WO2009064536A1

WO2009064536A1 - Vertebra attachment method and system

Info

Publication number: WO2009064536A1
Application number: PCT/US2008/077115
Authority: WO
Inventors: Fraser Cummins Henderson, Sr.; John W. Newman
Original assignee: Polaris Biotechnology, Inc.
Priority date: 2007-11-13
Filing date: 2008-09-19
Publication date: 2009-05-22
Also published as: EP2214579A1

Abstract

A vertebral attachment method and system (100) that minimizes or eliminates the risk of severing, compressing, impinging or otherwise injuring the vertebral artery vertebral vein, spinal nerve roots and/or spinal cord,. The system includes at least one plate (3) that may be anchored to a posterior region of a vertebra using at least one clamp (1) and fastener (2). The system may be specifically designed to retain a portion of the posterior region of the vertebra.

Description

VERTEBRA ATTACHMENT METHOD AND SYSTEM

BACKGROUND OF THE INVENTION

1. Field of Invention

The present invention is directed to a novel vertebra attachment method and system. Specifically, the invention pertains to a vertebra attachment method and system that may be used in spinal stabilization applications, such as fusing the occipitocervical junction and/or the spinal vertebrae.

2. Brief Description of the Prior Art

I. Spinal Anatomy

As shown in FIGURE 1, the human spinal column AlOO is comprised of a plurality of vertebrae Al which are divided into five regions. The cervical region includes seven vertebrae, C1-C7. The thoracic region includes twelve vertebrae, T1-T12. The lumbar region contains five vertebrae, L1-L5. The sacral region is comprised of five vertebrae, S1-S5, and the coccygeal region contains four vertebrae, Col-Co4.

The Cl vertebra A200 is the first vertebra of the spinal column and has a unique structure that enables it to support cranium A500. Cl vertebra A200 functions as a "sesamoid bone" between the C2 vertebra A300 and the cranium A500, enabling 45° left and right rotation and approximately 20° of flexion and extension. It is the most mobile bone in the body and allows for an extraordinary degree of repetitive movement with four degrees of freedom.

As shown in FIGURE 2, the Cl vertebra A200 has an anterior arch A2, a posterior arch A3 and two lateral masses A4. The posterior arch A4 comprises 2/5ths of the circumference of the vertebra and terminates at the dorsal midline in the posteriσ tubercle A5 and at the rudimentary spinous process A6,

The space between the lateral masses A4 is primarily occupied by the odontoid process A7, which is held in place by the transverse odontoid ligament A8. Unlike the other vertebrae of the spinal column, the vertebral body of the Cl vertebra, i.e. odontoid process A7, remains separated from the remainder of the Cl vertebia A200; odontoid process A7 also embryologically forms part of the C2 vertebra A300. The C2 vertebra A300 therefore enables rotation of the Cl vertebra A200 around the odontoid process A7.

The Cl vertebra A200 also includes a pair of transverse foramina AlO, located on the upper surface of the posterior arch A2 on either side of the spinal cord Al 1. Transverse foramina A9 directs vertebral artery A12 from lateral mass A4 to the upper surface of the posterior arch A3, where it continues into cranium A500, and supplies blood to the brainstem and occipital lobes of the brain. The vertebral artery is supported by a groove of the transverse foramina A9 on the surface of the posterior arch of the Cl vertebra A200 which may vary in size and depth. This groove can be bridged by anomalous ossification and posterior ponticulus.

The grooves AlO in the posterior arch A3, along which passes the first cervical nerves and vertebral arteries Al 2 from a lateral to a medial position are known as the transverse foramina A9; the foramena A9 generally guide the vertebral arteries Al 2 through lateral masses A4.

Lateral masses A4 are the most bulky parts of the Cl vertebra A200 and constitute the primary weight bearing surface for supporting cranium A500. Lateral masses A4 are ovoid and provide articular surfaces for the occipital condyles above, located at the base of the skull, and the lateral masses of the C2 vertebra A300 below. Due to their substantial bulk and load bearing capability, lateral masses A4 are typically selected as the location for screw placement during spinal fixation.

In contrast to the specialized anatomy of Cl vertebra A200, the anatomy cf a more standard vertebra is illustrated in FIGURE 3's depiction of the lumbar vertebra A400. Although the location of the physiological components of the lumbar vertebrae A400 may vary, its anatomy is similar to most vertebrae.

In general, most vertebrae include a vertebral body Al 3. Two short bones, the pedicles A 14, extend backward from each side of the vertebral body Al 3 to form a vertebral arch Al 5. At the posterior end of each pedicle A 14, vertebral arch Al 5 flares out into broad plates of bone, known as laminae A 16. Laminae Al 6 fuse with each other to form a spinous process A 17, which enables muscle and ligamentous attachment. A smooth transition from the pedicles A14 into laminae Al 6 is interrupted by the formation of a series of processes. Two transveise processes Al 8 thrust out laterally on each side from the junction of pedicle A14 with lamina A16. These transverse processes A18 serve as levers for the attachment of muscles to the vertebrae. Four articular processes, two superior A19 and two inferior A20, also arise from the junctions of pedicles A14 and laminae A16. The superior and inferior articular processes A19 and A20 each have a natural bony structure known as a facet; superior articular facet A21 faces dorsally, slightly and upward (cranially), while inferior articular facet A22 faces ventrally and downward (caudally).

As shown in FIGURE 4, when adjacent vertebrae are aligned, facets A21 and A22, capped with a smooth articular cartilage, interlock to form a facet joint A23, also known as a zygapophysial joint. An intervertebral disc A24 positioned between each pair of vertebrae permits a small amount of cushioned movement between the vertebrae. Thus, the structure and alignment of the vertebrae permit movement of the vertebrae relative to each other.

II. Spinal Stabilization Methods

Spinal instability is a severe problem, and may cause chronic, subacute or acute compression of the upper spinal coid. Instability of the uppermost vertebrae, Cl and C2, may result in compression of the medulla oblongata, and may cause significant neurological problems, such as altered sensation and motor function, altered respiratory function, altered cardiac, gastrointestinal, bowel and bladder function, or altered function of the autonomic nervous system. Compression may also cause neck pain, headache and bulbar symptoms, such as altered vision and hearing, difficulties with swallowing, altered speech, sleep apnea, numbness and weakness of the arms and legs, urinary urgency or incontinence, or the progressive loss of ability to walk. Sudden death may even occur upon the sudden compression of the medulla or upper spinal cord.

Conventional surgical methods for spinal stabilization, specifically stabilization of the occipitocervical junction, to correct injuries due to trauma or chronic spinal conditions, such as degenerative, metabolic, congenital, endocrinological, neoplastic or infectious spinal diseases are well known. Current stabilization techniques typically involve fixation of at least the Cl and C2 vertebrae A200, A300 to the cranium A500. Examples of conventional stabilization methods include posterior internal fixation involving procedures, such as the Brooks and Gallie technique, Magerl's transarticular screw technique, and the Harms and Melcher polyaxial screw fixation techniques.

A particularly effective conventional method for rigid fixation of the occipitocervical fixation involves inserting a screw under the transverse foramina AlO into the lateral mass A4 of the Cl vertebra A200. Additionally, insertion of C2 pedicle screws is also a frequently practiced technique for occipito-atlanto-axial fixation. In general, screw fixation has thus far been limited to insertion within the lateral mass A4 and pedicles Al 4. Although proven to have superior biomechanical capabilities and fusion rates in comparison to wiring techniques, screw fixation is a demanding technique and carries a substantial risk of injuring vertebral artery A12. The method can be highly dangerous, potentially severing or causing substantial harm to the vertebral artery A 12, shown in FIGURE 6. Blockage or thrombosis of the vertebral artery Al 2 can result in immediate brainstem stroke, "locked -in syndrome," or death. Conventional spinal stabilization methods, which requires inserting screws in the C 1 lateral mass A4, risks injuring the artery A12 at three locations: below the vertebral artery foramenA9, within the vertebral artery foramen A9 of the lateral mass A4, and in the transverse foramen AlO, These injuries to the vertebral artery A12 arise for three reasons; first, an errant screw may be inserted incorrectly and project below the vertebral artery foramen A9 striking the artery Al 2 before it enters the vertebral artery foramen A9; second, when the vertebral artery foramen A9 lies more medial than usual, which commonly occurs in 20-30% of patients, placement of the Cl lateral mass screw with the standard technique impales the aberrant vertebral artery A12; third, the presence of a bone anomaly in which the vertebral artery A12 is hidden by a bone bridge over the transverse foramen AlO, i.e. Kimmerle's anomaly also known as the "arcuate foramen" which has an 1.14% to 18% occurrence rate, precludes the safe identification and exposure of the artery Al 2 and may also result in the artery Al 2 bulging outward in areas where it is not covered by the bone abnormality.

The vertebral artery Al 2 may also be injured during the surgical exposure of the operative site. The vertebral artery A12 may derive from the internal carotid artery and enter into the space between the occiput and Cl vertebra arch, i.e. Pro-atlantal artery variant Type 1, or derive from the external carotid and enter between the Cl vertebral arch and C2 lamina, i.e. Pro-atlantal artery variant Type 2. In each case, the vertebral artery A12 in its anomalous course is at an increased risk of injury. Moreover, dissection of the lateral aspect of the lateral mass of Cl may result in injury and tearing of the vertebral artery Al 2 because: artery Al 2 frequently sits in an exposed position above rather than within the groove; there is a risk of avulsion of several vessels arising from the vertebral artery Al 2 and the muscular branch of the vertebral artery, and anomalous variants or rotation of the Cl vertebra places the vertebral artery A12 in the path of surgical exposure.

