WO2006023683A1

WO2006023683A1 - Implantable spinal device revision system

Info

Publication number: WO2006023683A1
Application number: PCT/US2005/029476
Authority: WO
Inventors: Richard Broman; Thomas Mcleer; Leonard Tokish, Jr.; Mark A. Reiley; Sean S. Suh
Original assignee: Archus Orthopedics, Inc.
Priority date: 2004-08-18
Filing date: 2005-08-17
Publication date: 2006-03-02
Also published as: EP1784147B1; EP1784147A1; US20050240266A1; AU2005277375A1; US20060058791A1; US7674293B2; CA2576958A1

Abstract

The invention discloses devices, methods and systems for an implantable revision device useful for altering the biomechanics of an implanted spinal arthroplasty device. The revision device has a first surface adapted to communicate with a natural anatomical surface; and a second surface adapted to engage a portion of the arthroplasty device. The device alters the biomechanics of the implanted spinal arthroplasty device permanently semipermanently and/or temporarily.

Description

IMPLANTABLE SPINAL DEVICE REVISION SYSTEM

CROSS-REFERENCE

This application is a continuation-in-part of commonly assigned U S Patent Application Serial No 11/071,541 to Kuiper et al , filed March 2, 2005, and also claims the benefit of U S Provisional Patent Application Serial Nos 60/643,556 to Reiley filed January 13, 2005, and 60/602,827 to McLeer filed August 18, 2004, the disclosures of which are both incorporated herein

FIELD OF THE INVENTION

The present invention generally relates to devices and surgical methods for treatment of various spinal pathologies More specifically, the present invention is directed to configurable and anatomically adaptable implantable devices for use in a spine and surgical procedures for altering the biomechanics of a spine, either temporarily or permanently The devices alter, replace and/or revise existing anatomy and/or previously implanted devices

BACKGROUND OF THE INVENTION

Back pain, particularly in the small of the back, or lumbosacral region (L4-S1) of the spme (see, FlG. 1), is a common ailment In many cases, the pain severely limits a person's functional ability and quality of life Back pain interferes with work, routine daily activities, and recreation It is estimated that Americans spend $50 billion each year on low back pain alone It is the most common cause of job-related disability and a leading contributor to missed work

Through disease or injury, the laminae, spinous process, articular processes, facets and/or facet capsules of one or more vertebral bodies along with one or more intervertebral discs can become damaged which can result in a loss of proper alignment or loss of proper articulation of the vertebra This damage can result in an anatomical change, loss of mobility, and pain or discomfort For example, the vertebral facet joints can be damaged by traumatic injury or as a result of disease Diseases damaging the spine and/or facets include osteoarthritis where the cartilage of joints is gradually worn away and the adjacent bone is remodeled, ankylosing spondylolysis (or rheumatoid arthritis) of the spme which can lead to spinal rigidity, and degenerative spondylolisthesis which results in a forward displacement of the lumbar vertebra on the sacrum Damage to facet joints of the vertebral body often results in pressure on nerves, commonly referred to as "pinched" nerves, or nerve compression or impingement The result is pain, misaligned anatomy, a change in biomechanics and a corresponding loss of mobility Pressure on nerves can also occur without facet joint pathology, e g , as a result of a herniated disc One conventional treatment of facet joint pathology is spine stabilization, also known as intervertebral stabilization Intervertebral stabilization desirably controls, prevents or limits relative motion between the vertebrae, through the use of spinal hardware, removal of some or all of the intervertebral disc, fixation of the facet joints, bone graft/osteo-inductive/osteo-conductive material positioned between the vertebral bodies (with or without concurrent insertion of fusion cages), and/or some combination thereof, resulting in the fixation of (or limiting the motion of) any number of adjacent vertebrae to stabilize and prevent/hmit/control relative movement between those treated vertebrae

Although spine fusion surgery is an efficacious treatment alternative, complications can, nonetheless, result Patients undergoing spine surgery frequently continue to experience symptoms For surgical procedures in the lumbar spine, failure rates as high as 37% have been reported after lumbar fusion and 30% for surgery without fusion See Eichholz, et al , "Complications of Revision Spinal Surgery," Neurosurg Focus 15(3) 1-4 (2003) Post- operative problems can include decompression related problems, and fusion related problems Decompression related problems (( e , loss of normal spine balance resulting in the head and trunk no longer being centered over the pelvis) include, for example, recurrent disc herniation, spinal stenosis, chronic nerve injury, infection, and decompression Fusion related problems can include, pain from the bone harvest site, failure of a fusion to develop, loosening of the implanted devices, nerve irritation caused by the devices, infection, and poor alignment of the spine

Stabilization of vertebral bodies can also be achieved (to varying degrees) from a wide variety of procedures, including the insertion of motion limiting devices (such as intervertebral spacers, artificial ligaments and/or dynamic stabilization devices), devices promoting arthrodesis (rod and screw systems, cables, fusion cages, etc ), and complete removal of some or all of a vertebral body from the spinal column (which may be due to extensive bone damage and/or tumorous growth inside the bone) and insertion of a vertebral body replacement (generally anchored into the adjacent upper and lower vertebral bodies) Various devices are known for fixing the spine and/or sacral bone adjacent the vertebra, as well as attaching devices used for fixation, including devices disclosed in U S Patent Nos 6,585,769, 6,290,703, 5,782,833, 5,738,585, 6,547,790, 6,638,321, 6,520,963, 6,074,391 , 5,569,247, 5,891,145, 6,090,111 , 6,451,021, 5,683,392, 5,863,293, 5,964,760, 6,010,503, 6,019,759, 6,540,749, 6,077,262, 6,248,105, 6,524,315, 5,797,911 , 5,879,350, 5,885,285, 5,643,263, 6,565,565, 5,725,527, 6,471,705, 6,554,843, 5,575,792, 5,688,274, 5,690,630, 6,022,350, 4,805,602, 5,474,555, 4,611,581, 5,129,900, 5,741,255, 6,132,430, and U S Patent Publication No 2002/0120272

More recently, various treatments have been proposed and developed as alternatives to spinal fusion Many of these treatments seek to restore (and/or maintain) some, or all, of the natural motion of the treated spinal unit, and can include intervertebral disc replacement, nucleus replacement, facet joint resurfacing, and facet joint replacement Such solutions typically include devices that do not substantially impair spinal movement See, U S Patent Nos 6,610,091 , 6,811,567, 6,902,580, 5,571,171, and Re 36,758, and PCT Publication Nos WO 01/158563, WO 2004/103228, WO 2005/009301, and WO 2004/103227 Thus, spinal arthroplasty has become an acceptable alternative to fusion, particularly in cases of degenerative disc disease Arthroplasty devices can be particularly useful because the devices are designed to create an artificial joint or restore the functional integrity and power of a joint

One device developed to treat patients with, for example, lumbar degenerative disc disease, is the Charite III artificial disc (DePuy Spine, a Johnson & Johnson Company), a device that replaces the natural intervertebral disc 34 Devices, such as the Charite are comprised of suitable orthopedic and biocompatible materials such as cobalt chromium and ultra-high molecular weight polyethylene (UHMWPE) The devices are designed to enable independent translation and rotation, which is a component of physiological motion See, for example, U S Patent Nos 6,793,678 and 6,770,095 In other instances, where a disc is removed, e g to treat a prolapsed disc, a wedge can be placed within the empty disc space to compensate for the removed natural disc and to support the adjoining vertebral bodies Further, a plate and screws may be used to hold the wedge in place, such as with an anterior cervical decompression and fusion system

SUMMARY OF THE INVENTION

Once the initial surgical treatment and implantation has been completed for any of these spinal devices (and their related surgical techniques), additional problems and/or complications, such as additional disc problems, future disc degeneration, stenosis, pseudoarthrosis, junctional failure of the spine, failure of the implant and/or additional nerve compression can occur In some cases, problems can occur much later, even years later These late onset complications can include, for example, further need for decompression, the onset of other spinal degeneration, requirements for revision of the spinal construct and/or need for fusion of the affected spinal motion segment(s)

Regardless of whether the complications result from decompression or from complications arising after the surgery, revision surgery is sometimes required Further, in some instances, it may be desirable to convert a spinal pathology that has been treated with, for example, an arthroplasty device that restores motion to the joint to a fusion device that limits motion within the joint This can particularly be true for patients that have required surgical intervention at an early age

Part of the invention disclosed herein includes the realization that there exists a need for devices that facilitate revision spinal surgery, desirably with minimal disruption to areas that have already undergone spinal surgery Needed devices include devices that alter the biomechanics of a joint, either temporarily or permanently, devices that replace and/or repair all or selected portions of an existing device, and devices that address complications or further spinal degeneration that have arisen since the initial surgical intervention

The invention discloses an implantable arthroplasty device revision system, components of which are configured for implantation in conjunction with an arthroplasty device and a first vertebra and a second vertebra comprising a spine reconstruction device for replacing bone comprising an elongated tubular member with an anchoring member on a portion of an exterior of the elongated tubular member, and an aperture adapted to communicate with a bone surface, a revision cap adapted to mate with a truncated stem of an implanted arthroplasty device comprising a cap adapted to mate with a stem of the implanted arthroplasty device and an arthroplasty device receiving housing connected to the cap, a revision stem comprising a stem having a cap at an end of the stem and an arthroplasty device receiving housing connected to the cap, a modular cephalad stem having an auxiliary sleeve adapted to receive a threaded female stem, a male stem, and a connector, a cross-linking arm having a length adapted to fit between a pair of cephalad stems, each end of which is adapted to connect to a cephalad arm, and an arthroplasty device joint controller adapted to control movement of an arthroplasty device joint having a base adapted to engage a device joint at a first location, a side and a top adapted to engage the device joint at a second location In alternate embodiments of the invention, methods are provided for revising an implanted device for treating a spinal pathology The methods provide for altering the existing biomechanics of the spme, either permanently or temporarily

