US20100204795A1 - Fixation device and method - Google Patents

Abstract

An implantable orthopedic stability device is disclosed. The device can have a contracted and an expanded configuration. A method of using the device between adjacent facet surfaces for support and/or fixation of either or both of the adjacent vertebrae is also disclosed.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application claims the benefit of U.S. Patent Application No. 61/113,691, filed on Nov. 12, 2008, the content of which is incorporated herein by reference in its entirety.
BACKGROUND OF THE INVENTION
• 1. Technical Field
• Devices and methods for fixation of tissue are disclosed. More specifically, the devices and methods can be for inter facet fusion of vertebrae or fusion of other bones to one another.
• 2. Background of the Art
• Spinal fusion is typically performed by a screw or rod system with an allograft, Titanium, or PEEK device placed between vertebral bodies. Facet screws have been used for many years but have not had favor due to lacking the ability to create bone growth across the facet joint. A typical facet screw is described in Sasso, Rick C., et al. “Translaminar Facet Screw Fixation”, World Spine Journal (WSJ). 2006; 1(1):34-39, <http://www.worldspine.org/Documents/WSJ/1-1/Sasso_TLFS.pdf> which is incorporated by reference in its entirety.
• A safe and effective facet fusion device alternative to a facet screw is desired. Furthermore a fusion device that can promote tissue growth across the facet joint is desired. A device that can be easily deployed into the facet joint and removed or repositioned is also desired.
SUMMARY OF THE INVENTION
• A device that can replace or supplement the screw or rod elements of a typical fusion system is disclosed. The device can be placed in the inter-facet space to fuse adjacent vertebrae and/or create a bone mass within the facet joint in a patient's spine. The device can be placed between adjacent vertebral bodies in the vetebral body articulating space, for example after a partial or complete discectomy in place of the removed disc.
• The device can be less invasive than typical existing devices. For example, the device can be in a compacted (i.e., small) configuration when inserted into a patient and transformed into an expanded (i.e., large) configuration when positioned at the target site. For example, the device can be expanded when the device is between the inferior and superior facet surfaces. The device can create less soft tissue (e.g., bone) disruption than a typical fusion system. The device in an expanded configuration can improve anchoring within the joint, structural stability, and create an environment for bone healing and growth leading to fusion between adjacent vertebrae.
• The device can have a first plate and a second plate. The device can be inserted and positioned into the joint so the first plate is in contact with a first articulating surface of the joint, and the second plate is in contact with a second articulating surface of the joint opposite of the first surface of the joint. For example, the opposite articulating surfaces can be opposed surfaces of vertebral plates or sides of a facet joint. Once inserted into the joint, the first plate can be rotatingly tilted away from the second plate and locked into position. The tilting and locking of the device can fuse the first articulating joint to the second articulating joint.
• During deployment into tissue (e.g., bone), one, two or more holes can be drilled into the target site to create a deployment hole in which to insert the device. The deployment hole can be round or non-round (e.g., by drilling more than one overlapping or adjacent hole, or crafting a square or rectangular hole), for example to substantially match the transverse cross-section of the device in a contracted configuration.
• The device can be cannulated, for example having a lateral (i.e., transverse or latitudinal) and/or lengthwise (i.e., longitudinal) channel through the device. The device can be deployed over a wire or leader, such as a guidewire. The device can be slid over the guidewire, with the guidewire passing through the longitudinal channel of the device.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1ais a side perspective view of a variation of the device in a contracted configuration.
• FIG. 1bis a variation of cross-section A-A ofFIG. 1a.
• FIG. 1cis a side perspective view of the device ofFIG. 1ain an expanded configuration.
• FIG. 1dis a variation of cross-section B-B ofFIG. 1c.
• FIG. 2ais side view of a variation of cross-section A-A ofFIG. 1a.
• FIG. 2bis side view of a variation of cross-section B-B ofFIG. 1b.
• FIG. 3ais a variation of cross-section A′-A′ ofFIG. 1a.
• FIG. 3bis a variation of cross-section B′-B′ ofFIG. 1b.
• FIG. 3cis a variation ofFIG. 1awith the top plate absent.
• FIGS. 4 through 8 illustrate various views and configurations of a variation of the device.
• FIG. 9 illustrates a partially unassembled variation of the device.
• FIGS. 10 and 11 illustrate variations of the top and bottom plates of the device in unassembled and assembled configurations, respectively.
• FIGS. 12 through 17 illustrate various views of the device ofFIGS. 4 through 8 on a variation of a deployment tool.
• FIG. 18aillustrates a variation of the device in a contracted configuration.
• FIG. 18billustrates the device ofFIG. 18ain an expanded configuration.
• FIG. 19aillustrates a variation of the device in a contracted configuration.
• FIG. 19billustrates the device ofFIG. 19ain an expanded configuration.
• FIG. 20 illustrates a variation of the device in a longitudinally expanded configuration.
• FIG. 21 illustrates the device ofFIG. 20 is a longitudinally contracted and radially expanded configuration.