Moreover, wide exposure of Cl vertebra required by conventional lateral mass screws fixation techniques may injure collateral blood supply. The occipital artery, through which vertebral artery A12 may receive its blood supply may be injured or compressed during exposure of the surgical site. Injury to these collateral arteries may consequently decrease blood supply to the vertebral artery A 12, and may potentially cause a stroke.

The lateral mass screw may also injure the covering of the spinal cord, known as the dura. A screw placed too close to the midline, may thus induce a cerebrospinal fluid leak. The Cl screw may also cause severe headaches by damaging the C2 nerve root A23, which exits just medial to where the Cl screw should be placed. Additionally, if the Cl screw is inserted too deep and passes into the retropharynx, it may cause hematoma or pass into the pharngeal cavity, thereby introducing bacteria into the retropharyngeal space or Cl anterior arch, and cause a serious infection. Therefore, screw placement on the Cl lateral mass carries significant risk.

Furthermore, conventional atlantoaxial transarticular screw fixation techniques may be inapplicable in several instances. It may be impossible to place a screw into a lateral Cl mass that is congenitally diminutive or eroded by trauma, neoplasm, or other pathological processes. Irreducible Cl and C2 subluxation may further preclude optimum placement of atlantoaxial transarticular screws, since the correct screwtrajectory traversing the articular surfaces of Cl and C2 cannot be achieved. Severe cervicothoracic kyphosis may contraindicate C 1 and C2 transarticular screw placement by obstructing the trajectory of the instruments used to insert the screws. Therefore, in addition to being dangerous, conventional lateral mass screw fixation may not be possible.

Despite the inherent difficulties and extreme danger of placing screws in the lateral mass of the Cl vertebra and similar risks involved in screw fixation of other vertebra, these lateral mass screw fixation procedures are becoming more commonplace. Therefore, there is a need to develop a vertebral attachment method that is safeand effective as well as a system that minimizes or eliminates injury to vertebral artery A12 and spinal cord Al l.

SUMMARY OF THE INVENTION Accordingly, it is an object of the invention to provide a method and system that accomplishes the goals of: successfully minimizing or eliminating the risk of severing, compressing, impinging or otherwise injuring the vertebral artery, vertebral vein, spinal nerve roots and/or spinal cord; developing a vertebral attachment system that may assist in the stabilization of the occipitocervical junction or the junctions between lower vertebrae; and minimizing the necessary duration of the surgical procedure. In order to achieve the above and other objects of the invention, the present invention is directed to a novel vertebral attachment method and system.

In a first aspect, the invention may be directed to an attachment system including a clamp that at least partially surrounds a posterior region of a vertebra, wherein the clamp has a first member, a second member, and an aperture. The system further includes a plate having an aperture, and a fastener, wherein the fastener extending through said apertures to secure the plate and clamp to the posterior region.

In a second aspect, the invention is directed to an attachment system including a clamp that at least partially surrounds the posterior arch of the Cl vertebra, wherein the clamp has a first member and a second member, each of which has an aperture. The system further includes a plate having an aperture, and a fastener, wherein the fastener extending through said apertures to secure the plate and clamp to the posterior region.

In a third aspect, the invention is directed to an attachment method that involves providing an attachment system, placing a clamp on the posterior region of a vertebra, aligning the first, second and third apertures, and fastening the attachment system to the vertebra by inserting the fastener thorough the first and second apertures.

BRIEF DESCRIPTION OF THE DRAWINGS FIGURE 1 is a perspective view of a human spinal column.

FIGURE 2 is a cross sectional view of a Cl vertebra. FIGURE 3 is a perspective view of a lumbar vertebra. FIGURE 4 is a perspective view of a vertebral lumbar facet joint. FIGURE 5 is a perspective view of the vertebral artery and Cl nerve relative to the Cl vertebra.

FIGURE 6 is a perspective view of an exemplary embodiment of a Cl attachment system being utilized to connect the Cl vertebra to another system that stabilizes the skull and spine.

FIGURE 7(a) is a perspective view of an exemplary embodiment of the clamp.

FIGURE 7(b) is a perspective view of an exemplary embodiment of the clamp on the posterior region arch of the Cl vertebra.

FIGURE 7(c) shows a drill creating a hole that penetrates the posterior arch of the Cl vertebra from the dorsal to ventral side.

FIGURE 7(d) is a perspective view of a screw placed through the clamp and adjacent to the posterior arch of the Cl vertebra.

FIGURE 8 is a cross section of a screw placed through the plate, the clamp, and posterior arch of the Cl vertebra that is secured with a spiral locking mechanism in the screw head.

FIGURE 9 is a perspective view of an exemplary attachment system wrapping around the spinous process of the thoracic vertebra using sublaminal screws.

FIGURE 10(a) is a top view of an exemplary embodiment of a plate.

FIGURE 10(b) is a side view of an exemplary embodiment of the plate shown in 9(a).

FIGURE 11 is a perspective view of a connector assembly placed within an aperture of a variable screw head.

FIGURE 12(a) is a perspective view of an attachment system wherein the clamps and plate are constructed as an integral device.

FIGURE 12(b) is a perspective view of the attachment system of Figure 12(a) fastened to an occiput plate. FIGURE 12(c) is a perspective view of the attachment system of Figure 12(a) with an applied bone graft material.

FIGURE 13 shows an apparatus for testing trial clamps.

FIGURE 14 is a perspective view of a system for effecting fusion of the human occipitocervical junction according to a preferred embodiment of the invention;

FIGURE 15 is a cross-sectional view of a portion of the system that is depicted in FIGURE 14;

FIGURE 16 is a cross-sectional view depicting a connector assembly that is constructed according to a preferred embodiment of the invention;

FIGURE 17 is a top plan view of the connector assembly that is depicted in FIGURE 16;

FIGURE 18 is a perspective view of a fastening tool that is designed to be used in conjunction with the connector assembly that is depicted in FIGURE 16, shown in a first operative position;

FIGURE 19 is a perspective view of the fastening tool that is shown in FIGURE 18, shown in a second operative position;

FIGURE 20 is a side view of one component of the system that is depicted in FIGURE 16;

FIGURE 21 is a cross-sectional view depicting certain components of the system that is shown in FIGURE 16;

FIGURE 22 is a cross-sectional view depicting certain components of the portion of the system shown FIGURE 14 that is depicted in FIGURE 21 ;

FIGURE 23 is a side view of an exemplary embodiment of a plate.

FIGURE 24 is a perspective view showing another embodiment of the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS For illustrative purposes, the principles of the present invention are described by referencing various exemplary embodiments. Although certain embodiments of the invention are specifically described herein, one of ordinary skill in the art will readily recognize that the same principles are equally applicable to, and can be employed in other systems and methods. Before explaining the disclosed embodiments of the present invention in detail, it is to be understood that the invention is not limited in its application to the details of any particular embodiment shown. Additionally, the terminology used herein is for the purpose of description and not of limitation. Furthermore, although certain methods are described with reference to steps that are presented herein in a certain order, in many instances, these steps may be performed in any order as may be appreciated by one skilled in the art; the novel method is therefore not limited to the particular arrangement of steps disclosed herein.

It must be noted that as used herein and in the appended claims, the singular forms "a", "an", and "the" include plural references unless the context clearly dictates otherwise. Thus, for example, reference to "clamp" may include a plurality of clamps and equivalents thereof known to those skilled in the art, and so forth. As well, the terms "a" (or "an"), "one or more" and "at least one" can be used interchangeably herein. It is also to be noted that the terms "comprising", "including", and "having" can be used interchangeably.

The present invention is directed to novel vertebra attachment systems and vertebral fastening methods. The technological basis of the invention is predicated upon the importance of developing an effective vertebral attachment system and method that may accomplish the following: first, enable spinal stabilization; second, prevent severing, compressing, impinging or otherwise injuring critical structures, such as the vertebral artery, vertebral vein, spinal cord, nerve roots exiting the spinal cord or a combination thereof during implant; and third, minimize the overall surgical duration. This may be accomplished by positioning a uniquely configured attachment system on a posterior region of a vertebra, distal from the aforementioned critical structures of the spine.

I. In accordance with an exemplary embodiment of the invention, FIGURE 6 shows an attachment system 100 that includes at least one clamp 1, atleast one fastener 2, and at least one vertebral plate 3 configured to be securely fastened to any vertebra Al of the spinal column AlOO. Attachment system 100 is designed such that clamp 1 and fastener 2 securely anchor vertebral plate 3 to a portion of vertebra Al. Vertebral plate 3 in turn may be connected to other orthopedic structures and assemblies. In an exemplary embodiment, attachment system 100 may be structurally configured to enable attachment to a posterior region of vertebra Al and may be able to withstand at least normal spinal loads. It is envisioned that the system of the present invention maybe compatible with any orthopedic structure or assembly to enable spinal stabilization between vertebrae and/or enable stabilization of the occipitocervical junction.

Clamp 1 may be any device capable of at least partially or wholly surrounding a portion of vertebra Al, and clamp 1 may have any dimension, configuration or geometric shape suitable for gripping, clasping, clipping or otherwise retaining a portion of vertebra Al . In an exemplary embodiment, at least one portion of clamp 1 conforms to a surface of vertebra Al. As shown in FIGURES 7(a)-7(b), clamp 1 may include a curved surface having a circumference of approximately 4 radians that encircles a portion of posterior arch A3 of the Cl vertebra A200. Preferably, clamp 1 may be sized and shaped to surround a posterior region of vertebra Al. In an exemplary embodiment, clamp 1 may have at least two members 5, 6 separated by a space sized to accommodate a portion of vertebra Al . Clamp 1 may also include at least one other member 7 to further facilitate the retention of vertebra Al. As shown in FIGURE 7(a), clamp 1 may have a U, semicircular or collar like shape. Preferably, clamp 1 is configured to be sufficiently thin and have a low profile such that it does not substantially obstruct, compress or impinge any adjacent vertebral components.