In various embodiments of the invention, a facet joint replacement device is provided for implantation on a vertebral body to replace a portion of the natural facet joint The implanted device is revised using a securing device of the invention installed on a joint of the facet joint replacement device The securing cap, or locking cap, prevents and/or limits articulation of the ball and cup joint of the arthroplasty device, converting the device to the equivalent of a spinal fusion device

In another embodiment of the invention, the implanted articulating joint device is revised by removing portions of the device and replacing the removed portions or components with components of the invention that secure or lock the remaining elements together, achieving an equivalent, or substantial equivalent, of a fusion device's functionality

The replacement components or devices of the invention are adapted to the pre-existing implanted arthroplasty devices such that some or all of the existing bone anchors do not need to be removed and/or disturbed to convert the articulating arthroplasty device to a device with controlled, limited and/or no movement In an embodiment of the invention, the invention includes an implantable device for revising an implanted spmal arthroplasty device comprising a first surface adapted to communicate with an anatomical surface of the spine, and a second surface adapted to engage a portion of the implanted spinal arthroplasty device In some embodiments, the first surface is configured to communicate with a revised anatomical surface In other embodiments, the revision device has threads adapted to engage the anatomical surface at a first end The threads can be positioned on an exterior surface of the revision device Additionally, a hollow aperture for receiving a connector of the arthroplasty device can be provided Where a hollow aperture is provided the aperture can be configured such that it is internally threaded to receive a connector of the arthroplasty device The revision device can also be adapted to deliver bone cement to the anatomical surface Additionally, or in the alternative, the revision device can be adapted at an end to engage an arthroplasty device The devices of the invention can be adapted to alter the biomechanics of the arthroplasty device, either permanently, semi-permanently, or temporarily In some embodiments, the revision device can be configured to secure the arthroplasty device and/or prevent movement of the arthroplasty device with respect to the anatomical surface(s) to which it is connected

In an embodiment of the invention, the invention includes an implantable device for altering the biomechanics of an implanted spinal arthroplasty device comprising a first surface adapted to communicate with an anatomical surface, and a second surface adapted to engage a portion of the arthroplasty device The revision device can also be configured to provide threads to engage the natural anatomical surface at a first end Threads can be positioned on an interior and/or exterior of the device The hollow aperture can be configured to receive a connector of the arthroplasty device In some embodiments, the revision device is adapted to deliver bone cement to the anatomical surface Additionally, the device can be configured to engage an arthroplasty device and/or alter the biomechanics of the arthroplasty device Where the biomechanics are altered, such alteration can be made permanently, semi-permanently, or temporarily The revision device can also be configured to secure the arthroplasty device, to prevent movement of the device with respect to the natural anatomical surface

In yet another embodiment of the invention, the invention includes an implantable spinal arthroplasty device revision system, components of which are configured for implantation in conjunction with a spinal arthroplasty device and a first and second vertebra of a spine, comprising at least one of a spine reconstruction device for replacing bone comprising an elongated tubular member with an anchoring member on a portion of an exterior of the elongated tubular member, an aperture adapted to communicate with a bone surface, and a proximal end adapted to replace a mating surface, a revision cap adapted to mate with a truncated stem of an implanted arthroplasty device comprising a cap adapted to mate with a stem of the implanted arthroplasty device and an arthroplasty device receiving housing connected to the cap, a revision stem comprising a stem adapted to be implanted within bone and having a cap at an end of the stem and an arthroplasty device receiving housing connected to the cap, a modular cephalad stem having an auxiliary sleeve adapted to receive a threaded female stem, a male stem, and a connector, a cross-linking arm having a length adapted to fit between a pair of cephalad arms of an arthroplasty device, each end of which is adapted to connect to a cephalad arm, and an arthroplasty device joint controller adapted to control movement of an arthroplasty device joint having a base adapted to engage a device joint at a first location, a side and a top adapted to engage the device joint at a second location Embodiments of the invention can also include an artificial disc, intervertebral wedges, bone filler, bone cement, and biocompatible adhesive Additionally, in some embodiments, the restoration units can be internally and/or externally threaded The restoration unit(s) can be configured such that it is adapted to replace a spine anatomy, such as pedicle, lamina, spinous processes, other processes and/or the vertebral body The restoration units are adapted to connect to an arthroplasty device Thus, in at least some embodiments, the arthroplasty device receiving housing is positioned adjacent the cap and/or the housing is adapted to connect to an element of an implanted arthroplasty device In some embodiments, the revision cap is a polyaxial element Further embodiments can include a configuration wherein the housing moves relative to the cap by a ball and socket connector The housing can be rotatably connected to the revision cap The revision cap can be adapted to engage the implanted arthroplasty device In some embodiments it may be desirable to provide for internal and/or external threading of the sleeve A female aperture forming a keyway can also be provided Additionally, the male stem can be configured to have a male protrusion adapted to fit within a configured female aperture of the auxiliary sleeve The modular cephalad stem can be adapted in some embodiments to provide anti-rotation of the male stem to the female auxiliary sleeve Further, the modular stem can include a securing member The base of the joint controller can be positioned on the arthroplasty device joint opposite a position of the top of the joint controller The revision system can also be configured so that the joint controller snap fits over the joint of the arthroplasty device In other embodiments, the joint controller has an aperture on the top of the device, which can further be adapted to receive a securing mechanism

In yet another embodiment of the invention, an implantable device for restoring a target surface area of a vertebral body, the implantable device comprising an elongated tubular member with an anchoring member on a portion of an exterior of the elongated tubular member at a first end, and an aperture adapted to communicate with a tissue and an aperture adapted to communicate with an implantable arthroplasty device at a second end

In yet another embodiment of the invention, an implantable device is provided for revising a previously implanted arthroplasty device having a fixation element, the implantable device comprising a cap adapted to mate with a stem of the previously implanted fixation element, and a housing connected to the cap on a first end and adapted to engage an element of an arthroplasty device on a second end Another embodiment of the invention includes an implantable device for use with an arthroplasty device, the implantable device comprising a stem having a tapered first end, and a housing adapted to engage an element of the arthroplasty device at a second end

Yet another embodiment of the invention provides an implantable device for use with an arthroplasty device, the implantable device comprising a modular stem having a first stem component with a male end, and a second stem component with a female end, wherein the male end is adapted to fit within the female end to prevent rotation and/or relative movement

In still another embodiment, an implantable device for use with an arthroplasty device, the implantable device comprising a cross-linking arm adapted to connect to a first arm of the arthroplasty device at a first end and a second arm of the joint arthroplasty device at a second end is provided In yet another embodiment of the invention, an implantable device for use with an arthroplasty device comprising a lock adapted to engage a joint of the arthroplasty device to reduce, control, modify and/or prevent articulation of the joint

Embodiments of the invention can also be practiced according to a method of revising an implanted arthroplasty device, the method comprising accessing an implanted spinal arthroplasty device, and inserting a revision device adapted to alter the biomechanics of the implanted spinal arthroplasty device Where methods are employed, the revision device can be configured to restore the operation of the implanted arthroplasty device Alternatively, or additionally, the revision can device can be configured to limit and/or modify the operation of the implanted arthroplasty device In practicing the method of the invention, the implanted arthroplasty device can be converted to a fusion device Revision can be achieved at the time of implantation of the arthroplasty device or at a subsequent time When performing the methods of the invention, a user will select, as many times as desirable, from a plurality of devices suitable for revising the arthroplasty device INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. BRIEF DESCRIPTION OF THE 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 by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which: FlG. 1 is a lateral elevation view of a normal human spinal column;

FlG. 2 is a superior view of a normal human lumbar vertebra;

FiG. 3 is a lateral elevational view of two vertebral bodies forming a functional spinal unit;

FiG. 4 is a posterolateral oblique view of a vertebrae from a human spinal column;

FlG. 5 is a perspective view of the anatomical planes of the human body; FlG. 6 is a perspective view of an implantable configurable modular spinal arthroplasty device;

FlG. 7 is a perspective view of the implantable configurable modular spinal arthroplasty device shown in FlG. 6, implanted;

FiG. 8 is a posterior view of an implantable configurable spinal arthroplasty device for replacing resected facet joints; FlG. 9 is a perspective view of a restoration device for replacing or augmenting a target bone structure;

FlG. 10A illustrates the device illustrated in FlG. 9 implanted within a vertebral body; FlG. 10B illustrates a vertebral body with two devices implanted therein;

FlG. 11A illustrates a restoration device implanted within in a vertebral body in combination with an spinal arthroplasty device; FiG. 11B illustrates a restoration device implanted with a facet repair device; FlG. lie illustrates a restoration device implanted with a device for replacing resected facet joints; FlG. llD illustrates a restoration device implanted with an arthroplasty device providing a surface for the cephalad arm(s);

