US20120071929A1 - Linked Bilateral Spinal Facet Implants and Methods of Use - Google Patents
Linked Bilateral Spinal Facet Implants and Methods of Use Download PDFInfo
- Publication number
- US20120071929A1 US20120071929A1 US13/179,765 US201113179765A US2012071929A1 US 20120071929 A1 US20120071929 A1 US 20120071929A1 US 201113179765 A US201113179765 A US 201113179765A US 2012071929 A1 US2012071929 A1 US 2012071929A1
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- United States
- Prior art keywords
- vertebra
- inferior
- prosthesis
- superior
- facet
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
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Definitions
- FIG. 1 is a perspective view of a portion of the spine
- FIG. 9 is a perspective view of an alternative left inferior facet prosthesis
- 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. 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. 45 is a perspective view of superior and inferior facet prostheses held against a vertebra by flexible fixation elements
- FIG. 48 is a perspective, cross-sectional view of the embodiment of the superior facet prosthesis and fixation element of FIG. 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. 53B is a top view of an inferior facet prosthesis according to one embodiment of the invention.
- 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 L4 inferior facet prosthesis fit on adjacent vertebrae to articulate against each other;
- the surgeon aligns the fixation element 200 with anatomic landmarks and simply drives the fixation element 200 through the first resected surface 112 and into the pedicle 11 .
- the fixation element 200 is driven into the vertebra 100 until a connection feature 213 (e.g., a screw thread) is just above the first superior resection surface 112 .
- the distal end 220 shown in FIG. 27 has a frusto-conical shape that allows the fixation element 200 to be driven or guided into the vertebra 100 .
- the distal end 220 could be shaped in the form of a spade tip, trochar tip, or twist drill tip to assist in the guidance of the fixation element 200 in the vertebra 100 .
- the fixation element 200 may also have a cutting flute (not shown) formed in the distal end 220 to help remove bone tissue and accommodate the guidance of the fixation element 200 in the vertebra 100 .
- the bone stabilizing portion 210 helps to secure the fixation element 200 to the vertebra 100 .
- FIG. 34 is a dorsal view illustrating how the inferior facet prosthesis 401 can articulate against the natural superior facet 43 , or the inferior facet prosthesis 402 can articulate against the superior facet prosthesis 303 .
- the right facet joint between the top vertebra 101 and the middle vertebra 102 is a hemiarthroplasty replacement with the inferior facet replaced by the inferior facet prosthesis 401 .
- the right facet joint between the middle vertebra 102 and the bottom vertebra 103 is a unilateral replacement with the inferior facet replaced by the inferior facet prosthesis 402 and the superior facet of the bottom vertebra 103 replaced by the superior facet prosthesis 303 .
- FIG. 43 shows a further step in the assembly of the implant construct described in FIG. 42 .
- the locking washer 800 is secured over the fixation element 200 and into the bone tissue by the enlarged head 500 .
- the locking washer 800 can alternatively be used to mechanically secure the inferior facet prosthesis 400 , or the combination of the inferior facet prosthesis 400 and the superior facet prosthesis 300 .
- the locking washer 800 is placed over the superior facet prosthesis 300 .
- the locking washer 800 may be placed under the superior facet prosthesis 300 , under the inferior facet prosthesis 400 and the superior facet prosthesis 300 , or between the superior facet prosthesis 300 and the inferior facet prosthesis 400 to stabilize the implant construct.
- the locking washer 800 also has prongs 830 that pass into the bone tissue of the vertebra 100 to help stabilize the implant construct.
- the prongs 830 in this embodiment of the locking washer 800 are elongated protrusions that taper to a tissue penetration tip 840 .
- the prongs have sidewalls 850 that provide a surface to resist torsion once the locking washer 800 penetrates the bone tissue.
- the prongs 830 may also be simple spikes that are either symmetrical or asymmetrical in cross-section that protrude from the locking washer body 805 .
- the shape and length of the locking washer prongs 830 are dependent on how the locking washer 800 is used.
- FIG. 46 is a dorsal view of a bilateral inferior facet prosthesis 1000 .
- the bilateral inferior facet prosthesis 1000 is a one-piece inferior facet prosthesis that has both a right inferior side 1040 and a left inferior side 1020 connected by a stabilizing bar 1010 . Both the right inferior side 1040 and the left inferior side 1020 are designed to fix to the top vertebra 101 at the respective inferior resection surface 121 ( FIG. 19 ) and at the first resection surface 112 .
- the bilateral inferior facet prosthesis 1000 allows replacement of both the left and the right inferior facets.
- the bilateral inferior facet prosthesis 1000 is placed over the left and right fixation elements 200 which extend into the bone of the top vertebra 101 . In the embodiment shown in FIG.
- the semispherical resection 1146 in the bone bed allows for less transverse process to be resected (vs. a flat bone bed resection).
- the semipherical resection 1146 in the bone bed also allows for more stable support of the superior facet prosthesis 1100 , than does a flat bone bed resection, as the superior facet prosthesis 1100 is polyaxially supported in such a way as to resist any shear forces applied between the semispherical resection 1146 and the coupling portion 1144 .
- “polyaxial” refers to a linear or angular force or motion acting with respect to at least two perpendicular axes.
- the coupling portion 1144 may seat directly against the semispherical resection 1146 .
- 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.
- FIG. 51 is a top view of the superior facet prosthesis 1100 , particularly showing the curved shape of the articulating surface 1122 and the semispherical bone engaging surface 1150 of the coupling portion 1144 . Additionally, FIG. 51 more clearly illustrates the angled flat 1156 on the apposition side of the superior facet prosthesis 1100 .
- the inferior facet angle I.beta. may be defined as the angle of the surface to which the articulating surface 1174 is most nearly parallel. Due to the shape of the inferior facet prostheses 1180 , 1182 , 1184 , 1186 , 1188 , or 1190 , this angle is the same as the inferior resection angle I.alpha., when measured according to the coordinate system of the superior facet prosthesis 1100 of FIG. 51 .
- one of the articulating surfaces 1122 , 1174 for example, the articulating surface 1122 of the superior facet prosthesis 1100 , has a cephalad end 1250 and a caudal end 1252 .
- the articulating surface 1122 also has a radius of curvature 1254 about an axis 1256 extending generally from the cephalad end 1250 end to the caudal end 1252 .
- the radius of curvature 1254 changes along the axis 1256 to provide greater clearance between the articulating surfaces 1122 , 1174 when the spine is under flexion.
- the changing radius of curvature 1254 provides less clearance between the articulating surfaces 1122 , 1174 when the spine is extended.
- ends of the flanges 1212 , 1214 that engage the stabilizing bar 1210 are angled towards each other. This angling avoids interference with surrounding bone and avoids interference with the superior facet or the superior facet prosthesis 1100 .
- the heads of the turnbuckles 1216 , 1218 can vary in size. As shown, the turnbuckle 1216 is larger than the turnbuckle 1218 .
- the larger head of the turnbuckle 1216 allows the surgeon to exert more torque on the turnbuckle 1216 , thereby allowing a more secure coupling of the flanges 1212 , 1214 to the stabilizing bar 1210 .
- the smaller head of the turnbuckle 1218 requires less space at the surgical site of the patient than the larger head of the turnbuckle 1216 . 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.
- FIG. 60 is a top view of the bilateral inferior facet prosthesis system 1200 .
- FIG. 61 is a bottom view of the bilateral inferior facet prosthesis system 1200 .
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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
- This application is a continuation application of a divisional application provided with the U.S. patent application Ser. No. 12/240,281 filed on Sep. 29, 2008 which claims priority to the following:
- pending U.S. application Ser. No. 11/734,502, filed Apr. 12, 2007 and entitled LINKED BILATERAL SPINAL FACET SUPERIOR AND INFERIOR IMPLANTS AND METHODS OF USE (Attorney's Docket No. FSI-04 CON), which is a continuation of U.S. application Ser. No. 10/860,495, filed Jun. 2, 2004 and entitled LINKED BILATERAL SPINAL FACET IMPLANTS AND METHODS OF USE (Attorney's Docket No. FSI-04). The foregoing documents are incorporated herein by reference.
- 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.
- 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.