In an exemplary embodiment, at least one aperture 8 may be located on clamp 1 for receiving fastener 2. The inner surface of aperture 8 may be smooth, partially threaded or completely threaded; aperture 8 may also include bevels, collars, insets or any other structure that would facilitate the retention of fastener 2. In an exemplary embodiment, clamp 1 may include a plurality or at least one pair of apertures 8. Preferably, at least one aperture 8 may be located on a first member 5 and on a second member 6 of clamp 1 such that said apertures are geometrically aligned. Apertures 8 of clamp 1 may have a variety of different sizes and shapes to accommodate different fasteners 2.

Clamp 1 may be fabricated from any high strength and biocompatible material. In an exemplary embodiment, clamp 1 may be fabricated from any material having sufficient material and mechanical properties that would enable load bearing applications including spinal stabilization. The material used to fabricate clamp 1 may include a biocompatiable metal, metal alloy, ceramic, polymer, such as a polymer from the polyaryletherketone family (PAEK) family, such as polyether ether ketone (PEEK) or polyether ketone ketone (PEKK), or composite material. Preferably, the material may include a metal alloy, such as titanium. Optionally, the surface of clamp 1 may be treated to adjust the frictional, wear or biocompatibility properties of clamp 1. In an exemplary embodiment, at least one portion of clamp 1 may be coated with a material, contoured, and/or textured to limit a range of motion of clamp 1 relative to the vertebra Al and/or vertebral plate 3. In another embodiment, clamp 1 may be coated with a material to minimize wear of clamp 1 and/or facilitate osteointegration.

Attachment system 100 may include any number of clamps 1 to attach vertebral plate 3 to vertebra Al . In an exemplary embodiment, a sufficient number of clamps 1 may be attached to vertebra Al to enable spinal stabilization applications. Preferably, the system may include at least about one to three clamps 1, more preferably, about two to three clamps 1.

As shown in FIGURES 7(a)-7(d), fastener 2 may removably secure clamp 1 to vertebra Al. Fastener 2 may be any element that is compatible with clamp 1 and vertebral plate 3 so as to enable load bearing applications, such as spinal stabilization. Fastener 2 may have any suitable dimension, configuration or geometric shape. In an exemplary embodiment, fastener 2 may include a threaded component, hook, latch, pin, nail, wire, tether, or combinations thereof. Preferably, fastener 2 may be sized and shaped to secure clamp 1 to a posterior region of vertebra Al . Attachment system 100 may include a plurality of fasteners 2 having different configurations and/or dimensions compatible with clamp 1 and vertebral plate 3. Fastener 2 may be fabricated from any material suitable for securing clamp 1 to vertebra Al . In an exemplary embodiment, fastener 2 may be fabricated from any high strength and biocompatible material. The material used to fabricate fastener 2 may include a biocompatiable metal, metal alloy, ceramic, polymer, such as a polymer from the polyaryl ether ketone family (PAEK) family, such as polyether ether ketone (PEEK) or polyether ketone ketone (PEKK), or composite material. Preferably, the material may include a metal alloy, such as titanium.

Optionally, fastener 2 may also include a lock 9 to further secure the retention of a portion of vertebra Al . Lock 9 may be any mechanism that ensures that fastener 2 is securely attached to clamp 1, vertebral plate 3 and/or vertebra Al. Lock 9 may also have any suitable dimension, configuration or geometric shape and may be fabricated from any suitable material. In an exemplary embodiment, lock 9 may be athreaded component, hook, latch, pin, nail, wire, tether, or combinations thereof.

In an exemplary embodiment, lock 9 may be threaded component, such as a screw, bolt, rivet, or nut. As shown in FIGURE 8, lock 9 may be a nut coupled to the head of fastener 2. Fastener 2 may be secured by preventing it from being unscrewed or otherwise detached from clamp 1, vertebral plate 3 and/or vertebra Al without first removing the nut. In one example, to remove the nut, it must be turned in the opposite direction in which a threaded fastener 2 must be turned to detach fastener 2.

As shown in FIGURES 7(a)-7(c), in one exemplary embodiment, fastener 2 may be a threaded component, such as a screw, rivet, or bolt. Preferably, fastener 2 may be a triple screw which possesses three functional portions along the length of the screw: a threaded portion for attachment to bone; a threaded or non-threaded portion to engage vertebral plate 3, and a threaded or non-threaded portion to engage clamp 1. The triple screw may provide increased stability by virtue of the combined fixation of the screw within vertebral plate 3, clamp 1 and the vertebra Al . The threaded component may have a small diameter, for example, about 1.5 mm to about 4 mm and a length of about 6 to about 20 mm. Fastener 2 may couple clamp 1 to vertebra Al by penetrating a portion of vertebra Al and clamp 1 at the dorsal and/or ventral apertures 8. Fastener 2 may also include a lock 9, such as a nut, that prevents loosening under applied physiological loads. In the exemplary embodiment shown in FIGURE 7(a), the tip of fastener 2 does not extend substantially past ventral aperture 8 of clamp 1 so as to injure the vertebral artery Al 2, vertebral vein, spinal nerve roots and/or spinal cord.

In the alternative exemplary embodiment of FIGURE 7(d), fastener 2 may be located adjacent to but does not penetrate the vertebra. In this embodiment, fastener 2 extends through clamp 1 at the dorsal and/or ventral apertures 8, and secures vertebraAl by functioning as a clasp or latch, passing adjacent to the vertebra. Because fastener 2 does not penetrate the vertebral body, this embodiment minimizes trauma and vertebra erosion. When fastener 2 is a triple screw, the length of the screw that extends adjacent to the vertebral body may optionally be non-threaded in this embodiment. As discussed above, fastener 2 may also include a lock 9 to prevent loosening under applied physiological loads.

Fastener 2 may be used to attach clamp 1 to any portion of vertebraAl that would enable load bearing applications, such as spinal stabilization. In exemplary embodiment, clamp 1 and fastener 2 may be attached to a posterior region of vertebraAl, preferably at a location sufficiently distanced from the vertebral artery A 12, vertebral vein, spinal nerve roots, spinal cord or a combination thereof to minimize the risk of possibly severing, compressing, impinging, or otherwise injuring the aforementioned spinal components. In an exemplary embodiment, clamp 1 and fastener 2 may be attached to the posterior arch A3 of the Cl vertebrae A200. Clamp 1 and fastener 2 may also be attached to a posterior region, such as the spinous process, pedicle or lamina, of the lumbar vertebrae, thoracic vertebrae, sacrum vertebrae, or coccygeal vertebrae FIGURE 9 shows attachment system 200 attached to a posterior region of an upper level thoracic vertebra, wherein a translamina screw engages the spinal canal by penetrating the cancellous and/or cortical bone of vertebra Al to secure attachment system 200. The same attachment system 200, with minor modifications, may be similarly located on any cervical, thoracic or lumbar vertebrae.

As shown in FIGURE 10(a), attachment system 100 of the present invention may further include at least one modular vertebral plate 3 that may be attached to clamp 1 and vertebra Al using fastener 2. Vertebral plate 3 functions as a scaffold that may be fastened to and stabilize one more other orthopedic structure, including spinal stabilization assemblies. Vertebral plate 3 may optionally be used to also position and bias a bone graft material, such as bone, a bone substitute or other non-osseous material, into close contact with and/or under pressure against, at least one vertebra Al so as to promote bone fusion.

Vertebral plate 3 may have any configuration, shape or dimension that may be compatible with clamp 1 and fastener 2 and that may enable load bearing applications, such as spinal stabilization. In an exemplary embodiment, the system may include a plurality of vertebral plates having different dimensions, configurations and sizes that may be customized to different vertebral regions or application. As shown in the exemplary embodiment of FIGURE 10(b), vertebral plate 3 may be curved along a portion of its body which may correspond to the curved surface of the Cl vertebra's A200 posterior arch A3. Preferably, vertebral plate 3 may be sized and/or shaped to complement a posterior region of vertebra Al . As shown in FIGURE 6, vertebral plate 3 may be a thin curved plate having at least one dimension that is approximately the same as that of vertebra A 1.

Vertebral plate 3 may also be elevated or extended to accommodate an enlarged vertebra caused by expansion duroplasty or an increased spinal canal size. In an exemplary embodiment, vertebral plate 3 may further include structure for adjusting a length of vertebral plate 3, whereby a lateral spacing distance between said first and second laterally spaced fastener 2 may be adjusted. In a preferred embodiment, this may be accomplished by constructing vertebral plate 3 out of two separate components that are attachable to each other, specifically a first connector portion 124 and a second connector portion 126, as is best shown in FIGURE 22. The plurality of apertures 130, 132 in vertebral plate 3 may be used to adjust the first connector portion 124 relative to the second connector portion 126. A coupling member 128 may be provided for securing the first connector portion 124 to the second connector portion 126 and is preferably applied centrally in a precise manner in order to stabilize the first and second connector portions 124, 126. Coupling member 128 may be a threaded component, hook, latch, pin, nail, wire, tether, or combinations thereof. In an exemplary embodiment, coupling member 128 is a threaded component, such as a rivet, bolt or screw, preferably a lock screw having a snap off head. A Vernier scale option may be used to generate the best precise fit, but other adaptations may be used, with the most important requirement being that a secure fit is created. Vertebral plate 3, including connector portions 124, 126 may be loaded with graft material and may be contoured or sized to accommodate the specific graft or implanted material size. In one possible alternative embodiment, the connector portions may be curved or may be straight with a rise to accommodate the anatomy of the vertebra and/or the application of any bone graft material.

