1190 ofFIG. 53D are not simply scaled up or down, but are varied according to a number of carefully selected parameters to cover the vast majority of morphologies occurring in the L4 vertebra and/or other vertebrae.
• The parameters of theprostheses1100,1162,1164,1166,1168 ofFIG. 53A and/or theprostheses1180,1182,1184,1186,1188,1190 ofFIG. 53D may include at least two dimensions that vary among the members of the kit independently of each other. Dimensions that vary independently of each other need not change according to any established relationship between the dimensions, but instead, one may change while the other remains the same between any two prostheses of the kit.
• FIG. 53E is a perspective view illustrating how asuperior facet prosthesis1100 and aninferior facet prosthesis1180 fit together. The surgeon selects an inferior facet prosthesis that, in addition to most adequately meeting the anatomy of the patient, has an articulating surface adapted for articulating with the articulating surface of the superior facet prosthesis selected.
• FIG. 53F is a dorsal view of asuperior facet prosthesis1100 and aninferior facet prosthesis1204 attached to the L5 and L4lumbar vertebrae102,101. InFIG. 53F, thesuperior facet prosthesis1100 is attached to the left side of theL5 vertebra102 and theinferior facet prosthesis1204 is attached to theleft L4 vertebra101. The twoprostheses1100,1204 are positioned on respective bone resections and oriented such that they articulate together through the range of motion naturally exhibited between the L4 andL5 vertebrae1100,1204. This range of motion includes flexion-extension, lateral left and right bending, torsion along a sagittal axis and combinations and coupling of all these ranges of motion.
• FIG. 53F shows theprostheses1100,1204 andvertebrae101,102 in a natural position. Thearticulation surface1174 of theinferior prosthesis1204 and thearticulation surface1122 of thesuperior prosthesis1100 are in contact in the neutral position. However, theprostheses1100,1204 are shaped to allow anatomic contact and articulation between the inferiorfacet articulation surface1174 and the superiorfacet articulation surface1122 throughout various anatomic ranges of motion.
• Also shown inFIG. 53F are two planes labeled “Plane1” and “Plane2” that that intersect along an axis (not shown) that passes through the contact areas of the superiorfacet articulation surface1122 and the inferiorfacet articulation surface1174.Plane1 is parallel to the page ofFIG. 53F, andPlane2 is perpendicular to the page.
• FIG. 53G is a posteriolaterial view of the same inferior andsuperior facet prostheses1100,1204 with the planes shown inFIG. 53F. InFIG. 53G,Plane2 is oriented parallel to the page andplane1 is oriented perpendicular to the page.FIG. 53G illustrates the saddle point (S1) of thevertebra102 to which thesuperior facet prosthesis1100 is coupled, and the saddle point (S2) of thevertebra101 to which theinferior facet prosthesis1204 is coupled. The saddle points S1, S2 are displaced from each other along an x offset (IX) parallel to the axis at whichPlane1 andPlane2 intersect, a y offset (IY) extending perpendicular toPlane2, or out of the page with respect toFIG. 53G, and a z offset (IZ) extending perpendicular toPlane1. The offsets IX, IY, and IZ may be used for implant sizing and/or selection, as will be discussed subsequently.
• FIG. 53H is a posteriolateral view showing a cross-section alongPlane2. This cross-section view cuts through the articulation surfaces1122,1174 of theprostheses1100,1204, thereby showing the convex shape of theinferior articulation surface1174 against the concave shape of thesuperior articulation surface1122.
• FIG. 53H also illustrates the cephalad andcaudal ends1250,1252 of thearticulation surface1122 of thesuperior facet prosthesis1100. Thearticulation surface1122 has a radius ofcurvature1254 generally about anaxis1256. However, since the radius ofcurvature1254 changes along the articulatingsurface1122, theaxis1256 may be the center of curvature for only a portion of thearticulation surface1122. The radius ofcurvature1254 is shown extending from theaxis1256 to thearticulation surface1122 inFIG. 53H. Furthermore,FIG. 53H illustrates a longitudinal axis1258 of the spine in general. Theaxis1256 is angled from the axis1258 by an offset angle1259. Since theaxis1256 and the axis1258 may not both be precisely parallel toPlane2, the offset angle1259 may have a component that extends out of the page with respect to the view ofFIG. 53H.
• FIG. 53I is a cephalad view showing a cross-section alongPlane1. This cross-section cuts through the articulation surfaces1122,1174 of the prostheses showing the convex shape of theinferior articulation surface1174 against the concave shape of thesuperior articulation surface1122. Each of the articulatingsurfaces1122,1174 has a curved shape. The articulatingsurfaces1122,1174 of the superior andinferior prostheses1100,1204, respectively, are shaped and relatively positioned to articulate against each other such that a medial-lateral range of relative motion between the first andsecond vertebrae101,102 increases significantly with flexion (i.e., forward bending) of the spine.