-
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 ingrowthsurface; -
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 L4 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. - Referring now to
FIG. 1 , there is shown a perspective view of asuperior vertebra 1 and aninferior vertebra 3, with anintervertebral disc 2 located in between. Thesuperior vertebra 1 hassuperior facets 43,inferior facets 6, a posterior arch (or lamina) 35 and aspinous process 46. Theinferior vertebra 3 hassuperior facets 7,inferior facets 44, a posterior arch (or lamina) 36 and aspinous process 45. Each of thevertebrae pedicles 11. Referring now toFIG. 2 , in a lateral view, the leftinferior facet 6 of thesuperior vertebra 1 shown inFIG. 1 has been resected and aninferior facet prosthesis 4 has been attached to thesuperior vertebra 1. Similarly, the leftsuperior facet 7 of theinferior vertebra 3 has been resected and asuperior facet prosthesis 5 has been attached to theinferior vertebra 3. -
FIG. 3 illustrates a dorsal view of the elements shown inFIG. 2 . It can be appreciated thatinferior facet prosthesis 4 replicates the natural anatomy when compared to the contralateralinferior facet 6 ofvertebra 1. Similarly, it can be appreciated thatsuperior facet prosthesis 5 replicates the natural anatomy when compared to the contralateralsuperior facet 7 ofvertebra 3. Neither theinferior facet prosthesis 4 nor thesuperior facet prosthesis 5 rests on thelamina 35. Turning now toFIG. 4 , a perspective view of thesuperior vertebra 1 with implantedinferior facet prosthesis 4 is provided. A bone resection on the left side of thesuperior vertebra 1, shown as aresection 31, has removed the naturalinferior facet 6 at the bony junction between theinferior facet 6 and thelamina 35. In this manner, any bone pain associated with a disease, such as osteoarthritis, or trauma of the leftinferior facet 6 will be eliminated as the involved bony tissue has been osteotomized. -
FIG. 5 illustrates a perspective view of theinferior facet prosthesis 4. Asurface 8 replicates the natural articular surface of the replacedinferior facet 6. Apost 9 provides a mechanism that can be used to affix theinferior facet prosthesis 4 to thesuperior vertebra 1. Thepost 9 is implanted into the interior bone space of theleft pedicle 11 on thesuperior vertebra 1 and may or may not extend into the vertebral body ofsuperior vertebra 1 to provide additional stability. -
FIG. 6 illustrates a cranial view of theinferior vertebra 3 with the implantedsuperior facet prosthesis 5. Aresection surface 32 represents the bony junction between the naturalsuperior facet 7 and thelamina 36. -
FIG. 7 illustrates a perspective view of thesuperior facet prosthesis 5. Asurface 38 replicates the natural articular surface of the replacedsuperior facet 7. Thepost 37 provides a mechanism usable to affix thesuperior facet prosthesis 5 to theinferior vertebra 3. Thepost 37 is implanted into the interior bone space of the left pedicle 11 (FIG. 6 ) on theinferior vertebra 3 and may or may not extend into the vertebral body of theinferior vertebra 3 to provide additional stability. - When the total facet joint is replaced, as shown in
FIGS. 2 and 3 , then the surface 8 (FIG. 5 ) articulates against the surface 38 (FIG. 7 ) to recreate the natural biomechanics of the spine motion segment made up of thesuperior vertebra 1, theinferior vertebra 3, and theintervertebral disc 2. Neither theinferior facet prosthesis 4 nor thesuperior facet prosthesis 5 rests on thelamina 35 or thelamina 36, respectively. -
FIG. 8 illustrates a perspective view of an alternativeinferior facet prosthesis 10 that may be implanted into the interior bone space of thelamina 35 of thesuperior vertebra 1. The interior bone space is accessed from theresection 31. -
FIG. 9 shows a perspective view of the alternativeinferior facet prosthesis 10, including afin 13 that extends into the interior bone space of the 35. Asurface 12 replicates the natural articular surface of the replaced facet. - The surfaces of the post 9 (
FIG. 5 ), the post 37 (FIG. 7 ), and the fin 13 (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 to
FIG. 10 , there is shown a lateral view of asuperior vertebra 14 and aninferior vertebra 16, with anintervertebral disc 15 located in between. The left inferior facet of thesuperior vertebra 14 has been resected and aninferior facet prosthesis 18 has been attached tosuperior vertebra 14 via ascrew fastener 17. Similarly, the left superior facet of theinferior vertebra 16 has been resected and asuperior facet prosthesis 19 has been attached tovertebra 16 via ascrew fastener 17. -
FIG. 11 illustrates a dorsal view of the elements ofFIG. 10 . It can be appreciated thatinferior facet prosthesis 18 replicates the natural anatomy when compared to the contralateralinferior facet 22 of thesuperior vertebra 14. Similarly, it can be appreciated thatsuperior facet prosthesis 19 replicates the natural anatomy when compared to the contralateralsuperior facet 21 of theinferior vertebra 16. Neither theinferior facet prosthesis 18 nor thesuperior facet prosthesis 19 rests on the lamina of thecorresponding vertebra - Turning now to
FIG. 12 , there is provided a perspective view of thesuperior vertebra 14 with the implantedinferior facet prosthesis 18. Aresection 34 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 naturalinferior facet 22 will be eliminated inasmuch as the involved bony tissue has been osteotomized. -
FIG. 13 illustrates a perspective view of theinferior facet prosthesis 18. Asurface 23 replicates the natural articular surface of the replaced facet. Aflange 25 contacts the pedicle 11 (FIG. 12 ) and ahole 24 receives thescrew fastener 17 to attach theinferior facet prosthesis 18 to thesuperior vertebra 14. -
FIG. 14 illustrates a cranial view of theinferior vertebra 16 with the implantedsuperior facet prosthesis 19. Aresection surface 33 represents the bony junction between the natural superior facet 21 (FIG. 11 ) and the corresponding lamina. -
FIG. 15 illustrates a perspective view of thesuperior facet prosthesis 19. Asurface 27 replicates the natural articular surface of the replaced facet. Aflange 39 contacts the pedicle 11 (FIG. 14 ) andhole 26 receives ascrew fastener 17 to attach thesuperior facet prosthesis 19 to theinferior vertebra 16. -
FIG. 16 provides a perspective view of an alternativesuperior facet prosthesis 40 with a bearingsurface 41 that mounts tosubstrate 42. The bearingsurface 41 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
surface 41 may be formed separately from the remainder of thesuperior facet prosthesis 40, so that the bearingsurface 41 and the remainder form components that can be assembled as needed. A kit of differently-sized prostheses may include multiple bearing surfaces like the bearingsurface 41 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 to
FIG. 17 andFIG. 18 , a singleintact vertebra 100 is shown.FIG. 17 is a dorsal view of thevertebra 100.FIG. 18 is a lateral view of thesame vertebra 100. Similar to the twovertebrae FIGS. 1 through 3 , thevertebra 100 has posterior anatomy comprising left and rightsuperior facets 43 on the superior, or top side in this view of thedorsal vertebra 100, left and rightinferior facets 6 on the inferior or bottom side of theposterior vertebra 100, left and righttransverse processes 105 extending laterally from the posterior portion ofvertebra 100, and left andright pedicles 11. Each of thesuperior facets 43 has a superior articulatingsurface 145. The posterior portion ofvertebra 100 also has a posterior arch (or lamina) 35, and aspinous process 46 that protrudes from thelamina 35 posteriorly, out of the page inFIG. 17 and to the left inFIG. 18 . InFIG. 17 , the bony structure of thesuperior facets 43 and theinferior facets 6 are intact, as it would be presented in a vertebra without significant tissue degeneration or remodeling resulting from facet joint disease. Although thevertebra 100 is shown inFIG. 17 as a generally structurally healthy and intact vertebra, if thevertebra 100 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 left
superior facet 43 and the rightsuperior facet 43 of thevertebra 100 are symmetrical inFIG. 17 andFIG. 18 . But in the case of avertebra 100 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 in
FIGS. 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 to
FIG. 19 andFIG. 20 which are dorsal and lateral views of the same vertebra shown inFIG. 17 andFIG. 18 after a portion of the rightsuperior facet 43 and a portion of the rightinferior facet 6 have been resected. The removal of a portion of thesuperior facet 43 by resection results in asuperior facet resection 111. In the resection shown inFIG. 19 andFIG. 20 , thesuperior resection 111 has two resulting faces, afirst resection surface 112 and asecond resection surface 113. Likewise, the inferior facet resection results in an inferiorfacet resection surface 121. - 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 the
pedicle 11 ortransverse process 105 to align the tissue removal tools in such a way as to remove the portion of the facet necessary to provide asuperior resection 111 that serves as a bone apposition surface or foundation to eventually support asuperior facet prosthesis 300, as shown inFIG. 22 . The leftsuperior facet 43 is shown intact in bothFIG. 19 andFIG. 20 , but a portion of the rightsuperior facet 43 is resected resulting in thefirst resection surface 112 and the adjacent second resection surface 113 (FIG. 19 ). The shape of thesuperior resection 111 will vary in accordance with the structure of the tissue removal tool. In the embodiment shown inFIG. 19 andFIG. 20 , thefirst resection surface 112 and thesecond resection surface 113 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 surface 112 will be formed in such a way that it will serve as a foundation to support the superior facet prosthesis 300 (FIG. 22 ). Thesecond resection surface 113 or other additional resection surfaces may or may not be present. -
FIG. 19 andFIG. 20 also show that a portion of theinferior facet 6 is resected by tissue removal instruments resulting in aninferior resection surface 121. Such resection is preferably effected so that resection is confined to the tissue of theinferior facet 6 and does not extend into the tissue of the posterior arch (or lamina) 35. InFIGS. 19 and 20 , the leftinferior facet 6 is intact, while a portion of the rightinferior facet 6 is resected resulting in theinferior resection surface 121 on the right side. The bone surrounding theinferior resection surface 121 is contoured by tissue removal tools in a shape designed to cradle and support an inferior facet prosthesis 400 (FIG. 23 ) on the medial side such that when theinferior facet prosthesis 400 is loaded on the lateral side it compresses against and is supported by theinferior resection surface 121. - Alternatively, the
inferior facet 6 can be resected, andinferior facet prosthesis 400 sized and shaped, so thatinferior facet prosthesis 400 does not engage theinferior resection surface 121. -
FIG. 21 is a dorsal view of thevertebra 100 with afixation element 200 placed through thesuperior resection 111 and into the bone of thepedicle 11 to receive the superior facet prosthesis 300 (FIG. 22 ). Thefixation element 200 is aligned and placed into thepedicle 11, similar to how other pedicle screws for posterior stabilization involved with vertebrae fusion are placed in thepedicle 11. In one method, a long guide wire (not shown), with a diameter sized to fit freely into a cannulation 211 (as also shown inFIG. 26 andFIG. 27 ) in thefixation element 200, is placed through thefirst resection surface 112 and into the bone of thepedicle 11. The alignment of the long guide wire can be confirmed by x-ray. Thefixation element 200 is then guided over the guide wire and driven into thevertebra 100 by a driver (not shown) engaged with a drive feature 212 (FIG. 21 ) on aproximal post 230 of thefixation element 200. Thefixation element 200 is driven into thevertebra 100 until a connection feature 213 (e.g., a screw thread) is just above thefirst resection surface 112. Thisconnection feature 213 is eventually used to secure thesuperior facet prosthesis 300 to thevertebra 100. - In a second method for guiding the