Vertebral plate 3 may be coupled to vertebra Al and clamp 1 any manner. In an exemplary embodiment, vertebral plate 3 may include one or more apertures 10 that may be compatible with fastener 2 and/or other orthopedic structures. Apertures 10 may be arranged in any manner along the body of vertebral plate 3. By incorporating a plurality of apertures 10 spread out along vertebral plate 3, attachment system 100 may support or connect to other attachment systems 100 and/or other orthopedic structures situated in various different locations. Additionally, apertures 10 may have a variety of different sizes and/or shapes so that vertebral plate 3 may be compatible with different fasteners 2 and/or orthopedic structures.

As shown in the exemplary embodiments of FIGURE 8, vertebral plate 3 may be anchored to the vertebral lamina or the posterior arch A3 of a Cl vertebra A200 by inserting fastener 2 through aperture 10 of vertebral plate 3, vertebra Al and the dorsal and/or ventral apertures 8 of clamp 1. Vertebral plate 3 may be located between clamp 1 and vertebra Al. Alternatively, as shown in FIGURE 6, clamp 1 may be located between vertebral plate 3 and vertebra Al .

Vertebral plate 3 may be fabricated from any high strength and biocompatible material. In an exemplary embodiment, vertebral plate 3 may be fabricated from any material having sufficient material and mechanical properties for load bearing applications, such as spinal stabilization. The material used to fabricatevertebral plate 3 may include a biocompatiable metal, metal alloy, ceramic, polymer, such as a polymer from the polyaryl ether ketone family (PAEK) family, such as polyether ether ketone (PEEK) or polyether ketone ketone (PEKK), or composite material. Preferably, the material may include a metal alloy, such as stainless steel and/or titanium. Optionally, the surface of vertebral plate 3 may be treated to adjust the frictional, wear or biocompatibility properties of vertebral plate 3. In an exemplary embodiment, at least one portion of vertebral plate 3 may be coated with a material, shaped and/or textured to limit a range of motion of vertebral plate 3 relative to the vertebra Al and/or clamp 1. In another embodiment, vertebral plate 3 may be coated with a material to minimize wear of vertebral plate 3 and/or facilitate osteointegration.

Optionally, the invention may further include a connector assembly 11 that may be used to removably couple vertebral plate 3 of attachment system 100 to other attachment systems 100 and/or other orthopedic structures to enable a wide variety of applications, including fusing two or more vertebrae and/or the occipitocervical junction. Connector assembly 11 may include any suitable fastening mechanism or structure.

In the exemplary embodiments of FIGURES 6 and 9, connector assembly 11 may include at least one system fastener 12, such as athreaded component, hook, latch, pin, nail, wire, tether, or combinations thereof that may be affixed to attachment system 100; preferably, system fastener 12 may be athreaded component, such as a screw, rivet or bolt. System fastener 12 may include a post 14 having a slot 15 for receiving a connection member 13. The device may be modular, wherein post 14 may include one or more slots 15 for retaining connection member 13. Additionally, system fastener 12 may be selectively inserted in a number of different apertures 10 ofvertebral plate 3. Apertures 10 may have different sizes and/or shapes and may also be oriented in different directions relative to one another to accommodate different system fasteners 12 and to enable a wide variety of applications.

Connector assembly 11 may further include at least one connection member 13, such as a supporting rod, which may be used to couple one or more attachment systems 100 to each other and/or to other orthopedic structures anchored to different regions of the spinal column or cranium. In an exemplary embodiment, connection member 13 may be angled and/or contoured to enable connection with orthopedic structures located at different positions. Additionally, connection members 13 may be oriented, angled, or contoured to minimize or eliminate injuries, such as ventral brainstem compression. Connection members 13 may also include an optional pre-established rise option to accommodate the non-linearity of the level of the posterior arch A3 of the Cl vertebra A200 relative to other orthopedic structures and/or other anatomical surfaces. Connection member 13 may be secured within slot 15 using a system lock 16, such as athreaded component, hook, latch, pin, nail, wire, tether or combinations thereof. In an exemplary embodiment, system lock 16 may be a threaded component such as a screw, rivet, bolt, or nut.

In the exemplary embodiment shown in FIGURE 6, system fastener 12 may be directly coupled to attachment system 100 by passing through vertebral plate 3 at aperture 10 and/or vertebra Al. In another exemplary embodiment, FIGURES 12(a)- 12(c) depict an exemplary attachment system 200 wherein system fastener 12 may be fastener 2. These figures show an occiputplate fastened directly to a vertebraAl using system fastener 12, which also functions to couple vertebral plate 3 to vertebra Al . This dual function of system fastener 12 significantly increases the efficiency and speed of surgical procedures. In another exemplary embodiment, system fastener 12 may be a triple screw which possesses three functional portions along the length of the screw: a threaded portion for attachment to bone; a threaded or non-threaded portion to engage vertebral plate 3, and a threaded or non-threaded portion to engage connection member 13. The triple screw may provide increased stability by virtue of the combined fixation of the screw within vertebral plate 3 and vertebra Al .

Connector assembly 11 may be constructed from any high strength and biocompatible material. In an exemplary embodiment, connector assembly 11 may be fabricated from any material having sufficient material and mechanical properties that would enable load bearing applications, such as spinal stabilization. The material used to fabricate connector assembly 11 may include a biocompatiable metal, metal alloy, ceramic, polymer, such as a polymer from the polyaryl ether ketone family (PAEK) family, such as polyether ether ketone (PEEK) or polyether ketone ketone (PEKK), or composite material. Preferably, the material may include a metal alloy, such as stainless steel and/or titanium. Optionally, the surface of connector assembly 11 may be treated to adjust the frictional, wear or biocompatibility properties of connector assembly 11. In an exemplary embodiment, at least one poition of connector assembly 11 may be coated with a material, shaped and/or textured to limit a range of motion of connector assembly 11 relative to the vertebral plate 3. In another embodiment, connector assembly 11 may be coated with a material to minimize wear and/or facilitate osteointegration. The modular attachment system of the present invention may be operatively assembled and customized to enable a wide variety of applications and to create acustom fit for each patient. For example, the attachment system may include a combination of any number of clamps 1, fastener 2, vertebral plates 3, and connector assemblies 11 having any of the above discussed configurations, shapes or dimensions. Clamp 1, vertebral plate 3 and fastener 2 of exemplary attachment system 100 may be assembled during surgery. Alternatively, as shown in the exemplary attachment system 200 of FIGURE 12 (a), one or more clamp 1 and vertebral plate 3 may be prefabricated as an integral device and subsequently fastened to vertebra Al using fastener 2 during surgery. Any orthopedic structure, such as a cranial and/or vertebral plate, may be fastened to attachment system. FIGURES 6 and 10(a) show an occipital plate anchored to an attachment system 100, 200, enabling stabilization of the occipitocervical junction.

The attachment systems of the present invention provides numerous advantageous over spinal fixation systems of the prior art. Because the attachment system may be located on the posterior portion of any vertebra, such as the posterior arch A3 of the Cl vertebra A200, it encumbers only the dorsal aspect of vertebra Al and therefore does not substantially interfere with fusion or the major tension forces exerted during flexion of the neck. Typically the posterior surface of the Cl vertebra A200 is the least acceptable locus of fusion because of the high shear over the posterior surface in flexion, extension and rotation; the major loading forces in extension occur on the cranial and caudal surfaces of the Cl vertebral arch. The attachment system is also advantageous because it may have a unique structural configuration that is: compatible with a posterior region of vertebra Al , sufficiently thin to minimize the risk of neural or spinal cord compression, and/or does not significantly weaken the vertebra to which it is fastened. Additionally, because the attachment system may also be formulated as a modular kit including a plurality of clamps 1, fastener 2, vertebral plates 3 and connector assemblies 11 of varying sizes and configurations, it may be customized for each application and/or patient. Furthermore, the attachment system provides an effective, fast and safe means for vertebra attachment.

II. Method An exemplary embodiment of the vertebra attachment method of the present invention may be used to enable a wide variety of spinal stabilization applications, including fusing the occipitocervical junction. The method may involve exposing the posterior occipitocervical junction and exposing the posterior arch A3 of Cl vertebra A200 without injuring the vertebral vein or artery Al 2 in the vertebral artery sulci. Before proceeding with the operation, the surgeon may check the CT or MRI to ensure that there is no stenosis at the level of Cl vertebra A200.

A curved instrument 4, such as a curette, as shown in FIGURE 13, may be used to open the plane ventral to the posterior arch A3. The same curved curette serves as a trial template for the clamp to be fitted around the posterior arch A3 of a patient, in order to select the most appropriately sized clamp 1 for implantation. The selected clamp 1 may be inserted approximately 10-15 mm on one side of the midline of posterior arch A3 by friction fitting clamp 1 around a portion of posterior arch A3. A second clamp 1 may be inserted approximately 10-15 mm on the opposite side of the midline. Optionally, a third clamp 1 may be placed at the midline of posterior arch A3. In instances where only one clamp 1 is used to anchor vertebral plate 3 to vertebra Al, clamp 1 may be inserted at the midline. Vertebral plate 3 may be inserted between the posterior vertebra and the clamps 1 , as shown in FIGURE 8, or placed above clamps 1 , as shown in FIGURE 6. One or more apertures 10 of vertebral plate 3 may then be aligned with one or more apertures 8 of clamp pair 1. Alternatively, one or more clamps 1 and vertebral plates 3 may be constructed as an integral device and positioned on posterior arch A3 of Cl vertebra A200.