• FIGS. 22 and 23 are transverse sectional views of a variation of a method for using the device.
• FIGS. 24 through 30 illustrate a variation of a method for using the device in a section of the spine.
• FIG. 31 illustrates a visualization of a variation of a method for deploying the device into the spine between adjacent vertebrae.
• FIGS. 32aand32billustrate visualizations of variations of the device deployed into the spine between adjacent vertebrae.
• FIGS. 33athrough33gillustrate visualizations of a variation of a method for preparing the target site for the device.
• FIGS. 34 and 35 illustrate visualizations of variations of the device inserted in contracted configurations into the anterior/posterior and lateral bone cavity target sites of the spine, respectively, to provide facet fusion.
• FIGS. 36 and 37 illustrate anterior/posterior, and lateral visualizations, respectively, of variations of multiple devices inserted in expanded configurations in multiple bone cavity target sites of the spine to provide facet fusion.
DETAILED DESCRIPTION
• Adevice1 is disclosed that can be inserted into atarget site73 with thedevice1 in a compressed or contracted (i.e., small) configuration. Once positioned in the deployment site, thedevice1 can be transformed into an expanded (i.e., larger, bigger) configuration. Thedevice1 can be inserted and expanded inorthopedic target sites73 for fixation and/or support. For example, thedevice1 can be inserted and expanded over a guidewire between adjacent vertebral facet surfaces (i.e., within a facet joint55).
• FIGS. 1athrough3cillustrate that thedevice1 can have atop plate3 attached to abottom plate5. Thetop plate3 can be attached to thebottom plate5 by one, two, three four or more pins2. The plates can have a substantially flat external surface facing outward from thedevice1. The pinlongitudinal axes13 can be substantially perpendicular to the plate surface planes of the external surfaces of the top3 and bottom5 plates when thedevice1 is in a contracted configuration, and perpendicular to the devicelongitudinal axis77.
• Thedevice1 can have amiddle plate4 positioned between thetop plate3 and thebottom plate5. Themiddle plate4 can be slidably attached to thetop plate3 and thebottom plate5. Thepins2 can be inpin slots11 in the top3 and/orbottom5 and/or middle4 plates. Thepin slots11 in themiddle plate4 can fix thepins2 with respect to the position of themiddle plate4 in the direction of a devicelongitudinal axis77. Thepin slots11 in the top3 and bottom5 plates can allow thepins2 to move along a devicelongitudinal axis77 with respect to the top3 and bottom5 plates to the extent of thepin slots11, at which point thepin slots11 will interference fit against thepins2 to prevent further motion of the top3 and bottom5 plates. Accordingly, the top3 and bottom5 plates can slide with respect to each other and to themiddle plate4 in the direction of the device longitudinal axis77 (and/or themiddle plate4 longitudinal axis).
• Thetop plate3 can have one or more angled and/orcurved ramps7 on the middle plate4-side of thetop plate3. Thebottom plate5 can have one or more angled and/or curved ramped7 on the middle plate4-side of thebottom plate5. Themiddle plate4 can have angled and/orcurved wedges6 on the top plate3-side and/or bottom plate5-side of themiddle plate4. Thewedges6 can interface with theramps7. For example, the top3 and bottom5 plates can be in a contracted, compressed, or otherwise non-expanded configuration when themiddle plate4 is in a first position relative to the top3 andbottom plates5. The top and/or bottom5 plates can be in an expanded, radially spread, or enlarged configuration when themiddle plate4 is in a second position (e.g., pulled away9) relative to the top and/or bottom5 plates.
• Themiddle plate4 can have no, one or twoside walls10. Theside walls10 can extend to about the height of thetop plate3 and/orbottom plate5 when thedevice1 is in a contracted or expanded configuration.
• Thetop plate3,bottom plate5, side plates and combinations thereof can haveingrowth channels12, windows, or ports. Theingrowth channels12 can be configured to encourage bone growth into the ingrowth channel. For example, theingrowth channels12 can have textured surface and/or be coated and/or partially or completely filled with one or more osteogenic or osteoinductive material, for example any of those disclosed below.
• FIGS. 3aand3billustrate that thepins2 can be contained by the top3 and bottom5 plates duringexpansion41 of thedevice1. Thepins2 can be radiopaque and/or anti-torque. Theside walls10 can brace or otherwise interference fit the top and/or bottom5 plates, for example to minimize lateral movement of the top and/or bottom5 plates relative to themiddle plate4.
• When thedevice1 is in an expanded configuration, the topplate surface plane15 and the bottomplate surface plane29 can rotate away from each other, as shown byarrow8, to form adevice expansion angle14. Thedevice expansion angle14 can be from about 1° to about 45°, more narrowly from about 2° to about 20°. For example, thedevice expansion angle14 can be about 5° or about 10°. Thedevice1 can have a ratchet, or steps or teeth on theramp7 andwedges6 to allow thedevice expansion angle14 to be expanded at discrete increments, such as increased at increments of about 0.25°, about 0.5°, about 1°, or about 2°.
• FIGS. 4 through 8 illustrate that the top and/or bottom5 plates can have inner panels that are adjacent to and oppose each other. The top and/or bottom5 plates can have respective deployment stop panels and/or wing panels (25,28). The deployment stop panels can extend at substantially perpendicular angles (e.g., from about 80° to about 100°, for example about 90°) from the inner panels. The wing panels (25,28) can extend at angles from the ends of the deployment stop panels away from the side of the inner panels. For example, the wing panels (25,28) can extend from the deployment stop panels at about 0° to about 60°, more narrowly from about 5° to about 45°, for example about 30°.