fixation element 200 into thepedicle 11, 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 surface 112 and into the bone of thepedicle 11. 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 thepedicle 11 to prepare a cavity for thefixation element 200. The guide wire and bone preparation instrument are then removed and thefixation element 200 is guided into the prepared cavity in thepedicle 11 by a driver (not shown) engaged with thedrive feature 212 on theproximal post 230 of thefixation element 200. Like in the first method, thefixation element 200 is driven into the vertebra until a connection feature 213 (e.g., a screw thread) is just above thefirst resection surface 112. Thisconnection feature 213 is eventually used to secure thesuperior facet prosthesis 300 to thevertebra 100. - In yet a third method of placing the
fixation element 200 in the pedicle, the surgeon aligns thefixation element 200 with anatomic landmarks and simply drives thefixation element 200 through the first resectedsurface 112 and into thepedicle 11. As with the first and second methods, thefixation element 200 is driven into thevertebra 100 until a connection feature 213 (e.g., a screw thread) is just above the firstsuperior resection surface 112. - In
FIG. 22 , a dorsal view illustrates asuperior facet prosthesis 300 placed around thefixation element 200. Thesuperior facet prosthesis 300 has afacet articulating component 320 that articulates against the inferior facet articulating surface of the vertebra above it. Thefacet articulating component 320 is preferably formed in the general shape of a blade or wing ear. Thesuperior facet prosthesis 300 also has abone apposition surface 322 that has been placed on thefirst resection surface 112 and anopening 324 in aflange 323 that surrounds thefixation element 200. The superiorfacet articulating component 320 has an articulatingsurface 321 generally adjacent to theflange 323 that is oriented in a direction that faces approximately the same direction that the original anatomic superior articulatingsurface 145 faced prior to resection. - This orientation of the articulating
surface 321 allows thesuperior facet prosthesis 300 to function as either a hemiarthroplasty implant and articulate against a natural anatomicinferior facet 6 or act as a portion of a unilateral prosthesis and articulate against aninferior facet prosthesis 400 on the vertebra superior (cephalad) to it. No portion ofsuperior facet prosthesis 300 rests on the lamina of thevertebra 100. 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 prosthesis 400 to the construct described inFIG. 22 . Theinferior facet prosthesis 400 generally has a shape similar to a longitudinal rod that is curved to match the contour of the inferior resection 121 (FIGS. 19 and 20 ). Theinferior facet prosthesis 400 has anopening 410 through itssuperior end 420 that is shaped to surround the portion of thefixation element 200 that protrudes from thefirst resection surface 112. InFIG. 23 , theinferior facet prosthesis 400 is placed over thesuperior facet prosthesis 300. However, the order of the placement of theprostheses inferior prosthesis 400 is placed on thefixation element 200 first, followed by thesuperior prosthesis 300. When only theinferior facet 6 or thesuperior facet 43 is being replaced, only the appropriate (superior or inferior)facet prosthesis fixation element 200 without the other (inferior or superior)facet prosthesis - 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, the
inferior facet prosthesis 400 may need to be larger than expected to conform to a particularly unusual or exceptionally large morphology of theinferior resection surface 121, and thesuperior facet prosthesis 300 may need to have an unusual angle to its articulatingsurface 321 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 the
fixation element 200 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 element 200 may be fabricated from ceramics, polymers, or biological materials such as allograft bone, composites, or other biocompatible structural materials. Likewise thesuperior facet prosthesis 300 and theinferior facet prosthesis 400 may be fabricated from metals, alloys, ceramics, polymers, biological materials, composites, or other biocompatible structural materials. - In
FIG. 24 , a dorsal view illustrates the addition of anenlarged head 500 to thefixation element 200. Theenlarged head 500 is tightened down to force theprostheses enlarged head 500 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 feature 520 (e.g., a screw thread) of theenlarged head 500 onto theconnection feature 213 of thefixation element 200. In the case of the threaded embodiment of theconnection feature 213, theenlarged head 500 is provided with a threadedconnection feature 520 and is driven onto thefixation element 200 by turning theenlarged head 500 and allowing the threads to drive all components of the implant between theenlarged head 500 and thefirst resection surface 112 against the bone at or near theresection surface 112. -
FIG. 25 is a perspective posterior view of the assembly of thefixation element 200, thesuperior facet prosthesis 300, and theenlarged head 500. Theenlarged head 500 has been placed on thefirst resection surface 112. -
FIG. 26 is a perspective, cross-sectioned view of the same construct shown inFIG. 25 . Thesuperior facet prosthesis 300, theenlarged head 500, thefixation element 200, and thevertebra 100 have been cut by across-sectioning plane 150 placed along an axis that passes through the center of thefixation element 200. Thecross-section plane 150 is shown for visualization purposes to illustrate, using a cross-sectioned view, how thevertebra 100,fixation element 200,superior facet prosthesis 300 and theenlarged head 500 engage each other. In actual surgery, it is highly unlikely that a surgeon would make a cut as illustrated by thecross-section 150 shown inFIG. 26 . -
FIG. 27 is a cranial, section view of thevertebra 100 and the implant, wherein thecross-section plane 150 is oriented to face the viewer. InFIG. 27 , thefixation element 200 is in thevertebra 100. The embodiment of thefixation element 200 inFIG. 27 comprises adistal end 220 that is shaped to guide thefixation element 200 into bone tissue, abone stabilizing portion 210 adjacent to the distal end, ashaft portion 240 adjacent to thebone stabilizing portion 210, aconnection feature 213 adjacent to theshaft portion 240, and adrive feature 212. - The
distal end 220 shown inFIG. 27 has a frusto-conical shape that allows thefixation element 200 to be driven or guided into thevertebra 100. Thedistal end 220 could be shaped in the form of a spade tip, trochar tip, or twist drill tip to assist in the guidance of thefixation element 200 in thevertebra 100. Thefixation element 200 may also have a cutting flute (not shown) formed in thedistal end 220 to help remove bone tissue and accommodate the guidance of thefixation element 200 in thevertebra 100. Thebone stabilizing portion 210 helps to secure thefixation element 200 to thevertebra 100. Thebone stabilizing portion 210 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 element 200 with the bone tissue to help stabilize thefixation element 200. InFIG. 27 , thebone stabilizing portion 210 has a unitarycontinuous bone thread 231. 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 thecannulation 211 is seen passing from thedistal end 220 of thefixation element 200 to theproximal post 230 of thefixation element 200. - The
drive feature 212 in the embodiment shown inFIG. 27 is an internal hex. However, any shape ofdrive feature 212 that transmits the loads necessary to drive thefixation element 200 into thevertebra 100 can be formed on theproximal post 230 of thefixation element 200. The depth of thedrive feature 212 formed in theproximal post 230 of thefixation element 200 is seen in the cross-sectional view ofFIG. 27 . Thedrive feature 212 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 post 230 of thefixation element 200 that engages with a corresponding internal drive feature on a driver tool (not shown). In this embodiment the depth of thedrive feature 212 is slightly longer than its cross-section is wide. This depth can be adjusted based on the material properties of thefixation element 200 and the drive tool (not shown). - The
fixation element 200 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 element 200 include titanium, titanium alloys, cobalt-chrome alloys, stainless steel alloys, zirconium alloys, other biocompatible metal materials, biocompatible ceramics, biocompatible composites, and biocompatible polymers. Thefixation element 200 may also have surface materials formed on the base material that provide material properties specific to a particular portion of thefixation element 200. For example, thebone stabilization portion 210 could be coated with materials that allow for improved bone ingrowth into the implant surface such as a hydroxylapatite, bioceramic, Bioglass.RTM., or other calcium phosphate derived material. The tribological bearing properties of the material in the areas that thefixation element 200 interfaces with other artificial elements may be improved by applying surface hardening techniques to the material of thefixation element 200 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, the
connection feature 213 is formed on the portion of thefixation element 200 that protrudes from thefirst resection surface 112. Thisconnection feature 213 is designed to connect theenlarged head 500 to thefixation element 200. In the embodiment of theconnection feature 213 shown inFIG. 21 ,threads 260 are on the external surface of this proximal section of thefixation element 200. Thesethreads 260 engage with the threads of the internal connection feature 520 (FIG. 27 ) of theenlarged head 500. Although theconnection feature 213 in this embodiment is threaded, other mechanical locking features (not shown) capable of locking thefixation element 200 and theenlarged head 500 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 feature 213. A corresponding construction may then be used as connection feature 520 of theenlarged head 500. - Also shown in
FIG. 27 is a cross-sectional view of thesuperior facet prosthesis 300. This embodiment of thesuperior facet prosthesis 300 has aflange 323 that has anopening 324 that receives thefixation element 200. In the assembled and implanted configuration of this embodiment, theflange 323 is positioned such that itsbone apposition surface 322 makes contact with thefirst resection surface 112. Although not shown in this embodiment, other embodiments of thesuperior facet prosthesis 300 have structures (e.g., spikes) that protrude into thefirst resection surface 112 to help resist torsion and other anatomic loads. Protruding from theflange 323 at a given angle .alpha., and a given distance X from theopening 324, is the articulatingcomponent 320. The articulatingsurface 321 of thefacet articulating component 320 replicates the natural articular surface of the replaced facet. Once the surgeon assesses the anatomy of thesuperior facet 43 that is being replaced, a particularsuperior facet prosthesis 300 is selected that has the angle .alpha. 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 prostheses 300 is provided to the surgeon and the surgeon selects thesuperior facet prosthesis 300 that best suits the situation. - After the
fixation element 200 and thesuperior facet prosthesis 300 are selected and placed, they are locked to thevertebra 100 by theenlarged head 500. As shown inFIG. 24 , theenlarged head 500 in this embodiment has aninternal connection feature 520 and a hexagonal shapedexternal drive feature 510 that is used to drive theenlarged head 500 over thefixation element 200 and against thesuperior facet prosthesis 300. The specific shape of theexternal drive feature 510 is dependent on the mating shape of the driver (not shown). - Referring to