As shown in FIGURE 6, after orienting clamp 1 and vertebral plate 3 on vertebra Al as desired, the surgeon may drill at least one hole at aperture 8 of clamp 1 that at least partially penetrates posterior arch A3 to an appropriate depth In an exemplary embodiment, the hole may penetrate the full thickness of posterior arch A3 of the Cl vertebra A200 or the full thickness of the lamina Al 9 of a lower vertebra. A fastener 2 may then be inserted through the hole and the dorsal and/or ventral apertures 8 of clamp 1. In an exemplary embodiment, fastener 2 may be optionally further secured to clamp 1 , vertebral plate 3 and/or vertebra Al with lock 9. Alternatively, as shown in FIGURE 7(d), after orienting clamp 1 and vertebral plate 3 on vertebra Al as desired, fastener 2 may be inserted through an aperture 10 of vertebral plate 3 and through the dorsal and/or ventral apertures 8 of clamp 1. In this embodiment, fastener 2 does not penetrate vertebra Al but rather secures clamp 1 and vertebral plate 3 to vertebra Al by functioning as a clasp or latch that passes adjacent to a portion of vertebra Al, thereby minimizing trauma and vertebra erosion. As discussed above, fastener 2 may also include a lock 9 to prevent loosening under applied physiological loads.

After inserting the first fastener 2, the location of a second clamp 1 may be readjusted relative to vertebra Al and/or aperture 10 of vertebral plate 3 as desired. At least a second aperture 8 and second aperture 10 may be aligned, and another fastener 2 may be attached in a similar manner using the previously discussed methods. Lock 9 may also optionally further secure the retention of vertebra Al.

Connector assemblies 11 may be used to couple one or more attachment systems to one another or to other orthopedic structures or assemblies. At least one system fastener 12 may be inserted through an aperture 10 of vertebral plate 3. In an exemplary embodiment, system fasteners 12 are only coupled to vertebral plate 3 and do not penetrate vertebra Al . Alternatively, a hole may be drilled at the location of aperture 10 so as to at least partially penetrate vertebra Al. System fastener 12 may be inserted through aperture 10 and the hole in vertebra Al to further secure the connection between the attachment systems and/or other orthopedic structures.

As shown in FIGURE 11, a connection member 13 may be inserted into at least one slot 15 of post 14. A system lock 16 may be fastened adjacent to or on top of the arms of post 14 to securely retain connection member 13. In an exemplary embodiment, system fastener 12 may be rotated relative to vertebral plate 3 to adjust the orientation of connection member 13 relative to attachment systems 100 and/or other orthopedic structures. As shown in FIGURE 6, one portion of the connection member 13 may be coupled to attachment system 100, and at least one other portion may be fastened to another attachment system and/or other orthopedic structures, such as an occipital plate. One or more connection member 13 may be fastened to multiple attachment systems and/or occipto cervical device to create a fixation assembly extends along one or more vertebrae Al.

An osteogenic bone graft material 17, may be applied to the junctions between attachment system 100 and connector assembly 11 to facilitate bone fusion. In an exemplary embodiment, osteogenic material 17 may include, without limitation, autograft, allograft, xenograft, demineralized bone, synthetic and natural bone graft substitutes, such as bio-ceramics and polymers, and osteoinductive factors. In an exemplary embodiment, osteogenic material 17 may include a bone morphogenetic protein (BMP), transforming growth factor βl, insulin-like growth factor, platelet-derived growth factor, fibroblast growth factor, LIM mineralization protein (LMP), and combinations thereof or other therapeutic or infection resistant agents, separately or held within a suitable carrier material. Additionally, osteogenic material 17 may also be applied partially along or completely cover any surface of clamp 1, fastener 2, vertebral plate 3, and/or any other orthopedic structure to which attachment system 100 is directly or indirectly connected to promote osteoblast generation and facilitate bone fusion. As shown in FIGURE 12(c), bone graft material 17 may be placed above, below or on any surface of attachment system 100 as well as any corresponding orthopedic structure.

In addition to stabilizing the occipitocervical junction, a similar method may be used for fusing any two or more spinal vertebrae. In general, the method may involve exposing the general region of the spinal column to be stabilized or fused, and exposing the specific vertebral region to which an attachment system of the present invention may be affixed. The attachment system may be fastened to the dorsal elements of the vertebra similar to the above discussed Cl attachment method. In an exemplary embodiment, the attachment system may be fastened to a region that is safely distanced from the spinal cord, spinal nerve roots, vertebral artery A12 and/or vertebral vein so as to avoid severing, compressing, impinging or otherwise injuring the these spinal components. In one embodiment the attachment system may be fastened to a posterior region, such as the spinous process pedicle and lamina, as shown in FIGURE 9. The attachment system may be coupled to at least one other attachment system and/or at least one other orthopedic structure, which is attached to another vertebra, using connector assembly 11. The vertebra attachment system and method of the present invention may be used to enable stabilization and/or fusion of the junction between any spinal vertebrae and/or the occipitocervical junction of humans as well as animals. Specifically, the invention may be used to enable spinal or occipitocervical instability due to trauma or chronic spinal conditions, such as degenerative spinal diseases, metabolic spinal diseases, congenital spinal diseases, endocrinological spinal diseases, neoplastic or infectious spinal diseases, or cancer. Examples of chronic spinal conditions which may be treated in part using the vertebra attachment system of the present invention include degenerative diseases, such as systemic lupus erythematosis and rheumatoid arthritis, and metabolic conditions, such as osteomalacia, osteogenesis imperfecta, hyperparathyroidism,Ricket's Disease and Hurler's Disease; which cause basilar invagination. Other examples of conditions which may be assisted with the present invention may include congenital conditions, such as Down's syndrome and Morquio's Syndrome or miscellaneous conditions, such as Chiari Malformation, assimilation of the atlas, Klippel-Feil syndrome, condylus tertius, hypochordal bow, dystopic odontoideum, which may cause compression of the upper spinal cord or brainstem.

III. Exemplary Occipitocervical Junction Stabilization System

FIGURE 14 shows one embodiment of attachment system 300 used in conjunction with an exemplary spinal system 400 to stabilize the occipitocervical junction. Attachment system 300 of the present invention differs from exemplary attachment systems 100, 200 in that: clamps 301, 401 maybe configured to retain connection members 313, 413 rather than directly retaining a portion of vertebra Al between its arms 116, 118 and fasteners 302, 402 in this embodiment, need not contact the vertebral body. Notably, it is envisioned that attachment systems 100, 200 may also be used in conjunction with the exemplary spinal system 400.

As shown in FIGURE 14, spinal system 400 may include a first bone forming material based structural member 27 and a second bone forming material based structural member 29. The two bone forming material based structural members 27, 29 may be bone grafts that are harvested from another part of the patient's body, such as a rib, grafts from a cadaver, or a material that is constructed and arranged to facilitate the growth of bone The invention is accordingly not limited to bone, but may use bone substitutes or non-osseous materials to accomplish long-term fixation of the cranium to the spine For example, the two bone forming material based structural members 27, 29 may be fabricated from a metallurgically bonded porous metal coating that is constructed and arranged to encompass and contain bone graft material, such as TRABECULAR METAL™ material by Zimmer Inc. of Warsaw, Indiana.

The two bone forming material based structural members 27, 29 could alternatively be fabricated from a bone forming material such as a bone substitute that is fabricated from a collagen base and contains bone forming materials, or bone enhancing chemicals. Thus a bone forming material could be embodied as a fabricated mesh that functions as a bone conductor into which bone growth would occur, or as a bone-like medium such as coralline hydroxyapatite, which serves as an osteoconductor for blood vessel formation and subsequent deposition of bone, which could be injected or poured into the space between the bones to be fused.

Alternatively, the bone forming material could be embodied as a metallic mesh- like substance that encourages or enables bone growth, such as tantalum mesh, which could be molded to fit into the space between the occiput and the spine, a bone allograft or a xenograft.

The first bone forming material based structural member 27 has a first portion 31 that is positioned and biased against the cranial bone so as to promote bone fusion between the cranial bone and the first bone forming material based structural member27. Accordingly, the second bone forming material based structural member29 has a first portion 27 that is positioned and biased against the cranial bone so as to promote bone fusion between the cranial bone and the second bone forming material based structural member 29. In one embodiment, these functions of positioning, support, biasing and promotion of fusion are effected through the use of an occipital connection system 23, which will be described in greater detail below.

The bone forming material based structural members 27, 29 preferably each have transverse cross-sectional area of approximately 1 cm². The first and second bone forming material based structural members 27, 29 further respectively have second portions 20, 22 that are positioned and biased against at least one cervical vertebral body of a human cervical spine so asto promote bone fusion between the cervical vertebral body and the respective bone forming material based structural member 27, 29. This function may be effectuated through the use of attachment system 300. Preferably, spinal system 400 facilitates a fusion between said bone forming material based structural members 27, 29 and both the C 1 and C2 cervical vertebral bodies A200, A300.

Spinal system 400 may further include an occipital connection system 23, which includes a cranial plate member 24 that is shaped so as to define an outer edge 26, an outer surface 28 and an inner surface 30, as is best shown in FIGURE 15. Cranial plate member 24 is preferably shaped to define a graft accommodation space 32 between the cranial plate member 24 and the cranium A500. The graft accommodation space 32 is preferably defined in part by a flange 25, which is defined in the cranial plate member 24 by a portion of the cranial plate member 24 including the caudal portion of the outer edge 26 that is elevated away from the cranium A500 with respect to a portion of the inner surface 30 that is contacting the cranium, so that the graft accommodation space 32 is open to a space outside of the graft accommodation space 32.