FlG. 12A illustrates an alternate design of a revision device featuring an adapter cap for receiving a portion of an implanted spinal arthroplasty device; FlG. 12B is a device having an offset adapter cap; FiG. 12c illustrates a device implanted into a vertebral body such that the cap of the device can function as a pedicle replacement; FiG. 13A illustrates an alternate embodiment of a device of FiG. 12 having an alternate design for the adapter cap; FlG. 13B illustrates the device shown in FiG. 13A implanted in a vertebral body;

FlG. 14A illustrates an adapter cap implanted in combination with an arthroplasty device; FiG. 14B illustrates an adapter cap implanted in combination with another arthroplasty device; FlG. 14c illustrates an adapter cap implanted in combination with the facet replacement device of FiG. 8; FiG. 15A illustrates a perspective view of component parts of a replaceable modular stem system for use in an implantable spinal arthroplasty device; FiG. 15B illustrates a side view of replaceable modular stem system;

FiG 16A illustrates side view of a replaceable modular stem system of an alternate embodiment; FlG. 16B illustrates a cross-section of the modular system depicted in FiG. 16A; FiG. 16c illustrates an optional tie-down connector in combination with the system; FiG. 17 illustrates an alternate embodiment of a modular stem system having a bushing;

FiG. 18 illustrates the modular stem system of FiG. 17 connected to a housing; FiG. 19 illustrates an implanted arthroplasty device having a cross-linking arm installed;

FiG. 20A illustrates a securing device for use in connection with an arthroplasty device to revise and/or modify, control, or limit motion of the arthroplasty device; FlG. 20B is a top view of the securing device; FlG. 20c is a side view of the securing device; FlG. 2OD is a bottom view of the securing device; FlG. 2OE is a cross-sectional view of the securing device;

FiG. 21A illustrates a side view of the securing device of FiG. 20 in combination with a portion of the arthroplasty device of FiG. 7; FlG. 21B illustrates a perspective view of the securing device in combination with a portion of the arthroplasty device; FlG. 21c is a perspective view from an anterior perspective of the securing device in combination with a portion of the arthroplasty device; FlG. 2lD is a top view of the securing device with a portion of the arthroplasty device; FiG. 21E is a bottom view of the securing device with a portion of the arthroplasty device;

FiG. 22A is a perspective view of an implanted arthroplasty device with the securing device of FlG. 20; FiG. 22B is a perspective view of another implanted arthroplasty device with the securing device of FiG. 20; FlG. 22C is a perspective view of yet another implanted arthroplasty device with the securing device of FlG. 20;

FlGS. 23 illustrates a caudal cup incorporating a flange and a compression device to control movement of the cross-member of an arthroplasty device;

FlG.24A-D illustrates modifications to the caudal cup of an arthroplasty device to prevent dislocation and/or alter the biomechanics of the arthroplasty device; and

FiG. 25 is a flow chart illustrating the methods of revising the biomechanics of a patient having an implantable device. DETAILED DESCRIPTION OF THE INVENTION

The invention relates generally to implantable devices, apparatus or mechanisms that are suitable for implantation within a human body to restore, augment, and/or replace soft tissue and connective tissue, including bone and cartilage, and systems for treating spinal pathologies. In some instances the implantable devices can include devices designed to replace missing, removed or resected body parts or structure. The implantable devices, apparatus or mechanisms are configured such that the devices can be formed from parts, elements or components which alone or in combination comprise the device. The implantable devices can also be configured such that one or more elements or components are formed integrally to achieve a desired physiological, operational or functional result such that the components complete the device. Functional results can include the surgical restoration and functional power of a joint, controlling, limiting or altering the functional power of a joint, and/or eliminating the functional power of a joint by preventing joint motion. Portions of the device can be configured to replace or augment existing anatomy and/or implanted devices, and/or be used in combination with resection or removal of existing anatomical structure.

The devices of the invention are designed to interact with the human spinal column 10, as shown in FIG. 1, which is comprised of a series of thirty-three stacked vertebrae 12 divided into five regions. The cervical region includes seven vertebrae, known as C1-C7. The thoracic region includes twelve vertebrae, known as T1-T12. The lumbar region contains five vertebrae, known as L1-L5. The sacral region is comprised of five fused vertebrae, known as S1-S5, while the coccygeal region contains four fused vertebrae, known as Col-Co4. An example of one of the vertebra is illustrated in FiG. 2 which depicts a superior plan view of a normal human lumbar vertebra 12. Although human lumbar vertebrae vary somewhat according to location, the vertebrae share many common features. Each vertebra 12 includes a vertebral body 14. Two short boney protrusions, the pedicles 16, 16', extend dorsally from each side of the vertebral body 14 to form a vertebral arch 18 which defines the vertebral foramen 19. At the posterior end of each pedicle 16, the vertebral arch 18 flares out into broad plates of bone known as the laminae 20 The laminae 20 fuse with each other to form a spinous process 22 The spinous process 22 provides for muscle and ligamentous attachment A smooth transition from the pedicles 16 to the laminae 20 is interrupted by the formation of a series of processes Two transverse processes 24, 24' thrust out laterally, one on each side, from the junction of the pedicle 16 with the lamina 20 The transverse processes 24, 24' serve as levers for the attachment of muscles to the vertebrae 12 Four articular processes, two superior 26, 26' and two inferior 28, 28', also rise from the junctions of the pedicles 16 and the laminae 20 The supeπor articular processes 26, 26' are sharp oval plates of bone rising upward on each side of the vertebrae, while the inferior processes 28, 28' are oval plates of bone that jut downward on each side See also FlG.4.

The superior and inferior articular processes 26 and 28 each have a natural bony structure known as a facet The superior articular facet 30 faces medially upward, while the inferior articular facet 31 (see FiG. 3) faces laterally downward When adjacent vertebrae 12 are aligned, the facets 30, 31, which are capped with a smooth articular cartilage and encapsulated by ligaments, interlock to form a facet joint 32 The facet joints are apophyseal joints that have a loose capsule and a synovial lining

As discussed, the facet joint 32 is comprised of a superior facet and an inferior facet (shown in FlG. 4) The superior facet is formed in the vertebral level below the joint 32, and the inferior facet is formed in the vertebral level above the joint 32 For example, in the L4-L5 facet joint shown in FlG. 3, the superior facet of the joint 32 is formed by bony structure on the L5 vertebra (i e , a superior articular surface and supporting bone 26 on the L5 vertebra), and the inferior facet of the joint 32 is formed by bony structure on the L4 vertebra (; e , an inferior articular surface and supporting bone 28 on the L4 vertebra) The angle formed by a facet joint located between a superior facet and an inferior facet changes with respect to the midline depending upon the location of the vertebral body along the spine The facet joints do not, in and of themselves, substantially support axial loads unless the spine is m an extension posture (lordosis) As would be appreciated by those of skill in the art, the orientation of the facet joint for a particular pair of vertebral bodies changes significantly from the thoracic to the lumbar spine to accommodate a joint's ability to resist flexion-extension, lateral bending, and rotation

An intervertebral disc 34 located between each adjacent vertebra 12 (with stacked vertebral bodies shown as 14, 15 in FlG. 3) permits gliding movement between the vertebrae 12 The structure and alignment of the vertebrae 12 thus permit a range of movement of the vertebrae 12 relative to each other FlG. 4 illustrates a posterolateral oblique view of a vertebrae 12, further illustrating the curved surface of the superior articular facet 30 and the protruding structure of the inferior facet 31 adapted to mate with the opposing superior articular facet As discussed above, the position of the inferior facet 31 and superior facet 30 varies on a particular vertebral body to achieve the desired biomechamcal behavior of a region of the spine

Thus, overall the spine comprises a series of functional spinal units that are a motion segment consisting of two adjacent vertebral bodies, the intervertebral disc, associated ligaments, and facet joints See Posner, I, et al "A biomechamcal analysis of the clinical stability of the lumbar and lumbosacral spine " Spine 7:374-389 (1982)

As previously described, a natural facet joint, such as facet joint 32 (FlG. 3), has a superior facet 30 and an inferior facet 31 In anatomical terms, the superior facet of the joint is formed by the vertebral level below the jomt, which can thus be called the "caudal" portion of the facet joint because it is anatomically closer to the tail bone or feet of the person The inferior facet of the facet joint is formed by the vertebral level above the joint, which can be called the "cephalad" portion of the facet joint because it is anatomically closer to the head of the person Thus, a device that, in use, replaces the caudal portion of a natural facet joint (/ e , the superior facet 30) can be referred to as a "caudal" device Likewise, a device that, in use, replaces the cephalad portion of a natural facet joint (ι e , the inferior facet 31) can be referred to a "cephalad" device

When the processes on one side of a vertebral body 14 are spaced differently from processes on the other side of the same vertebral body, components of the devices on each side would desirably be of differing sizes as well to account for anatomical difference that can occur between patients Moreover, it can be difficult for a surgeon to J determine the precise size and/or shape necessary for an implantable device until the surgical site has actually been prepared for receiving the device In such case, the surgeon typically can quickly deploy a family of devices possessing differing sizes and/or shapes during the surgery Thus, embodiments of the spinal devices of the present invention include modular designs that are either or both configurable and adaptable Additionally, the vaπous embodiments disclosed herein may also be formed into a "kit" or system of modular components that can be assembled in situ to create a patient specific solution As will be appreciated by those of skill in the art, as imaging technology improves, and mechanisms for interpreting the images (e g , software tools) improve, patient specific designs employing these concepts may be configured or manufactured prior to the surgery Thus, it is within the scope of the invention to provide for patient specific devices with integrally formed components that are pre- configured