• During use, the deployment stop panels and/or the wing panels (25,28) can interference fit against the outside of the bone (e.g., the facet) to prevent overinsertion or misplacement of thedevice1 into thetarget site73. The deployment stop panels and/or wing panels (25,28) can contact the facets and/or vertebral body side wall when implaned in the vertebral body disc space. The deployment stop panels and/or wing panels (25,28) can abut and interference fit against the bone outside of the joint of thetarget site73 to prevent thedevice1 from being inserted too far into the joint space. Additional anchoring elements, such as drive screws, can be inserted through the deployment stop panel and/or wing panel (25,28) and the adjacent tissue (e.g., into the vertebral side wall and or facet) before, during or after thedevice1 is expanded to fix thedevice1 to thetarget site73. Thedevice1 can be retrieved or repositioned, for example, by grabbing and pulling on the deployment stop panel and/or wing panel (25,28).
• Thetop plate3 and/orbottom plate5 can have surface texturing, for example coring or gripping teeth on the outward-facing surface of the inner panels. The top and/or bottom5 plates can haveramps7 and/orslots21 andtabs18. Theramps7 can be on the inward-facing surfaces of the tabs. The tabs can be partially bendable away from the plane of the inner panel. For example, as shown inFIG. 6, when thewedges6 of themiddle plate4 are received by theramps7 of the inner panels, thewedges6 can push the tabs outwardly to extend from the plane of the inner panels. During use, the extended tabs can interference fit against the surrounding tissue (e.g., bone).
• Thetop plate3 and/orbottom plate5 can have astop seat20 formed into the top and/orbottom plate5 along the outer surface of the deployment stop panels. Thestop seat20 can be recessed into the deployment stoop panels. Thestop seat20 can be configured to receive a middle stop plate on themiddle plate4. As shown inFIG. 6, when themiddle plate4 is fully inserted between thetop plate3 and thebottom plate5, the middle stop plate can lie flush in thestop seat20.
• The top and/or bottom5 plates can have grooves formed along the inner-surface of the inner panels extending to the top plates. The grooves can formslots21 when thetop plate3 andbottom plate5 are adjacent to each other.
• Themiddle plate4 can have one or more rails16. Therails16 can be on opposite sides of themiddle plate4. Therails16 can extend along the length of themiddle plate4. Therails16 can be configured to insert and slide through theslots21 formed in the top and/or bottom5 plates. The leading edge of therail16 can be angled, for example to a point or angled but with a flat front surface (as shown).
• Therails16 can have one ormore wedges6. For example, eachrail16 can have twowedges6 on the side of therail16 facing thetop plate3 and twowedges6 on the side of therail16 facing thebottom plate5. Therails16 can be spaced longitudinally along therail16.
• Themiddle plate4 can have one ormore ingrowth channels12. For example, theingrowth channels12 on themiddle plate4 can be arranged in a grid of two by threeingrowth channels12. Theingrowth channels12 can be located between opposing rails16.
• Themiddle plate4 can be inserted between the top3 and bottom5 plates. Themiddle plate4 can be inserted along the length of the space between the topinner panel26 and bottominner panel23 until the middle plate stop19 interference fits against thestop seat20. The top-bottom plate gap24 can expand, for example up to about 100% or, more narrowly, up to about 50% from the contracted top-bottom plate gap24.
• FIG. 8 illustrates that the taps can be pushed outward by thewedges6 and/or the top3 and bottom5 plates can have ports in place of the tabs. Thewedges6 from themiddle plate4 can extend into or out of the outer side of the ports (accordingly, thewedges6 would be the tabs as labeled inFIG. 8).
• The inner surface of the topinner panel26 and the inner surface of the bottominner panel23 can form substantially equal device expansion angles14 whether thedevice1 is in an expanded (i.e., top3 and bottom5 plates apart) or contracted (i.e., top3 and bottom5 plates together) configuration.
• Thedevice1 can have no pins or pin slots.
• FIG. 9 illustrates that therails16 on themiddle plate4 can have one ormore rail extensions30. For example, eachrail16 can have inwardly extendingrail extensions30 along the length of therails16 on one or both sides of themiddle plate4 facing the inner panels. Theslots21 can haveslot extensions31. For example, eachslot21 can have aslot extension31 corresponding to therail extensions30 on themiddle plate4. Theslots21 can be t-slots. Therail extensions30 can be configured to be slidably received by theslot extensions31.
• FIGS. 10 and 11 illustrate that the bottom plate5 (as shown) and/ortop plate3 can have one or more tabs extending in the direction of thetop plate3. The tabs can extend from the deployment stop panels, in the plane of the deployment stop panels, pointed toward the opposing deployment stop panel. The tabs can have tab ends34 at the termini of the tabs. The tab ends34 can have a locking feature, such as a flared end, brads, and expanded radius, or combinations thereof.
• Thetop plate3 can have one ormore tab slots33, corresponding to the positions, shapes, and sizes of the tabs. Thetab slots33 can be configured to receive the tabs. Thetab slots33 can havetab windows32. Thetab windows32 can be configured to receive the tab ends34, for example the locking feature of the tab ends34. Thetab windows32 can be open to the surface of the corresponding panel in which thetab end34 is located.
