CN101027006A - Adjacent level facet arthroplasty devices, spine stabilization systems, and methods - Google Patents

Abstract

The invention discloses an implantable facet arthroplasty device suitable for treating adjacent level disease. The device is designed for implantation between a first vertebra and a second vertebra. Components of the device include: a crossbar; a first component having a first attachment mechanism adapted to attach to a first location of a spinal fusion device attached to a first vertebra and a second attachment mechanism adapted to attach to the crossbar; and a second component having a second attachment mechanism adapted to attach to a second location of a spinal fusion device attached to the first vertebra and a second attachment mechanism adapted to attach to the crossbar. The first component articulates relative to the second component and the first vertebra articulates relative to the device itself.

Description

Adjacent facet arthroplasty device, spinal stabilization system and method

cross reference

This application claims priority to US Provisional Application No. 60/602,826, filed August 18, 2004, and US Provisional Application No. 60/691,946, filed June 17, 2005, which are hereby incorporated by reference.

This application is related to the following pending US patent applications: Application Serial No. 10/973,939, filed October 25, 2004; and Application Serial No. 10/973,834, filed October 25, 2004.

technical field

The present invention relates to devices, systems and methods for treating spinal disorders, including devices for replacing or restoring portions of bone. The devices, systems and methods of the present invention are designed to achieve spinal stabilization and facet replacement. The devices, systems and methods are also designed to achieve spinal fusion at a portion of the vertebral column and stabilization of the spine adjacent to the fused portion.

Background technique

Back pain, especially in the "back lumbar" or lumbosacral (L4-S1 ) region of the spine, is a common condition. This pain severely limits a person's functional capacity and quality of life. Back pain interferes with work, daily activities, and recreation. It is estimated that Americans spend $50 billion a year on low back pain alone. This is the most common cause of work-related incapacity and the leading factor in not getting a job.

Through disease or injury, the bony plates, spinous processes, facets, or bony surfaces of one or more vertebral bodies can be damaged so that the vertebrae can no longer articulate with each other or align properly. This can lead to unwanted anatomy, loss of mobility and pain or discomfort. For example, the facet joints of the spine can be damaged by trauma or various diseases. These conditions include osteoarthritis, ankylosing spondylitis (rheumatoid arthritis), and degenerative spondylolisthesis. Rheumatoid arthritis can cause vertebral stiffness, and degenerative spondylolisthesis can cause forward displacement of the lumbar spine on the sacrum. Damage to the facet joints of the vertebral bodies often results in nerve pressure, also known as nerve "pinching," or nerve compression or impingement. The result is pain, anatomical misalignment, and a corresponding loss of mobility. Nerve pressure can also occur without facet joint disease, such as in the case of a herniated disc.

One of the traditional treatments for facet joint disease is spinal stabilization, also known as intervertebral stabilization. Intervertebral stabilization is expected to control, prevent or limit relative movement between vertebrae through the use of vertebral components, removal of some or all of the intervertebral discs, fixation of facet joints, bone implants/bone induction/ Osteoconductive substances (with or without simultaneous insertion of a fusion scaffold) and/or some combination thereof, resulting in fixation (or limited movement) of any number of adjacent vertebrae to stabilize and prevent/limit/control these treatments Relative movement between passing vertebrae. Stabilization of the vertebral body includes the insertion of motion-restricting devices (e.g. intervertebral spaces, artificial ligaments, and/or dynamic stabilization devices) through which articular fixation is facilitated (rod and screw devices, cable fixation devices, fused scaffolds, etc.) Spine Complete removal of some or all of the vertebral bodies (attributable to extensive bone damage and/or tumor growth within the bone); and insertion of a vertebral body replacement (usually buckled into the adjacent upper and lower vertebral bodies). Devices for the fixation of the vertebrae and/or the scrotum adjacent to the vertebrae, as well as attachment devices for the fixation are known, including Patent Nos. 、6090111、6451021、5683392、5863293、5964760、6010503、6019759、6540749、6077262、6248105、6524315、5797911、5879350、5885285、5643263、6565565、5725527、6471705、6554843、5575792、5688274、5690630、6022350、4805602、5474555 , 4611581, 5129900, 5741255, 6132430; and US Patent Publication 2002/0120272.

A common concern with spinal fusion techniques involves increased stress on the vertebrae adjacent to the fused spine. If one or more functional spinal units (a functional spinal unit consists of a pair of adjacent vertebrae and discs with a facet joint between them) are fused, the elastic unit (now fused or reduced elastic) is fused. The provided stress and tension are transferred (at least partially) to adjacent spinal units. If these increased stresses begin to damage and/or deteriorate other spinal units - which can often occur in the segment directly adjacent to the fused segment - this deterioration is often referred to as "adjacent segment disease" or adjacent segment disease . See Kulkarni et al. J. Neurosurg. 100(1 Suppl Spine): 2-6 (2004) "Accelerated spondylotic changes adjacent to the fused segment following central cervical corpectomy: magnetic resonance imaging study evidence". If adjacent segments deteriorate to the point where surgical intervention is required, the infected/deteriorated spinal unit gradually fuses (or in some manner, restricts and/or controls movement), further exacerbating the stress on the still unfused facets , and over time, often results in multi-segmented or "cascade" fusion of the vertebrae. The spine may be fused, for example, using a spinal fixation system. See US Patent Nos. 6,280,443, 6,086,590, 6,190,388, and 5,800,433; and European Patent No. 1205152A1.

Recently, various treatments have been proposed and produced as alternatives to spinal fusion. Many of these approaches attempt to restore (and/or preserve) the natural motion of some or all of the treated spinal unit, and may include disc replacement, facet joint repair, and facet joint replacement. Such protocols usually include devices that do not substantially affect the movement of the vertebrae. See US Patent Nos. 6,610,091, 6,811,567, 6,902,580, 5,571,171, and Re36,758; PCT Publication Nos. WO01/158563, WO2004/103228, WO2005/009301, and WO2004/103227.

Contents of the invention

One aspect of the present invention includes recognizing that there is a need for a device for adjacent facets that provides stability and protects the joint between two adjacent vertebrae, fusion of adjacent vertebrae of two adjacent vertebrae or fixed part. There is also a need for a system and/or device that can be attached to devices that already include pedicle screws and/or other types of vertebral mounting devices (including spinal fusion components such as rods and screws or other types of fusion and/or devices) or non-fused vertebral mounting device), which can relieve the stress on the unfused vertebrae. In addition, there is a need for a facet joint replacement device that has components that can be selectively attached to pre-existing vertebral components (and/or can be used for limited retrofit) as desired by the physician. pre-existing vertebral components or additions to address various surgical situations) and various anatomical structures including bone plates, pedicles, and/or applied directly to the vertebral body or body (or some combination thereof, including simultaneous fixation on Vertebral components and bone positions). In addition, there is a need for a facet joint replacement device that can be implanted into the vertebral condyles that advantageously strengthens and/or stabilizes the facet joint/disc near one or more fused condyles to treat , reducing and/or preventing the onset of adjacent segment disease in one or more unfused vertebral segments. In addition, there is a need for a facet joint and disc replacement device that can be used to revise or "detach" a fused vertebral segment (or segments) and restore those segments. Part or all of the natural motion of a segment or segments. In addition, there is a need for a facet joint replacement device that can be used to modify one or more fused joints of a multi-joint arthroplasty so that at least some of the motion of the multi-joint arthroplasty can be restored, i.e., four joints Parts of the arthrodesis can be "tipped off," leaving two single-joint arthroplasties separated by the articulation section that includes the facet arthroplasty device.