A configurable modular device design, such as the one enabled by this invention, allows for individual components to be selected from a range of different sizes and utilized within a modular device One example of size is to provide caudal and cephalad stems of various lengths A modular implantable device design allows for individual components to be selected for different functional characteristics as well One example of function is to provide stems having different surface features and/or textures to provide anti-rotation capability Other examples of the configurability of modular implantable device of the present invention as described in greater detail below

Implantable devices of the present invention are configurable such that the resulting implantable spinal device is selected and positioned to conform to a specific anatomy or desired surgical outcome The adaptable aspects of embodiments of the present invention provide the surgeon with customization options during the implantation or revision procedure It is the adaptability of the present device systems that also provides adjustment of the components during the implantation procedure to ensure optimal conformity to the desired anatomical orientation or surgical outcome An adaptable modular device of the present invention allows for the adjustment of various component-to-component relationships One example of a component-to-component relationship is the rotational angular relationship between a crossbar mount and the crossbar Other examples of the adaptability of modular device of the present invention as described in greater detail below Configurability may be thought of as the selection of a particular size of component that together with other component size selections results in a "custom fit" implantable device Adaptability then can refer to the implantation and adjustment of the individual components within a range of positions in such a way as to fine tune the "custom fit" devices for an individual patient The net result is that embodiments of the modular, configurable, adaptable spinal device and systems of the present invention allow the surgeon to alter the size, orientation, and relationship between the vaπous components of the device to fit the particular needs of a patient during the actual surgical procedure

In order to understand the configurability, adaptability and operational aspects of the invention, it is helpful to understand the anatomical references of the body 50 with respect to which the position and operation of the devices, and components thereof, are described There are three anatomical planes generally used in anatomy to describe the human body and structure within the human body the axial plane 52, the sagittal plane 54 and the coronal plane 56 (see FlG. 5) Additionally, devices and the operation of devices are better understood with respect to the caudal 60 direction and/or the cephalad direction 62. Devices positioned within the body can be positioned dorsally 70 (or posteriorly) such that the placement or operation of the device is toward the back or rear of the body Alternatively, devices can be positioned ventrally 71 (or anteriorly) such that the placement or operation of the device is toward the front of the body Various embodiments of the spinal devices and systems of the present invention may be configurable and variable with respect to a single anatomical plane or with respect to two or more anatomical planes For example, a component may be described as lying within and having adaptability in relation to a single plane For example, a stem may be positioned in a desired location relative to an axial plane and may be moveable between a number of adaptable positions or within a range of positions Similarly, the various components can incorporate differing sizes and/or shapes in order to accommodate differing patient sizes and/or anticipated loads

Turning now to FlG. 6, an isometric view of a modular, configurable and adaptable implantable spinal arthroplasty device 100 is depicted The spinal arthroplasty device 100 is illustrated implanted into vertebral bodies 14 The arthroplasty device 100 and the various revision devices disclosed herein can be formed of a variety of materials For example, where the devices have bearing surfaces (ι e surfaces that contact another surface), the surfaces may be formed from biocompatible metals such as cobalt chromium steel, surgical steel, titamum, titanium alloys, tantalum, tantalum alloys, aluminum, etc Suitable ceramics and other suitable biocompatible materials known in the art can also be used Suitable polymers include polyesters, aromatic esters such as polyalkylene terephthalates, polyamides, polyalkenes, poly(vmyl) fluoride, PTFE, polyarylethyl ketone, and other materials that would be known to those of skill in the art Various alternative embodiments of the spinal arthroplasty device could comprise a flexible polymer section (such as a biocompatible polymer) that is rigidly or semi rigidly fixed to the adjacent vertebral bodies whereby the polymer flexes or articulates to allow the vertebral bodies to articulate relative to one another The spmal arthroplasty device 100 includes a crossbar 105, a pair of cephalad arms 120, 120' and a pair of caudal arms 150, 150' In this exemplary embodiment the facets of the spine (see FlG. 4, 30) are replaced by the cooperative operation of the crossbar 105, the cephalad arms 120, 120' and the adaptable crossbar mounts 775, 175' that join the cephalad arms 120, 120' to the crossbar 105, interacting with the caudal arms 150, 150' which form cups to receive the crossbar 105 The components of the spinal facet arthroplasty device 100 are designed to provide appropriate configurability and adaptability for the given disease state, patient specific anatomy and spinal level where the implant occurs

The crossbar 105 has a first end 110 and a second end 775 In the illustrated embodiment the crossbar 705 is a two piece bar where the first end 110 is attached to a threaded male portion having threads The crossbar second end 775 is attached to a threaded female portion sized to receive the threads The threaded ends allow for the width of the crossbar to be adjusted to mate with the width between caudal bearings 750 Additional alternative embodiments of the crossbar 105 could include a series of solid crossbars of varying widths and/or thicknesses, or an adjustable crossbar having some form of locking or biasing mechanism (such as a spring-loaded tensioner or detent mechanism, etc )

A pair of cephalad arms 120, 120' are also illustrated in the exemplary embodiment of the configurable and adaptable spinal arthroplasty device 100 of the present invention Each cephalad arm 120, 120' includes a bone engaging end 725, 725' and an end 140 adapted to couple to the crossbar 105 The cephalad end 140 is adapted to engage the crossbar 105 and includes an arm 145 and an elbow 147 The cephalad end 140 is attached to the crossbar using the crossbar mount 175 The bone engaging end 125 includes a cephalad stem 130 and a distal tip 135 The cephalad stem 130 and the distal tip 135 are threaded or otherwise configured to engage Alternatively, the distal tip 135 could be formed integrally with the cephalad stem 130, of the same or a different material as the cephalad stem 130 In the illustrated embodiment of the cephalad stem 130, surface features 132 are provided

Surface features 132 can be, for example, a textured surface or other surface such as, for example, surface features to assist in bony in-growth Similarly, the illustrated embodiment of the distal tip 135 can have surface features 137

The crossbar mount 175 is a connection structure to couple the cephalad arms 120, 120' to the crossbar 105 In the illustrated embodiment, the crossbar mount 175 includes a cephalad arm engaging portion 172, a crossbar engaging portion / 74 and a fixation element 176 Fixation element can be a screw, stem, cork-screw, wire, staple, adhesive, bone, and other material suitably adapted for the design As will be described in greater detail below, embodiments of the crossbar mount 175 provide adaptability between the cephalad elements 120 and the crossbar 105 and the loading characteristics of the crossbar ends 110, 115 and the caudal cups 150, 150' FiG. 7 illustrates a perspective view of the implantable arthroplasty device of FlG. 6 implanted with respect to two vertebral bodies 14, 14'

Another implantable arthroplasty device 200 is illustrated in FlG. 8 FlG. 8 shows an artificial joint structure for replacing a natural facet joint (FlG. 3, 32) The cephalad structure 210 has a bearing element 212 with a bearing surface 214 The caudal structure 220 has a bearing element 222 with a bearing surface 224 Conventional fixation elements 226 attach the cephalad structure 210 and caudal structure 220 to a vertebra 14 in an orientation and position that places bearing surface 214 in approximately the same location as the natural facet joint surface the caudal facet joint 220 replaces As will be appreciated by those of skill in the art, the facet joint may also be placed in a location other than the natural facet joint location

The cephalad structure 210 and the caudal structure 220 illustrated in FlG. 8 address issues relating to facet joint degeneration and can restore biomechanical motion The illustrated structures can also be configured to provide design features having more modular components or to provide attaching mechanism for attachment to the spinal bone in a variety of orientations and/or locations without departing from the scope of the invention

Turning now to FlG. 9, an implantable device suitable for spine reconstruction is configured The spine reconstruction device 300 comprises an implantable restoration unit designed to compensate for natural spinal anatomy that has been damaged by surgical procedures, such as drilling holes, is damaged (due to trauma, tumor and/or removal of spinal structures and/or spinal instrumentation) or is missing, e g missing pedicles, posterior arch, etc As a result of damage to the spinal anatomy there may not be enough natural bone structure available to enable the spine anatomy to be modified or restored using implantable devices, such as those described above Thus, one or more implantable restoration units can be used to augment the spinal anatomy enabling use, or continued use, of an implantable device The implantable restoration unit 300 is comprised of an elongated tube 310 sized to engage a portion of a vertebral body having a proximal endp and a distal end d The elongated tube 310 has a length 312 that can be modified to provide an anchoring feature, such as threads 314 (illustrated), and/or to provide a surface features that assists in bony in-growth Augmentation can be provided using, for example, resorbable bone cement, which increases the strength of both cannulated and non-cannulated restoration units The anchoring feature is positioned distally 315 on the device such that it is positioned further within the body relative to the opposing end Where the elongated tube 310 extends beyond the exterior of the vertebral body, the exterior surface of the tube 310 can be smooth 316 The smooth exterior surface is positioned proximally 317 on the device At least a portion of the interior of the tube can be filled with bone filler or allograft material 318. Suitable bone filler material includes, the use of bone material derived from demineralized allogenic or xenogenic bone and can contain substances for example, bone morphogenic protein, which induce bone regeneration at a defect site. See, U.S. Patent Nos. 5,405,390; 5,314,476; 5,284,655; 5,510,396; 4,394,370; and 4,472,840, which disclose compositions containing demineralized bone powder. See also U.S. Patent No. 6,340,477, which discloses a bone matrix composition. The distal end 315 of the device 300 can feature an aperture 319 thus enabling the allograft material 318 to come into contact with natural bone material within an area to be restored, for example, a vertebral body. Alternatively, a hardenable material can be provided within the device 300. The hardenable material can comprise bone cement, such as polymethyl methacrylate, or any of a variety of suitable biocompatible polymers known to those skilled in the art. As will be appreciated by those skilled in the art, the amount of bone filler used in conjunction with the restoration device 300 can vary. Thus, for example, the entire lumen of the device can be filled with bone filler, or only a portion of the device. In addition to the aperture 319 provided at the distal end 315, additional apertures can be provided along the length of the elongated body to enable the content located within the device to contact the bone. As shown in FlG. 9, the restoration device 300 has been configured with a flat proximal end 321. The flat end would be useful where the restoration device 300 is implanted in a location where the natural bone anatomy is flat, or substantially flat. Alternatively, a flat configuration could be useful where the design of the device to be mated with the restoration device has been configured to be joined to a flat surface. Alternatively, as will be appreciated by those skilled in the art, the proximal end 321 of the restoration device 300 can be configured such that the end is adapted to conform to the anatomy of the bone structure (or to the design of the spinal implant) to allow anatomical restoration (or allow implantation of the implant).