FIG. 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 head 500. Embodiment A is the threadedfixation element 200 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 fins 285 configured to resist torsion when thefixation element 200 is in thevertebra 100. Embodiment C is an oval shaped cross-section design that is wider in the first direction 286 than the second direction 287 to resist torsion. If the width in the first direction 286 is equal to the width in the second direction 287, the cross-section shape becomes more of a circle andbone stabilization portion 210 becomes more of a press-fit peg. Embodiment D is a square cross-section design with four approximatelyperpendicular sides 288. Thecorners 289 of thesides 288 help to resist torsion. Embodiment E is a triangular cross-section design with threesides 291 to resist torsion. Embodiment F is an anchor-like design that is driven into the vertebra, with the wire arches orbarbs 290 being compressed against the host bone and applying a radial expansion force so as to lock the structure to the bone. - Referring to
FIG. 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 head 500′. Embodiment G is similar to the threadedfixation element 200 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 fins 285 configured to resist torsion when the fixation element is in thevertebra 100. Embodiment I is an oval shaped cross-section design that is wider in a first direction 286 than in a second direction 287 to resist torsion. If the width in the first direction 286 is equal to the width in the second direction 287, the cross-section shape becomes more of a circle and thebone stabilization portion 210 becomes more of a press-fit peg. Embodiment J is a square cross-section design with four approximatelyperpendicular sides 288. Thecorners 289 of thesides 288 help to resist torsion. Embodiment K is a triangular cross-section design with threesides 291 to resist torsion. - Embodiment L is an anchor-like design that is similar to Embodiment F in
FIG. 28 , but with an attached or integrally formedenlarged head 500′. As embodiment L is driven into the vertebra, wire arches orbarbs 290 are compressed and apply radial expansion force against the wall of the prepared bone and into thepedicle 11, resulting in a locking anchor. -
FIG. 29 is a perspective view of a radially expandingfixation element 600. The radially expandingfixation element 600 comprises two main elements, anexpansion sleeve 620 and acentral element 610 that is inside of theexpansion sleeve 620. The radially expandingfixation element 600 is placed into thevertebra 100 and then thecentral element 610 is drawn outward relative to theexpansion sleeve 620 resulting in radial expansion of thefixation element 600. This is shown inFIG. 30 . - Referring to
FIG. 30 , side and bottom views illustrate thefixation element 600 ofFIG. 29 . As aproximal post 630 of thecentral element 610 is pulled axially along its longitudinal axis, and the expansion sleeve is held axially in the bone by compression fit,talons 621 on theexpansion sleeve 620 are radially expanded outward by amandrel 660 on thecentral element 610. The talons orfingers 621 provide both torsional and axial stability to the radially expandingfixation element 600. This provides a secure fixation element for fixation of the remaining implant components. Furthermore, expansion of thefixation element 600 may cause thefixation element 600 to center itself within thepedicle 11. -
FIG. 31 is a perspective, cross-sectional view of across-pin element 700 engaged with thefixation element 200 to help secure thefixation element 200 both torsionally and axially. Thecross-pin element 700 is columnar in shape having adistal end 710, a midsection 730 (with a length along its longitudinal axis that is longer than its transverse cross-sectional width), and a proximal post 720. Thedistal end 710 is shaped to penetrate through bone tissue and into across hole 280 formed in thefixation element 200. Instrumentation (not shown) is used to align thecross-pin element 700 with the cross-hole 280 via fixation of the instrumentation to thedrive feature 212 or thecannulation 211 on thefixation element 200 and alignment of the direction of insertion of thecross-pin element 700 with the cross-hole 280. Once thecross-pin element 700 is in place in the bone and through thefixation element 200, the torsional and axial stability of thefixation element 200 is improved. - The various embodiments of the
fixation element 200 described above and shown inFIG. 28 throughFIG. 31 function in conjunction with theenlarged head 500 to hold theinferior facet prosthesis 400 and/or thesuperior facet prosthesis 300 to their respective resection surfaces 112, 113, and/or 121. Various combinations of this modular implant will be described below and shown inFIGS. 32 through 37 . Although these figures illustrate the use of thefixation element 200 and theenlarged head 500 as the mechanism for securing theprostheses vertebra 100, other clamping devices such as the screw fastener 17 (FIG. 10 ) may be used to mount theprostheses screw prostheses 17 shown inFIGS. 10 through 12 may pass through either the opening 324 (FIG. 22 ) in thesuperior facet prosthesis 300 or the opening 410 (FIG. 23 ) in theinferior facet prosthesis 400 or through both of theseopenings screw fastener 17 acts as the securing mechanism by pressing theinferior facet prosthesis 400 and thesuperior facet prosthesis 300 against their respective resection surfaces 112, 113, and/or 121. -
FIGS. 32 through 37 demonstrate different combinations of assemblies of facet replacement prostheses. The basic components of the prosthesis are thefixation element 200, thesuperior facet prosthesis 300, theinferior facet prosthesis 400, and theenlarged head 500. However, as described above, ascrew fastener 17 can replace thefixation element 200 and theenlarged head 500. - Referring to
FIG. 32 , a dorsal view illustrates three sequential layers of vertebrae. Atop vertebra 101 is above amiddle vertebra 102, and themiddle vertebra 102 is above abottom vertebra 103. 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 vertebra 101 and themiddle vertebra 102, aninferior facet prosthesis 401 is articulating against asuperior facet prosthesis 302 to form an artificial unilateral joint. The inferior facet of themiddle vertebra 102 is replaced by aninferior facet prosthesis 402 and the superior facet of thebottom vertebra 103 is replaced bysuperior facet prosthesis 303. Thus, a second unilateral prosthetic joint is formed that is also on the right side and is located at the level between themiddle vertebra 102 and thebottom vertebra 103.FIG. 32 demonstrates the difference in shape of theinferior facet prosthesis 401 that is implanted around thefixation element 201 without asuperior facet prosthesis 300 and aninferior facet prosthesis 402 that is implanted around afixation element 202 and over asuperior facet prosthesis 302. The opening 410 (not visible) of theinferior facet prosthesis 401 on thetop vertebra 101 in this assembly is offset more laterally than the opening 410 (not visible) in theinferior facet prosthesis 402 for themiddle vertebra 102. This is because thefixation element 201 is implanted more laterally on thetop vertebra 101 to preserve more of the superior facet since it is not replaced by a prosthesis at this level. - Referring to
FIG. 33 , a dorsal view illustrates thetop vertebra 101 in intact form, without resection of the facets. Portions of both the superior and inferior facets on the right side of themiddle vertebra 102 are replaced by asuperior facet prosthesis 302 and aninferior facet prosthesis 402. Only the right superior facet of thebottom vertebra 103 is replaced (i.e., by a superior facet prosthesis 303) inFIG. 33 . Thus, a hemiarthroplasty replacement has been performed on the right facet joint between thetop vertebra 101 and themiddle vertebra 102 and a unilateral replacement has been performed between themiddle vertebra 102 and thebottom vertebra 103. The assembly shown inFIG. 33 demonstrates how thesuperior facet prosthesis 302 can articulate against the naturalinferior facet 6 and thesuperior facet prosthesis 303 can articulate against theinferior facet prosthesis 402. -
FIG. 34 is a dorsal view illustrating how theinferior facet prosthesis 401 can articulate against the naturalsuperior facet 43, or theinferior facet prosthesis 402 can articulate against thesuperior facet prosthesis 303. The right facet joint between thetop vertebra 101 and themiddle vertebra 102 is a hemiarthroplasty replacement with the inferior facet replaced by theinferior facet prosthesis 401. The right facet joint between themiddle vertebra 102 and thebottom vertebra 103 is a unilateral replacement with the inferior facet replaced by theinferior facet prosthesis 402 and the superior facet of thebottom vertebra 103 replaced by thesuperior facet prosthesis 303. - Referring to
FIG. 35 , a dorsal view shows another example of how thesuperior facet prosthesis 303 can articulate against the naturalinferior facet 6 or thesuperior facet prosthesis 302 can articulate against theinferior facet prosthesis 401. In this assembly of the implant, the right side between thetop vertebra 101 and themiddle vertebra 102 is a unilateral replacement and the right side between themiddle vertebra 102 and thebottom vertebra 103 is a hemiarthroplasty replacement. - Referring to
FIG. 36 , a dorsal view shows another example of how theinferior facet prosthesis 402 can articulate against the naturalsuperior facet 43, or theinferior facet prosthesis 401 can articulate against thesuperior facet prosthesis 302. The right facet joint between thetop vertebra 101 and themiddle vertebra 102 is a unilateral replacement with the inferior facet of thetop vertebra 101 replaced by theinferior facet prosthesis 401 and the superior facet of themiddle vertebra 102 replaced by thesuperior facet prosthesis 302. The right facet joint between themiddle vertebra 102 and thebottom vertebra 103 is a hemiarthroplasty replacement with the inferior facet replaced by theinferior facet prosthesis 402. - Referring to
FIG. 37 , a dorsal view illustrates only one level, that between themiddle vertebra 102 and thebottom vertebra 103, being replaced on the right side. The right facet joint between themiddle vertebra 102 and thebottom vertebra 103 is a unilateral replacement with the inferior facet of themiddle vertebra 102 replaced by theinferior facet prosthesis 402 and the superior facet of thebottom vertebra 103 replaced by thesuperior facet prosthesis 303. -
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 prosthesis 305 with a curved articulatingcomponent 330 has a curved articulatingsurface 331. This curved articulatingsurface 331 allows for a more distributed contact load between an inferior facet prosthesis, such as theinferior facet prosthesis 400 ofFIG. 23 , and the curved articulatingsurface 331. This allows slightly more flexibility in the position that the surgeon places the curvedsuperior facet prosthesis 305 than thesuperior facet prosthesis 300 previously described. The articulatingsurface 321 of thesuperior facet prosthesis 300 previously described is relatively flat. The articulatingsurface 331 of the curvedsuperior facet prosthesis 305 is curved. Since the bearing portion of theinferior facet prosthesis 400 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 to
FIG. 39 a perspective view illustrates abone ingrowth feature 390 on asuperior facet prosthesis 306. Thebone ingrowth feature 390 can be any surface that allows bone to grow into the implant between thefirst resection surface 112 of thevertebra 100 and theapposition surface 322 of the implant. Examples of bone ingrowth features 390 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 to