In one embodiment of the present invention, an implantable facet arthroplasty device connecting a first vertebra and a second vertebra comprises: a crossbar; a first member having a shape adapted to fuse with a spinal column connected to the first vertebra; a first connection mechanism for connecting the first position of the device and a second connection mechanism adapted to engage the crossbar; A second linkage and a second linkage adapted to engage the crossbar, wherein the first member articulates relative to the second member; furthermore, the first vertebra articulates relative to the facet arthroplasty device. The device also includes a first arm having a bone-engaging end adapted to be coupled to the vertebral body at a first end and adapted to engage the crossbar at a second end. Additionally, the device may be configured to engage a caudal or cephalic vertebral body. Arthroplasty devices suitable for use with the present invention include spinal fusion devices, such as devices comprising a pair of elongated members configured to extend along adjacent vertebrae and a plurality of linkages for mounting the fusion device to vertebrae. Extends in part of the cephalic and caudal vertebrae. In some embodiments, the second arm has a bone-engaging end adapted to couple to the vertebral body at a first end and to engage the crossbar at a second end. The second arm may be configured to engage the caudal or cephalic vertebral body. In some embodiments, the first arm may be adapted to articulate relative to the second arm.

In another embodiment of the present invention, an implantable spinal restoration device includes: an elongated member configured to extend along a portion of the length of a vertebra adjacent to the cephalic and caudal vertebrae; An elongated member is attached to a portion of a vertebra; a facet arthroplasty element; a strut having a first end and a second end sized to span a portion of the vertebral body and adapted to receive a facet at the first end and the second end an arthroplasty element; and a connector adapted to couple the support to the elongate member. Embodiments may also include an arm having a bone-engaging end adapted to be coupled to the vertebral body at a first end and adapted to engage the support at a second end. The arms may also be configured to engage the caudal and/or cephalic vertebral bodies. A second arm may also be provided having a first end adapted to engage the vertebral body at a first end and a second end adapted to engage the crossbar. The first arm may be configured to articulate relative to the second arm. The support member may also be configured to be sized to span a portion of the vertebral body between the left and right bone plates, eg, between the left and right pedicles of the vertebral body. Thus, the support may further be adapted to have an adjustable width. Furthermore, the facet arthroplasty element is positioned relative to the support, providing a symmetrical anatomy. The facet arthroplasty element may also be positioned relative to the support to provide an asymmetrical anatomy. Additionally, the end of the strut is adapted to receive the opening in the facet arthroplasty element. The facet arthroplasty element may also be selected from a plurality of facet arthroplasty elements each having an opening of a different depth. Embodiments of the present invention may provide even weight distribution on the vertebral body.

Yet another embodiment of the present invention includes an adaptable, implantable spinal stabilization device comprising: a crossbar having a first end and a second end; a pair of vertebral engaging elements, each vertebral engaging element having a bone engaging end and an end adapted to be attached to a crossbar; and a pair of fixation elements, each fixation element having a first end and a second end adapted to secure the fixation element to a spinal fusion device, the first end having an end adapted to receive a crossbar The facet of the department. The device may further include an arm having a bone engaging end adapted to be coupled to the vertebral body at a first end and adapted to engage the support at a second end. The arm may be further configured to engage the caudal or cephalic vertebral bodies. The second arm of this embodiment may be configured to engage the vertebral body at a first end and a second end adapted to engage the crossbar. In this example, the first arm may be configured to articulate relative to the second arm. The strut may be sized to span the portion of the vertebral body between the left plate and the left plate, or the portion of the left vertebral body between the pedicle and the left pedicle. The support may further be adapted to have an adjustable width. Embodiments of the present invention may be positioned relative to the support to provide a symmetrical anatomy or an asymmetrical anatomy. The ends of the struts may also be adapted to receive openings in the facet arthroplasty element. In addition, each facet arthroplasty element may also be selected from a plurality of facet arthroplasty elements each having openings of different depths. Utilizing the support also allows the weight to be evenly distributed on the vertebral body.

Embodiments of the present invention include a method of modifying spinal fusion surgery to provide support for adjacent vertebrae comprising: accessing a vertebral location with a spinal fusion device comprising a pair of elongated members connected to adjacent caudal vertebral bodies and cranial connecting a facet arthroplasty device, the facet arthroplasty device comprising articulation means adapted to receive a crossbar and an attachment means adapted to be attached to an elongate member of a spinal fusion device; and closing the wound. In one embodiment method, vertebrae adjacent to the spinal fusion device are stabilized.

Another embodiment of the present invention includes an implantable adjacent-level arthroplasty device for implantation between a first vertebra and a second vertebra having an engaging fusion device therebetween. A vertebra, the arthroplasty device comprising: a crossbar; a first member having a first connection mechanism adapted to connect with a first location of a spinal fusion device connected to the first vertebra and a second connection adapted to engage the crossbar mechanism; and a second member having a second connection mechanism adapted to connect to a second location of the spinal fusion device connected to the first vertebra and a second connection mechanism adapted to engage the crossbar, wherein the first member Articulating relative to the second member; wherein the first vertebra articulates relative to the facet arthroplasty device.

All publications and patent applications mentioned in this specification are herein incorporated by reference as if each individual publication or patent application were specifically and individually indicated to be incorporated herein by reference.

Description of drawings

The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained with reference to the following detailed description and accompanying drawings, which set forth illustrated embodiments in which the principles of the invention are applied, in which:

Fig. 1 is the side view of common people's spine;

Fig. 2 is the top view of common people's lumbar spine;

Figure 3 is a side view of a functional spinal unit;

Fig. 4 is the posterolateral perspective view of vertebra;

5 is a perspective view of an anatomical plane of a human body;

6A-B are side and rear views of the vertebral fixation system;

7A-C are views of one embodiment of an adjacent-level facet arthroplasty device;

Figures 8A-C are views of another embodiment of an adjacent-level facet arthroplasty device; Figure 8D shows yet another embodiment;

Figure 9A is a rear view of the embodiment of Figure 7 connected to a spinal fusion device; Figure 9B is a side view of the device of Figure 9B; Figure 9C is a perspective view of the device;

Figure 10A is a rear view of the embodiment of Figure 8A connected to a spinal fusion device; Figure 10B is a side view of the device of Figure 8B; Figure 10C is a perspective view of the device;

Figure 11A is a rear view of another embodiment of a facet replacement system, wherein the device is inserted into a vertebral fixation system; Figure 11B is a side view of the installed device; Figure 11C is a perspective view of the installed device;

Figures 12A-U describe various connection and attachment systems suitable for use with the present invention;

Figure 13 is a flowchart of the method of the present invention; and

Figure 14 is a flowchart of another method of the present invention.

Detailed ways

While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that these embodiments are provided by way of example only. Numerous variations, changes, and substitutions will occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. The invention is therefore intended to cover the following claims defining the scope of the invention, methods and apparatus falling within the scope of the claims and their equivalents.

The present invention relates to implantable devices, including prostheses adapted for implantation in the human body, to restore and/or strengthen connected tissues, such as bone; and systems for treating vertebral lesions. The present invention generally relates to implantable devices, devices or mechanisms adapted for implantation in the human body to restore, strengthen and/or replace soft and connective tissues, such as bone and cartilage; and systems for treating vertebral lesions. In various embodiments, implantable devices may include devices designed to replace missing, removed or resected body parts or tissues. An implantable device, device or mechanism is configured such that the device is composed of parts, elements or components, which alone or in combination comprise the device. Implantable devices can also be configured such that one or more elements or components are integrally formed to achieve the desired physiological, operational and functional effects such that these components complete the device. Functional effects can include surgical repair and functional strength of the joint, controlling, limiting, or altering the functional strength of the joint, and/or eliminating functional strength of the joint by preventing joint motion. Portions of the device may be configured to replace or augment existing bone and/or an implanted device, and/or be used in combination with resection or removal of existing anatomical structures.

The device of the present invention is designed to be combined with the human spine 10, which, as shown in Figure 1, includes a set of thirty-three vertebrae 12 divided into five regions. The neck consists of seven vertebrae, C1-C7. The thorax includes twelve vertebrae, T1-T12. The lumbar region consists of five vertebrae, L1-L5. The sacrum includes five fused vertebrae, S1-S5, while the coccyx includes four fused vertebrae, Co1-Co4.