• When thetop plate3 andbottom plate5 are pressed toward each other, as shown by arrows inFIG. 11, thetabs18 can be slidably received by thetab slots33. The tab ends34 can releasably lock into thetab windows32. Thetab windows32 can be visually inspected to insure thetab end34 is present, for example, as an indicator that thebottom plate5 is fully engaged with, and fixedly attached to, thetop plate3.
• FIGS. 12 through 16 illustrate that thedevice1 can be removably attached to adeployment tool35. Thedeployment tool35 can provide a proximally retracting force (a “pull” deployment) or distally extending force (a “push” deployment) against thedevice1 to expand and/or lock thedevice1 depending on the design of thedevice1 and thedeployment tool35.
• Thedeployment tool35 can have adeployment tool case36. Thedeployment tool35 can havegrasping fingers37 extending from the distal end of thedeployment tool case36. The graspingfingers37 can be extended distally away from thedeployment tool case36, radially expanding from the other graspingfingers37 and releasing thedevice1. The graspingfingers37 can be retracted proximally toward the distal end of thedeployment tool case36, radially contracting toward the other graspingfingers37 and compressing against and holding thedevice1.
• Two graspingfingers37 can releasably attach on opposite sides of thetop plate3, for example against the surface of the topdeployment stop panel27 facing the topinner panel26. Two graspingfingers37 can releasably attach on opposite sides of thebottom plate5, for example against the surface of the bottomdeployment stop panel22 facing the bottominner panel23. Themiddle plate4 can be aligned with theslots21.
• FIG. 17 illustrates that thedeployment tool35 can have ananvil38. Theanvil38 can hold themiddle plate4 in place, which can transmit the force to the top3 and bottom5 plates, holding the top3 and bottom5 plates in compression against the graspingfingers37, as shown inFIGS. 12 through 16. Once thedevice1 is placed into a target site73 (e.g., within a facet joint55), theanvil38 can be translated, as shown by arrow, to force themiddle plate4 between thetop plate3 and thebottom plate5. Thedevice1 can be expanded. The tabs and/orwedges6 can then interference fit to prevent themiddle plate4 from retreating and themiddle plate4 can be fixedly attached to the top3 and bottom5 plates. The graspingfingers37 can be extended from thedeployment tool case36, radially expand away from one another, and release thedevice1. Theanvil38 can be withdrawn into thedeployment tool case36.
• FIGS. 18aand18billustrate that thedevice1 can havecells39 or pores. Thecells39 can be open when thedevice1 is in a contracted configuration and/or open when thedevice1 is in an expanded configuration so material can pass through thecells39 to an inner longitudinal channel or lumen inside of thedevice1, and/or to the opposite side of thedevice1. For example, bone or other tissue growth can occur through thecells39. The bone growth can pass through and encompass thedevice1.
• Thedevice1 can have a round or circular transverse cross-section. Thedevice1 can be ductile or deformable. Thedevice1 can be resilient.
• FIG. 18aillustrates thedevice1 can be loaded on amandrel40 ordeployment tool35 in a contracted configuration.FIG. 18billustrates that a first end of thedevice1 can be radially expanded by themandrel40 orother deployment tool35 while the second end of thedevice1 can remain contracted.
• FIGS. 19aand19billustrate that thedevice1 can have insubstantial pores orcells39. For example, substantially no material can flow or otherwise pass through thecells39 or pores of thedevice1.
• FIG. 20 illustrates that thetop plate3 can be rotatably attached to thebottom plate5. Thetop plate3 and thebottom plate5 can be integral with or attached to aplate hinge44. Thetop plate3 andbottom plate5 can be attached at a first end at theplate hinge44. Thetop plate3 andbottom plate5 can be unattached at a second end away from theplate hinge44.
• Thetop plate3 and/orbottom plate5 can have asurface texture17 on the outward-facing surface. For example, thesurface texture17 can beribs43 oriented along the longitudinal axis of thedevice1.
• Thetop plate3 andbottom plate5 can form aside port46. Themiddle plate4 can be slidably received by theside port46. Themiddle plate4 can have aside wall10. Theside wall10 can obstruct, cover, and/or seal the external side of theside port46.
• Themiddle plate4 can have amiddle plate port47. The plate hinge44 can have aplate hinge port45. Themiddle plate port47 and theplate hinge port45 can be aligned along the longitudinal axis of thedevice1. Adeployment tool35 can be releasably attached to themiddle plate port47 and/or theplate hinge port45. Thedeployment tool35 can compress themiddle plate port47 toward theplate hinge port45.
• Themiddle plate4 can have one or more middle plate ramps48, for example positioned adjacent to the inner surfaces of thetop plate3 and thebottom plate5. When themiddle plate4 is longitudinally extended away from the top3 and bottom5 plates, as shown inFIG. 20, the plane of thetop plate3 can be can be substantially parallel to the plane of thebottom plate5.
• FIG. 21 illustrates that themiddle plate4 can be translated toward theplate hinge44. For example, adeployment tool35 can exert a compression force on theplate hinge44 and themiddle plate4, translating themiddle plate4 toward themiddle plate ramp48, as shown byarrow50. The top plate ramps can rotate, as shown byarrows49, thetop plate3 away from thebottom plate5.