FIG. 40 , a perspective view shows theinferior facet prosthesis 400, which is formed in the general shape of a finger or talon. More particularly, theinferior facet prosthesis 400 is formed with aflange 420 on its superior side shaped to fit between theenlarged head 500 and either thesuperior facet prosthesis 300 or thefirst resection surface 112. Theflange 420 has anopening 410 that is dimensioned to allow theinferior facet prosthesis 400 to fit over theproximal post 230 of thefixation element 200 and around theshaft portion 240 of thefixation element 200. Theinferior facet prosthesis 400 also has aninferior portion 450 on the opposite side of theflange 420 that has abone apposition side 440 that is shaped to contact the surface of the inferior facet resection surface 121 (FIG. 19 ) and ajoint articulation side 430 that is shaped to articulate against a natural or prosthetic superior facet. - Referring to
FIG. 41 , a perspective view shows aninferior facet prosthesis 460 also formed in the general shape of a finger or talon. Theinferior facet prosthesis 460 is formed with asuperior end 420 having anopening 410 that is dimensioned and shaped to accept thefixation element 200. Theinferior facet prosthesis 460 is generally columnar in shape, having a curved length designed to conform to the prepared anatomy of thevertebra 100. Theinferior facet prosthesis 460 ofFIG. 41 has aninferior portion 470, which is shown opposite thesuperior end 420, and slightly medially offset from thesuperior end 420. This medial offset of theopening 410 relative to theinferior portion 470 allows theinferior facet prosthesis 400 to be anchored to the bone by thefixation element 200 and secured to the bone by theenlarged head 500, or thesuperior facet prosthesis 300 in combination with theenlarged head 500, at an anatomical position that allows optimal bone fixation. Theinferior facet prosthesis 460 ofFIG. 41 has abone ingrowth surface 441 and a joint articulatingside 430 on itsinferior end 470. In this embodiment, thebone ingrowth surface 441 is a textured structure that permits bone cells to grow into the implant surface. The shape of thebone ingrowth surface 441 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 surface 441 is shaped to mate with the inferior resectedbone surface 121 shown inFIG. 19 andFIG. 20 . -
FIG. 42 shows an exploded, perspective view of thevertebra 100 with thesuperior facet prosthesis 300 installed. Anadditional locking washer 800 is used to assist in stabilizing the attachment of thesuperior facet prosthesis 300 to thefirst resection surface 112. The construction of the implant assembly shown inFIG. 42 is similar to that of the assembly shown inFIG. 25 with the addition of the lockingwasher 800 that is placed over and around theproximal post 230 of thefixation element 200. - Referring to
FIG. 43 , a perspective view shows the same implant ofFIG. 42 with theenlarged head 500 locked onto thefixation element 200 and pushing the lockingwasher 800 against thesuperior facet prosthesis 300 and into the bone tissue. This added bone penetration of the lockingwasher 800 helps to fix thesuperior prosthesis 300 such that the entire assembly is more mechanically stable with respect to thevertebra 100. -
FIG. 43 shows a further step in the assembly of the implant construct described inFIG. 42 . InFIG. 43 , the lockingwasher 800 is secured over thefixation element 200 and into the bone tissue by theenlarged head 500. Although this embodiment of the lockingwasher 800 is only shown with thesuperior facet prosthesis 300, the lockingwasher 800 can alternatively be used to mechanically secure theinferior facet prosthesis 400, or the combination of theinferior facet prosthesis 400 and thesuperior facet prosthesis 300. In the embodiment of the lockingwasher 800 shown inFIG. 42 andFIG. 43 , the lockingwasher 800 is placed over thesuperior facet prosthesis 300. However, the lockingwasher 800 may be placed under thesuperior facet prosthesis 300, under theinferior facet prosthesis 400 and thesuperior facet prosthesis 300, or between thesuperior facet prosthesis 300 and theinferior facet prosthesis 400 to stabilize the implant construct. -
FIG. 44 shows a perspective view of the lockingwasher 800. The lockingwasher 800 has abody 805 with anopening 810 that is dimensioned to fit over theproximal post 230 of thefixation element 200. The lockingwasher 800 also has ananti-rotation feature 820 that mates with either thesuperior facet prosthesis 300 or theinferior facet prosthesis 400 or a combination of both theinferior facet prosthesis 400 and thesuperior facet prosthesis 400. Theanti-rotation feature 820 shown in this embodiment is a flat surface, however, any feature that would rotationally constrain the lockingwasher 800 to the other components of the implant (such as a tab, groove, taper or other geometric shape) can be formed on the lockingwasher 800 as an anti-rotation feature. The lockingwasher 800 also hasprongs 830 that pass into the bone tissue of thevertebra 100 to help stabilize the implant construct. Theprongs 830 in this embodiment of the lockingwasher 800 are elongated protrusions that taper to atissue penetration tip 840. The prongs havesidewalls 850 that provide a surface to resist torsion once the lockingwasher 800 penetrates the bone tissue. Theprongs 830 may also be simple spikes that are either symmetrical or asymmetrical in cross-section that protrude from the lockingwasher body 805. The shape and length of the lockingwasher prongs 830 are dependent on how the lockingwasher 800 is used. Theprongs 830 of the lockingwasher 800 that holds only one of theinferior facet prosthesis 400 or thesuperior facet prosthesis 300 to thevertebra 100 may be shorter than prongs of a locking washer that holds both theinferior facet prosthesis 400 and thesuperior facet prosthesis 300 to thevertebra 100. -
FIG. 45 shows a perspective view of thesuperior facet prosthesis 300 andinferior facet prosthesis 400 held to thevertebra 100 by an adjunctiveflexible fixation element 900 and a secondaryflexible fixation element 910. Theseflexible fixation elements 900 and/or 910 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. Theflexible fixation elements 900 and/or 910 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 aflexible element structure 900 and/or 910 such as those shown inFIG. 45 . The adjunctiveflexible element 900 shown inFIG. 45 is shown attached to and securing theelongated head 500. A flexible element attachment portion 580 (e.g., including an opening) mates theflexible element 900 to the elongated head. However, the adjunctiveflexible fixation element 900 may alternatively or additionally be attached to thefixation element 200, thesuperior facet prosthesis 300, theinferior facet prosthesis 400 or any combination of the above listed elements. A flexible fixation attachment portion 480 (e.g., including an opening) in theinferior facet prosthesis 400 allows the secondaryflexible fixation element 910 to secure theinferior facet prostheses 400 to thevertebra 100. Theflexible fixation elements 900 and/or 910 may be secured to thevertebra 100 by physically wrapping them around anatomic features such as theposterior arch 35, thespinous process 46,transverse process 105, or a combination of these anatomic features. Theflexible element 900 and the secondaryflexible element 910 may also be secured to thevertebra 100 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 theflexible fixation element 900 and/or the secondaryflexible fixation element 910 to thevertebra 100. -
FIG. 46 is a dorsal view of a bilateralinferior facet prosthesis 1000. The bilateralinferior facet prosthesis 1000 is a one-piece inferior facet prosthesis that has both a rightinferior side 1040 and a leftinferior side 1020 connected by a stabilizingbar 1010. Both the rightinferior side 1040 and the leftinferior side 1020 are designed to fix to thetop vertebra 101 at the respective inferior resection surface 121 (FIG. 19 ) and at thefirst resection surface 112. The bilateralinferior facet prosthesis 1000 allows replacement of both the left and the right inferior facets. In this embodiment, the bilateralinferior facet prosthesis 1000 is placed over the left andright fixation elements 200 which extend into the bone of thetop vertebra 101. In the embodiment shown inFIG. 46 , the rightinferior side 1040 is articulating against the rightsuperior facet prosthesis 300 attached to thebottom vertebra 102. Also in this embodiment, the leftinferior side 1020 is articulating against the left naturalsuperior facet 43 of thebottom vertebra 102. The stabilizingbar 1010 of the bilateralinferior prosthesis 1000 is designed to stabilize theleft side 1020 and theright side 1040 so that they are secure. -
FIG. 47 illustrates a perspective view of asuperior facet prosthesis 1100 coupled to thevertebra 3. Thesuperior facet prosthesis 1100 has a bone apposition surface (not shown) that has been placed on afirst resection surface 1112 and an opening (not shown) in aflange 1116 that surrounds afixation element 1110, and coupled thereto by a locking fastener such as acastle nut 1114 or the like. Thesuperior facet prosthesis 1100 has a superiorfacet articulating component 1120 with an articulatingsurface 1122 generally adjacent to theflange 1116. The articulatingsurface 1122 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 articulatingsurface 1122 allows thesuperior facet prosthesis 1100 to function as either a hemiarthroplasty implant by articulating against a natural anatomicinferior facet 6 or as a unilateral prosthesis by articulating against an inferior facet prosthesis on the vertebra superior (cephalad) to it, such as theinferior facet prosthesis 4 shown inFIG. 5 , theinferior facet prostheses 10 shown inFIGS. 8 and 9 , and theinferior facet prosthesis 400 shown inFIG. 40 , as well as those described below. - The
facet articulating component 1120 is preferably formed in the general shape of a blade or wing ear, wherein the articulatingsurface 1122 has a concave shape. In the embodiment shown, the articulatingsurface 1122 curves from an orientation generally perpendicular to theflange 1116 towards an orientation generally parallel to theflange 1116 from adistal end 1124 thereof to aproximal end 1126 thereof. - The concave shape of the articulating
surface 1122 provides more tolerance for a miss-match with the natural anatomicinferior facet 6 or with theinferior facet prosthesis 4 on the vertebra superior to it. Functionally, the clearance between the concave shape of the articulatingsurface 1122 and the adjacentinferior facet 6 orinferior facet prosthesis 4 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 thevertebra 3 cut by across-sectioning plane 1130 placed along an axis that passes through the center of thefixation element 1110. Thecross-section plane 1130 shown cutting through thevertebra 3 and the implant ofFIG. 47 is shown for visualization purposes to illustrate, using a cross-sectioned view, how thevertebra 3,fixation element 1110, andsuperior facet prosthesis 1100 engage each other. - The
fixation element 1110 provides a mechanism that affixes thesuperior facet prosthesis 1100 tovertebra 3.Fixation element 1110 is implanted into the interior bone space of the left pedicle 11 (FIG. 6 ) on thevertebra 3 and may or may not extend into the vertebral body ofvertebra 3 to provide additional stability. Thefixation element 1110 can take the form of a screw (as shown), or any of the devices shown inFIGS. 28-30 . Thefixation element 1110 has adrive feature 1140, 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 element 1110 into thevertebra 3 can be formed on aproximal post 1142 of thefixation element 1110. - The depth of the
drive feature 1140 formed in theproximal post 1142 of thefixation element 1110 is seen in the cross-sectional view ofFIG. 48 . Thedrive feature 1140 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 post 1142 of thefixation element 1110 that engages with a corresponding internal drive feature on a driver tool (not shown). Theflange 1116 of thesuperior facet prosthesis 1100 is secured to thefixation element 1110 by thecastle nut 1114 or the like. - The
flange 1116 of thesuperior facet prosthesis 1100 includes acoupling portion 1144 having a generally semisphericalbone engaging surface 1150 on the apposition side of thesuperior facet prosthesis 1100 that engages a correspondingsemispherical resection 1146 in the bone bed of the pedicle ofvertebra 3. 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. - The