An example of a vertebra is shown in FIG. 2, which depicts an enlarged view of the lumbar spine 12 of an average person. Although a person's lumbar spine differs slightly depending on location, the vertebrae share many common characteristics. Each vertebra 12 includes a vertebral body 14 . Two short bony protrusions, pedicles 16, 16' extend dorsally from each side of the vertebral body 14 to form a vertebral arch 18 defining a vertebral foramen.

At the rear end of each pedicle bone 16 , the vertebral arch 18 is opened to form a flat bone plate, ie, a bone plate 20 . The bone plates 20 fuse together to form spinous processes 22 . Spinous processes 22 provide muscular and ligamentous connections. The smooth transition from the pedicle 16 to the bone plate 20 is interrupted by a series of spinous processes.

Two transverse spinous processes 24 , 24 ′ protrude from the junction of the pedicle bone 16 and the bone plate 20 to both sides. Transverse spinous processes 24 , 24 ′ serve as rods for muscular attachment to vertebrae 12 . Four articular processes, two superior articular processes 26 , 26 ′ and two inferior articular processes 28 , 28 ′, also protrude from the junction of pedicle bone 16 and bone plate 20 . The superior articular processes 26, 26' are pointed oval-shaped bones projecting upward on either side of the vertebrae, while the inferior articular processes 28, 28' are oval-shaped bones projecting downward on both sides. See Figure 4.

Both superior articular process 26 and inferior articular process 28 have a natural bony structure called a bony surface. The superior facet 30 is oriented in a medial-upward direction, while the inferior facet 31 (see FIG. 3 ) is oriented in a lateral-downward direction. When the adjacent vertebrae 12 are aligned, the facets 30 , 31 are covered by smooth articular cartilage and encased by ligaments that interlock into facet joints 32 . Facet joints are spinous bone joints with a loose capsule and a synovial membrane.

As noted above, facet joint 32 includes superior and inferior facets. The superior facet is formed by the facet of the vertebra below the joint 32 and the inferior facet is formed in the facet of the vertebra above the joint 32 . For example, in the L4-L5 facet joint as shown in Figure 3, the upper facet of the joint 32 is formed by the bony structure on the L5 vertebra (that is: the upper facet and supporting bone 26 on the L5 vertebra), and the lower facet of the joint 32 The facets are formed by the bony structures on the L4 vertebra (ie: superior articular facet and supporting bone 28 on the L4 vertebra). The angle formed by the facet joints located between the superior and inferior facets varies relative to the midline according to the positioning of the vertebral bodies along the spine. The facet joints within and by themselves support essentially no axial loads unless the spine is in an expanded state (lordosis). As understood by those skilled in the art, the orientation of the facet joints of a particular pair of vertebral bodies changes significantly from the thoracic to the lumbar spine to provide the joint's ability to resist expansive flexion, lateral bending, and rotation.

Intervertebral discs 34 between adjacent vertebrae 12 (with bulky vertebral bodies, indicated as 14, 15 in FIG. 3 ) allow sliding movement between the vertebrae 12 . The structure and arrangement of the vertebrae 12 thus allows a range of motion of the vertebrae 12 relative to each other. Figure 4 shows a posterolateral perspective view of vertebra 12, further illustrating the curvature of the superior facet 30 and the protruding structure of the inferior facet 31 adapted to mate with the opposing superior facet. As noted above, the position of the inferior facet 31 and superior facet 30 on a particular vertebral body is varied to achieve the desired biomechanical behavior of the vertebral region.

Thus, the entire spine includes a series of functional spinal units, which are areas of motion that include two adjacent vertebral bodies, intervertebral discs, associated ligaments, and facet joints. See Posner, I, et al. A biomechanical analysis of the clinical stability of the lumbar and lumbrosacral spine. Spine 7:374-389 (1982).

A natural facet joint, such as facet joint 32 ( FIG. 3 ), has an upper facet 30 and an inferior facet 31 , as previously described. Anatomically, the upper facet of the joint is formed by the vertebral facets of the lower facet of the joint, so it can be called the "facet" of the facet joint because it is anatomically closer to the coccyx or the human foot. tail" part. The lower facet of the facet joint is formed by the facets of the vertebrae above the joint, so since it is anatomically closer to the human head, it can be called the "head" portion of the facet joint. Thus, a device that in use replaces the caudal portion of the natural facet joint (ie, superior facet 30) may be referred to as a "caudal" device. Likewise, a device that in use replaces the head portion of the natural facet joint (ie, the inferior facet 31 ) may be referred to as a "head" device.

When the spinous processes on one side of the vertebral body 14 are spaced differently than the spinous processes on the other side of the same vertebral body, the components on both sides of the device are of different sizes, showing anatomical differences that can occur between patients . Furthermore, it can be difficult for a surgeon to determine the exact size and/or shape required for an implanted device until the surgical site to receive the device has actually been prepared. In such cases, typically the surgeon quickly deploys a family of devices protruding in different sizes and/or shapes during the procedure. Accordingly, embodiments of the vertebral device of the present invention include a modular arrangement that is configurable and/or modifiable. In addition, the various embodiments disclosed herein can also form a "kit" or system of modular components that can be assembled in the field to form a patient-specific solution. As will be appreciated by those skilled in the art, due to improvements in imaging techniques, as well as improvements in mechanisms (eg, software tools) for interpreting images, patient-specific designs using these concepts can be deployed or fabricated prior to surgery. Accordingly, it is within the scope of the present invention to provide a pre-configured patient specific device having integrally formed components.

A configurable modular device design, such as that available through the present invention, allows individual components to be selected from different size ranges and used in modular devices. An example of a size is to provide tail and head stems of different lengths. Modular implantable devices also allow individual components to be selected for different functional characteristics. An example of a function is to provide stems with different surface features and/or textures that provide anti-rotation capabilities. Other examples of the configuration capabilities of the modular implantable device of the present invention are described in greater detail below.

The implantable devices of the present invention can be configured to select and configure a synthetic implantable spinal device to conform to a particular anatomy or desired surgical outcome. An adaptive aspect of embodiments of the present invention is to provide the physician with customization options during implantation or revision. The adaptability of the present invention also provides for adjustment of components during implantation to ensure optimal compliance with desired bone positioning or surgical outcome. The adaptable modular arrangement of the present invention enables adjustment of component-to-component relationships. An example of a member-to-member relationship is the rotational angle relationship between the beam mount and the beam. Other examples of the adaptability of the modular apparatus of the present invention are described in greater detail below. Configurability can be viewed as the selection of specific sized components that, together with other component sized selections, result in a "specially configured" implantable device. Adaptability then refers to the implantation and adjustment of individual components within a range of positioning in such a way that a "custom fit" device is fine-tuned for an individual patient. The net result is that the modular, configurable, adaptable spinal device and system of the present invention allow the physician to vary the size, position and relationship between the various components of the device during the actual procedure to suit the specific needs of the patient.

In order to understand the deployability, adaptability and operational aspects of the present invention, it is advantageous to understand the anatomical reference of the body 50 relative to which the position and orientation of the device and its components are described. There are three anatomical planes commonly used in anatomy to describe the human body and its internal structures: the axial plane 52, the sagittal plane 54, and the coronal plane 56 (see FIG. 5). Additionally, the device and operation of the device will be better understood with respect to the tail 60 orientation and/or the cephalad 62 orientation. Device 70 disposed within the body may be positioned dorsally (or posteriorly) so that placement or manipulation of the device is toward the back or rear of the body. Alternatively, device 72 may be positioned ventrally (or anteriorly), so that placement or manipulation of the device is toward the front of the body. Embodiments of the spinal devices and systems of the present invention are configurable and variable with respect to one anatomical plane or with respect to two or more anatomical planes. For example, a component may be described as lying in a plane and being adaptable or operable with respect to a plane. For example, the stem may be provided in a desired position relative to the axial plane and be movable between or within a range of positions which may be adapted. Similarly, the various components may comprise different sizes and/or shapes to accommodate different patient sizes and/or expected loads.