• A “significant” increase in the medial-lateral range of motion refers to a difference in the range of motion that approximates the natural motion of the spine to a degree sufficient to be noticeable by the patient. More precisely, a “significant” increase may refer to the existence of at least one additional millimeter of clearance between articulating surfaces of a facet joint under flexion, as compared to the same facet joint under extension. Furthermore, a “significant” increase in the medial-lateral range of motion may refer to the existence of two additional millimeters of clearance between the articulating surfaces.
• As shown inFIG. 53H, one of the articulatingsurfaces1122,1174, for example, the articulatingsurface1122 of thesuperior facet prosthesis1100, has acephalad end1250 and acaudal end1252. The articulatingsurface1122 also has a radius ofcurvature1254 about anaxis1256 extending generally from thecephalad end1250 end to thecaudal end1252. The radius ofcurvature1254 changes along theaxis1256 to provide greater clearance between the articulatingsurfaces1122,1174 when the spine is under flexion. Similarly, the changing radius ofcurvature1254 provides less clearance between the articulatingsurfaces1122,1174 when the spine is extended.
• In this embodiment, the articulatingsurface1122 is shaped such that, when thesuperior facet prosthesis1100 is coupled to the vertebra, theaxis1256 is significantly anteriorly inclined at thecephalad end1250 to provide greater clearance between the articulatingsurfaces1122,1174 when the spine is under flexion. In addition to or in the alternative to variation of the radius ofcurvature1254 from thecephalad end1250 to thecaudal end1252, the radius ofcurvature1254 could vary along a medial-lateral direction of the articulating surface.
• More precisely, with brief reference toFIG. 51 again, the radius of curvature may be larger toward a medial end1260 and alateral end1262 of the articulatingsurface1122 than at acentral portion1264 thereof. The radius of curvature could also be substantially infinite toward the medial and lateral ends, such that the articulating surface of the superior prosthesis has acurved region1268 proximate thecentral portion1264, a first tangent flat1270 disposed medially of and tangent to thecurved region1268, and a second tangent flat1272 disposed laterally of and tangent to thecurved region1268.
• If desired, the inferior facet prosthesis may have an articulating surface with a three-dimensionally curved, generally elliptical shape. A three-dimensionally dimensionally curved, generally elliptical shape may have the appearance of a stretched spheroid or the like. Accordingly, a three-dimensionally curved, generally elliptical shape has a first cross section having a generally elliptical shape and a second cross section perpendicular to the first cross section, having a semicircular shape. Alternatively, an inferior facet prosthesis may have an articulating surface with a generally cylindrical or semispherical shape, as illustrated in connection withFIGS. 40, 53B, and 53C, for example.
• According to one alternative embodiment, the articulating surface of the superior facet prosthesis may have a uniform, substantially unchanging radius of curvature. The relative medial-lateral motion between the vertebra and the adjacent vertebra may still increase significantly with flexion of the spine due to the curvature of the inferior facet prosthesis. The radius of curvature of the articulating surface of the inferior facet prosthesis may change along an axis thereof, either along the cephalad-caudal direction or along the medial-lateral direction, to provide greater clearance between the articulating surfaces when the spine is under flexion. According to yet another alternative, the variation in motion in the medial-lateral direction may be obtained, not through a variable radius of curvature, but rather, through the relative positioning of the superior and inferior facet prostheses.
• Returning toFIGS. 53F, 53G, 53H, and 53I, the materials used to construct the articulating surfaces of theprostheses1100,1174 may be selected from a group consisting of a polymeric material, a polymeric bearing material attached to a metal substrate, a ceramic bearing material, a metal bearing material, and combinations thereof. A variety of surface coatings, treatments, and the like may be used to enhance the performance and/or longevity of theprostheses1100,1174.
• Thesuperior facet prosthesis1100 may be shaped such that, when thesuperior facet prosthesis1100 is coupled to thevertebra102, theaxis1256 is significantly anteriorly inclined from a longitudinal axis (not shown) of the spine to provide greater clearance between the articulatingsurfaces1122,1174 when the spine is under flexion. In this application, “significantly anteriorly inclined” refers to the presence of a deliberate offset, from the longitudinal axis of the spine, that has a meaningful effect on the facet joint of which the corresponding prosthesis is a part. The offset angle1259 between theaxis1256 and the longitudinal axis1258 of the spine may range from about −2.5° to about 14.5°. More precisely, the offset angle1259 may range from about 5° to about 10°. Yet more precisely, the offset angle1259 may be about 7.25°.
