|Publication number||US20100204795 A1|
|Application number||US 12/617,526|
|Publication date||Aug 12, 2010|
|Filing date||Nov 12, 2009|
|Priority date||Nov 12, 2008|
|Also published as||US20100222884, WO2010056895A1|
|Publication number||12617526, 617526, US 2010/0204795 A1, US 2010/204795 A1, US 20100204795 A1, US 20100204795A1, US 2010204795 A1, US 2010204795A1, US-A1-20100204795, US-A1-2010204795, US2010/0204795A1, US2010/204795A1, US20100204795 A1, US20100204795A1, US2010204795 A1, US2010204795A1|
|Inventors||E. Skott Greenhalgh|
|Original Assignee||Stout Medical Group, L.P.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Referenced by (14), Classifications (38), Legal Events (1)|
|External Links: USPTO, USPTO Assignment, Espacenet|
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.
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.
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.
A device 1 is disclosed that can be inserted into a target site 73 with the device 1 in a compressed or contracted (i.e., small) configuration. Once positioned in the deployment site, the device 1 can be transformed into an expanded (i.e., larger, bigger) configuration. The device 1 can be inserted and expanded in orthopedic target sites 73 for fixation and/or support. For example, the device 1 can be inserted and expanded over a guidewire between adjacent vertebral facet surfaces (i.e., within a facet joint 55).
The device 1 can have a middle plate 4 positioned between the top plate 3 and the bottom plate 5. The middle plate 4 can be slidably attached to the top plate 3 and the bottom plate 5. The pins 2 can be in pin slots 11 in the top 3 and/or bottom 5 and/or middle 4 plates. The pin slots 11 in the middle plate 4 can fix the pins 2 with respect to the position of the middle plate 4 in the direction of a device longitudinal axis 77. The pin slots 11 in the top 3 and bottom 5 plates can allow the pins 2 to move along a device longitudinal axis 77 with respect to the top 3 and bottom 5 plates to the extent of the pin slots 11, at which point the pin slots 11 will interference fit against the pins 2 to prevent further motion of the top 3 and bottom 5 plates. Accordingly, the top 3 and bottom 5 plates can slide with respect to each other and to the middle plate 4 in the direction of the device longitudinal axis 77 (and/or the middle plate 4 longitudinal axis).
The top plate 3 can have one or more angled and/or curved ramps 7 on the middle plate 4-side of the top plate 3. The bottom plate 5 can have one or more angled and/or curved ramped 7 on the middle plate 4-side of the bottom plate 5. The middle plate 4 can have angled and/or curved wedges 6 on the top plate 3-side and/or bottom plate 5-side of the middle plate 4. The wedges 6 can interface with the ramps 7. For example, the top 3 and bottom 5 plates can be in a contracted, compressed, or otherwise non-expanded configuration when the middle plate 4 is in a first position relative to the top 3 and bottom plates 5. The top and/or bottom 5 plates can be in an expanded, radially spread, or enlarged configuration when the middle plate 4 is in a second position (e.g., pulled away 9) relative to the top and/or bottom 5 plates.
The middle plate 4 can have no, one or two side walls 10. The side walls 10 can extend to about the height of the top plate 3 and/or bottom plate 5 when the device 1 is in a contracted or expanded configuration.
The top plate 3, bottom plate 5, side plates and combinations thereof can have ingrowth channels 12, windows, or ports. The ingrowth channels 12 can be configured to encourage bone growth into the ingrowth channel. For example, the ingrowth channels 12 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.
When the device 1 is in an expanded configuration, the top plate surface plane 15 and the bottom plate surface plane 29 can rotate away from each other, as shown by arrow 8, to form a device expansion angle 14. The device expansion angle 14 can be from about 1° to about 45°, more narrowly from about 2° to about 20°. For example, the device expansion angle 14 can be about 5° or about 10°. The device 1 can have a ratchet, or steps or teeth on the ramp 7 and wedges 6 to allow the device expansion angle 14 to be expanded at discrete increments, such as increased at increments of about 0.25°, about 0.5°, about 1°, or about 2°.