The cranial plate member 24 is preferably a monolithic plate, composed of metal, poyetheretherketone (PEEK), bio-absorbable compound, bone or bone substitute. The cranial plate member 24 preferably has a thickness of more than lmm and less than lcm at the edges, and may vary in thickness. For instance the edge 26 of cranial plate member 24 may be lmm, but the central part may be increased to 15 mm. The cranial plate member 24 may be ovoid, rectangular, polyhedral or a composite of straight edges and curves, and thus is not confined to a particular shape or perimeter. The cranial plate member 24 may be coated or made of a bio-compatible material, or coated with substances which are known to improve or accelerate surface attachment, or to promote bone fusion. The cranial plate member 24 may or may not contain a metallurgically bonded porous metal coating. The cranial plate member 24 may be slightly curved so as to be complementary to the curve of the cranium, or may be flat, or may undergo a contouring process by the surgeon or assistant at the time of surgery.

The flange 25 is an elevated contour arising from the cranial plate member 24. The flange 25 makes available for fusion the underlying cranial surface; the elevation of the flange 25 exposes the cranial bone surface to the overlying bone graft. The flange 25 may be constructed from the same material as the remainder of the cranial plate member 24, or it may be a constructed as a separate component that is attachable to thecranial plate member 24. The purpose of the flange 25 is to incorporate, to enclose orto provide a fulcrum in which bone graft materials or substitutes, or other materials, may be held for the purpose of achieving a bone union or other permanent rigid or non-rigid attachment between the cranium and the spine.

The flange 25 may be non-perforated or may include one or multiple perforations and could be composed of a mesh or mesh-like construction. The flange 25 is preferably perforated to allow in-growth of bodily tissue or blood vessels. The flange 25 has a perforated plus non-perforated surface area of more than 15% of the area of the plate member component.

The thickness of the flange 25 is 0.5 to 5mm thickness. The purpose of the flange 25 is to entrap the bone forming substances or other structural members in close union with the underlying cranium and to facilitate in the case of bone, morphogenesis through application of load, that is, through pressure and stabilization of the bone forming substances to enhance the milieu favoring new bone formation. The flange 25 may be capable of being mechanically altered in shape to further compress the graft.

The flange 25 will preferably rise from the plane of the portion of thecranial plate member 24 that contacts the cranial bone for a distance that is more than about 5mm, to allow placement of a thickness of material that is adequate to provide stability for growth. It is envisioned that malleable, or woven-bone forming substrates could be used to promote fusion, or indeed provide the scaffolding itself for fusion. Conversely, other materials could be used beneath the flange 25 to provide non-osseous, non-rigid fixation. Flange 25 will preferably allow the passage or inset of rods, plates or other materials for connecting the cranial plate to the spine. The purpose of this is to lower the profile of the rod, and to minimize the potential deformity of overlying tissue. Thus, a rod may pass through a perforation in a mesh of the flange to connect to the triple screw. Alternately, the flange 25 may have a groove, a pop-out section or perforations to allow passage of the stabilization element connecting cranium to spine.

In an alternative embodiment, the flange 25 might serve to provide attachment for a non-osseous union between the cranium and spine. The flange 25 thus may have both a physiological function and a mechanical function.

Flange 25 is envisioned in the preferred embodiment to arise from the lower aspect of the cranial plate member 24. However, alternate embodiments would allow positioning of a single or multiple flanges 25 in various locations, such as the middle, the upper or the sides of the cranial plate member 24. Thus the flange should not be construed to exist only as an elevation from the lower edge of the cranial plate member 24, but, for instance, may be centered on the cranial plate member 24; a rim of cranial plate member 24 could thus fully encompass flanges 25.

Whilst the preferred embodiment of the flange 25 is curved to minimize its profile by conforming to anatomic contour, alternate forms may include box-like constructs, or even a multiplicity of shapes and sizes that could be chosen for a given application, and then be secondarily attached to the cranial plate member 24. For example, a low profile, curved flange 25 could be applied to the cranial plate member 24 over the cranium of an asthenic child; another embodiment, for a larger person, may be a larger box-like adaptation designed to facilitate the incorporation of a more rectangular, synthetic bone- forming substance or other non-osseous compound. It is thus envisioned that flange 25 may offer a multiplicity of options to enable a wide variety of applications that may be patient customized.

As is shown in FIGURE 15, the first portion 27 of the second bone material based structural member 29 is preferably positioned within the graft accommodation space 32 defined by the flange 25 so that the inner surface 30 of thecranial plate member 24 is biased to provide compressive pressure against the second bone material based structural member 29. This compression will facilitate bone fusion between the second bone material based structural member 29 and the cranium A500.

As FIGURE 14 shows, the first portion 31 of the first bone material based structural member 27 is similarly positioned within the graft accommodation space 32 and impressively biased against the cranial bone to promote bone fusion.

Alternatively, the cranial plate member 24 could be fabricated so as to include more than one graft accommodation space, so that each of the two structural members27, 29 could be separately positioned within different accommodation spaces that are defined by the inner surface 30 of the cranial plate member 24.

The inner surface 30 of the cranial plate member 24 is preferably composed of a material that promotes bone fusion. This could be accomplished by coating the cranial plate member 24 with anyone of a number of conventional bone growth promoting substances or by fabricating the cranial plate member 24 from a porous material that is constructed and arranged to encompass and contain bone graft material, such as TRABECULAR METAL™ material. Cranial plate member 24 further preferably has a plurality of perforations 34 defined therein. Perforations 34 preferably have a minimum diameter of at least 400 microns, so as to best facilitate the growth of blood vessels within the newly formed bone tissue. A portion 48 of the outer surface 28 of the cranial plate member 24 may be grooved in order to accommodate instrumentation, as will be described in greater detail below.

Cranial plate member 24 preferably has a plurality of pre-drilled threaded mounting holes 36, 38, 40, 44, 46, 72 defined therein for facilitating attachment of the cranial plate member 24 to first portions 54, 58 of first and second connection members 313, 413 by means of first and second system fasteners 312, 412, respectively. The cranial plate member 24 will therefore preferably include manifold screw holes in order to permit the connection members 313, 413 to be secured to the cranial plate member 24 and locations that are most suitable for an individual patient. A central screw hole 40 will serve to anchor a central plate screw 42. There may be multiple central screw holes 40. The central sciew holes 40 may be positioned approximately in the midline of the patient's body and cranium in order to permit placement of screws into the thickest part of the skull, which usually runs fiom the inion to the opisthion. These holes 40 may be threaded, partially threaded or not threaded.

On each side of the midline, cranial plate member 24 may have at least one additional hole 38, 44, 46, 72 which is positioned to receive a screw, such as triple screw 70, which engages in the plate member and serves to anchor stabilization elements, such as rods, plates or other structures, from the cervical spine. Holes 38, 44, 46, 72 may cluster, may overlap, may be placed in an arc, or may be oriented contiguously or in separate locations. Holes 38, 44, 46, 72 may be placed around the edge of the flange 25, or on the flat portion of the cranial plate member 24. These holes may be reinforced with extra thickness and may be either threaded or non-threaded. Second portions 56, 60 of the first and second connection members 313, 413 are secured to the cervical spine of the patient, as will be described in greater detail below.

The central plate screw 42 provides primary attachment of the cranial plate member 24 to the skull. It is robust, cortically threaded, of variable length, preferably having a length within a range of about 7mm to about 12mm. The central plate screw 42 preferably has a thickness within a range of about 2mm to about 10mm, with a blunted end. It may have a spiral lock feature that locks the screw 42 into the cranial plate member 24, or not. It may be lagged to provide increased loading pressure on the cranial plate member 24, or not. It can be made of titanium alloy, of bone, or of a bone forming or bone compatible substance. For example, a ceramic, or hydroxyl-apatite composite or metal alloy / bone composite could be used.

In an alternative embodiment, a screw/rivet could be used in lieu of the central plate screw 42 for rapid application. The screw or screw /rivet would preferably have torque strength of greater than 35 inch Ib and generate sufficient pullout strength to prevent dislodgement from the cortex. The screw or screw /rivet would be placed near the middle of the cranial plate member 24, and be fashioned to pass through the central screw hole 40 on the cranial plate member 24. The first and second connection members 313, 413 provide the main structural connection between the cranium A500 and the upper cervical spine during the immediate postoperative period. Connection members 313, 413 are preferably standard titanium rods, approximately of 3-4 mm gauge, bent to conform to the correct craniospinal angle. The salient differences from other rods currently available are two-fold. The first is an angle reflecting the corrected reduction of the angle (α angle,FIGURE 20) between the cranium and that of the spine; in the preferred embodiment this will be pre-set within a range of about 75° to about 90°. Accordingly, the first and second connection members 313, 413 are contoured to ensure a postoperative craniospinal relationship that confers a clivo-axial angle, i.e. the angle between the dorsum of the second cervical vertebra and the dorsum of the clivus, approaching about 145-165°, and more preferably about 155 to 165°. Simultaneously, the degree of ventral brainstem compression should be rendered close to zero, by virtue of the reduction of angulation between the cranium and spine, and in some cases by the posterior translation of the cranium upon the spine.

Second, the craniospinal connection members 313, 413 will have a pre- established rise option (the α rise, FIGURE 20), to accommodate the non-linearity of the level of the posterior arch A3 of the Cl vertebra A200 to the surface of the lamina A16 of the C2 vertebra A300 and lateral mass A4 of the C3 vertebra. Accordingly, the presence of the pre-established α rise will allow the connection members 313, 413 to contact the Cl and C2 laminae A 16.

System fasteners 312, 412 are shown in greater detail in FIGURE 16. In a preferred embodiment, an unthreaded hole 68 is defined in the first portion 54 of the first connection member 313 and a threaded hole 72 is provided in the cranial plate member 24. System fastener 312 advantageously includes a unique triple screw 70 that has a first threaded portion 70 at an intermediate section thereof that is sized and pitched to mate with the threaded hole 72 in the cranial plate member 24 and a second threaded portion 76 at a lower section thereof that is constructed and arranged to be screwed into the cranial bone 78.