As shown in FiG. 10A, the implantable restoration unit 300 has been implanted within a vertebral body 14. The threads 314 located on the distal end 315 are positioned within the vertebral body 14. The smooth end 316 located at the proximal end 321 is positioned outside the vertebral body 14 such that the implantable restoration unit 300 would substitute for a pedicle (see FiG. 2, 6). Once the implantable restoration unit is in place, a replacement device can be provided, such as a device that replaces the transverse process. Bone cement 320, or other suitable material, can be used to further anchor the device 300 within the target bone. Turning now to FlG. 10B, a spine segment having both its pedicles 16, 16' (shown in Fig. 2) replaced with implantable restoration unit 300 devices is depicted. In addition to be used to replace, restore and/or augment the pedicles, the implantable restoration unit can be used to replace, restore and/or augment the lamina and any of the processes of the vertebral body. FlG. 11A illustrates a implantable restoration unit 300 as described above with respect to FiG. 9 implanted within in a vertebral body 14 in combination with a spinal arthroplasty device 320. The device 300 has been implanted such that it is positioned to substitute for a pedicle (16 of FiG. 2) and provides a replacement pedicle surface 322 for the arthroplasty device 320 to engage. The arthroplasty device 320 can be configured to engage the pedicle or replacement pedicle surface provided during the surgical or revision surgical procedure. The device 320 can further be configured to provide an anchoring mechanism, such as a screw or bolt, which passes through an aperture or interior bore provided in the device 320 and screws into the implantable restoration unit 300. FiG. 11B illustrates a yet another implantable restoration unit 300 implanted with a facet repair device 330. In this embodiment, the implantable restoration unit 300 is positioned within the vertebral body 14 at its distal end and engages the facet repair device 330 at its proximal end. In yet another example of the versatile implantable restoration unit 300, FlG. lie illustrates an implantable restoration unit 300 implanted with a device for replacing resected facet joints. The implantable restoration unit 300 is positioned to provide a surface for the facet joint device to engage As is evident from these examples, the implantable restoration unit 300 can be used in a wide variety of applications and in combination with a wide variety of implantable devices FlG. HD illustrates another embodiment, wherein the implantable restoration unit 300 is used in conjunction with the arthroplasty device of FlG. 7 to provide a surface for a cephalad arm to mate with FiG. 12A illustrates an adapter cap device 400 for revising an implanted arthroplasty device The adapter cap device 400 is designed to receive a portion of an implanted spinal arthroplasty device, such as those illustrated above The device 400 is adapted to attach to an elongated shaft or stem 402 which has been positioned within a vertebral body 12 of a spine The stem 402 can be, e g , the previously implanted shaft of an existing arthroplasty device (such as that shown in FlG. 7) and a pointed distal end 403 The stem 402 is configured such that it can have a smooth exterior or an exterior surface treatment (as illustrated) The exterior treatment would be provided to facilitate the mating of the stem of the adapter cap device to the body with which it was mating The proximal end 403 of device 400 has an adapter cap 404 which has been configured such that it can be attached to and removed from the stem 402 The adapter cap 404 is configured to provide an aperture sized with a diameter that enables a snug fit around the diameter of the shaft 402 The adapter cap 404 can be joined to the stem 402 using methods known in the art, including, but not limited to, swaging, crimping and/or bonding The adapter cap 404 is connected to a polyaxial housing 406 by a neck 408 The neck 408 connection enables the polyaxial housing 406 to assume differing orientations relative to the oπentation of the stem 402, thus accommodating a variety of arthroplasty devices The proximal end 410 of the polyaxial housing can be configured to receive a variety of connectors and devices depending upon the design of the arthroplasty device to be accommodated Alternatively, the existing proximal end of an implanted device may be cut and removed, and the adapter cap device 400 may be positioned over the remaining neck of the device

Turning now to FiG. 12B, a revision polyaxial device 400 similar to the device of FiG. 12A IS depicted In this embodiment, the shaft 402 mates with the adapter cap 414 to provide an arthroplasty device receiving housing that is offset to a central axis x of the stem 402. The adapter cap 414 is similarly configured to the adapter cap 404 of FlG. 12A in that the cap portion enables the housing 406 to be positioned off the central axis x of the stem The offset adapter cap provides additional flexibility to the design enabling the adapter cap to mate with a variety of anatomical surfaces, including resected surfaces or damaged surfaces, along with a wide variety of arthroplasty devices The cap attaches to stem 165

FiG. 12C illustrates a device 400 implanted into a vertebral body 12 such that the cap of the device can function as a pedicle replacement In this illustration, there is no preexisting stem or other device, and device 400 therefore includes an integral stem 165. The device 400 can be implanted such that the device (desirably and generally) does not intersect the central sagittal axis 411 of the vertebral body The housing and cap can be configured to provide a fixed structure, or can be configured to enable the housing and cap to be engaged such that rotation between the two elements is enabled FiG. 13A illustrates another embodiment of a device 420 of FiG. 12 suitable for a stand-alone application, i e , without attaching to a portion of an existing implant In this embodiment, the stem 422 is configured such that it incorporates a polyaxial element or housing 424. The housing 424 further engages a ball 427 attached to a neck 428 that provides further flexibility between the polyaxial element and an arthroplasty device to which it is mated When implanted, as shown in FlG. 13B, the device 420 can be implanted into a vertebral body 12 such that the device abuts or intersects the central sagittal axis 410 of the vertebral body These devices can be preformed and used for implantation during the installation of an initial arthroplasty device or can be used in conjunction with revision surgery to provide additional flexibility and adaptability to the device performance. In addition, these devices can be used to attach to commercially available spinal fusion instrumentation, including generally-available spine rods and screws.

FlG. 14A illustrates an adapter cap implanted in combination with an arthroplasty device. The arthroplasty device comprises a body that engages a surface of the vertebra and a stem 165. The adapter cap of FlG. 13 has been modified to enable the adapter to communicate with the arthroplasty device. FlG. 14B illustrates an adapter cap implanted in combination with another arthroplasty device. In this embodiment, the adapter cap has again been modified to enable the cap to mate with the implantable device that restores the inferior facet. Turning now to FlG. 14C yet another adapter cap assembly 400 is depicted implanted in combination with the facet replacement device of FlG. 8. In this instance, the adapter cap has been modified to enable the device to receive the threaded bolt that secures the device.

FiG. 15A illustrates a perspective view of component parts of a replaceable modular stem system for use in an implantable spinal arthroplasty device. The system 450 includes an internally and externally threaded auxiliary sleeve shell 452. A threaded female tip 454 fits within an aperture of the sleeve shell 452. The threaded female tip 454 has a threaded first end 455 and a configured aperture 456 on the opposing end. A male stem 458 is provided for communicating with the female threaded tip 454. The male stem 458 has a configured protrusion 460 (male member) on one end that mates with the configured aperture 456 (female member) on the threaded female tip 454. The configured protrusion 460 is configured to key within the female threaded tip 454 to create a snug fit between the configured aperture 456 and the configured protrusion 460. The system 450 can be further held together by use of a threaded dowel pin 460, that fits within a receiving aperture 462 of the stem 458. Once the system is configured and in place, the snug fit and keyed configuration of the threaded tip 454 and configured aperture 456 for receiving the tip prevents movement of the stem 458 with respect to the sleeve shell 452. The threaded dowel pin 460, further prevents movement of the stem 458 with respect to the sleeve shell 452 and the system overall. If desired, the stems 458 can comprise a set of differing size, length and/or shape stems to accommodate anatomical and/or surgical variability, as previously described.