• Referring briefly again toFIG. 51 andFIG. 53G, one method of selecting inferior and superior facet prosthesis will be described. The appropriate prosthesis of the kit of superior facet prostheses may be selected by, for example, forming a semicircular resection centered at a position along thepedicle axis1170 of thevertebra102, at a known displacement from the saddle point S1. Certain offsets, such as X₁, and X₂, as shown inFIG. 51, may be measured with between the saddle point S1 and the most medial and anterior point P1.
• Based on X₁and X₂, values of the resection angle α and the facet angle β may be obtained. The values of α and β may be used to select the appropriate superior facet prosthesis of the kit by, for example, looking up the values of α and β on a lookup table or the like. The remaining dimensions of the selected superior facet prosthesis may thus be determined based on the combination of α and β.
• The appropriate prosthesis of the kit of inferior facet prostheses may also be selected by making a limited number of measurements. More precisely, a semicircular resection may be formed at a position centered along the pedicle axis of thevertebra101, at a known displacement from the saddle point S2. One or more of the offsets IX, IY, and IZ may be measured between the resections of the saddle points S1 and S2.
• Based on the values of IX, IY, and/or IZ obtained, the values of Iα and Z (as illustrated inFIG. 53C) are determined. The values of Iα and Z may be used to select the appropriate inferior facet prosthesis of the kit by, for example, looking up the values of Iα and Z on a lookup table or the like. The remaining dimensions of the selected inferior facet prosthesis may thus be determined based on the combination of Iα and Z.
• The above-described selection method is beneficial because a relatively small number of linear measurements may be made to determine which set of prostheses is most appropriate for a given patient. Ease of measurement is important because the measurements must generally be performed during surgery. Accordingly, easier, more rapid. measurements enable surgery to be more rapidly and safely carried out. In alternative embodiments, different measurement schemes may be carried out, and may include different linear measurements, angular measurements, and the like. In this application, measuring the “relative positions” of bony landmarks may include measurement of linear displacements, angular displacements, or any combination thereof.
• In alternative embodiments, a kit of superior and/or inferior prosthesis need not have multiple one-piece prostheses, but may instead have multiple components designed to be assembled together to provide a prosthesis having the necessary parameters. For example, each of a plurality of semispherical bone contacting portions may be connectable to any of a plurality of articulating surfaces, via a plurality of connecting members. Selecting a prosthesis may then entail selecting a bone contacting portion, an articulating surface, and a connecting member. The bone contacting portion, articulating surface, and connecting member may then be coupled together via set screws, adhesives, interference fits, or the like.
• If desired, the manner in which the various components are attached together may also be adjustable to enable further adjustability of the dimensions of a selected prosthesis. Such a kit of components may also include additional components such as bearing surfaces, as described in connection withFIG. 16. As yet another alternative, a single prosthesis may be adjustably deformed, for example, through the use of a lever-operated manual press, a hydraulic press, or the like, to provide the desired dimensions prior to attachment to a patient's vertebra.
• After asemispherical resection1146 has been formed in a vertebra and the corresponding prosthesis has been selected, a flat resection, such as thefirst resection surface1112 ofFIG. 48, may be formed. The flat resection may be contiguous with thesemispherical resection1146, or may be separated from thesemispherical resection1146 by an expanse of unresected bone. The determination of which prosthesis to use may also indicate to the surgeon the proper placement of the flat resection to properly receive the selected prosthesis. After the flat resection has been formed, the selected prosthesis may be attached to the vertebra. The procedure may be the same as or similar to that described above for installation of the inferior and superior facet prostheses.
• FIG. 54 is a dorsal view of a bilateral inferiorfacet prosthesis system1200 in situ. The bilateral inferiorfacet prosthesis system1200 is a multi-piece inferior and superior facet prosthesis that has both a rightinferior facet prosthesis1202 and a leftinferior facet prosthesis1204 connected by a crosslink, which may take the form of a stabilizingbar1210. Both the rightinferior facet prosthesis1202 and the leftinferior facet prosthesis1204 are designed to be affixed to thetop vertebra101 at the respective inferior facet resection surfaces121 (FIG. 19).