Triple screws 70 have the unique characteristic of deriving stability from fixation within the skull, the cranial plate member 24 and around the rod or plate that connects the cranium to the spine. In addition, the triple screw 70 has a number of functions: first, it connects the plate to the cranium; second, it connects the craniim to the craniospinal connecting devices; third, it eliminates plate torque around the central screw 42. In so doing, it eliminates one of the steps common to all other craniospinal devices: that of an additional and independent means of attaching the cranial plate member 24 to the craniospinal rod or plate connector.

Triple screws 70 may possess three functional portions: a threaded portion for attachment to the cranial bone 78; a threaded or non threaded portion to engage the cranial plate member 24; and a threaded portion for attaching the connection member 313. The central or intermediate portion may be threaded to enhance binding to the cranial plate member 24 or non-threaded to allow a lag effect upon the cranial plate member 24 in order to allow the insertion of triple screw 70 to tighten the plate member down to the cranial bone 78, depending upon the requirements of the particular stabilization.

The triple screws 70 may be placed in one of many potential screw holes on each side of the cranial plate member 24, in order to accommodate to the variability of the system that attaches the cranium to the cervical spine. Whilst thetriple screws 70 are shown in the upper portion of the plate member in the illustrated embodiment, they may in another embodiment be placed in the lower aspect of the cranial plate member 24. They are not limited to being positioned at lateral opposite sides of the cranial plate member 24, but may be placed near the middle of the cranial plate member 24. The triple screw 70 can be turned to any direction to accommodate the craniospinal rod or connector system.

The triple screw 70 will preferably be inserted through the cranial plate member 24 and screwed into the skull. The triple screw 70 will provide increased stability to the plate and rod system by virtue of the combined fixation of triple screw 70 within the cranial plate member 24 and the skull. The triple screw 70 maybe threaded at the level of the skull with a cortical or cancellous thread or could in another embodimentutilize a rivet-type fixation. In any event, the internal portion of the screw is firmly fixated to the skull. Triple screw 70 further includes a third threaded portion 80 at an upper portion thereof that is sized in pitch to mate with an internally threaded hexagonal nut 82. As is shown in FIGURE 17, which provides a top plan view of the connector assembly 62, an upper surface of the triple screw 70 is provided with a slot for receiving a screwdriver blade.

FIGURES 18-19 depict a unique tool 86 that is constructed and arranged to be used in conjunction with the connector assembly 62 and the triple screw 70. Tool 86 includes a handle 88 and a shaft 90 that may be provided with a universal joint 92 for accessibility purposes, e.g. to accommodate non-orthogonal placement of the screw. For instance, if access to the triple screw 70 is encumbered by a patient'scorpulence, the screw may be inserted at an angle. A screwdriver blade 94 is provided at a distal end of the shaft 90 and is preferably sized and shaped to be effectively received by the slot 84 that is defined in the upper surface of the triple screw 70. Additionally, tool 86 preferably includes a sleeve 96 that is slidable upwardly and downwardly on the lower portion of the shaft 90 between a first retracted position that is shown in FIGURE 18 and a second, extended operative position that is shown in FIGURE 19. Sleeve 96 is shaped to define an internally threaded socket that mates with the external thread 80 of the triple screw 70. Sleeve 96 is further mounted to the shaft 90 so that it is prevented from rotating with respect to the shaft 90. Accordingly, a surgeon may use the tool 86 in the operative position that is shown in FIGURE 18 in order to tighten the triple screw 70 with respect to the cranial plate member 24 and the cranial bone 78 with the sleeve 96 stabilizing the tool 86 with respect to the triple screw 70 and preventing the blade 94 from slipping out of the slot 84.

Referring now to FIGURES 21-22, spinal system 400 further incorporates an embodiment of attachment system 300 for positioning and biasing the second portions 20, 22 of the first and second bone forming material based structural members27, 29 against at least one cervical vertebral body of a human cervical spine so as to promote bone fusion between the cervical vertebral body and the respective bone forming material based structural member 27, 29. In one embodiment, the vertebral attachment system 300 includes a vertebral plate 303 that is positioned to compress the first bone material based structural member 20 and the second bone material based structural member 22 against a vertebral body such as the vertebral body C2 that is depicted in FIGURE 21. The vertebral plate 303 may hold a graft material in close contact with the underlying spinal vertebrae to facilitate in-growth of blood vessels or other tissue, as is depicted in FIGURES 21-22. Additionally, the vertebral plate 303 stabilizes the two sides of the spinal system 400, connecting the respective connection members 313, 413 from one side to that of the other, thereby decreasing the potential for toggling.

Accordingly, the vertebral plate 303 is connected to the first structural connection member 313 at one portion thereof that includes a first clamp 301 for releasably clamping one end of the vertebral plate 303 to the first structural connection member 313. In one embodiment, the first clamp 301 includes a curved plate portion 116 that curves about most of the circumference of a first structural connection member 313. A fastener 302 extends through first and second holes that are defined in the curved plate portion303 for tightening and loosening the first clamp 301 with respect to the first structural connection member 313.

Likewise, the vertebral plate 303 is connected to the second structural connection member 413 at a second portion thereof that includes a second clamp 402 for releasably clamping a second, opposite end of the vertebral plate 303 to the second structural connection member 413. The second clamp 402 includes a curved plate portion 118 that curves about most of the circumference of the second structural connection member 413. A fastener 402 extends through first and second holes that are defined in the curved plate portion 118.

The curved plate portions 116, 118 of the respective clamps 301, 401 may extend around the circumference of the respective connection member 313, 413 as viewed in transverse cross-section for an angular distance of at least three radians. In addition, the fasteners 302, 402 may be positioned on the medial side of the respective connection member 313, 413. The vertebral plate 303 may be curved so as to be concave on a side thereof that is positioned to contact the first bone material based structural member 20 and said second bone based structural member 22.

The vertebral plate 303 further includes structure for adjusting a length of the vertebral plate 303, whereby a lateral spacing distance between said first and second laterally spaced structural connection members may be adjusted. The structure may include two separate components that are attachable to each other, specifically a first curved connector portion 124, a second curved connector portion 126, and a coupling member 128 as is best shown in FIGURE 23. The first connector portion 124 may have a plurality of adjustment apertures 130 defined therein while the second connector portion 126 similarly has a plurality of adjustment apertures 132 defined therein.

The surgically implantable instrumentation of spinal system 400 that has been described above, including the cranial plate member 24 the connection members 313, 413 and the vertebral plate 303 may alternatively be fabricated from a bioabsorbable material that progressively loses its strength and mass over time as it is absorbed into the human body. The ideal bioabsorbable material would have a composition that would retain sufficient strength for a sufficient period of time for adequate bone fusion and bone mass to develop so that the first and second bone forming material based structural members 27, 29 would provide adequate structural strength to maintain the fusion of the human occipitocervical junction at all times and under all foreseeable circumstances.

Referring now to FIGURE 24, a occipital connection system 140 that is constructed according to an alternative embodiment of the invention includes an integrated fixation member 142 having a cranial plate member 144 and first and second appendages 146, 148 that are integral and preferably unitary with the cranial plate member 144. The appendages 146, 148 would intimately relate to the posterior arch A3 of the Cl vertebra A200, the lateral mass A4 of the C2, C3 vertebrae and any of the lower vertebrae. The goal of the monolithic design would be to simplify and increase the efficiency of application and stabilization of the device to the craniospinal junction. Cranial plate member 144 is preferably constructed identically to the plate portion described above with reference to the previously described embodiment except as is described otherwise herein. The first and second appendages 146, 148 are preferably rigid and in the preferred embodiment are fabricated from a pair of generally parallel extending connection members 513, 613. Appendages 146, 148 are preferably preformed as described above with reference to the first embodiment of the invention so as to be bent at an angle reflecting the corrected reduction of the angle (α angle,FIGURE 20) between the cranium and that of the spine, which in the preferred embodiment this wil be pre-set within a range of about 75° to about 90°. Accordingly, the first and second integrated appendages 146, 148 are contoured to ensure a postoperative craniospinal relationship that confers a clivo-axial angle (the angle between the dorsum of the second cervical vertebra and the dorsum of the clivus) approaching about 15Sl 65° and more preferably about 155-165°. Simultaneously, the degree of ventral brainstem compression should be rendered zero, by virtue of the reduction of angulation between the cranium and spine, and in some cases by the posterior translation of cranium upon spine.

In addition, the integrated appendages 146, 148 preferably incorporate a pre- established rise option (the α rise, described above with reference to FIGURE 20), to accommodate the non-linearity of the level of the posterior arch A3 of the Cl vertebra A200 to the surface of the lamina Al 6 of the C2 vertebra A300 and lateral mass A4 of the C3 vertebra. The presence of the pre-established α rise will allow the integrated appendages 146, 148 to contact the Cl and C2 laminae A16, as shown in FIGURE 24.

Another advantageous feature of the embodiment of the invention that is depicted in FIGURE 24 is the provision of adjustment slots 156, 158 in the first and second appendages 146, 148, respectively, to permit positional adjustment of the integrated fixation member 142 with respect to the pedicle screws 102, 104 that are used to secure the first and second appendages 146, 148, respectively, to the C2 vertebrae. AsFIGURE 24 shows, adjustment slot 158 as well as adjustment slot 156 may include a plurality of prepositioned apertures or adjustment holes 160, 162 to permit indexing of the pedicle screw 104 within the appendage 148 or variability of screw purchase. Likewise, adjustment slots 154 may be provided in the respective portions of the first and second appendages 146, 148 that are constructed and arranged to be secured to the Cl vertebrae A200 by pedicle screws 106, 108. This portion of the appendages 146, 148 is may be constructed so as to be slightly flared at the Cl vertebrae A200 to allow lateral variability.