FIG. 6A is a view of a portion of the spine 10 with a side view of a spinal fusion implant 100 (such as a spinal fusion rod and screw set commercially available from SeaSpine, Inc.) positioned in the sagittal plane. The vertebral implant 100 includes a rod 110 secured to the spine 10 with one or more anchors 120 , such as bone screws passing through the vertebral body 14 . The anchor 120 is fixed to the rod 110 by the connection means 115 . FIG. 6B is a rear view of a portion of spine 10 with vertebral implant 100 . The vertebral implant has a pair of rods 110, 110' that are secured to the spine 10 using one or more anchors 120 (as shown in Figure 9A) that are secured to the rods by connecting means 115 110, 110'.

Other vertebral fixation systems may also be employed without departing from the scope of the present invention. For example, cables may be used instead of rods to stabilize the spine. Use of the device in conjunction with fixation devices positioned anteriorly, posteriorly, and laterally relative to the spine is also contemplated.

Figure 7A is a rear view of a fixable facet replacement system 200 in accordance with one embodiment of the present invention. Apparatus 200 includes a crossbar 205, a pair of head arms 220, 220' and a pair of connectors 230, 230'. In this example, the facets 30 and 31 of the vertebral body are replaced by the cooperating operation of the crossbar 205, the head arms 220, 220' and the adaptable crossbar mount 276 which interacts with the tail device 250, which holds the head The arms 220 , 220 ′ are connected to the crossbar 205 . The components of the head implantable device 200 are designed to provide proper configuration and adaptability to the specific pathology, patient specific anatomy, and spinal segment in which the implantation occurs.

Crossbar 205 includes a first end 210 and a second end 215 . The crossbar 205 may be made of two rods, in which case the first end is connected to a threaded boss (not shown) with threads. The second end 215 of the crossbar may be connected to a threaded recess capable of receiving threads. It is foreseeable that the threaded ends allow the width of the crossbar to be adjusted to match the width between the tail supports 250 . Another embodiment of the crossbar 205 may comprise a series of solid crossbars of varying width and/or thickness, or with some locking or biasing device (such as a spring-loaded tensioner or positioning device) as foreseen by those skilled in the art. device). Furthermore, in alternative embodiments, end 210 may be configured with a threaded protrusion (instead of a recess) that fits into a threaded recess of crossbar 205 without departing from the scope of the present invention.

A pair of head arms 220 may also be represented in the exemplary embodiment of the fixable, adaptable and implantable device 200 of the present invention. Each head arm 220 , 220 ′ includes a bone engaging end 225 , 225 ′ and an end 240 , 240 ′ adapted to connect to the crossbar 205 . Tail end 240 adapted to engage crossbar 205 includes arm 245 and elbow 247 . The tail end 240 is connected to the crossbar using a crossbar mount 276 . The head bone-engaging end 225 includes a head stem 230 and a tip 235 . Head stem 230 and tip 235 are threaded or otherwise configured to engage bony structure. Alternatively, tip 235 may be integrally formed with head stem 230 from the same or a different material as head stem 230 . The surface of the head stem 230 may be a textured surface or any other modified surface, such as a surface that facilitates or promotes bone growth.

Crossbar mount 275 is a connection structure that connects head prosthetic element 220 to crossbar 205 . In the illustrated embodiment, the crossbar mount 275 includes a head arm engagement portion 272 , a crossbar engagement portion 274 and a securing element 276 . The embodiment of the crossbar mount 275 provides for adaptability between the loading characteristics of the cranial prosthetic element 220 and the crossbar 205 and the crossbar ends 10 , 215 and the caudal prosthesis 250 .

A pair of tail support members 250 is also shown in the exemplary embodiment of the configurable, adaptable head stabilization device 200 of the present invention. Each aft support element 250 includes an aft cup-shaped socket 251 . The caudal cup 251 includes a surface 255 adapted to receive the end of the crossbar and a flat surface for engaging the caudal stem head engagement surface. Tail connectors 230 , 230 ′ are provided to connect the implantable device 200 to the rods 110 , 110 ′ of the vertebral implant 100 below the connector device 115 . Clamping device 230 may be attached to different parts of vertebral implant 100, including rods 110, 110' or connecting device 115. Other means of attachment to all or part of the vertebral implant 100 may be provided, including cruciform connectors and/or lateral rod connectors (not shown) or combinations thereof. The clamping means 230, 230' may further be adapted to be fixed on the vertebral implant 100 by providing additional connection means 231 such as bolts.

Figure 7B shows implantable device 200 in side view; Figure 7C shows device 200 in perspective view. As can be foreseen by those skilled in the art, in some cases the device may be configured to work with only one head arm, thus resulting in a 3 point fixation device which in turn is attached to the spinal fusion device. In the case of a 3-point fixation design, the head arm 220 can be attached to the crossbar 205 such that the length of the arm 220 from the bone-engaging end 225 to the cross-bar-engaging end 240 passes through the vertical length of the sagittal plane 54 through the vertebrae. midline. Other attachment means may be provided without departing from the scope of the present invention.

Figure 8A is a rear view of a fixable facet replacement system 300 according to another embodiment of the present invention. Apparatus 300 includes a crossbar 305, a pair of head arms 320, 320' and a pair of head links 330, 330'. In this exemplary embodiment, the facets 30, 31 of the vertebral body are replaced by the cooperation of the crossbar 305, a pair of head arms 320, 320' and the adaptable crossbar seat 275 to attach the device to the implant. , interacting with the tail device 350 , the crossbar mount 275 connects the head arms 320 , 320 ′ to the crossbar 305 . The components of the caudal implantable device 300 can be designed to provide the proper configuration and adaptability for the particular pathology, patient-specific anatomy, and spinal segment at which the implantation occurs.

The crossbar 305 has a first end 310 and a second end 315 . The crossbar 305 may be made of two rods, in which case the first end 310 is connected to a threaded boss (not shown) having threads. The second end 315 of the crossbar may be connected to a threaded recess sized to accommodate the threads. It is foreseeable that the threaded ends allow the width of the crossbar to be adjusted to match the width between the tail supports 350 . Another embodiment of the crossbar 305 may comprise a series of solid crossbars of varying width and/or thickness, or with some locking or biasing device (such as a spring-loaded tensioner or positioning device) as would be foreseen by those skilled in the art. device). Further, in alternative embodiments, end 310 may be configured with a threaded protrusion (instead of a recess) that fits into a threaded recess of crossbar 305 without departing from the scope of the present invention.

A pair of tail supports 350 is also shown in the exemplary embodiment of the configurable, adaptable device 300 of the present invention. Each tail support 350 includes a tail cup 351 and a fixation element 360 . The caudal cup 351 includes a surface 355 adapted to receive the end of the crossbar and a flat surface for engaging the caudal stem head engagement surface. Fixation element 360 includes a tail stem 365 and a tip 370 . Alternatively, tip 370 may be integrally formed with tail stem 365 from the same or a different material as tail stem 365 . Tail stem 365 and tip 370 may be threaded or otherwise configured to engage.

Head connectors 330, 330' are provided to connect the implantable device 300 to the rods 110, 100' of the vertebral implant 100 below the connecting device 115. Clamping device 330 may be attached to various parts of vertebral implant 100 , including rods 110 , 100 ′ or connecting device 115 . Other means of attachment to all or part of the vertebral implant 100 may be provided, including cruciform connectors and/or lateral rod connectors (not shown) or combinations thereof. The clamping means 330, 330' may further be adapted to be fixed on the vertebral implant 100 by providing additional connecting means 331 such as bolts or screws.