• Thedevice1 can have one or more radiopaque and/orechogenic markers51. For example, thedevice1 can have alignedmarkers51 on thetop plate3,middle plate4 andbottom plate5. When thedevice1 is in a contracted pre-deployment configuration, themarkers51 can be located immediately adjacent to one another, for example appearing as asingle marker51. When thedevice1 is in an expanded configuration, themarkers51 can move apart from each other, indicating to a doctor performing the implantation and deployment procedure using visualization (e.g., x-ray or ultrasound-based) that thedevice1 has expanded. Under visualization themarkers51 can also indicate the location and orientation of thedevice1.
Method of Using
• The cartilage can be partially, substantially or completely removed from the inter facet joint. A three-dimensional cavity shape can be formed into the facet surfaces, for example to improve stability and fusion of thedevice1 when thedevice1 is implanted. A bone removal tool can be used on the facet surfaces prior to the insertion of the implant to remove and shape bone and/or other tissue. The bone removal tool can be cannulated and have guides to assure proper depth and orientation within the facet joint55 space. The bone removal tool (which can also remove cartilage and other tissue) can be round or non-round. The bone removal tool can be shaped to match the shape profile of the unexpanded implant.
• FIG. 22 illustrates that thedevice1 can be inserted along theimplant pathway54 into thetarget site73, such as between the superiorarticular process53 and inferiorarticular process56 of a facet joint55. Thedevice1 can be inserted into the facet joint55 without protruding into thevertebral foramen57. (Thespinous process52 is shown as a landmark for illustrative purposes.) Thedevice1 can be partially or completely radially expanded before or after inserting thedevice1 into thetarget site73. An expandedbone cavity68 can optionally be drilled into the facet joint55 before insertion of thedevice1 in which thedevice1 can be inserted.
• FIG. 23 illustrates that thedevice1 can then be expanded, as shown by arrows, and held in place by an interference or friction fit within thebone cavity68 in the facet joint55. Regular spinal loads, such as compression of the facet joint55, can provide additional anchoring and settling (i.e., stop migration) of thedevice1. Thedevice1 can expand into a reverse taper, as shown inFIG. 22. For example, the end of thedevice1 closer to thevertebral foramen57 can eapnd to a larger radius than the end of thedevice1 further from thevertebral foramen57.
• Thedevices1 can be made from PEEK, any medical grade polymer or metal, or any other material disclosed herein. Thedevice1 can be coated, for example with bone morphogenic protein (BMP), ceramic, and/or any other material disclosed herein.
• FIGS. 24 through 30 illustrate a variation of the location of thedevice1 and the fusion location when thisdevice1 is deployed in use. Thedevice1 can be deployed less (e.g., minimally) invasively, over thewire66, percutaneously, used with a vertebral body replacement or fusion cage, or combinations thereof. Thedevice1 can be expandable and un-expandable for removal or repositioning.
• FIG. 24 illustrates that afirst vertebra84 can have afirst facet surface86. Asecond vertebra85 can be adjacent to thefirst vertebra84. Thesecond vertebra85 can have asecond facet surface87 adjacent to thefirst facet surface86. Animplant pathway54 for thedevice1 can be substantially parallel with the first86 and second87 facet surfaces. Thedevice1 can be pushed into the space between the first86 and second87 facet surfaces.
• FIG. 25 illustrates that the implant angle can minimize the needle or punch from damaging the spinal cord. The spinal cord is protected by the vertebral arch (lamina) just below the inferiorarticular process56 of the facet joint55. Thespine62 can have a spinallongitudinal axis61. Theimplant pathway54 in the sagittal plane measured from the coronal63 side of the longitudinal axis can have a sagittal implant pathway angle60. Thesagittal implant pathway54 angle can be from about 40° to about 110°, for example about 60°.
• FIG. 26 illustrates that during spinal flexion or extension, as shown byarrows64, the articular facet surfaces can experienceshear forces65 relative to each other. Thedevice1 can be oriented perpendicular to the shear motion, for example with the plane of the surface of the inner panels aligned with the shear forces65.
• FIGS. 27 (and33b,33cand33d) illustrates that awire66 can be inserted between the articular processes. Thewire66 can be a guidewire, lead, catheter, or combinations thereof. Thewire66 can be placed along theimplant pathway54.Deployment tools35 and/or thedevice1 can be inserted along thewire66. Thewire66 can be removed after positioning,expansion41, or at any other time during deployment of thedevice1 ordeployment tools35. The vertebral arch (lamina) can be stop the wire66 (and device1) insertion, for example, protecting the spinal cord and nerves.
• FIGS. 28 (and33e,33fand33g) illustrate that abone cavity68 can be created. The bone shaping and removal can be performed with adrill67 or other bone removal tool. Thedrill67 can slide over and follow thewire66 to the outer surface of the facet articular surface. Thedrill67 can have a guide to orient thedrill67 with a cutting plane. The cutting plane can be the space between the inferior and superiorarticular process53 of the articular surfaces and sharp edges, for example the plain of thearticular processes69, as shown inFIG. 28. Thedrill67 can cut, shape and remove tissue, such as bone and/or cartilage. The creation of thebone cavity68 can create a bloody bone surface to aid in regrowth and fusing of the bones on which the cavity was created.
• FIGS. 29 (and31) illustrates that thedevice1 can be removably attached to a delivery system ordeployment tool35. Thedeployment tool35 can insert thedevice1 into thetarget site73. For example thedeployment tool35 can be pushed over thewire66 as shown by arrow.