• The bilateralinferior facet prostheses1202,1204 allow replacement of both the left and the right inferior facets. In this embodiment, the inferior prostheses are placed over left andright fixation elements1232,1234 that extend into thetop vertebra101. In the embodiment shown inFIG. 54, the right inferior side is articulating against a rightsuperior facet prosthesis1100 attached to the first resection surface1112 (FIG. 49) of thebottom vertebra102. Also in this embodiment, the leftinferior facet prosthesis1204 is articulating against the left natural superior facet of thebottom vertebra102.
• The stabilizingbar1210 of the bilateralinferior prosthesis system1200 is designed to stabilize the leftinferior facet prosthesis1204 and the rightinferior facet prosthesis1202 so that they are secure. The stabilizingbar1210 also allows the left and rightinferior facet prostheses1204,1202 to support each other rather than requiring stabilizing members to be coupled to the spine lamina or the resected inferior facet tissue. Further, the stabilizingbar1210 can compress the left and rightinferior facet prostheses1202,1204 against the resected bone to improve bony ingrowth and apposition.
• As also shown inFIG. 54, the stabilizingbar1210 is coupled to the left and rightinferior prostheses1202,1204 by a gripping mechanism. The gripping mechanism may include any of a variety of structures, including clips, clamps, adhesive-bonds, threaded fasteners, and the like. In the embodiment ofFIG. 54, the gripping mechanism includes fore andaft flanges1212,1214 that engage the stabilizingbar1210 to form a groove-and-rod joint. The fore andaft flanges1212,1214 are compressed together with threaded tumbuckles1216,1218 to pinch the stabilizingbar1210 there between.
• The pinching action of theflanges1212,1214 allows the distance between the left and rightinferior prostheses1202,1204 to be adjusted to best suit the anatomy of the patient. During surgery, the surgeon would use a tool (not shown) to compress the left and rightinferior prostheses1202,1204 to the desired positions and then tighten theturnbuckles1216,1218 to secure the stabilizingbar1210.
• FIG. 55 is a perspective view of the bilateral inferiorfacet prosthesis system1200. The rightinferior facet prosthesis1202 includes a convex articulatingsurface1220 that engages an articulatingsurface1122 of thesuperior facet prosthesis1100. In one embodiment, the articulatingsurface1122 of thesuperior facet prosthesis1100 has a concave shape (FIGS. 47, 51).
• In this application, the term “convex” relates to a surface that bulges outward with a three-dimensional curvature. Accordingly, a convex surface is not just a sectorial portion of a cylinder, but rather, has some outward curvature along two perpendicular directions. A convex surface may be “semispherical,” or in other words, may include some sectorial portion of a sphere, which may be less than a hemisphere. However, a convex surface need not be semispherical, but may instead have contouring that provides a portion of an oval, elliptical, parabolic, and/or irregular cross sectional shape. A convex surface also need not be curved in whole or in part, but may instead have one or more planar portions.
• In this application, “concave” refers to a surface with a central portion that is recessed with respect to at least two peripheral portions positioned on either side of the central portion. A concave surface may be formed by planar regions, curves, or combinations thereof. The central portion may be recessed along only one dimension, as with a surface defined by an interior section of a cylindrical wall. Alternatively, the central portion may be recessed along two perpendicular dimensions, so that the central portion is recessed with respect to at least four peripheral portions arranged around the central portion. Accordingly, the surface may include a semispherical section, a three-dimensional parabolic or ellipsoidal section, or any other three-dimensionally curved shape.
• As another alternative, the central portion of a concave surface may be recessed along one direction and distended with respect to a perpendicular direction, so that the concave surface takes on a shape similar to that of the rounded groove of a pulley that is designed to receive a rope. Like a convex surface, a concave surface need not be curved in whole or in part, but may instead have one or more planar portions.
• FIG. 56 is a lateral view of the bilateral inferiorfacet prosthesis system1200 andsuperior facet prosthesis1100. The rightinferior prosthesis1202 includes amember1230 upon which theflanges1212,1214 clamp. In the embodiment shown, themember1230 is a ball-shapedmember1230 upon which theflanges1212,1214 clamp to form a ball-and-socket joint. The ball-and-socket joint and groove-and-rod joint provide multiple degrees of freedom for variable positioning of the left and rightinferior prostheses1202,1204. More precisely, the ball-and socket joint enables tri-axial rotation, i.e., rotation about three perpendicular axes, until theflanges1212,1214 are pressed about themember1230 to resist further relative rotation.
• The ball-and-socket joint enables relative motion between theinferior prostheses1202,1204 along the anterior/posterior directions and along the cephalad/caudal directions. The groove-and-rod joint enables relative motion between theinferior prostheses1202,1204 along the lateral/medial directions. However, when theturnbuckles1216,1218 are tightened, the displacement between the ball-shapedmembers1230 of theinferior prostheses1202,1204 becomes fixed, and the ball-shapedmembers1230 are no longer freely pivotable with respect to theflanges1212,1214. Thus, the relative positions and orientations of theinferior prostheses1202,1204 may be fixed by tightening theturnbuckles1216,1218.