As may be visualized from viewing FIGURE 24, several possibilities of latitude are offered for the screw heads at the Cl vertebra A200, and several options for the screw heads of C2 are also available. The appendages 146, 148 may be solid, tubular, porous or even a metallurgically bonded porous metal coating that is constructed and arranged to encompass and contain bone graft material, such as TRABECULAR METAL™ by Zimmer Inc. of Warsaw, Indiana.

An exemplary method for achieving occipitocervical fusion using spinal system 400 and attachment system 300 of the present invention will now be described. A patient is first positioned prone with a Mayfield pin headrest in an appropriate sterile surgical environment. The posterior cranium (subocciput) will then be surgically exposed.

The suboccipital bone will then preferably be lightly drilled or sculpted in order to create a flat and even surface for the positioning of the cranial plate member 24. The cranial plate member 24 will then be aligned with the long axis of the patient's body and will be positioned symmetrically about the midline axis, so that the central screw hole 40 is preferably bisected by the midline axis of the patient's cranium as viewed in rear elevation. The center of the central screw hole 40 will then be marked on the cranium, and the cranial plate member 24 will be removed.

A central hole will then be surgically drilled in the cranium, preferably to a depth of 5-10 mm. using a high speed drill, then by a conventional surgical hand drill to complete the drilling, preferably to a total depth of between about 8 mm to about 12 mm. The screw hole will be tapped to a depth that is about 1 mm longer than the screw to be used. For example, for a 10mm screw, tap to 11 mm depth. The cranial plate member 24 will then be repositioned on the midline. The central cortical screw 42 will then be inserted into the tapped hole and tightened, lagging down the cranial plate member 24 to achieve solid fixation.

The left Cl and C2 screws 102, 106 will then be respectively inserted into the Cl and C2 vertebral bodies as is best shown in FIGURES 14 and 21.

The left pie-contoured connection member 313 is loosely positioned within the first clamp 302 of the vertebral plate 303 and is secured to the left Cl and C2 screws 102, 106.

The triple screw position for the first connector assembly 62 that best aligns with the pre-contoured occipito-cervical connection member 313 is then selected. The triple screw purchase selected is then drilled in the cranium. The lateral screw purchase may then be tapped if it is not been pre-threaded. The triple screw 70 is inserted.

The same operation is performed, again choosing the most appropriate position for the triple screw 70 for the second system fastener 412.

The Mayfield headholder is then released, and an open reduction of the craniocervical junction is performed under fluoroscopy and under direct inspection. It is ensured that the abnormal angulation (kyphosis) of the craniospinal angle, and any abnormal translation of the skull is reduced, and that there is no rotation or lateral bending and no subluxation at lower spinal levels. The head-holder is then relocked.

The clivioaxial angle is then measured with the goal of achieving an optimal clivioaxial angle of 150° to 165°.

The connection members 313, 413 are then placed into the triple screws 70 within the respective system fastener 312, 412 and the hex nuts 82 are placed over the screws 70 and tightened.

The exposed suboccipital bone, the posterior arch A3 of the Cl vertebra A200 and the lamina Al 6 and facet joints A22 of the C2 vertebra A300 are then surgically decorticated. The first portions 31, 27 of the first and second bone forming material based structuial member 27, 29 are then inserted into the graft accommodation space 32 that is defined between the cranial plate member 24 and the cranium, as is best shown in FIGURE 15. The cephalad part of the bone forming material based structural member should be fashioned to fit precisely and under pressure beneath the flange 25 of the cranial plate member 24. In some embodiments, the caudal edge 26 of the cranial plate member 24 may now be bent down towards the cranium to further compress the graft. The caudal end of the graft should lie on the decorticated Cl and C2 vertebrae (and lower levels where indicated) dorsal elements.

The graft loading vertebral plate 303 is then positioned to hold down, under pressure, the portions of the first and second bone forming material based structural members 27, 29 that are positioned over and against the Cl and C2 vertebrae dorsal elements. This is best illustrated in FIGURES 21-22.

The fasteners 302, 402 are then tightened on the vertebral plate 303.

Demineralized bone matrix may then be applied to the fusion areas and more cancellous bone may be applied to complete the fusion. A layered wound closure is then performed conventionally over a drain.

A method according to an alternative embodiment of the invention would utilize the integrated fixation member 142 that is depicted in FIGURE 24. In this method, the steps may be slightly reordered. First, placement of the screws into the lateral massA4 or posterior arch A3 of the Cl vertebra A200 and into the lateral mass A4 or pedicle Al 4 of the C2 vertebra A300, or into the lateral masses of the lower cervical or thoracic vertebrae would be performed.

Second the monolithic construct including the cranial plate member 144 and the integrated appendages 146, 148, which are surrogates for the rods 56 and 58 described with reference to the first embodiment of the invention, is applied over the screw heads.

Third, the craniospinal reduction is performed. Fourth, the cranial plate member 144 is screwed to the skull with the central screw 42. The top loading nuts 106, 108 are then tightened down over the screw heads of the vertebral screws.

In all other respects, this method is identical to the method first described above.

Several embodiments of the present invention have been described herein. Nevertheless, it will be understood that various modifications may be made without departing form the spirit and scope of the invention. Accordingly, other embodiments are within the scope of the following claims.

Claims

Amendments to the Claims;

This listing of claims will replace all prior versions, and listings, of claims in the application. Any claims that have been canceled are to be considered canceled without prejudice as to their resubmission:

Listing of Claims:

1. (Original) An attachment system comprising: a clamp comprising: a first member sized to at least partially surround a posterior region of a vertebra; a second member sized to at least partially surround a posterior region of a vertebra; and a first aperture; a plate comprising a body and a second aperture formed in said body, wherein said plate is operatively associated with said clamp and wherein said first aperture is aligned with said second aperture; and a first fastener, wherein said fastener extends through said aligned first and second apertures to secure said plate and said clamp to said posterior region of a vertebra.

2. (Original) The system of claim 1, wherein said posterior region is a posterior arch of a Cl vertebra.

3. (Original) The system of claim 1, wherein said first aperture is located on said first member, wherein said second member comprises a third aperture and wherein said fastener aligns said first, second and third apertures.

54. (Currently Amended) The system of claim 1, wherein said clamp has a configuration selected from the group consisting of: a U shape, a semi-circular shape and a collar.

56. (Currently Amended) The system of claim 1, wherein said plate comprises a plurality of apertures located along said body, wherein at least two apertures have a different dimension.

όl. (Currently Amended) The system of claim 1, wherein said fastener is a threaded component selected from the group consisting of: a screw, a rivet and a bolt.

1%. (Currently Amended) The system of claim 1, further comprising a lock located on said fastener.

89. (Currently Amended) The system of claim 1, further comprising: a rod capable of connecting said attachment system to an orthopedic structure; a second fastener comprising a third aperture and a lock, wherein said rod is retained in said third aperture by said lock, and wherein said second fastener is attached to said plate.

94-0. (Currently Amended) The system of claim 1, wherein said clamp, and said plate are integrally formed.

1044. (Currently Amended) An attachment system comprising: a clamp comprising: a first member comprising a first aperture; and a second member comprising a second aperture, wherein said first and second members are sized to at least partially surround a posterior arch of a Cl vertebra; a plate comprising a third aperture, wherein said plate is operatively associated with said clamp, and wherein said first, second and third apertures are aligned; and a fastener, wherein said fastener extends through said aligned first, second and third apertures to secure said plate and said clamp to said posterior arch.

1143. (Currently Amended) An attachment method comprising: providing the attachment system comprising: a clamp comprising: a first member sized to at least partially surround a posterior region of a vertebra; a second member sized to at least partially surround a posterior region of a vertebra; and a first aperture located on said first member; a third aperture located on said second member; a plate comprising a body and a second aperture formed in said body, wherein said plate is operatively associated with said clamp and wherein said first aperture is aligned with said second aperture; and a first fastener, wherein said fastener extends through said first and second apertures to secure said plate and said clamp to said posterior region of a vertebra; placing said clamp on a posterior region of a vertebra; aligning said first, second and third apertures of said clamp; and fastening said attachment system to said posterior region by inserting said fastener through said first aperture and said second aperture.

124-3. (Currently Amended) The method of claim 1145, wherein said posterior region is located a distance from a spinal component selected from the group consisting of: a spinal cord, a \ertebral artery, a vertebral vein, spinal nerve roots and a combination thereof, wherein said step of inserting said fastener does not sever, compress, impinge or injure said spinal component.

1244. (Currently Amended) The method of claim 1244, wherein said spinal component is a vertebral artery. 144-5. (Currently Amended) The method of claim JJ_.+2, wherein said posterior region is selected from the group consisting of: posterior arch, spinous process, pedicle and lamina

15+6. (Currently Amended) The method of claim 14i§, wherein in said posterior region is a posterior arch of a Cl vertebra.

16+7. (Currently Amended) The method of claim ϋ+3, wherein said step further comprises drilling a hole through said vertebra and wherein said securing step further comprises extending said fastener through said hole and said first and second apertures.

12+8. (Currently Amended) The method of claim JJ t2, wherein said securing step further comprises inserting said fastener through said first and second apertures such that said fastener is adjacent to and does not penetrate said posterior region.

18+9. (Currently Amended) The method of claim 1112, wherein said method involves fastening said plate to a second plate.

1930. (Currently Amended) The method of claim J/7+S, wherein said fastening step stabilizes an occipitocervical junction or a junction between two vertebrae.