• Thedevice1 can be positioned such that the first plate is against thefirst facet surface86 and the second plate is against thesecond facet surface87. For example, the inner panels can be against the facet surfaces. Teeth or texturing on the panels and/or plates can be pressed against the facet surfaces and frictionally resist withdrawal from the deployed position. The stop panels and/or wing panels (25,28) can abut bone and/or other tissue and stop insertion of thedevice1 into thetarget site73.
• The opposed facet surfaces can compress against thedevice1, for example, releasably fixing thedevice1 in the facet joint55.
• When thedevice1 is positioned as desired (e.g., into the drilledbone cavity68 and/or between unaltered surfaces forming the facet joint55) and expanded and/or locked, thedeployment tool35 can then release thedevice1. Thedevice1 can lock itself into place with outward expansion, wedging, or interference force when receiving a release force from thedeployment tool35 or otherwise.
• FIG. 30 illustrates that thedevice1 can be expanded between the first and second articular process facet surfaces. Thedevice1 can resist the shear forces shown inFIG. 26. The adjacent articular facet surfaces can regrow through and around thedevice1 and fuse to each other (for example, with the cartilage removed).
• FIG. 31 illustrates thedeployment tool35 inserted to atarget site73 in vivo between afirst vertebra84 and asecond vertebra85. For example, thedevice1 can be placed at thetarget site73 after a partial or complete discectomy. When thedevice1 is in a contracted configuration, the tool can position thedevice1 between a first vertebral body92 of thefirst vertebra84 and a secondvertebral body93 of thesecond vertebra85. Thedevice1 can be inserted into the target site73 a direction substantially parallel to the surfaces of the vertebral body end plates. Thedevice1 can be placed between a firstvertebral end plate90 of the first vertebral body92 and the adjacent second vertebral end plate91 of the secondvertebral body93. In this inter-vertebral location, thetop plate3 of thedevice1 can be in contact with or directly adjacent to the firstvertebral end plate90. Thebottom plate5 of thedevice1 can be in contact with or directly adjacent to the second vertebral end plate91.
• FIGS. 32aand32billustrate that thedeployment tool35 can radially expand thedevice1 between the firstvertebral end plate90 and the second vertebral end plate91. Thetop plate3 can press against and/or embed into the firstvertebral end plate90. Thebottom plate5 can press against and/or embed into the second vertebral end plate91. Thedevice1 can fuse thefirst vertebra84 to thesecond vertebra85.
• Thedevice1 can be filled with a filled before or after radial expansion. Tissue ingrowth can occur into thetop plate3 through thetop ports42,bottom plate5 through the bottom ports, and elsewhere through thedevice1.
• FIGS. 33athrough33gillustrate visualizations of a variation of a method for preparing thetarget site73 for thedevice1.FIG. 33aillustrate a visualization of thespine62 with thetarget site73 identified, such as a facet joint55.FIGS. 33band33cillustrates that a leader orwire66, such as a guidewire, can be inserted or otherwise deployed into thetarget site73, for example, thewire66 can be percutaneously inserted in a minimally invasive procedure. Thewire66 can be inserted into the facet articular space, for example between thefirst facet surface86 and the adjacentsecond facet surface87. Thewire66 can be anteriorly and/or posteriorly inserted, as shown inFIG. 33b. The33cillustrates that thewire74 can be laterally inserted.
• FIG. 33dillustrates that afirst wire88 can be inserted into the first facet joint82. Asecond wire89 can be inserted into the second facet joint83. Thefirst wire88 can be inserted in an anteriorly/posteriorly direction, or a lateral direction. Thesecond wire89 can be inserted in an anteriorly/posteriorly direction, or a lateral direction.
• FIGS. 33eand33fillustrate that thedrill67 can be inserted, as shown by arrow, over the wire to thetarget site73, such as thepedicles75. Thedrill67 can then be used to drill away a portion of thebone76, for example, creating abone cavity68 as shown inFIG. 33gfor insertion of thedevice1.
• FIGS. 34 and 35 illustrate visualizations of variations of thedevice1 inserted in contracted configurations into the anterior/posterior andlateral bone cavity68target sites73 of thespine62, respectively, to provide facet fusion. Thedevices1 can have radiopaque and/orechogenic visualization markers51, for example themarkers51 can be along thetop plate3,bottom plate5, and one or more panels of the plates. The first and/orsecond deployment tools80 and81 can also have one ormore markers51. Thedevices1 can be inserted into multiplefacet bone cavity68target sites73 of thespine62 to provide facet fusion. Afirst device78 can be inserted into a first facet joint82 and asecond device79 can be inserted into a second facet joint83. The first78 and second79 devices can be inserted bilaterally, for example both devices can be inserted between the samefirst vertebra84 andsecond vertebra85 on opposite lateral sides.FIGS. 36 and 37 illustrate visualizations of variations of thedevices1 in expanded configurations in multiplefacet bone cavity68target sites73 of thespine62 to provide facet fusion. Thefirst device78 andsecond device79 can be expanded in the first facet joint82 and thesecond device79 can be inserted in the second facet joint83.
• BecauseFIGS. 35 and 37 are lateral views, the facet joints are substantially viewed at the same location and are not substantially distinguishable in the view.