Turning now to FlG. 15B, a side view of replaceable modular stem system 450 is illustrated. As can be appreciated by this view, the sleeve shell 452 can be threaded into target bone 451 using the external threads 455. Anchoring of the sleeve shell 452 to the bone 451 can be achieved by use of the threads alone (e.g., for healthy bone) or the threads in combination with bone cement 464. Additionally, where the target bone is weak, the site can be drilled-out, bone cement can be applied, and the stem can then be threaded into the bone cement. The revision system depicted in FlGS. 15A-B can be used to revise or replace, for example, caudal and/or cephalad arms of a spinal arthroplasty device, such as the devices depicted in FlGS. 6-7. Due to the modularity of the design, substitutes for components can easily be employed. As described with respect to FiG. 9, the sleeve shell 452 can be used to replace a missing or damaged pedicle, and can be used to assist in reconstruction. FiG 16A illustrates a side view of a replaceable modular stem system 470 of an alternate embodiment to the system illustrated in FlG. 15. The modular stem system 470 has a sleeve feature 472 that enables the male stem 474 to fit within the female stem 472. Additionally, an external tie-down or sleeve 476 can be provided that provides an additional anchoring feature between the male and female stem. An alternate anchoring mechanism, in the form of a set screw 478, is provided to further anchor the two pieces together. The set screw can have a configured aperture on its upper surface shaped to mate with a corresponding driver tool, e.g. cross-headed screwdriver, flat headed screw driver, and the like. FiG. 16B illustrates the modular system depicted in FlG. 16A, further illustrating the configured aperture 486 on the female stem 472 and the configured male protrusion 480 on the male stem that provides an anti- rotation and/or anti-displacement feature(s) between the two pieces when mated FIG. 16C illustrates the external

16A

FlG. 17 illustrates yet another alternate embodiment of a modular stem system 500 having a modular stem 502 with a female opening 504 for receiving a male connector 506 of a connecting arm 508 The mating of the modular stem 502 and the connecting arm 508 is further enhanced by virtue of a friction and/or compression fit between the two components Friction fit can be achieved by use of, for example, a bushing 510 A suitable bushing would include a swaging bushing Systems of this design can be used on a post-operative revision of a total facet arthroplasty device Where the total facet arthroplasty device is revised, the surgeon may cut the cephalad stem of the total facet arthroplasty device and remove the caudal bearing A suitable cut would be made perpendicular to the axis of the exposed shaft Following posterior lumbar interbody fusion (PLIF) or translaminar PLIF, a modular rod extension can be swaged into a dovetail feature, as shown in FlG. 18 FlG. 18 further illustrates the modular stem system of FlG. 17 connected to a housing 512 The housing can be used to link elements, such as the cephalad element to the caudal element, or to connect cephalad arms to a cross-member If desired, the caudal cup can be removed from the caudal stem, to allow access to the intervertebral space for a PLIF, with the caudal cup or some other construct replaced back onto the caudal stem once the interbody procedure has been completed

As shown in FlG. 19 an implanted arthroplasty device can have a cross-linking arm 518 installed to further reinforce the assembly The cross-linking arm can also further prevent movement of the arms relative to the cross¬ bar member The cross-linking arm 518 can be implanted to further reinforce the device or provide additional control of movement or articulation between the arms, e g cephalad arms, and the cross-member, or can be used to secure a single loose cephalad arm in a desired position and/or orientation The cross-linking arm can be formed of a single device that connects at either end, using any suitable connection mechanism or structure Alternatively, the cross-linking arm can be comprised of components that mate, to functionally achieve an arm and provide additional flexibility with respect to length FlG. 20A illustrates a securing device for use in connection with an arthroplasty device to revise and/or modify, control, or limit motion of the arthroplasty device The securing device has a body 520 with a distal surface 521 havmg pan- of prongs 522, 522' When installed, the prongs 522, 522' form a base and are positioned below the crossbar member and the indenture 524 of the securing device engages the anchors on three sides When used with a device of FlG. 7, the prongs can be positioned below the caudal cup which receives an end of the crossbar member, while the top sits above the crossbar end (110, 115) to secure the end in place within the caudal cup 150

The prongs 522, 522' engage a wall 526 of the securing device on one side The wall 526 mates with a top or roof 528 that fits above the cross-bar member The top 528 has an aperture 529. The aperture 529 can function as a detent, catch or plunger to snap fit over the ball end 110 of the crossbar member in an arthroplasty device Alternatively, the securing device can be a securing mechanism, such as a set screw 530 FlG. 20B is a top view of the securing device 520 From this perspective, it is apparent that the top 528 can be positioned off a central axis of the device to the two prongs 522, 522', thus also potentially positioning the aperture 529 off the central axis as well FiG. 20C IS a side view of the securing device, illustrating the angled configurations of the sides 557, 557 ' back wall 526 The angled configuration positions the top 528, which can have a smaller dimension in at least one direction (e g , length or width) than the length or width formed by the prongs and the wall FlG. 2OD is a bottom view of the securing device 520 FiG. 2OE IS a cross-sectional view of the securing device taken through an axis parallel to the prongs 522, 522' FlG. 21A illustrates a side view of the securing device of FlG. 21 in combination with a portion of an arthroplasty device, such as the arthroplasty device of FiG. 7. The prongs 522, 522' sit below the caudal cup 150, holding the caudal cup in a fixed position. The top 528 of the securing device 520 sits above an end of the cross- member 110, which fits within the caudal cup 150. An anchoring device 530 (see FIG. 20A) can be fed through the aperture to engage the end of the cross-member and hold it in position within the caudal cup 150. As illustrated, the caudal cup 150 is tilted t toward an axial plane 52, enabling the caudal cup to secure the cross-member at a location. Adjustment of the position of the caudal cup relative to the cross-member end can affect the position of the device. FiG. 21B illustrates a perspective view of the securing device in combination with a portion of the arthroplasty device. From this perspective, a set screw 530 located within the aperture 529 on the top of the securing device can be seen. FlG. 21c is a perspective view from a partially anterior view of the securing device again in combination with a portion of the arthroplasty device. FlG. 2lD is a top view of the securing device 520 with a portion of the arthroplasty device. As evident from this perspective, the caudal cup extends on one side past the prong 522'. The set screw 530 is positioned off-center relative to the length of the securing device, but the top of the securing device is positioned over the end of the cross-member. FlG. 21 E is a bottom view of the securing device engaging an arthroplasty device. From this view, it is illustrated that the prongs 522, 522' are seated beneath, for example, the caudal cup of the arthroplasty device.

Thus, the implanted arthroplasty device can be revised to incorporate locks or "fusion caps" that desirably convert the device from an articulating joint replacement construct to a non-articulating (or controlled and/or limited articulation) spinal fusion construct. In this embodiment, the fusion cap can be installed on or into the caudal cups to desirably immobilize the cephalad bearings within the cups. In various embodiments, the fusion caps could immobilize the cephalad bearings by direct compression or contact, through use of a set screw or other device to secure the cephalad bearing relative to the cup, or the fusion cap could contain or cover an encapsulating material, such as bone cement, which could fill the caudal cup and immobilize the cephalad bearing. Various techniques could be used in conjunction with the installation of such fusion caps, and the cap could be installed prior to, during, or after the completion of a concurrent spinal fusion procedure, including the removal of intervertebral disc material, installation of fusion cages, and/or introduction of material (such as bone graft material) that desirably promotes spinal fusion. Alternative embodiments could incorporate bearings of different shapes or sizes (not shown), including square or non-spherical bearings and/or bearings shaped to that fit snugly into and accommodate most or all of the interior of the caudal cup (not shown), that can be secured within the cup in a similar manner. Turning now to FlG.22 A, a perspective view of an implanted arthroplasty device 600 with the securing device of FlG. 21 is illustrated. The arthroplasty device 600 features a pair of caudal cups 150 engaging a cross- member 110. The cephalad arms have been removed, but it has been determined desirable to keep the caudal cups and cross-bar in place. The use of the securing device enables the caudal cup and crossbar member to be retained in position even without one or more of the cephalad arms to anchor the cross-member. Additionally, as will be appreciated by those of skill in the art, one of the two cephalad arms could be removed with the use of one or two of the securing devices to provide a three-point secured device (i.e., rigidly connecting two caudal cups to a single cephalad arm). The securing device engages the caudal cup and an end of the cross-member in the manner described above. FiG. 22B is a perspective view of another implanted arthroplasty device 602 having a pair of caudal cups 150, 150' engaging a cross-member 110 and a pair of cephalad arms 120, 120' extending vertically toward the adjacent vertebra 12 along with the securing device of FlG. 21. FlG. 22c is a perspective view of yet another implanted arthroplasty device 604 with the securing device of FiG. 21. Additional modifications of the caudal cup of an arthroplasty device are also possible in order to improve the operation and reliability of the arthroplasty device through the range of spinal motion. Further, these modifications can change the operation of the device from one enabling a full range of motion, to a device that enables less than a full range of motion, or to a device that restricts range of motion (this "restriction" could extend from allowing full motion to allowing partial or controlled motion to allowing no motion - thus functionally achieving some of all of the effects of a fusion device). One such modification is illustrated in FiG. 23. Caudal cup 150' is a modified version of the caudal cup 150 shown in FlG. 7. The caudal cup 150' includes an upper crossbar end retainer 702 and a lower crossbar end retainer 704. The upper and lower crossbar end retainers 702, 704 may optionally be provided to reduce the likelihood that the crossbar ends 110, 115 will slide out of contact with or leave an acceptable area adjacent the caudal cup surface 755 (dislocate). In a similar manner, the posterior surface of the caudal cup could also be closed (not shown), thereby capturing and holding the crossbar ends 110, 115 and limiting and/or preventing posterior movement of the crossbar relative to the caudal cups. In this alternate embodiment, the caudal cups could also comprise a "clamshell" design with the lower portion (as shown in FlG. 23) and a mating shape (not shown) that clamps, bolts, clips, or bonds to the lower portion, substantially closing the posterior side of the cup.