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 the device 1 into the target site 73. 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 the target site 73 to prevent the device 1 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 the device 1 is expanded to fix the device 1 to the target site 73. The device 1 can be retrieved or repositioned, for example, by grabbing and pulling on the deployment stop panel and/or wing panel (25, 28).
The top plate 3 and/or bottom plate 5 can have surface texturing, for example coring or gripping teeth on the outward-facing surface of the inner panels. The top and/or bottom 5 plates can have ramps 7 and/or slots 21 and tabs 18. The ramps 7 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 in
The top plate 3 and/or bottom plate 5 can have a stop seat 20 formed into the top and/or bottom plate 5 along the outer surface of the deployment stop panels. The stop seat 20 can be recessed into the deployment stoop panels. The stop seat 20 can be configured to receive a middle stop plate on the middle plate 4. As shown in
The top and/or bottom 5 plates can have grooves formed along the inner-surface of the inner panels extending to the top plates. The grooves can form slots 21 when the top plate 3 and bottom plate 5 are adjacent to each other.
The middle plate 4 can have one or more rails 16. The rails 16 can be on opposite sides of the middle plate 4. The rails 16 can extend along the length of the middle plate 4. The rails 16 can be configured to insert and slide through the slots 21 formed in the top and/or bottom 5 plates. The leading edge of the rail 16 can be angled, for example to a point or angled but with a flat front surface (as shown).
The rails 16 can have one or more wedges 6. For example, each rail 16 can have two wedges 6 on the side of the rail 16 facing the top plate 3 and two wedges 6 on the side of the rail 16 facing the bottom plate 5. The rails 16 can be spaced longitudinally along the rail 16.
The middle plate 4 can have one or more ingrowth channels 12. For example, the ingrowth channels 12 on the middle plate 4 can be arranged in a grid of two by three ingrowth channels 12. The ingrowth channels 12 can be located between opposing rails 16.
The middle plate 4 can be inserted between the top 3 and bottom 5 plates. The middle plate 4 can be inserted along the length of the space between the top inner panel 26 and bottom inner panel 23 until the middle plate stop 19 interference fits against the stop seat 20. The top-bottom plate gap 24 can expand, for example up to about 100% or, more narrowly, up to about 50% from the contracted top-bottom plate gap 24.
The inner surface of the top inner panel 26 and the inner surface of the bottom inner panel 23 can form substantially equal device expansion angles 14 whether the device 1 is in an expanded (i.e., top 3 and bottom 5 plates apart) or contracted (i.e., top 3 and bottom 5 plates together) configuration.
The device 1 can have no pins or pin slots.
The top plate 3 can have one or more tab slots 33, corresponding to the positions, shapes, and sizes of the tabs. The tab slots 33 can be configured to receive the tabs. The tab slots 33 can have tab windows 32. The tab windows 32 can be configured to receive the tab ends 34, for example the locking feature of the tab ends 34. The tab windows 32 can be open to the surface of the corresponding panel in which the tab end 34 is located.
When the top plate 3 and bottom plate 5 are pressed toward each other, as shown by arrows in
The deployment tool 35 can have a deployment tool case 36. The deployment tool 35 can have grasping fingers 37 extending from the distal end of the deployment tool case 36. The grasping fingers 37 can be extended distally away from the deployment tool case 36, radially expanding from the other grasping fingers 37 and releasing the device 1. The grasping fingers 37 can be retracted proximally toward the distal end of the deployment tool case 36, radially contracting toward the other grasping fingers 37 and compressing against and holding the device 1.
Two grasping fingers 37 can releasably attach on opposite sides of the top plate 3, for example against the surface of the top deployment stop panel 27 facing the top inner panel 26. Two grasping fingers 37 can releasably attach on opposite sides of the bottom plate 5, for example against the surface of the bottom deployment stop panel 22 facing the bottom inner panel 23. The middle plate 4 can be aligned with the slots 21.
The device 1 can have a round or circular transverse cross-section. The device 1 can be ductile or deformable. The device 1 can be resilient.
The top plate 3 and/or bottom plate 5 can have a surface texture 17 on the outward-facing surface. For example, the surface texture 17 can be ribs 43 oriented along the longitudinal axis of the device 1.