• Any or all elements of thedevice1 and/or other devices or apparatuses described herein can be made from, for example, a single or multiple stainless steel alloys, nickel titanium alloys (e.g., Nitinol), cobalt-chrome alloys (e.g., ELGILOY® from Elgin Specialty Metals, Elgin, Ill.; CONICHROME® from Carpenter Metals Corp., Wyomissing, Pa.), nickel-cobalt alloys (e.g., MP35N® from Magellan Industrial Trading Company, Inc., Westport, Conn.), molybdenum alloys (e.g., molybdenum TZM alloy, for example as disclosed in International Pub. No. WO 03/082363 A2, published 9 Oct. 2003, which is herein incorporated by reference in its entirety), tungsten-rhenium alloys, for example, as disclosed in International Pub. No. WO 03/082363, polymers such as polyethylene teraphathalate (PET), polyester (e.g., DACRON® from E.I. Du Pont de Nemours and Company, Wilmington, Del.), poly ester amide (PEA), polypropylene, aromatic polyesters, such as liquid crystal polymers (e.g., Vectran, from Kuraray Co., Ltd., Tokyo, Japan), ultra high molecular weight polyethylene (i.e., extended chain, high-modulus or high-performance polyethylene) fiber and/or yarn (e.g., SPECTRA® Fiber and SPECTRA® Guard, from Honeywell International, Inc., Morris Township, N.J., or DYNEEMA® from Royal DSM N.V., Heerlen, the Netherlands), polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyether ketone (PEK), polyether ether ketone (PEEK), poly ether ketone ketone (PEKK) (also poly aryl ether ketone ketone), nylon, polyether-block co-polyamide polymers (e.g., PEBAX® from ATOFINA, Paris, France), aliphatic polyether polyurethanes (e.g., TECOFLEX® from Thermedics Polymer Products, Wilmington, Mass.), polyvinyl chloride (PVC), polyurethane, thermoplastic, fluorinated ethylene propylene (FEP), absorbable or resorbable polymers such as polyglycolic acid (PGA), poly-L-glycolic acid (PLGA), polylactic acid (PLA), poly-L-lactic acid (PLLA), polycaprolactone (PCL), polyethyl acrylate (PEA), polydioxanone (PDS), and pseudo-polyamino tyrosine-based acids, extruded collagen, silicone, zinc, echogenic, radioactive, radiopaque materials, a biomaterial (e.g., cadaver tissue, collagen, allograft, autograft, xenograft, bone cement, morselized bone, osteogenic powder, beads of bone) any of the other materials listed herein or combinations thereof. Examples of radiopaque materials are barium sulfate, zinc oxide, titanium, stainless steel, nickel-titanium alloys, tantalum and gold.
• Thedevice1 can be made from substantially 100% PEEK, substantially 100% titanium or titanium alloy, or combinations thereof.
• Any or all elements of thedevice1 and/or other devices or apparatuses described herein, can be, have, and/or be completely or partially coated with agents for cell ingrowth.
• Thedevice1 and/or elements of thedevice1 and/or other devices or apparatuses described herein can be filled, coated, layered and/or otherwise made with and/or from cements,fillers70, and/or glues known to one having ordinary skill in the art and/or a therapeutic and/or diagnostic agent. Any of these cements and/orfillers70 and/or glues can be osteogenic and osteoinductive growth factors.
• Examples of such cements and/orfillers70 includes bone chips, demineralized bone matrix (DBM), calcium sulfate, coralline hydroxyapatite, biocoral, tricalcium phosphate, calcium phosphate, polymethyl methacrylate (PMMA), biodegradable ceramics, bioactive glasses, hyaluronic acid, lactoferrin, bone morphogenic proteins (BMPs) such as recombinant human bone morphogenetic proteins (rhBMPs), other materials described herein, or combinations thereof.
• The agents within these matrices can include any agent disclosed herein or combinations thereof, including radioactive materials; radiopaque materials; cytogenic agents; cytotoxic agents; cytostatic agents; thrombogenic agents, for example polyurethane, cellulose acetate polymer mixed with bismuth trioxide, and ethylene vinyl alcohol; lubricious, hydrophilic materials; phosphor cholene; anti-inflammatory agents, for example non-steroidal anti-inflammatories (NSAIDs) such as cyclooxygenase-1 (COX-1) inhibitors (e.g., acetylsalicylic acid, for example ASPIRIN® from Bayer AG, Leverkusen, Germany; ibuprofen, for example ADVIL® from Wyeth, Collegeville, Pa.; indomethacin; mefenamic acid), COX-2 inhibitors (e.g., VIOXX® from Merck & Co., Inc., Whitehouse Station, N.J.; CELEBREX® from Pharmacia Corp., Peapack, N.J.; COX-1 inhibitors); immunosuppressive agents, for example Sirolimus (RAPAMUNE®, from Wyeth, Collegeville, Pa.), or matrix metalloproteinase (MMP) inhibitors (e.g., tetracycline and tetracycline derivatives) that act early within the pathways of an inflammatory response. Examples of other agents are provided in Walton et al, Inhibition of Prostoglandin E₂Synthesis in Abdominal Aortic Aneurysms, Circulation, Jul. 6, 1999, 48-54; Tambiah et al, Provocation of Experimental Aortic Inflammation Mediators and Chlamydia Pneumoniae, Brit. J. Surgery 88 (7), 935-940; Franklin et al, Uptake of Tetracycline by Aortic Aneurysm Wall and Its Effect on Inflammation and Proteolysis, Brit. J. Surgery 86 (6), 771-775; Xu et al, Sp1 Increases Expression of Cyclooxygenase-2 in Hypoxic Vascular Endothelium, J. Biological Chemistry 275 (32) 24583-24589; and Pyo et al, Targeted Gene Disruption of Matrix Metalloproteinase-9 (Gelatinase B) Suppresses Development of Experimental Abdominal Aortic Aneurysms, J. Clinical Investigation 105 (11), 1641-1649 which are all incorporated by reference in their entireties.
• Any elements described herein as singular can be pluralized (i.e., anything described as “one” can be more than one). Any species element of a genus element can have the characteristics or elements of any other species element of that genus. The above-described configurations, elements or complete assemblies and methods and their elements for carrying out the invention, and variations of aspects of the invention can be combined and modified with each other in any combination.