FlG. 24A illustrates yet another alternate design of a caudal cup 150 incorporating a flange 712 which creates a pocket 714 to contain and/or secure a cephalad bearing element of an arthroplasty device (such as the device shown in FiG. 6) that can be positioned within the pocket when the arthroplasty device is assembled. When this design of caudal cup 150 is deployed in an arthroplasty device, it secures the bearing element 115 (as shown in FlG. 23) when the arthroplasty device is articulated to one or more extreme limits of its range of motion. Thus, for example, when the cephalad and caudal elements are compressed together (such as during extension of the spine), the cephalad bearing element (115 in FlG. 23) will slide along the caudal bearing element in the cephalad direction, coming to rest in the pocket 714 formed by the interior surface 715 of the caudal cup 150. When the bearing (not shown) is positioned within the pocket 714 any increased compressive force acting on the device will desirably seat the bearing even further into the pocket 714, reducing and/or eliminating any opportunity for the bearing to slide out of the cup and potentially dislocate the device. If desired, a similar flange and pocket (not shown) can be formed on the opposing (cephalad) side of the caudal cup 150, to capture the cephalad bearing and prevent dislocation of the bearing surface from the cephalad cut during flexion of the device. Thus, the flange can provide a hard stop for the bearing surface during flexion. If desired, this alternative caudal cup design (incorporating the flange 712) could be implanted in patients prone to dislocation (during the initial facet replacement procedure) or it could be implanted in a subsequent surgical procedure to replace a non- flanged caudal cup after the patient has dislocated the facet joint replacement incorporating a non-flanged cup design. Similarly, the various other embodiments disclosed herein could be used to replace and/or retrofit components already implanted within a patient, or could be used prophylactically during the initial implantation surgery to ensure against failure of the implant. In alternative embodiments, such as that shown in FiG. 24B, additional crossbar motion can be accommodated by altering the caudal cup width (w_cup) or adjusting the distance between the medial edge 721 and the lateral edge 723 in some embodiments. If desired, the upper edge 720 can be configured to curve over the top to enclose (either partially or fully) the upper portion of the cup 150. In other embodiments, the radius of the curve that transitions between the lateral edge 723 and the upper edge 720 and the radius of the curve that transitions between the lateral edge 723 and the lower edge 725 may also be adjusted to accommodate the various shapes of the crossbar end 115 and outer surface. In additional alternative embodiments, the medial edge 727 and lateral edge 723 can be configured such that the edges are nonparallel, with respect to each other. In other embodiments, the medial edge 721 and the lateral edge 723 could have an arcuate shape, or the cup 150 could be completely enclosed with a flexible and/or rigid cover or cap. In other embodiments, the medial edge 721 could have a raised lip or ridge (not shown) which would desirably assist in retaining the cephalad bearing within the caudal cup 150. Such arrangements could help prevent dislocation of the construct and/or allow for spontaneous and/or controlled relocation of the bearing surface (operatively, minimally invasively or non-invasively, including non-operative manipulation of the patient's spine through chiropractic procedures, etc.).

In one alternate embodiment, once the cephalad and caudal components of the device has been secured to the targeted vertebral bodies, one or more elastic compression devices or "bands" 740 could be secured about the caudal cups and bearing elements (see FlG. 24c), to the vertebral bodies themselves, between other parts of the cephalad or caudal arms, or any combination thereof. This configuration could be especially useful if a device dislocates one or more times. Properly positioned and/or tensioned, these "bands" would tend to keep the bearing surfaces and caudal cups in contact and/or close proximity, even under extreme and/or unusual loading conditions, and thus reduce and/or eliminate the opportunity for the bearing elements to dislocate. Moreover, in the event that dislocation of the implant did occur, the bands could prevent and/or limit motion of the dislocated joint (by holding the bearing surfaces and caudal cups together), and thus reduce or eliminate damage to other tissues (such as the spinal cord, various other nerves and/or circulatory/connective tissues) resulting from the dislocation. In fact, the compression of the bands might make it possible to eventually "reduce" the dislocation and/or repair the dislocated device through external manipulation and/or minimally-invasive surgery. If desired, one or more "bands" could be secured between the articulating surfaces of the device, or between the various arms, cups, stems and/or cross-arms of the construct elements, with varying results. In one embodiment, such a band could be looped around the base of the caudal cup, and around the corresponding cross-arm, in a figure-8 shape. Properly positioned and tensioned, this arrangement would allow the cup and cephalad bearing to articulate without allowing the band to slip off (either or both) the cup and cross-arm. Depending upon the length and size of the band, and the tension therein, the band could positioned and tighten to reduce and/or ultimately prevent any significant articulation of one or both sides of the facet joint replacement device. If desired, the band could be tightened and/or loosened in a minimally-invasive manner, during the implantation procedure and/or during a subsequent procedure.

In another alternate embodiment, the compression device could comprise an elastic or pliable material, which may or may not be surrounded by a non-elastic housing, whereby the elastic material allows various movement of the bearing surfaces (with resistance commensurate to the flexibility of the material, as well as flexibility allowed by the coupling to the device components), but the optional non-elastic housing acts as an ultimate "stop" to movement of the bearing surfaces relative to the caudal cup. Such embodiments could include one or more "encapsulated" bearing surfaces, such as shown in FlGS. 24C-D, which show two caudal cup and cephalad bearing pairs (of a facet replacement device), each pair surrounded by a flexible skin or "jacket" 740 which permits relative movement between the cup and bearing, but which desirably encapsulates or isolates the cup and bearing pair from the surrounding environment (totally or partially or some combination thereof). In practice, the jacket 740 can serve many functions, including (but not limited to) (1) as a shock absorber or brake to slow, control, modify and/or limit movement of the bearing/cup complex throughout and/or at the extreme ranges of motion, (2) as a stop or limiter to reduce and/or prevent complete or partial dislocation of the joint, (3) as a barrier to prevent surrounding tissues from invading the bearing surfaces and/or being "pinched" or damaged between moving surfaces, and (4) as a barrier or "filter" to prevent "bearing wear particulate," or other bearing by-products, from reaching and impacting surrounding tissues (or to contain fluids or other materials including, but not limited to, joint lubricating fluids, antibiotics and/or fluids that provide a biological marker and/or indicator - including bioreactive materials - upon rupture or compromise of the barrier). In a similar manner, the jacket 740 could encompass the entire bearing construct, with only the cephalad and caudal stems (and possibly the crossbar, depending upon whether the jacket encompasses one or both bearing constructs) protruding through the jacket and extending into the vertebral bodies. Depending upon the type of polymer (or other material) used, as well as the physical properties and orientation of the polymer, the jacket 740 could be designed to control the motion of the device in a desired manner, and could also control the movement of the device to more accurately replicate the natural motion of the spinal segment. For instance, a polymer jacket could be designed to allow a greater degree of freedom in flexion/extension, but limit (to some extent) the degree of lateral bending or torsion of the same segment, by proper choice and orientation of the polymer or other material. In one alternative embodiment, the band could comprise a flexible, polymeric (including, but not limited to, biocompatible polymeric) material.

In various alternative embodiments, the physical properties of the materials used could be selected based on an ability to alter over time or in response to one or more biological, environmental, temperature and/or externally induced factors, altering the properties of the material {i.e., polymers, ceramics, metals - Nitinol - etc.). For example, the material could comprise a material that hardens over time (or in the presence of body fluids, proteins, or body heat, etc.), which initially allows the components to freely articulate at the time of implantation (and thus

I minimize the stresses experienced by the anchoring components), but which hardens and subsequently resists movement to a greater degree once the component anchoring has solidified or bonded to the surrounding bone. Biodegradable materials can be used in embodiments to adapt an implanted device to achieve a temporary fixation of the device. By preventing movement for a period of time, healing can be facilitated, among other things. Once a suitable amount of time has passed and the biodegradable material (or other types of materials) degrades (or otherwise alters its material properties in some manner), the device will then return to its initial state of biomechanical movement. Where the material alteration is induced by externally induced factors (such as directed radiation, rf and/or sonic energy), the external factor could desirably alter the physical properties of the material(s) in a partially or completely reversible manner (depending upon the type, duration, frequency and/or amplitude of the induced factor), allowing for controlled alteration of the material properties in a minimally-invasive and/or completely non-invasive manner.

Similarly, the "band" could comprise an elastic, non-elastic or rigid material, such as stainless steel cable, which desirably prevents relative motion of the device components beyond a certain pre-defined maximum extension, flexion, rotation and/or torsion. In various embodiments, the band could alternatively be installed to limit motion of the device to prevent dislocation, or to minimize or control the articulation of the device to some degree (such as to protect a disc replacement device against unwanted motion in one or more directions, protect an adjacent fused level against unwanted stresses, or to protect various tissues from experiencing stresses and/or damage). If desired, the cable could be tightened or loosened post-surgery, in a minimally-invasive manner, to alter performance of the device.

Where the revision involves a spinal level incorporating an artificial disc replacement, the revision instrumentation could include wedges or "shims" that could be used to immobilize the artificial disc (thereby augmenting the motion modification provided by the revision component) and/or further increase the likelihood of achieving a successful fusion in combination with the revision constructs described herein. FlG. 25 illustrates a method for altering the biomechanics of an implanted spinal arthroplasty device, or revising an implanted arthroplasty device. An incision may be created in a selected location to access the implanted arthroplasty device 800. However, as will be appreciated by those of skill in the art, scenarios can arise wherein a surgeon is implanting a spinal arthroplasty device and determines that the condition of the patient warrants revising the biomechanics of the device during the initial implantation. More commonly, however, revision will be performed at a time subsequent to implantation of the spinal arthroplasty device, thus requiring a second, or subsequent, surgical intervention.