Figure 8B shows implantable device 300 in side view; Figure 8C shows device 300 in perspective view. Similar to the modification described above in Figure 7, as would be foreseen by those skilled in the art, in some cases the device may be configured to provide only one caudal arm, thus resulting in a 3-point fixation device which in turn is attached to the spinal fusion device . Where a 3-point fixation design is used, the caudal arm 320 may be attached to the crossbar 305 such that the length of the arm 320 from the bone-engaging end to the cross-bar-engaging end 340 passes through the midline of the vertebra along the vertical length of the sagittal plane 54 .

Figure 8D shows an implantable device 300 suitable for use in a fusion system that alters the median length to prepare for movement of the target junction. Device 301 has a crossbar 305 joined at each end to two caudal cup sockets 350 . Tail arms 320, 320' are provided to couple the device to a vertebral fixation system (eg, device 100). Head connectors 230, 230' are provided to connect the device to a second vertebral fixation system. Thus, implantable device 301 provides an articulating means between two implantable devices that stabilize the spinal muscles in a caudal and cephalad direction. Tail arms 320 , 320 ′ or head connectors 230 , 230 ′ may be configured to engage spinal fusion device 100 along stem 110 , fixation element 120 or connection device 115 . Structures may include providing a hole to accommodate, for example, a screw that engages the fusion device 100, or configuring the arms 320, 320' or links 230, 230' to hook around the fusion device, such as around a rod.

Figures 9A, 9B and 9C illustrate the spinal fusion implant 100 and the facet replacement device 200 implanted on a portion of the spine 10 (see Figure 7A). Spinal fusion implant 100 has been described relative to facet replacement device 200 . However, the orientation of the spinal fusion implant 100 and the facet replacement device 200 may vary, as would be foreseen by those skilled in the art. For purposes of illustration, the fixation means of the spinal fusion implant 100 are not described in each paragraph to avoid obscuring the invention. Device 200 is configured so that it can be implanted during an open surgical procedure, or can be implanted in a less invasive and/or minimally invasive manner. In desired embodiments, the various components of device 100 may be delivered transdermally. And while the various components described can be implanted in the pedicle, these components and variations thereof can be implanted or fixed in the pedicle, periosteum, vertebral body or combinations thereof. Figures 10A, 10B and 10C illustrate another system 98 to achieve spinal stabilization and restoration of facet function.

Figure 1 IA shows the implanted system 97 from the rear view. Two or more vertebrae are stabilized by the spinal fusion implant 100 and the facet articulation of the next adjacent head vertebra is partially or fully replaced by the device 200, while the facet articulation of the next adjacent head vertebra is partially Ground or all are replaced by device 300. Figure 11B shows implant system 97 in side view; Figure 11C shows the device in perspective view. The length of the spinal stabilization device 100 used may vary according to the number of vertebrae to be fused, as foreseen by those skilled in the art. As will be appreciated by those skilled in the art, the device of Fig. 8D may also be used in a system such as 97 to provide articulation for fusion combinations.

Figure 12 shows in whole or in part various connection and attachment designs useful in embodiments of the present invention. FIG. 12A shows a connector 400 having a support 402 attached to an arm 404 . Connector 400 has an arm mount 406 that connects arm 404 to sleeve 410 . The connector shown in FIG. 12B enables a vertebral implant such as those devices described above to be secured to the spine by positioning portions of the vertebral body within hooks 410 . The shaft 110 of the vertebral implant (shown in FIGS. 7-8 ) is then inserted laterally through the opening 412 defined between the side portion 414 of the extension portion 416 and the flange 418 of the connector portion 420 . The rod can then be displaced axially along the U-shaped slot 422 . A fastener (not shown) can be threaded through the side 414 of the extension 416 along the shaft portion 424 and into threaded engagement with the threads of the flanges 418, 418', which causes the lower portion of the fastener to engage the extension rod 110 (FIG. 6) Press the rod 110 tightly on the bottom of the U-shaped groove 422 . Figure 12C illustrates another internal fixation device suitable for use with the present invention. The internal fixation device 430 is connected to the fixation rod 110 , 110 ′ and includes a hook 432 having a screw device 434 with a shaft 436 . The hook 432 has a true hook element 438 and a hook and loop element 440 that grips a portion of the spinal column. The hook and loop element 440 is used to fix the fixing rod 110 and is mutually fixed with the hook 432 . The hook and loop element 440 forms a slot having a slot bottom 442 and two side walls 444, 444' adjoining the slot bottom 442, against which the securing rod 110, 110' rests. The two side walls 444, 444' of the shackle element 440 are clamped together by means of a screw device having a shaft 436, by means of which the fixing rod 110, 110' can be clamped in place in the area where it is housed within the shackle element 440 .

Figure 12D shows a transconnector 450 suitable for use with the present invention. A connector 450 connects two elongated vertebral stabilizers 452, 452' (but they may also comprise plates), which are secured to multiple vertebrae by fixation elements not shown. The transconnector has a connection assembly having a first part 454 and a second part 456 each having an end terminating in a clip 458, 458'. Multiple clamping structures can be used. They can be the same or different. For example, the clip on one side can be closed while the clip on the opposite side can be open. Preferably, however, each clip includes a recess 458, 458' to accommodate a corresponding rod. Set screws may be used and received in screw holes each terminating in an angled region 462, 462' which biases the rod into contact with the recess. The longitudinal axis of the set screw is offset from the longitudinal axis of the rod receiving recess such that the set screw can bias the rod into the recess. The set screw may include a hexagon socket or other suitable torsional drive for tightening. When assembled, the recesses 458, 460 both open to the central inner line or facets facing each other. This arrangement can be used for the initial arrangement of the connector on the rod 110 (FIG. 6). Thus, the connector arrangement can be arranged on the rod and then fixed with respect to the length. The second part 456 of the transconnector includes an aperture 462 that receives an extension 464 that extends outwardly from the clip 458 of the first part 454 . The extension can be moved in and out of the hole 462 to shorten or expand the length of the connected space, and the extension 464 can be rotated in the hole 462 to change the relative angle of the opening of the rod recess of the clip to accommodate the longitudinal axis of the rod 110. The relative angle of change. Further, the first and second components 454 , 456 may include a stop mechanism, such as a flanged end of the extension 464 . When in use, the flanged end is inserted into a vertical keyway 466, which is a vertical slot in the first part which has an enlarged opening slightly larger than the diameter of the annular flange and which can accommodate a larger diameter entry of the flanged end. Notches may be provided on each side of the keyway to allow captured movement of the flange end within the keyway, but restrict movement out of the keyway. The vertical slot area is slightly wider than the diameter of the extension. Thus, when the flanged end slides down toward the bore 462 , the keyway 466 confines it within the vertical keyway 466 . When the extension reaches the end of the keyway 466 it moves inwardly into the bore 462 .

FIG. 12E shows the rod 110 with the screw connector 470 . A hollow connector 472 is provided to engage the rod 110 . The fastener 474 is pivotally connected to a threaded bone fixation bolt 476 so that the connector 470 connects the rod or cable 110 to the bone.