semispherical resection 1146 may be said to be “inversely shaped” with respect to the coupling portion because thesemispherical resection 1146 has a generally concave surface that matches the generally convex surface of thecoupling portion 1144. Although thecoupling portion 1144 and thesemispherical resection 1146 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 portion 1144 is convex and thesemispherical resection 1146 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 of
FIGS. 47 and 48 , thecoupling portion 1144 is integrally formed with the articulatingsurface 1122 of the superiorfacet articulating component 1120. Thecoupling portion 1144 may be said to be “attached to” the articulatingsurface 1122 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. - The
semispherical resection 1146 in the bone bed allows for less transverse process to be resected (vs. a flat bone bed resection). Thesemipherical resection 1146 in the bone bed also allows for more stable support of thesuperior facet prosthesis 1100, than does a flat bone bed resection, as thesuperior facet prosthesis 1100 is polyaxially supported in such a way as to resist any shear forces applied between thesemispherical resection 1146 and thecoupling portion 1144. In this application, “polyaxial” refers to a linear or angular force or motion acting with respect to at least two perpendicular axes. Thecoupling portion 1144 may seat directly against thesemispherical resection 1146. 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. - The
coupling portion 1144 has a fixationelement receiving aperture 1148 that can be made slightly larger than a circumferential diameter of thefixation element 1110 taken in a direction perpendicular to a longitudinal axis thereof to provide accurate polyaxial seating of theimplant 1100 in relation to the resected bone bed andfixation element 1110, as well as to provide increased tolerance for miss-match. An implant engaging end 1154 of the castle nut 1114 (or other fastener) also has a semispherical shape for engaging a semispherical nut engaging side of thecoupling portion 1144 of thesuperior facet prosthesis 1100 at the final position of thesuperior facet prosthesis 1100. - The semispherical shape of the
coupling portion 1144 enables thecoupling portion 1144 to move polyaxially against thesemispherical resection 1146. Movement “against” the semispherical resection refers to movement in which thecoupling portion 1144 remains substantially continuously in contact with thesemispherical resection 1146 so as to slide against thesemispherical resection 1146. Accordingly, during installation, a surgeon can position thecoupling portion 1144 against thesemispherical resection 1146 and then pivot thecoupling portion 1144 along three perpendicular axes, without removing thecoupling portion 1144 from thesemispherical resection 1146. Thecoupling portion 1144 simply rotates against thesemispherical resection 1146. - The phrase “polyaxial motion” refers to any combination of translation and/or rotation along at least two perpendicular axes. Since the
coupling portion 1144 is pivotable with respect to thesemispherical resection 1146 along three perpendicular axes, thecoupling portion 1144 is “tri-axially pivotable” with respect to thesemispherical resection 1146. - When the
superior facet prosthesis 1100 has been rotated to the proper orientation, the articulatingsurface 1122 is positioned for proper articulation against the corresponding inferior facet or inferior facet prosthesis. The orientation of thecoupling portion 1144 may then be fixed with respect to thesemispherical resection 1146 by tightening the castle nut 1114 (or another fastener) on thefixation element 1110, thereby firmly gripping thecoupling portion 1144 against thesemispherical resection 1146. Accordingly, thecoupling portion 1144 is “selectively polyaxially movable” with respect to thesemispherical resection 1146 because thecoupling portion 1144 is movable with respect to thesemispherical resection 1146 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 fixation
element receiving aperture 1148, 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 end 1154 of the castle nut 1114 (or other fastener) can be deformable such that the implant engaging end 1154 conforms under pressure to the adjacent surface of the
coupling portion 1144 regardless of the angle of the surface with respect to the axis of thecastle nut 1114. The deformable end can be formed of a plastic such as polyethylene attached to the metal body of thecastle nut 1114, 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 resection 1112 and corresponding angled flat 1156 on the apposition side of thesuperior facet prosthesis 1100 in combination with thesemispherical resection 1148. - The surfaces of the apposition side of the
coupling portion 1144 and flat 1156, as well asfixation element 1110, 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 thevertebra 3 with afixation element 1110 portion implant placed through thesemispherical resection 1146 in theresection surface 1112 and into the bone of thepedicle 11. Thefixation element 1110 is aligned and placed into thepedicle 11 in a manner similar to that of other pedicle screws for posterior stabilization vertebrae fusion procedures. - In
FIG. 50 , a perspective view illustrates thesuperior facet prosthesis 1100 in place around thefixation element 1110. Thecastle nut 1114 has not yet been installed. As shown, thecoupling portion 1144 has a semisphericalnut engaging surface 1152. -
FIG. 51 is a top view of thesuperior facet prosthesis 1100, particularly showing the curved shape of the articulatingsurface 1122 and the semisphericalbone engaging surface 1150 of thecoupling portion 1144. Additionally,FIG. 51 more clearly illustrates the angled flat 1156 on the apposition side of thesuperior facet prosthesis 1100. -
FIG. 52 is an illustration of a rear view of thesuperior facet prosthesis 1100. In this context, “rear” means as viewed from along the axis of the fixationelement receiving aperture 1148.FIG. 52 particularly shows the curved shape of the articulatingsurface 1122 and the semisphericalnut engaging surface 1152 of thecoupling portion 1144. -
FIG. 53A shows a kit including a plurality of differently configuredsuperior facet prostheses superior facet prostheses adjacent prosthesis superior facet prostheses - Referring again to
FIG. 51 , which shows a singlesuperior facet prosthesis 1100, some of the physical dimensions that change between the differently sizessuperior facet prostheses FIG. 53A ) are a resection angle (.alpha.), an x offset (X.sub.1), a y offset (Y.sub.1), a facet angle (.beta.), 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 articulating
surface 1122. Thesuperior pedicle axis 1170 is the axis that is colinear with the longitudinal axis of thefixation element 1110 that is positioned through thepedicle 11 nearest to the resected superior facet (not shown). Thesuperior pedicle axis 1170 extends through a saddle point S1, which is offset as shown, by an offset 1176, which may be about 2 mm, from the fixationelement receiving aperture 1148. Thesuperior pedicle axis 1170 is parallel with the direction of the y offset (Y.sub.1). The direction of the x offset (X.sub.1) is perpendicular to the direction of the y offset (Y.sub.1). The direction of the x offset (X.sub.1) 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 articulating
surface 1122. As shown, P4 is displaced from the saddle point S1 by an x offset (X.sub.4) and a y offset (Y.sub.4). The direction of the X.sub.4 offset is parallel to that of the X.sub.1 offset, and the direction of the Y.sub.4 offset is parallel to that of the Y.sub.1 offset. - The resection angle (.alpha.) for the
superior facet prostheses 1100 can range from 50 to 85.degree. However, the optimal range of the resection angle (.alpha.) for the majority of patients will range from 30.degree. to 70.degree. Thus, by way of example, a family containing nine sets ofsuperior facet prostheses 1100 can be provided with the resection angles (a) varying in increments of 5.degree. Sets ofsuperior facet prostheses 1100 would be provided with resection angles (a) at 30.degree., 35.degree., 40.degree., 45.degree., 50.degree., 55.degree., 60.degree., 65.degree. and 70.degree. - The x offset (X.sub.1) for the
superior facet prosthesis 1100 can range from 5 mm to 30 mm. However, for the majority of patients, the x offset (X.sub.1) will range from 10 mm to 20 mm. Therefore a family ofsuperior facet prostheses 1100 can be provided with the x offset (X.sub.1) varying in increments of 5 mm. Thus, sets ofsuperior facet prostheses 1100 would be provided with x offset (X.sub.1) at 10 mm, 12 mm, 14 mm, 16 mm, 18 mm, and 20 mm to providesuperior facet prostheses 1100 that cover the statistical range for the majority of the population of patients needingsuperior facet prostheses 1100. - The y offset (Y.sub.1) for the
superior facet prosthesis 1100 can range from 2 mm to 20 mm. However, for the majority of patients, the y offset (Y.sub.1) will range from 5 mm to 15 mm. Therefore a family ofsuperior facet prostheses 1100 can be provided with the y offset (Y.sub.1) varying in increments of 2 mm. Thus, sets ofsuperior facet prostheses 1100 would be provided with y offset (Y.sub.1) at 5 mm, 7 mm, 9 mm, 11 mm, 13 mm, and 15 mm to providesuperior facet prostheses 1100 that cover the statistical range for the majority of the population of patients needingsuperior facet prostheses 1100. - The x offset (X.sub.4) for the
superior facet prosthesis 1100 can range from about 5 mm to about 25 mm. However, for the majority of patients, X.sub.4 will range from about 8 mm to about 20 mm. A family of superior facet prostheses may be provided with X.sub.4 values varying in increments of 2 mm. Thus, sets ofsuperior facet prostheses 1100 would be provided with X.sub.4 values of 8 mm, 10 mm, 12 mm, 14 mm, 16 mm, 18 mm, and 20 mm to providesuperior facet prostheses 1100 that cover the statistical range for the majority of the population of patients needingsuperior facet prostheses 1100. - The y offset (Y.sub.4) for the
superior facet prosthesis 1100 can range from about −5 to about 15 mm. However, for the majority of patients, Y.sub.4 will range from about −2 mm to about 10 mm. A family of superior facet prostheses may be provided with Y.sub.4 values varying in increments of 2 mm. Thus, sets ofsuperior facet prostheses 1100 would be provided with Y.sub.4 values of −2 mm, 0 mm, 2 mm, 4 mm, 6 mm, 8 mm, and 10 mm to providesuperior facet prostheses 1100 that cover the statistical range for the majority of the population of patients needingsuperior facet prostheses 1100. - The facet angle (.beta.) for the
superior facet prosthesis 1100 can range from 50.degree. to 120.degree. However, for the majority of patients, the facet angle (.beta.) will range from 60.degree. to 100.degree. Therefore a family ofsuperior facet prostheses 1100 can be provided with the facet angle (.beta.) varying in increments of 5.degree. Thus, sets ofsuperior facet prostheses 1100 would be provided with the angle (.beta.) at 60.degree., 65.degree., 70.degree., 75.degree., 80.degree., 85.degree., 90.degree., 95.degree., and 100.degree. to providesuperior facet prostheses 1100 that cover the statistical range for the majority of the population of patients needingsuperior facet prostheses 1100. - Once the surgeon assesses the anatomy of the superior facet that is being replaced, a particular
superior facet prosthesis 1100 is selected that has the curvature and overall angle of the articulatingsurface 1122, with respect to theflange 1116 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 prostheses 1100 is provided to the surgeon and the surgeon selects thesuperior facet prosthesis 1100 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 .alpha., X.sub.1, Y.sub.1, .beta., X.sub.4, Y.sub.4, 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.