Once the incision is made the implanted arthroplasty device is accessed 802. Unless, the biomechanics have been assessed prior to surgical access and a device has been preselected, the surgeon can then select a revision device 804, e.g. from a kit, that is adapted to alter the biomechanics or revise the arthroplasty device. Whether selected in advance of surgery, or during the surgical procedure, the surgeon next inserts the revision device 806. As discussed above, the revision device can be one that alters the biomechanics, whether temporarily or permanently, or otherwise revises the implanted arthroplasty device. The step of selecting a revision device and implanting a revision device can be repeated as often as required to achieve the desired result. Once the surgeon is satisfied that the desired result is achieved, the incision is closed 808.

While preferred embodiments of the present invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now 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. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.

Claims

CLAIMSWHAT IS CLAIMED IS:

1. An implantable device for revising an implanted spinal arthroplasty device comprising:

(a) A first surface adapted to communicate with an anatomical surface of the spine; and (b) A second surface adapted to engage a portion of the implanted spinal arthroplasty device.

2. The device of claim 1 wherein the first surface communicates with a revised anatomical surface.

3. The device of claim 1 wherein the revision device has threads adapted to engage the anatomical surface at a first end.

4. The device of claim 3 wherein the threads are positioned on an exterior surface of the revision device.

5. The device of claim 1 wherein the revision device has a hollow aperture for receiving a connector of the arthroplasty device.

6. The device of claim 5 wherein the aperture is internally threaded to receive a connector of the arthroplasty device.

7. The device of claim 1 wherein the revision device is adapted to deliver bone cement to the anatomical surface.

8. The device of claim 1 wherein the revision device is adapted at an end to engage an arthroplasty device.

9. The device of claim 1 wherein an end of the revision device is adapted to engage an arthroplasty device.

10. The device of claim 1 wherein the revision device alters the biomechanics of the arthroplasty device.

11. The device of claim 10 wherein the revision device alters the biomechanics of the arthroplasty device for a period of time.

12. The device of claim 10 wherein the revision device alters the biomechanics of the arthroplasty device permanently.

13. The device of claim 10 wherein the revision device alters the biomechanics of the arthroplasty device semi-permanently.

14. The device of claim 1 wherein the revision device secures the arthroplasty device.

15. The device of claim 1 wherein the revision device prevents movement of the arthroplasty device with respect to the anatomical surface to which it is connected.

16. An implantable device for altering the biomechanics of an implanted spinal arthroplasty device comprising:

(a) A first surface adapted to communicate with an anatomical surface; and

(b) A second surface adapted to engage a portion of the arthroplasty device.

17. The device of claim 16 wherein the revision device has threads adapted to engage the natural anatomical surface at a first end.

18. The device of claim 17 wherein the threads are positioned on an exterior surface of the revision device.

19. The device of claim 16 wherein the revision device has a hollow aperture for receiving a connector of the arthroplasty device.

20. The device of claim 19 wherein the aperture is internally threaded to receive a connector of the arthroplasty device.

21. The device of claim 16 wherein the revision device is adapted to deliver bone cement to the anatomical surface.

22. The device of claim 16 wherein the revision device is adapted at an end to engage an arthroplasty device.

23. The device of claim 16 wherein an end of the revision device is adapted to engage an arthroplasty device.

24. The device of claim 16 wherein the revision device alters the biomechanics of the arthroplasty device for a period of time.

25. The device of claim 16 wherein the revision device alters the biomechanics of the arthroplasty device permanently.

26. The device of claim 16 wherein the revision device alters the biomechanics of the arthroplasty device semi-permanently.

27. The device of claim 16 wherein the revision device secures the arthroplasty device.

28. The device of claim 16 wherein the revision device prevents movement of the arthroplasty device with respect to the natural anatomical surface to which it is connected.

29. An implantable spinal arthroplasty device revision system, components of which are configured for implantation in conjunction with a spinal arthroplasty device and a first and second vertebra of a spine, comprising at least one of: a spine reconstruction device for replacing bone comprising an elongated tubular member with an anchoring member on a portion of an exterior of the elongated tubular member, an aperture adapted to communicate with a bone surface, and a proximal end adapted to replace a mating surface; a revision cap adapted to mate with a truncated stem of an implanted arthroplasty device comprising a cap adapted to mate with a stem of the implanted arthroplasty device and an arthroplasty device receiving housing connected to the cap; a revision stem comprising a stem adapted to be implanted within bone and having a cap at an end of the stem and an arthroplasty device receiving housing connected to the cap; a modular cephalad stem having an auxiliary sleeve adapted to receive a threaded female stem, a male stem, and a connector; a cross-linking arm having a length adapted to fit between a pair of cephalad arms of an arthroplasty device, each end of which is adapted to connect to a cephalad arm; and an arthroplasty device joint controller adapted to control movement of an arthroplasty device joint having a base adapted to engage a device joint at a first location, a side and a top adapted to engage the device joint at a second location.

30. The revision system of claim 29 further comprising an artificial disc.

31. The revision system of claim 29 further comprising intervertebral wedges.

32. The revision system of claim 29 wherein the implantable restoration unit incorporates bone filler or bone cement within a lumen of the elongated tubular member.

33. The revision system of claim 29 wherein the implantable restoration unit incorporates biocompatible adhesive within a lumen of the elongated tubular member.

34. The revision system of claim 29 wherein the implantable restoration unit is internally threaded.

35. The revision system of claim 29 wherein the implantable restoration unit is externally threaded.

36. The revision system of claim 29 wherein the implantable restoration unit is adapted to replace a spine anatomy wherein the spine anatomy is selected from pedicle, lamina, process and vertebral body.

37. The revision system of claim 29 wherein the implantable restoration unit is adapted to connect to an arthroplasty device.

38. The revision system of claim 29 wherein the arthroplasty device receiving housing is positioned adjacent the cap.

39. The revision system of claim 29 wherein the housing is adapted to connect to an element of an implanted arthroplasty device.

40. The revision system of claim 29 wherein the revision cap is a polyaxial element.

41. The revision system of claim 29 wherein the housing moves relative to the cap by a ball and socket connector.

42. The revision system of claim 29 wherein the housing is rotatably connected to the revision cap.

43. The revision system of claim 29 wherein the revision cap is adapted to engage the implanted arthroplasty device.

44. The revision system of claim 29 wherein the auxiliary sleeve is internally and externally threaded.

45. The revision system of claim 29 wherein the auxiliary sleeve has a configured female aperture forming a keyway.

46. The revision system of claim 29 wherein the male stem has a configured male protrusion adapted to fit within a configured female aperture of the auxiliary sleeve.

47. The revision system of claim 29 wherein the modular cephalad stem is adapted to provide antirotation of the male stem to the female auxiliary sleeve.

48. The revision system of claim 29 wherein the modular stem has a securing member.

49. The revision system of claim 29 wherein the base of the joint controller is positioned on the arthroplasty device joint opposite a position of the top of the joint controller.

50. The revision system of claim 29 wherein the joint controller snap fits over the joint of the arthroplasty device.

51. The revision system of claim 29 wherein the joint controller has an aperture on the top of the device.

52. The revision system of claim 51 wherein the aperture is adapted to receive a securing mechanism.

53. An implantable device for restoring a target surface area of a vertebral body, the implantable device comprising an elongated tubular member with an anchoring member on a portion of an exterior of the elongated tubular member at a first end, and an aperture adapted to communicate with a connective tissue and an aperture adapted to communicate with an implantable arthroplasty device at a second end.

54. An implantable device for revising a previously implanted arthroplasty device having a fixation element, the implantable device comprising a cap adapted to mate with a stem of the previously implanted fixation element, and a housing connected to the cap on a first end and adapted to engage an element of an arthroplasty device on a second end.

55. An implantable device for use with an arthroplasty device, the implantable device comprising a stem having a tapered first end, and a housing adapted to engage an element of the arthroplasty device at a second end.

56. An implantable device for use with an arthroplasty device, the implantable device comprising a modular stem having a first stem component with a male end, and a second stem component with a female end, wherein the male end is adapted to fit within the female end to prevent rotation.

57. An implantable device for use with an arthroplasty device, the implantable device comprising a cross-linking arm adapted to connect to a first arm of the arthroplasty device at a first end and a second arm of the joint arthroplasty device at a second end.

58. An implantable device for use with an arthroplasty device comprising a lock adapted to engage a joint of the arthroplasty device to reduce articulation of the joint.

59. A method of revising an implanted arthroplasty device, the method comprising: (a) Accessing an implanted spinal arthroplasty device; and

(b) Inserting a revision device adapted to alter the biomechanics of the implanted spinal arthroplasty device.

60. The method of claim 59 wherein the revision device restores the operation of the implanted arthroplasty device.

61. The method of claim 59 wherein the revision device limits the operation of the implanted arthroplasty device.

62. The method of claim 59 wherein the revision device converts the implanted arthroplasty device to a fusion device.

63. The method of claim 59 wherein the spinal arthroplasty device is revised at the time of implantation.

64. The method of claim 59 wherein the spinal arthroplasty device is accessed during a subsequent interventional procedure.

65. The method of claim 59 further comprising the step of selecting a revision device.

66. The method of claim 65 further wherein the step of selecting a revision device is repeated and the step of inserting a revision device is repeated.