FIG. 12F shows a perspective view of mounting device 480 . The device 480 includes a connector 482 having two screws 484, 484' adapted to form a screw-nut connection through a conduit 486 engaging a head 488 of the connector. The connector has two vertical planes, including a front and a rear, which are substantially parallel and extend continuously for the full height of the connector. The connector also has two horizontal planes, including top and bottom surfaces 492, 492', which are parallel to each other and substantially perpendicular to the vertical plane 490 described above. The connector has a generally cylindrical conduit 486 extending parallel to and intermediate the front and rear faces and perpendicular to top and bottom surfaces 492, 492' through which the conduit 486 opens outwardly. The connector is axially symmetrical with respect to the axis of the conduit 486 . The connector has two grooves 494, 494' extending substantially parallel to the top and bottom surfaces 492, 492' in two sides 496 of the connector which are perpendicular to the front and The rear 490 extends. Each slot 494, 494' generally has an upper face 498 parallel to the top face 492 of the connector, a ventral face parallel to the side face 496 of the connector, and a lower face facing the upper face 498 and perpendicular to the front and back faces 490 while being slightly inclined inwardly of the connector. 498' formed groove. The angle between the upper and lower sides 498, 498' of the groove may be in the range of 2-10 degrees, for example. The slots 494, 494' cooperate with the conduit 486 extending therebetween to form a housing for receiving the cruciform member 500, as described below. Still further, on each side of the shaft of the conduit 486, the grooves 494, 494' form two joints between which the conduit 486 and the frame extend. The portion of the connector extending over the joint forms the header 502 . The two sides 496 on the head 502 are formed like two segments of a common cylinder coaxial with the duct 486 . The connector has a cylindrical bottom surface 504 adjacent the bottom surface 498 of the connector, perpendicular to the pipe 486 and midway between the two sides 496 . Between them, the slots 494, 494' and the cylindrical surface 504 form two jaws 506, 506', each connected to the head 502 by two joints. On each joint, the connector has a notch 508 extending away from the jaws 506, 506' towards the head 502. The diameter of the conduit 486 in the head 502 is smaller than its diameter in the rest of the connector. Inside the head 502, the pipe 486 is threaded.

It has two bolts 484 each adapted to form a bolt-and-nut connection by engaging into the conduit 486 of the head 502 of the respective connector. Each bolt 484 has a hex socket head 510 to receive a socket wrench to screw the bolt 484 into the pipe 486 . The device has two longitudinally rectilinear rods 512, 512' for extending along the patient's vertebrae, each rod being secured to the vertebrae using fixation elements known in the art. The two rods 512, 512' generally have a circular profile as shown, having the same diameter as the cylindrical surface 504 between the jaws. The jaws 506, 506' are adapted to make face-to-face contact with the rod. The cylindrical faces 504 of the jaws together extend over an arc of more than 180 degrees and are chosen as a function of the characteristics of the connector so that the jaws 506, 506' can be snapped onto the rods 512, 512'. The cylindrical surface 504 of the jaws presents a geometric profile that extends beyond the bottom surface 492 ′ of the connector 482 . Thus, when the rod 512, 512' is engaged between the jaws 506, 506', the rod protrudes radially beyond the jaws. Finally, the device has a rectilinear cross-shaped member 513 of generally rectangular cross-section, adapted to be received in the housing, just past the connector 482 .

FIG. 12G shows another connecting device 520 . The rod 110 is received through a hole 522 in a pivot head 524 connected to a fixation dowel 526 which is used to secure the device 520 to the bone.

In Fig. 12H, positioning and locking device 530 is made up of upper jaw piece 532 and lower jaw piece 534, and upper jaw piece 532 and lower jaw piece 534 have the open face that is machined together with assembly notch 536, make a Positioned on the other and pivoted relative to the other to retain the opening 538 at the opposite end. A sleeve or hollow shaft 540 is passed through both jaws 532, 534 at an appropriate angle relative to the clamped jaw opening and then through the opposite end of the jaws. The sleeve 540 has the shape of a conical frustum in its upper part 542 with a groove 544 starting from the upper part 542 and extending in the direction of the axis of the sleeve, stopping approximately mid-lower along its length. The lower portion of the sleeve 540 is threaded at 546 and screws into a nut 548 that clamps the two jaws 532, 534 together. Springs in the form of staples or bent wires are housed in holes 552 made in each of the jaws 532, 534 on opposite sides of the opening of the clamping jaws. The upper jaw 532 has a conical recess in its upper portion and a cylindrical hole for receiving the sleeve 540, the lower jaw 534 has a hole with two opposing flats to hold the sleeve 540 in place, In particular, these planes are not shown in the figures and play a role in preventing rotation. Sleeve 540 may have a smaller diameter at the threaded lower portion and have two opposing flats in its midsection, not shown, which engage flats on lower jaw 534 to prevent sleeve 540 from The jaws turn and lock the nut. There is clearance between the sleeve 540 and the apertures of the jaws 534, 536 which allows the jaw assembly 530 to pivot outwardly against the facing of the staple spring 550 prior to the tightening operation. The gap enables the jaws 532, 534 to be separated sufficiently to clamp a member between the faces of each jaw, such as a rod or ring along which the device can slide and thereby change position. The rod 110 can be inserted into the sleeve 540 and locked in place by the clamping action of the upper conical position of the sleeve 540, when the nut 548 is tightened to pull the sleeve 540 down into the conical slot of the upper jaw 532, The sleeve 540 is deformed inwardly. This causes the upper part of the sleeve 540 to deform inwardly in the region of the groove 544 . This rod 110 can remain fixed in the actual assembled position, so that the relative positions of all the components of the device can be adjusted before final operation of the device.

FIG. 12I is a perspective view of the constructed clamp 550 with a small cutout to indicate the connection between the pin connector 552 and the connecting rod 110 . The screw 554 is tightened so that the pin 556 rests on the outer surface 558 of the clamp body 560 end. This action tightens the pin to the clamp, preventing rotation of the pin connector 552 and thus the pin. Also, the pin 556 is prevented from moving axially relative to the connector 552 . Tightening the screw 554 also engages the rod engaging surface 580 of the connector 552 with the connecting rod 110 . This interference has the multiple effect of further inhibiting any movement of the gripped clamp 550 . First, friction between the rod engaging surface 580 and the outer surface of the rod 110 further prevents any rotation of the pin connector 552 . Furthermore, the force exerted by the pin connector in this connection pushes the rod 110 in the direction of the arrow b. This ensures that the rod 110 is secured to the rear wall 582 of the slot 584, thereby providing a good rigid mechanical connection between the connecting rod 110 and the clamp body 560, preventing the clamp body from rotating around the connecting rod 110 or sliding along the connecting rod 110. When screw 554 is tightened, clamp body 560 does not substantially press down on or cap over the connecting rod. This is simply an interference between the rod engagement surface and the rod 110 that prevents movement between the rod 110 and the clamp 550 .

FIG. 12J shows a connection mechanism 570 having a nut 572 including a female thread 574 for engaging a shaft 576 of a fixed rod 578 . The nut 572 has a clamp 580 that engages the rod 110 . The clamp 580 forms an adjustable aperture 582 . Holes 582 are adjusted by tightening fasteners 584 .

Figure 12K shows a bone screw 590 suitable for use with the present invention. A bone screw 590 is shown attached to a jig 592, having a longitudinal axis L1, while the jig 592 is attached to a vertebral implant rod 594, having a longitudinal axis L2. Clamp 592 includes clamp screw 596 , arm 598 , rod interface washer 600 , set screw 602 and nut 604 . The clamp screw 596 has a hole 606 that receives the rod 594 and the hole is shown as surrounding the rod 594 , although it is still understood that a hole open on the side could be used to load the top of the rod 594 into the clamp 592 . Set screw 602 is inserted into threaded opening 608 and into hole 606 of clamp screw 596 such that set screw 602 pushes against rod 594 . Arm 598 has a hole 610 for receiving bone screw 590 . When the set screw 602 is fixed to the rod 594 , the arm 598 is simultaneously fixed to the clamp 592 . When set screw 602 is pushed against rod 594 , rod 594 pushes against rod interface washer 600 which clamps arm 598 between rod interface washer 600 and stop 612 . In this manner, set screw 602 acts as a kind of compression member to tighten clamp 592 and achieve substantial fixation of arm 598 to rod 594 .

Figure 12L depicts a fastener 620 suitable for use with the present invention. The fastener 620 has a hole 622 that receives the rod 110 (not shown), and is used to increase and decrease the diameter of the hole 622 to facilitate engaging the rod 110 . A screw 624 is provided communicating through a second hole 626 to reduce the hole 622 for receiving the rod.