- The
prostheses FIG. 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 prosthesis 1172. The inferior facet prosthesis 1172 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 prosthesis 1172 and a center point C1 of thearticulation surface 1174. The saddle point S1 ofFIGS. 53B and 53C is defined in a manner similar to that of thesuperior facet prosthesis 1100 ofFIG. 51 . - As shown in
FIGS. 53B and 53C , the inferior facet prosthesis 1172 has a semispherical coupling portion similar to thecoupling portion 1144 of thesuperior facet prosthesis 1100 introduced in the description ofFIG. 47 . Accordingly, the inferior facet prosthesis 1172 provides the same type of tri-axial pivotal motion during installation as thecoupling portion 1144, as described previously. The coupling portion of the inferior facet prosthesis 1172 may also be nested in thecoupling portion 1144 of thesuperior facet prosthesis 1100, or vice versa, to enable independent polyaxial adjustment of theprostheses semispherical resection 1146. - Referring to
FIG. 53D , a perspective view illustrates a kit ofinferior facet prostheses inferior facet prostheses 1180 in the kit ofFIG. 53D . These dimensions may include an inferior resection angle (I.alpha.), an inferior x offset (X), an inferior y offset (Y), an inferior facet angle (I.beta.), 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 I.alpha. is the angle of the flat resection to be made in the vertebra, for example, the
vertebra 101 illustrated in some of the preceding drawings, to serve as a backing for the articulating surface of the selectedinferior facet prosthesis superior facet prosthesis 1100, as illustrated inFIG. 51 , the inferior resection angle I.alpha. may be approximately the same as the facet angle .beta. for thesuperior prosthesis 1100 because the articulation surfaces 1122, 1174 are to be positioned generally parallel to each other. Due to the clearance between the articulatingsurfaces inferior facet prosthesis surfaces inferior facet prosthesis surface 1174 may be adjusted as needed to permit theinferior facet prosthesis corresponding vertebra 101. Accordingly, I.alpha. need not be determined based on measurement of thevertebra 101, but may instead be inferred based on the selection of thesuperior facet prosthesis - The inferior facet angle I.beta. may be defined as the angle of the surface to which the articulating
surface 1174 is most nearly parallel. Due to the shape of theinferior facet prostheses superior facet prosthesis 1100 ofFIG. 51 . - The
inferior pedicle axis 1170 is the axis that is collinear with the longitudinal axis of thefixation element 1110 that is positioned through thepedicle 11 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 the
inferior facet prosthesis 1180 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 prostheses 1180 can be provided with the inferior x offset (X) varying in increments of 2 mm. Thus, sets ofinferior facet prostheses 1180 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 prostheses 1180 that cover the statistical range for the majority of the population of patients needinginferior facet prostheses 1180. - The inferior y offset (Y) for the
inferior facet prosthesis 1180 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 prostheses 1180 can be provided with the inferior y offset (Y) varying in increments of 2 mm. Thus, sets ofinferior facet prostheses 1180 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 prostheses 1180 that cover the statistical range for the majority of the population of patients needinginferior facet prostheses 1180. - The inferior facet articulation radius (IR) for the
inferior facet prosthesis 1180 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 the
inferior facet prosthesis 1180 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 prostheses 1180 can be provided with the inferior z offset (Z) varying in increments of 1 mm. Thus, sets ofinferior facet prostheses 1180 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 prostheses 1180 that cover the statistical range for the majority of the population of patients needinginferior facet prostheses 1180. If desired, a kit having ten inferior facet prostheses may be assembled. Like theprostheses FIG. 53A , theprostheses FIG. 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 the
prostheses FIG. 53A and/or theprostheses FIG. 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 prosthesis 1100 and aninferior facet prosthesis 1180 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 prosthesis 1100 and aninferior facet prosthesis 1204 attached to the L5 and L4lumbar vertebrae FIG. 53F , thesuperior facet prosthesis 1100 is attached to the left side of theL5 vertebra 102 and theinferior facet prosthesis 1204 is attached to theleft L4 vertebra 101. The twoprostheses L5 vertebrae -
FIG. 53F shows theprostheses vertebrae articulation surface 1174 of theinferior prosthesis 1204 and thearticulation surface 1122 of thesuperior prosthesis 1100 are in contact in the neutral position. However, theprostheses facet articulation surface 1174 and the superiorfacet articulation surface 1122 throughout various anatomic ranges of motion. - Also shown in
FIG. 53F are two planes labeled “Plane 1” and “Plane 2” that that intersect along an axis (not shown) that passes through the contact areas of the superiorfacet articulation surface 1122 and the inferiorfacet articulation surface 1174.Plane 1 is parallel to the page ofFIG. 53F , andPlane 2 is perpendicular to the page. -
FIG. 53G is a posteriolaterial view of the same inferior andsuperior facet prostheses FIG. 53F . InFIG. 53G ,Plane 2 is oriented parallel to the page andplane 1 is oriented perpendicular to the page.FIG. 53G illustrates the saddle point (S1) of thevertebra 102 to which thesuperior facet prosthesis 1100 is coupled, and the saddle point (S2) of thevertebra 101 to which theinferior facet prosthesis 1204 is coupled. The saddle points S1, S2 are displaced from each other along an x offset (IX) parallel to the axis at whichPlane 1 andPlane 2 intersect, a y offset (IY) extending perpendicular toPlane 2, or out of the page with respect toFIG. 53G , and a z offset (IZ) extending perpendicular toPlane 1. 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 alongPlane 2. This cross-section view cuts through the articulation surfaces 1122, 1174 of theprostheses inferior articulation surface 1174 against the concave shape of thesuperior articulation surface 1122. -
FIG. 53H also illustrates the cephalad andcaudal ends articulation surface 1122 of thesuperior facet prosthesis 1100. Thearticulation surface 1122 has a radius ofcurvature 1254 generally about anaxis 1256. However, since the radius ofcurvature 1254 changes along the articulatingsurface 1122, theaxis 1256 may be the center of curvature for only a portion of thearticulation surface 1122. The radius ofcurvature 1254 is shown extending from theaxis 1256 to thearticulation surface 1122 inFIG. 53H . Furthermore,FIG. 53H illustrates alongitudinal axis 1258 of the spine in general. Theaxis 1256 is angled from theaxis 1258 by an offsetangle 1259. Since theaxis 1256 and theaxis 1258 may not both be precisely parallel toPlane 2, the offsetangle 1259 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 alongPlane 1. This cross-section cuts through the articulation surfaces 1122, 1174 of the prostheses showing the convex shape of theinferior articulation surface 1174 against the concave shape of thesuperior articulation surface 1122. Each of the articulatingsurfaces surfaces inferior prostheses second vertebrae - 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 in
FIG. 53H , one of the articulatingsurfaces surface 1122 of thesuperior facet prosthesis 1100, has acephalad end 1250 and acaudal end 1252. The articulatingsurface 1122 also has a radius ofcurvature 1254 about anaxis 1256 extending generally from thecephalad end 1250 end to thecaudal end 1252. The radius ofcurvature 1254 changes along theaxis 1256 to provide greater clearance between the articulatingsurfaces curvature 1254 provides less clearance between the articulatingsurfaces - In this embodiment, the articulating
surface 1122 is shaped such that, when thesuperior facet prosthesis 1100 is coupled to the vertebra, theaxis 1256 is significantly anteriorly inclined at thecephalad end 1250 to provide greater clearance between the articulatingsurfaces curvature 1254 from thecephalad end 1250 to thecaudal end 1252, the radius ofcurvature 1254 could vary along a medial-lateral direction of the articulating surface. - More precisely, with brief reference to
FIG. 51 again, the radius of curvature may be larger toward amedial end 1260 and alateral end 1262 of the articulatingsurface 1122 than at acentral portion 1264 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 region 1268 proximate thecentral portion 1264, a first tangent flat 1270 disposed medially of and tangent to thecurved region 1268, and a second tangent flat 1272 disposed laterally of and tangent to thecurved region 1268. - If desired, the inferior facet prosthesis may have an articulating surface with a three-dimensionally curved, generally elliptical shape. A three-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 with
FIGS. 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 to
FIGS. 53F , 53G, 53H, and 531, the materials used to construct the articulating surfaces of theprostheses prostheses - The
superior facet prosthesis 1100 may be shaped such that, when thesuperior facet prosthesis 1100 is coupled to thevertebra 102, theaxis 1256 is significantly anteriorly inclined from a longitudinal axis (not shown) of the spine to provide greater clearance between the articulatingsurfaces angle 1259 between theaxis 1256 and thelongitudinal axis 1258 of the spine may range from about −2.5.degree. to about 14.5.degree. More precisely, the offsetangle 1259 may range from about 5.degree. to about 10.degree. Yet more precisely, the offsetangle 1259 may be about 7.25.degree. - Referring briefly again to
FIG. 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 axis 1170 of thevertebra 102, at a known displacement from the saddle point S1. Certain offsets, such as X.sub.1 and X.sub.2, as shown inFIG. 51 , may be measured with between the saddle point S1 and the most medial and anterior point P1. - Based on X.sub.1 and X.sub.2, values of the resection angle .alpha. and the facet angle .beta. may be obtained. The values of .alpha. and .beta. may be used to select the appropriate superior facet prosthesis of the kit by, for example, looking up the values of .alpha. and .beta. 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 .alpha. and .beta.