• An alternative embodiment replaces the ball shapedmember1230 with a member (not shown) of differing shape and flanges adapted to engage the alternative member. Other potential shapes that allow a range of adjustability and movement between the left and rightinferior prostheses1202,1204 and theflanges1212,1214 prior to clamping include, but are not limited to, columnar and annular shapes.
• The ball-shapedmember1230 shown inFIG. 56 has several divots formed thereon. Upon compression of theflanges1212,1214, the flanges deform into the divots to provide enhanced coupling and resistance to slippage therebetween. An alternative embodiment of the ball-shapedmember1230 has circumferential or axial splines (FIG. 63) formed thereon, which “bite” into theflanges1212,1214. Other alternative surface features of the ball-shapedmember1230 include knurling, nubs, grooves, facets, and combinations of any of the above.
• Similarly, the stabilizingbar1210 can have surface features to enhance coupling to theflanges1212,1214. Exemplary surface features include longitudinal splines, knurling, divots, nubs, and grooves. Splines prevent rotation of the stabilizingbar1210 with respect to theflanges1212,1214. Knurling advantageously prevents both rotation and translation of the stabilizingbar1210 with respect to theflanges1212,1214.
• Theflanges1212,1214 can be formed of a material softer than that of the stabilizingbar1210 and the ball-shapedmembers1230 to further enhance coupling. Illustrative materials for the stabilizingbar1210 and ball-shapedmembers1230 are Cobalt-Chrome (Co—Cr) alloys, Titanium (Ti) and stainless steel alloys. However, other biocompatible materials such as rigid polymers including PEEK and PEAK can be formed into the shapes of thestabilization bar1210, and/or the ball-shapedmembers1230. In one alternative embodiment, theflanges1212,1214 are formed integrally with or rigidly attached to the left and rightinferior prostheses1202,1204.
• Referring again toFIG. 54, ends of theflanges1212,1214 that engage the stabilizingbar1210 are angled towards each other. This angling avoids interference with surrounding bone and avoids interference with the superior facet or thesuperior facet prosthesis1100.
• With continued reference toFIG. 54, it is seen that the heads of theturnbuckles1216,1218 can vary in size. As shown, theturnbuckle1216 is larger than theturnbuckle1218. The larger head of theturnbuckle1216 allows the surgeon to exert more torque on theturnbuckle1216, thereby allowing a more secure coupling of theflanges1212,1214 to the stabilizingbar1210. The smaller head of theturnbuckle1218 requires less space at the surgical site of the patient than the larger head of theturnbuckle1216. Therefore, the surgeon can select a turnbuckle head having the desired size, weighing the benefits of more applied torque of the larger head with the reduced spatial requirements of the smaller head.
• An alternative embodiment replaces the stabilizingbar1210 with a flexible link, such as a cable of a biocompatible material. Yet another alternative embodiment includes a stabilizing bar having threaded ends. Instead of pinching flanges, the threaded ends of the stabilizing bar extend through flanges of the left and rightinferior prostheses1202,1204. Threaded fasteners engage the threaded ends of the stabilizing bar. The threaded fasteners are then tightened to provide the desired positioning of the left and rightinferior prostheses1202,1204. In another variation, the stabilizing bar is rotated such that the threads of the stabilizing bar engage fixed threaded portions of the flanges.
• FIG. 57 is a cranial view of the bilateral inferiorfacet prosthesis system1200.
• FIG. 58 is a bottom in situ view of the bilateral inferiorfacet prosthesis system1200 in situ.
• FIG. 59 is rear view of the bilateral inferiorfacet prosthesis system1200 in isolation.
• FIG. 60 is a top view of the bilateral inferiorfacet prosthesis system1200.
• FIG. 61 is a bottom view of the bilateral inferiorfacet prosthesis system1200.
• FIG. 62 is a perspective view of the rightinferior prosthesis1204.
• FIGS. 63 and 64 are perspective and end views, respectively, of various ball-shapedmembers1240,1242,1244 that may be included in theinferior prostheses1202,1204 in place of themembers1230, the ball-shapedmembers1240,1242,1244 having differing surface features, particularlycircumferential grooves1302,longitudinal grooves1304, andknurling1306.
• FIG. 65 is a dorsal view of the bilateral inferiorfacet prosthesis system1200, in whichcastle nuts1320 are attached to the left andright fixation elements1232,1234 and to thefixation member1110.
• While various embodiments have been described above, it should be understood that they have been presented by way of example only, and not by way of limitation. Thus, the breadth and scope of the invention should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims and their equivalents.