The stop assembly 630 of FIG. 12M includes a set screw 632 and a generally rectangular stop block 634 into which the ramp 636 and rod 110 extend. The stop 634 has a rod channel 638 that receives the rod 110 . The rod 110 (not shown) may have a substantially circular cross-section; however, rods having various other cross-sections may be used with correspondingly modified rod channels 638, such as hexagonal or elliptical cross-sections. Block 634 includes a transverse channel 640 that receives an inner end 642 of ramp 636 and communicates with rod channel 638 . Transverse channel 640 includes a plurality of engaging surfaces 644 that engage similarly shaped retention flats or teeth 646 projecting radially outward from inner end 642 of ramp 636 . Engagement between the engagement surface 644 on the block 634 and the teeth 648 on the inner end 642 prevents the angled member 636 from rotating about the longitudinal central axis 650 of the inner end 642 . It will be appreciated that a differently shaped engagement surface may be formed in the transverse channel 640 to receive a similarly shaped retaining surface formed on the block 634 .

Another connecting device 660 is shown in FIG. 12N . The jaws 662, which are attached to the vertebra, are formed by two curved jaws of corresponding concavity, one curved jaw 664 forming part of the body 666 of the jaw, and the other curved jaw 668 being independent and having a shape which passes snugly through The cylindrical side extension 610 of the forceps body 666 enables axial or rotational displacement thereof to adapt the relative position of the two jaws to the shape and size of the vertebral region to which they are fixed. There is a fixed pin 670 in place to hold the movable jaw 668 in place, and another fixed pin 672 to maintain the insertion of the connecting extension 674 of the pincer rod connector 676 and pass through the through hole 679 Wire 678 is tensioned for lateral displacement of the vertebrae.

FIG. 12O shows another connecting device 680 . The crossbar 682 is provided with a clamping device 684 having a suitably sized hole 686 . The proper size hole 686 can be adjusted by an adjustment screw 688 . Aperture 686 is configured to receive rod 110 , for example.

FIG. 12P shows replaceable device 640 . A pair of parallel bars 642, 642' is provided. The first parallel bar 642 opposite the second parallel bar 642' is integrally formed with the connector 644. The second parallel rod 642 ′ can be fed into the hole 646 of the connector 644 . A nut 648 is provided to secure the second nut 642 ′ within the bore 646 .

FIG. 12Q shows a connector 770 with a rod 110 attached to a crossbar 772. FIG. The rod is secured through hole 774 . A nut 776 is provided to secure the rod 110 .

Figure 12R shows a connector arrangement 780 suitable for use with the present invention in perspective, end and top views. The device connects a vertebral implant rod 110 having a longitudinal axis L1 to the shaft of a vertebral fixation element having a longitudinal axis. Connection device 780 includes screw 782 , clevis 784 , rod interface washer 786 and set screw 788 . The screw 782 has a hole 790 for receiving the rod 110 in the vertebral implant. While a closed bore is described, it is envisioned that a side open bore could be used to allow top loading of the connector stem. Set screw 786 is inserted into threaded opening 792 in screw 786 and into hole 790 such that set screw 786 pushes against rod A. Clevis 784 is a U-shaped piece with holes to receive vertebral fixation elements or screws B, and when set screw 788 is pressed against rod A, the clevis is simultaneously tensioned. Rod B may be roughened and the interior of clevis 784 may be correspondingly roughened to increase friction between the two pieces. The fixing screw 788 pushes the rod A, and the rod A pushes the rod interface gasket 786. This force squeezes the ends 796, 798 of the clevis 784 together between the rod interface gasket 786 and the stop 800, which compresses the clevis 784 between the rod interface gasket 786 and the stop 800 .

Figure 12S shows a multiaxial connector 700 suitable for the present invention. The connector 700 has a first connecting piece 702 pierced with a hole 704 for receiving a second threaded portion 706 of a set screw 708, and another hole 710 comprising in its interior an annular track 712 of spherical profile and a groove 714, the groove 714 passes through the hole 704 to appear inside the hole 710 in the ring track 716, the second connector 718, which is pierced with the hole 720, and the hole 720 is used to receive the flower stem 722 of the threaded hole 724, and the flower stem 722 is connected with the clip Tight bolts 726 cooperate to lock the rod in the conversion and connection device 728, forming a ball connection that enables the first and second members to be connected together such that the connecting parts can pivot relative to each other so that the connecting rod 729 exhibits A specific angular position and the ability to laterally offset the connecting rod relative to the axis of rotation of the connecting piece.

FIG. 12T shows a connection device 730 having a longitudinal member 732 and a housing 734 . Longitudinal member 732 has an aperture 736 that receives rod 110 in, for example, a vertebral device. Open side holes can be used to allow top loading of the rod. Threaded openings 738 are provided for attachment with setscrews 740 . The housing 734 has a channel 742 to accommodate the shaft or shank of the vertebral fixation element.

Figure 12U shows a connection device 750 for use with offset connectors or elongated shafts. Device 750 has a holed bolt 752 for attachment to bone. A fence bolt 752 fits within a bore 754 of a fixing element 756 . Cross member 758 connects fixing element 756 to rod bracket 760 . Rod 110 fits within bore 762 of the rod bracket. A set screw 764 is provided to secure the position of the rod within the hole. A second set screw 766 is provided to fix the position of the guard bolt 752 within the bore 754 of the fixation element 756 .

A variety of connectors suitable for use with the present invention include, for example, those described in U.S. Patent Nos. 0013588 and 2002/0082601; European Patent Nos. 1205152 and 1103226; PCT Patent Publication Nos. WO01/30248, WO02/34150, WO01/67972, WO02/02024, WO01/06939 and WO02/24149.

Turning now to FIG. 13, a flow chart describing the method is shown. First, an incision 800 is made to approximate the desired location of the spine. As foreseen, the device of the present application may be implanted simultaneously with the implantation of a spinal fusion device such as a rod and screw, or may be implanted in a subsequent step. If the device is implanted at the same time as the fusion device, the physician may proceed with implanting the spinal fusion device 801 first. Alternatively, when a fusion device has already been implanted (eg, when this step modifies a previous surgical step), then the physician accesses the implanted device 802 immediately after making the incision 800 . The physician may then select one or more adjacent level arthroplasty devices 804 for use with the implanted spinal fusion device. Once the device is selected 804 , the device is implanted 806 . As one skilled in the art can foresee, due to the modularity of the design used, the physician can select a first adjacent-level arthroplasty device, implant it with a spinal fusion device, and then, based on experience or suitability of the device, Choose from different devices for in situ appearance. Additionally, adjustments to the connection of adjacent arthroplasty devices may be made without departing from the scope of the present invention. The incision is then closed 808 once the physician is satisfied with the selection.

Figure 14 depicts a flowchart of another embodiment of the method of the present invention, particularly suitable for the correction of fused functional spinal units for partial or full natural motion. First, an incision 900 is made to approximate the target location of the spine. The spinal fusion device may be implanted 901 at that time or in a previous step. As mentioned above, this step lends itself well to the next steps. The physician then exposes at least a portion of the spinal fusion device 902 . The doctor can then move and/or modify the existing spinal fusion device. Movement and/or modification includes excision of individual fusion components such as rods. If desired, the physician may access the disc space 903 to separate the arthrodesis through the disc space and move any fusion shells and/or other associated intervertebral fusion devices (including intervertebral spacers and/or dynamic stabilization devices) 904 . The physician may implant an artificial disc or nerve nucleus replacement 905, if desired. The physician may select one or more adjacent level arthroplasty devices 906 to use with the remaining components of the spinal fusion device. Once the device is selected 906, the device is then implanted 907.