- 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 the
vertebra 101, 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 I.alpha. and Z (as illustrated in
FIG. 53C ) are determined. The values of I.alpha. and Z may be used to select the appropriate inferior facet prosthesis of the kit by, for example, looking up the values of I.alpha. 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 I.alpha. 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 with
FIG. 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 a
semispherical resection 1146 has been formed in a vertebra and the corresponding prosthesis has been selected, a flat resection, such as thefirst resection surface 1112 ofFIG. 48 , may be formed. The flat resection may be contiguous with thesemispherical resection 1146, or may be separated from thesemispherical resection 1146 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 system 1200 in situ. The bilateral inferiorfacet prosthesis system 1200 is a multi-piece inferior and superior facet prosthesis that has both a rightinferior facet prosthesis 1202 and a leftinferior facet prosthesis 1204 connected by a crosslink, which may take the form of a stabilizingbar 1210. Both the rightinferior facet prosthesis 1202 and the leftinferior facet prosthesis 1204 are designed to be affixed to thetop vertebra 101 at the respective inferior facet resection surfaces 121 (FIG. 19 ). - The bilateral
inferior facet prostheses right fixation elements top vertebra 101. In the embodiment shown inFIG. 54 , the right inferior side is articulating against a rightsuperior facet prosthesis 1100 attached to the first resection surface 1112 (FIG. 49 ) of thebottom vertebra 102. Also in this embodiment, the leftinferior facet prosthesis 1204 is articulating against the left natural superior facet of thebottom vertebra 102. - The stabilizing
bar 1210 of the bilateralinferior prosthesis system 1200 is designed to stabilize the leftinferior facet prosthesis 1204 and the rightinferior facet prosthesis 1202 so that they are secure. The stabilizingbar 1210 also allows the left and rightinferior facet prostheses bar 1210 can compress the left and rightinferior facet prostheses - As also shown in
FIG. 54 , the stabilizingbar 1210 is coupled to the left and rightinferior prostheses FIG. 54 , the gripping mechanism includes fore andaft flanges bar 1210 to form a groove-and-rod joint. The fore andaft flanges turnbuckles bar 1210 there between. - The pinching action of the
flanges inferior prostheses inferior prostheses turnbuckles bar 1210. -
FIG. 55 is a perspective view of the bilateral inferiorfacet prosthesis system 1200. The rightinferior facet prosthesis 1202 includes a convex articulatingsurface 1220 that engages an articulatingsurface 1122 of thesuperior facet prosthesis 1100. In one embodiment, the articulatingsurface 1122 of thesuperior facet prosthesis 1100 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 system 1200 andsuperior facet prosthesis 1100. The rightinferior prosthesis 1202 includes amember 1230 upon which theflanges member 1230 is a ball-shapedmember 1230 upon which theflanges inferior prostheses flanges member 1230 to resist further relative rotation. - The ball-and-socket joint enables relative motion between the
inferior prostheses inferior prostheses turnbuckles members 1230 of theinferior prostheses members 1230 are no longer freely pivotable with respect to theflanges inferior prostheses turnbuckles - An alternative embodiment replaces the ball shaped
member 1230 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 prostheses flanges - The ball-shaped
member 1230 shown inFIG. 56 has several divots formed thereon. Upon compression of theflanges member 1230 has circumferential or axial splines (FIG. 63 ) formed thereon, which “bite” into theflanges member 1230 include knurling, nubs, grooves, facets, and combinations of any of the above. - Similarly, the stabilizing
bar 1210 can have surface features to enhance coupling to theflanges bar 1210 with respect to theflanges bar 1210 with respect to theflanges - The
flanges bar 1210 and the ball-shapedmembers 1230 to further enhance coupling. Illustrative materials for the stabilizingbar 1210 and ball-shapedmembers 1230 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 bar 1210, and/or the ball-shapedmembers 1230. In one alternative embodiment, theflanges inferior prostheses - Referring again to
FIG. 54 , ends of theflanges bar 1210 are angled towards each other. This angling avoids interference with surrounding bone and avoids interference with the superior facet or thesuperior facet prosthesis 1100. - With continued reference to
FIG. 54 , it is seen that the heads of theturnbuckles turnbuckle 1216 is larger than theturnbuckle 1218. The larger head of theturnbuckle 1216 allows the surgeon to exert more torque on theturnbuckle 1216, thereby allowing a more secure coupling of theflanges bar 1210. The smaller head of theturnbuckle 1218 requires less space at the surgical site of the patient than the larger head of theturnbuckle 1216. 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 stabilizing
bar 1210 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 prostheses inferior prostheses -
FIG. 57 is a cranial view of the bilateral inferiorfacet prosthesis system 1200. -
FIG. 58 is a bottom in situ view of the bilateral inferiorfacet prosthesis system 1200 in situ. -
FIG. 59 is rear view of the bilateral inferiorfacet prosthesis system 1200 in isolation. -
FIG. 60 is a top view of the bilateral inferiorfacet prosthesis system 1200. -
FIG. 61 is a bottom view of the bilateral inferiorfacet prosthesis system 1200. -
FIG. 62 is a perspective view of the rightinferior prosthesis 1204. -
FIGS. 63 and 64 are perspective and end views, respectively, of various ball-shapedmembers inferior prostheses members 1230, the ball-shapedmembers circumferential grooves 1302,longitudinal grooves 1304, andknurling 1306. -
FIG. 65 is a dorsal view of the bilateral inferiorfacet prosthesis system 1200, in whichcastle nuts 1320 are attached to the left andright fixation elements fixation member 1110. - 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 (16)
1. A method comprising:
securing a left coupling portion to a left side of a first vertebra;
securing a right coupling portion to a right side of the first vertebra;
positioning a left articular surface to replace a left natural articular surface of the first vertebra;
positioning a right articular surface to replace a right natural articular surface of the first vertebra;
securing a crosslink to the left and right coupling portions; and
wherein the crosslink is adjustable laterally with respect to the left and right coupling portions.
2. The method of claim 1 , wherein securing the left coupling portion to the left side comprises implanting a left fixation member in a left pedicle of the first vertebra; wherein securing the right coupling portion to the right side comprises implanting a right fixation member in a right pedicle of the first vertebra.
3. The method of claim 1 , wherein the left coupling portion and the left articular surface are both incorporated into a unitarily formed left prosthesis, wherein the right coupling portion and the right articular surface are both incorporated into a unitarily formed right prosthesis.
4. The method of claim 1 , wherein actuating the first locking mechanism to secure the crosslink to the other of the left and right coupling portions comprises providing any of a plurality of relative positions of the left and right articular surfaces.
5. The method of claim 1 , wherein actuating the first locking mechanism to secure the crosslink to the other of the left and right coupling portions comprises providing any of a plurality of relative orientations of the left and right articular surfaces.
6. The method of claim 1 , wherein the crosslink comprises a rod, wherein actuating the first locking mechanism to secure the crosslink to the other of the left and right coupling portions comprises gripping the crosslink.
7. The method of claim 1 , wherein actuating the first locking mechanism to secure the crosslink to the other of the left and right coupling portions comprises securing the crosslink in a position in which the crosslink does not contact the first vertebra.
8. The method of claim 1 , wherein securing the crosslink to one of the left and right coupling portions comprises actuating a second locking mechanism from a posterior approach.
9. The method of claim 1 , further comprising polyaxially adjustably coupling the crosslink to one of the left and right coupling portions.
10. The system of claim 1 , wherein positioning the left articular surface to replace the left natural articular surface comprises positioning the left articular surface to replace an inferior left natural articular surface of the first vertebra; wherein positioning the right articular surface to replace the right natural articular surface comprises positioning the right articular surface to replace an inferior right natural articular surface of the first vertebra.
11. A method comprising:
securing a left coupling portion to a left side of a first vertebra;
securing a right coupling portion to a right side of the first vertebra;
positioning a left articular surface to replace a left natural articular surface of the first vertebra;
positioning a right articular surface to replace a right natural articular surface of the first vertebra such that the right articular surface is displaced from the left articular surface;
coupling a crosslink to the left and right coupling portions; and
wherein the crosslink is adjustable laterally with respect to left and right coupling portions.
12. The method of claim 11 , wherein securing the left coupling portion to the left side comprises implanting a left fixation member in a left pedicle of the first vertebra; wherein securing the right coupling portion to the right side comprises implanting a right fixation member in a right pedicle of the first vertebra.
13. The method of claim 11 , wherein the left coupling portion and the left articular surface are both incorporated into a unitarily formed left prosthesis, wherein the right coupling portion and the right articular surface are both incorporated into a unitarily formed right prosthesis.
14. The method of claim 11 , wherein polyaxially adjustably coupling the crosslink to the other of the left and right coupling portions comprises utilizing a ball-and-socket joint to control motion of the crosslink relative to the other of the left and right coupling portions.
15. The method of claim 11 , wherein coupling the crosslink to one of the left and right coupling portions comprises coupling the crosslink in a position in which the crosslink does not contact the first vertebra.
16. The method of claim 11 , wherein coupling the crosslink to one of the left and right coupling portions comprises polyaxially adjustably coupling the crosslink to the one of the left and right coupling portions.
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