Claims (20)

What is claimed is:

1. A surgical method comprising:

providing a prosthesis, wherein the prosthesis comprises a fixation element and an articulating component attached to the fixation element, wherein the articulating component comprises an articulating surface; and

inserting the prosthesis via the fixation element into a bone member.

2. The method ofclaim 1, wherein the prosthesis further comprises a flange between the fixation element and the articulating component.

3. The method ofclaim 2, wherein the flange comprises an opening that surrounds the fixation element.

4. The method ofclaim 2, wherein the flange is attached to the fixation element via a castle nut.

5. The method ofclaim 1, wherein the articulating component is in the shape of a blade or wing ear.

6. The method ofclaim 1, wherein the articulating surface has a concave shape.

7. The method ofclaim 1, wherein the articulating surface curves from an orientation generally perpendicular to the flange towards an orientation generally parallel to the flange from a distal end thereof to a proximal end thereof.

8. The method ofclaim 1, wherein a proximal portion of the fixation element includes a drive feature.

9. The method ofclaim 8, wherein the drive feature comprises an internal hex.

10. A surgical method comprising:

resecting a portion of a bone member;

providing a prosthesis, wherein the prosthesis comprises a fixation element and an articulating component attached to the fixation element, wherein the articulating component comprises an articulating surface;

inserting the prosthesis via the fixation element into the bone member.

11. The method ofclaim 10, wherein the bone member comprises a pedicle.

12. The method ofclaim 10, wherein the prosthesis further comprises a coupling portion attached to the articulating component.

13. The method ofclaim 12, wherein the coupling portion comprises a bone engaging surface that engages the resected portion of the bone member.

14. The method ofclaim 13, wherein the coupling portion comprises a generally semispherical surface.

15. The method ofclaim 10, wherein the prosthesis further comprises a flange with an opening that surrounds the fixation element.

16. The method ofclaim 10, wherein the fixation element comprises a drive feature in the form of a hex socket.

17. The method ofclaim 10, wherein the articulating surface is concave.

18. A surgical method comprising:

providing a prosthesis comprising:

a fixation element implantable into a vertebra;

a coupling portion shaped to be coupled to the fixation element, the coupling potion having a bone engaging surface positioned to abut the vertebra; and

an articulating surface attached to the coupling portion; and

inserting the prosthesis into a bone member.

19. The method ofclaim 18, wherein the prosthesis is inserted into a pedicle.

20. The method ofclaim 18, wherein the bone engaging surface is concave.

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