Claims (13)

1. A method of using an orthopedic support device comprising:

positioning an implantable device between a first facet surface of a first vertebra and a second facet surface of a second vertebra, wherein the first vertebra is adjacent to the second vertebra, and wherein the first facet surface is adjacent to the second facet surface; and

expanding the implantable device between the first facet surface and the second facet surface.

2. The method ofclaim 1, further comprising removing some of the first facet surface.

3. The method ofclaim 2, further comprising removing some of the second facet surface.

4. The method ofclaim 1, wherein positioning further comprises inserting a flexible leader between the first facet surface and the second facet surface, and delivering the implantable device on the leader.

5. The method ofclaim 4, further comprising removing the leader from between the first facet surface and the second facet surface.

6. The method ofclaim 1, wherein expanding comprises longitudinally compressing the implantable device.

7. A method of using an orthopedic support device comprising:

positioning an implantable device between a first facet surface of a first vertebra and a second facet surface of a second vertebra, wherein the first vertebra is adjacent to the second vertebra, and wherein the first facet surface is adjacent to the second facet surface, and wherein the implantable device has a first plate in contact with the first facet surface and a second plate in contact with the second facet surface; and

fixing the first plate to the position of the second plate.

8. The method ofclaim 7, wherein fixing comprises inserting a third plate between the first plate and the second plate.

9. The method ofclaim 7, wherein fixing comprises compressing the first plate and the second plate between the first facet surface and the second facet surface.

10. The method ofclaim 7, wherein the

11. An implantable orthopedic device having a longitudinal axis comprising:

a first plate,

a second plate, and

a third plate,

wherein the first plate has a first panel and a second panel, and wherein the first panel is extending from a second panel at about a perpendicular angle to the first panel; and wherein the second plate has a first panel and a second panel, and wherein the first panel is extending from a second panel at about a perpendicular angle to the first panel; and wherein the third plate is located between the first panel of the first plate and the first panel of the second plate.

12. The device ofclaim 11, wherein the third plate comprises a first unidirectional engaging feature, and wherein the first unidirectional engaging feature is received by a receiving feature on the first panel of the first plate.

13. The device ofclaim 12, wherein the third plate comprises a second unidirectional engaging feature, and wherein the second unidirectional engaging feature is received by a receiving feature on the first panel of the second plate.

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