As one skilled in the art can foresee, due to the modularity of the devices used, the physician can select a first adjacent-level arthroplasty device, implant it together with the spinal fusion device, and then, based on experience or suitability of the device, Choose from different devices for in situ appearance. Additionally, adjustments to the connection of adjacent arthroplasty devices may be made without departing from the scope of the present invention. The incision is then closed 908 once the physician is satisfied with the selection. It should also be understood that the present method may be used to modify the fusion of a functional vertebral device, or may be used for any portion or location of a spinal fusion that spans multiple vertebral levels.

Claims (41)

CLAIMS 1. An implantable facet arthroplasty device for coupling with a first vertebra and a second vertebra, said facet arthroplasty device comprising: (a) crossbars; (b) a first member having a first connection mechanism adapted to connect to a first location of a spinal fusion device connected to a first vertebra and a second connection mechanism, the second connection mechanism adapted to engage the crossbar; and (c) a second member having a second connection mechanism adapted to connect to a second location of the spinal fusion device connected to the first vertebra and a second connection mechanism adapted to engage the crossbar, wherein the first member articulates relative to the second member; and the first vertebra articulates relative to the facet arthroplasty device. 2. The implantable facet arthroplasty device of claim 1, further comprising a first arm having a shape adapted to be coupled to the vertebral body at a first end and adapted to engage at a second end. The bone-engaging end of the crossbar. 3. The implantable facet arthroplasty device of claim 2, wherein the first arm is configured to engage a caudal vertebral body. 4. The implantable facet arthroplasty device of claim 2, wherein the first arm is configured to engage a head vertebral body. 5. The implantable facet arthroplasty device of claim 1, further comprising a spinal fusion device. 6. The implantable facet arthroplasty device of claim 5, wherein the spinal fusion device comprises a pair of elongated members and a plurality of connecting mechanisms, the elongated members configured to extend along the spine The connecting mechanism is used to mount the spinal fusion device on the caudal vertebra and the cephalic vertebra. 7. The implantable facet arthroplasty device of claim 2, further comprising a second arm having a shape adapted to be coupled to the vertebral body at a first end and adapted to engage at a second end. The bone-engaging end of the crossbar. 8. The implantable facet arthroplasty device of claim 7, wherein the second arm is configured to engage a caudal vertebral body. 9. The implantable facet arthroplasty device of claim 7, wherein the second arm is configured to engage a head vertebral body. 10. The implantable facet arthroplasty device of claim 7, wherein the first arm is articulated relative to the second arm. 11. An implantable spinal restoration device comprising: (a) an elongated member configured to extend along a portion of the length of the spine adjacent to the cephalic and caudal vertebrae; (b) a connecting mechanism adapted to connect said elongate member to a portion of the spine; (c) facet arthroplasty elements; (d) a support member having a first end and a second end sized to span a portion of the vertebral body, and adapted to receive a facet arthroplasty element at the first end and the second end; and (e) A connector adapted to connect the support to the elongate member. 12. The implantable spinal restoration device of claim 11, further comprising an arm having a bone engaging end adapted to be coupled to a vertebra at a first end and adapted to engage the support at a second end. 13. The implantable spinal restoration device of claim 12, wherein the arm is configured to engage a caudal vertebral body. 14. The implantable spinal restoration device of claim 12, wherein the arm is configured to engage a head vertebral body. 15. The implantable spinal restoration device of claim 12, further comprising a second arm having a first end adapted to engage a vertebral body at a first end and a first end adapted to engage a crossbar. Two ends. 16. The implantable spinal restoration device of claim 15, wherein the first arm is articulated relative to the second arm. 17. The implantable spinal restoration device of claim 11, wherein the support member is sized to span a portion of the vertebral body between the left and right bone plates. 18. The implantable spinal restoration device of claim 11, wherein the support member is sized to span a portion of the vertebral body between the left and right pedicles. 19. The implantable spinal restoration device of claim 11, wherein the support member is further adapted to have an adjustable width. 20. The implantable spinal restoration device of claim 11, wherein the facet arthroplasty element is positioned relative to the support to provide a symmetrical anatomy. 21. The implantable spinal restoration device of claim 11, wherein the facet arthroplasty element is positioned relative to the support to provide an asymmetrical anatomy. 22. The implantable spinal restoration device of claim 11, wherein the end of the support is adapted to receive the opening in the facet arthroplasty element. 23. The implantable spinal restoration device of claim 11, wherein the facet arthroplasty element is selected from a plurality of facet arthroplasty elements, each having an opening of a different depth. 24. The implantable spinal restoration device of claim 11, further comprising utilizing the support to evenly distribute weight on the vertebral body. 25. An adaptable, implantable spinal stabilization device comprising: (a) a crossbar having a first end and a second end; (b) a pair of vertebra engaging elements, each vertebra engaging element having a bone engaging end and an end adapted to be connected to a crossbar; and (c) a pair of fixation elements, each fixation element having a first end having a surface adapted to receive the end of a crossbar and a second end adapted to secure the fixation element to the spine on the fusion system. 26. The adaptable, implantable spinal stabilization device of claim 25, further comprising an arm having an arm adapted to be attached to a vertebra at a first end and adapted to engage a support at a second end. Bone joint. 27. The adaptable, implantable spinal stabilization device of claim 25, wherein the arms are configured to engage the caudal vertebral bodies 28. The adaptable implantable spinal stabilization device of claim 25, wherein the arms are configured to engage the vertebral bodies of the head. 29. The adaptable, implantable spinal stabilization device of claim 25, further comprising a second arm having a first end engaging a vertebral body at a first end and adapted to engage a crossbar the second end of . 30. The adaptable implantable spinal stabilization device of claim 25, wherein the first arm is articulated relative to the second arm. 31. The adaptable implantable spinal stabilization device of claim 25, wherein the support member is sized to span the portion of the vertebral body between the left bone plate and the left bone plate. 32. The adaptable implantable spinal stabilization device of claim 25, wherein the support member is sized to span the portion of the vertebral body between the left pedicle and the left pedicle. 33. The adaptable implantable spinal stabilization device of claim 25, wherein the support member is further adapted to have an adjustable width. 34. The adaptable implantable spinal stabilization device of claim 25, wherein the facet arthroplasty element is positioned relative to the support to provide a symmetrical anatomy. 35. The adaptable implantable spinal stabilization device of claim 25, wherein the facet arthroplasty element is positioned relative to the support to provide an asymmetrical anatomy. 36. The adaptable implantable spinal stabilization device of claim 25, wherein the ends of the struts are adapted to receive openings in the facet arthroplasty element. 37. The adaptable implantable spinal stabilization device of claim 25, wherein the facet arthroplasty element is selected from a plurality of facet arthroplasty elements each having an opening of a different depth. 38. The adaptable implantable spinal stabilization device of claim 25, further comprising utilizing the braces to evenly distribute weight across the vertebral bodies. 39. A method of revising spinal fusion surgery to provide support to adjacent vertebrae comprising: (d) proximate to a location on the spine with a spinal fusion device comprising a pair of elongated members attached adjacent the caudal and cephalic vertebral bodies; (e) attaching a facet arthroplasty device, the facet arthroplasty device comprising an articulation linkage adapted to receive a crossbar and an linkage adapted to attach to an elongate member of a spinal fusion device; and (f) Close the wound. 40. The method of revised spinal fusion surgery of claim 39, wherein the vertebra adjacent to the spinal fusion device is stabilized. 41. An implantable adjacent level arthroplasty device for implantation between a first vertebra and a second vertebra having a vertebra engaging a fusion device therebetween, said The forming unit includes: (g) Cross bars; (h) a first member having a first connection mechanism adapted to connect to a first location of a spinal fusion device connected to a first vertebra and a second connection mechanism adapted to connect to said crossbar; and (i) a second member having a second connection mechanism adapted to connect to a second location of the spinal fusion device connected to the first vertebra and a second connection mechanism adapted to connect to said crossbar, wherein the first member articulates relative to the second member; and the first vertebra articulates relative to the facet arthroplasty device.

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