The top plate 3 and bottom plate 5 can form a side port 46. The middle plate 4 can be slidably received by the side port 46. The middle plate 4 can have a side wall 10. The side wall 10 can obstruct, cover, and/or seal the external side of the side port 46.
The middle plate 4 can have a middle plate port 47. The plate hinge 44 can have a plate hinge port 45. The middle plate port 47 and the plate hinge port 45 can be aligned along the longitudinal axis of the device 1. A deployment tool 35 can be releasably attached to the middle plate port 47 and/or the plate hinge port 45. The deployment tool 35 can compress the middle plate port 47 toward the plate hinge port 45.
The middle plate 4 can have one or more middle plate ramps 48, for example positioned adjacent to the inner surfaces of the top plate 3 and the bottom plate 5. When the middle plate 4 is longitudinally extended away from the top 3 and bottom 5 plates, as shown in
The device 1 can have one or more radiopaque and/or echogenic markers 51. For example, the device 1 can have aligned markers 51 on the top plate 3, middle plate 4 and bottom plate 5. When the device 1 is in a contracted pre-deployment configuration, the markers 51 can be located immediately adjacent to one another, for example appearing as a single marker 51. When the device 1 is in an expanded configuration, the markers 51 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 the device 1 has expanded. Under visualization the markers 51 can also indicate the location and orientation of the device 1.
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 the device 1 when the device 1 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 joint 55 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.
The devices 1 can be made from PEEK, any medical grade polymer or metal, or any other material disclosed herein. The device 1 can be coated, for example with bone morphogenic protein (BMP), ceramic, and/or any other material disclosed herein.
The device 1 can be positioned such that the first plate is against the first facet surface 86 and the second plate is against the second facet surface 87. 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 the device 1 into the target site 73.
The opposed facet surfaces can compress against the device 1, for example, releasably fixing the device 1 in the facet joint 55.
When the device 1 is positioned as desired (e.g., into the drilled bone cavity 68 and/or between unaltered surfaces forming the facet joint 55) and expanded and/or locked, the deployment tool 35 can then release the device 1. The device 1 can lock itself into place with outward expansion, wedging, or interference force when receiving a release force from the deployment tool 35 or otherwise.
The device 1 can be filled with a filled before or after radial expansion. Tissue ingrowth can occur into the top plate 3 through the top ports 42, bottom plate 5 through the bottom ports, and elsewhere through the device 1.
Any or all elements of the device 1 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.
The device 1 can be made from substantially 100% PEEK, substantially 100% titanium or titanium alloy, or combinations thereof.
Any or all elements of the device 1 and/or other devices or apparatuses described herein, can be, have, and/or be completely or partially coated with agents for cell ingrowth.
The device 1 and/or elements of the device 1 and/or other devices or apparatuses described herein can be filled, coated, layered and/or otherwise made with and/or from cements, fillers 70, 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/or fillers 70 and/or glues can be osteogenic and osteoinductive growth factors.
Examples of such cements and/or fillers 70 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 E2 Synthesis 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.
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|Cooperative Classification||A61F2002/30515, A61F2310/00952, A61F2002/3008, A61F2002/305, A61F2/4611, A61F2310/00101, A61F2310/00023, A61F2002/30492, A61F2210/0004, A61B17/7064, A61F2250/0098, A61F2002/4627, A61F2002/30579, A61F2002/30062, A61F2/4455, A61F2310/00029, A61F2002/30594, A61F2002/30471, A61F2310/00137, A61F2250/0006, A61F2002/30387, A61F2220/0091, A61F2220/0025, A61F2/4405, A61F2310/00796, A61F2002/4677, A61F2310/00976, A61F2002/30538, A61F2002/30841, A61F2310/00017, A61F2002/30522, A61F2310/0097|
|European Classification||A61F2/44F, A61F2/46B7, A61F2/44A, A61B17/70P2|
|Apr 27, 2010||AS||Assignment|
Effective date: 20090416
Owner name: STOUT MEDICAL GROUP, L.P., PENNSYLVANIA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:GREENHALGH, E. SKOTT;REEL/FRAME:024297/0704