US20120209385A1 - Anterior intervertebral fusion with fixation system, device and method - Google Patents
Anterior intervertebral fusion with fixation system, device and method Download PDFInfo
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- US20120209385A1 US20120209385A1 US13/371,242 US201213371242A US2012209385A1 US 20120209385 A1 US20120209385 A1 US 20120209385A1 US 201213371242 A US201213371242 A US 201213371242A US 2012209385 A1 US2012209385 A1 US 2012209385A1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
- A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
- A61F2/447—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages substantially parallelepipedal, e.g. having a rectangular or trapezoidal cross-section
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
- A61B17/1662—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body
- A61B17/1671—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the spine
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- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/84—Fasteners therefor or fasteners being internal fixation devices
- A61B17/86—Pins or screws or threaded wires; nuts therefor
- A61B17/864—Pins or screws or threaded wires; nuts therefor hollow, e.g. with socket or cannulated
-
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- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
- A61B17/8875—Screwdrivers, spanners or wrenches
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30317—The prosthesis having different structural features at different locations within the same prosthesis
- A61F2002/30326—The prosthesis having different structural features at different locations within the same prosthesis differing in height or in length
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2002/30772—Apertures or holes, e.g. of circular cross section
- A61F2002/30784—Plurality of holes
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
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- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
- A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
- A61F2002/30879—Ribs
Definitions
- the present disclosure relates to spinal implants and associated instrumentation.
- Various embodiments are directed to an anterior intervertebral fusion with fixation system, device and method.
- a healthy spinal disc is a fibroelastic structure with a non-compressible viscous center that articulates adjacent vertebrae. Due to its deformable geometry, the disc not only supports normal functional loads of the human body, but also evenly distributes the stresses applied during body movement and positioning.
- the disc interfaces with associated superior and inferior vertebrae via large surface areas known as vertebral endplates.
- vertebral endplates are thin regions of dense bone (e.g. 1 mm-3 mm) that support high stresses at articulating junctions.
- Intervertebral discs and adjacent articulations progressively deteriorate with age. This natural degenerative process results in various degrees of pathological changes, mostly affecting the geometry and elasticity of a vertebral disc. In severe cases, reduced disc volume results in foraminal compression that mechanically irritates nerve roots and causes neurocompressive syndrome. This often causes severe chronic pain that can only be resolved surgically.
- fusion which immobilizes two adjacent vertebral bodies (vertebrae) to prevent motion-sensitive pain and inflammation. This is accomplished by distracting the vertebrae to a healthy disc height, inserting a disc implant and allowing bone to grow between and through the disc implant until the vertebrae fuse into a solid bony structure. To facilitate proper healing under normal conditions of motion, the disc implant is used to maintain temporary positioning until the bone achieves fusion. The implant is secured to the vertebrae using fixation elements.
- Devices and systems may integrate fixating members directly into the disc implant. These implants have garnered the nickname “standalone” due to their ability to self-fixate without the use of secondary fixation elements.
- obtrusive fixation elements are delivered directly through implant pilot openings into the vertebra, which fixate the implant to the vertebrae and prevent implant failure under remaining ranges of motion (e.g., lateral, sliding, extension). Nevertheless, during these motions, connectivity between fixation elements and vertebrae may become weakened causing the fixation elements to slip or extrude out of the implant.
- an intervertebral fusion with fixation device in a particular embodiment, includes a spacer with an insertion wall, a trailing wall opposite to the insertion wall, a first lateral wall, a second lateral wall opposite to the first lateral wall, a top surface, and a bottom surface opposite to the top surface.
- the intervertebral fusion with fixation device further includes a first fixating element rigidly preloaded in a first portion of the spacer along a first linear trajectory, the first fixating element configured to penetrate and secure to a first vertebra by advancing along the first linear trajectory.
- the device also includes a second fixating element rigidly preloaded in a second portion of the spacer along a second linear trajectory that is different from the first linear trajectory, the second fixating element configured to penetrate and secure to a second vertebra by advancing along the second trajectory.
- the intervertebral fusion with fixation device includes a through opening having an entrance proximate the top surface and an exit proximate the bottom surface to facilitate contact and in-growth of bone fusion material with the first vertebra and second vertebra.
- an integrated drill and screwdriver instrument in another particular embodiment, includes a handle, a driving element configured to engage a head of a bone screw and rotate the bone screw into a vertebra, and a drilling element extending from the from the driving element.
- the drilling element is configured to extend through a cannula of the bone screw and to penetrate the vertebra.
- the driving element is configured to engage the head of the bone screw as the drilling element penetrates through a vertebral endplate.
- an intervertebral fusion with fixation system configured to be implanted between plural vertebrae.
- the device includes a spacer with an insertion wall, a trailing wall opposite to the insertion wall, a first lateral wall, a second lateral wall opposite to the first lateral wall, a top surface, and a bottom surface opposite to the top surface.
- the device further includes a first fixating element rigidly preloaded in a first portion of the spacer along a first linear trajectory, the first fixating element configured to penetrate and secure to a first vertebra by advancing along the first linear trajectory.
- the device also includes a second fixating element rigidly preloaded in a second portion of the spacer along a second linear trajectory that is different from the first linear trajectory, the second fixating element configured to penetrate and secure to a second vertebra by advancing along the second trajectory.
- the system also includes an integrated integrated drill and screwdriver instrument.
- the integrated instrument includes a handle, a driving element configured to engage a head of a bone screw and rotate the bone screw into a vertebra, and a drilling element extending from the from the driving element.
- the drilling element is configured to extend through a cannula of the bone screw and to penetrate the vertebra.
- the driving element is configured to engage the head of the bone screw as the drilling element penetrates through a vertebral endplate.
- a method to secure plural vertebrae includes implanting an intervertebral fusion with fixation device between plural vertebrae.
- the fusion with fixation device includes a spacer, a first fixating element rigidly preloaded in a first portion of the spacer along a first linear trajectory, and a second fixating element rigidly preloaded in a second portion of the spacer along a second linear trajectory that is different from the first linear trajectory.
- the method further includes driving the first fixating element along the first linear trajectory to penetrate the first vertebra and to secure the spacer to a first vertebra, and driving the second fixating element along the second linear trajectory to penetrate the second vertebra and to secure the spacer to a second vertebra.
- a method to assemble an intervertebral fusion with fixation device includes rigidly preloading a first fixating element in a first portion of a spacer along a first linear trajectory and a second fixating element in a second portion of the spacer along a second linear trajectory, the first linear trajectory being different from the second linear trajectory.
- FIG. 1 is a perspective view of an example spacer of an intervertebral fusion with fixation device
- FIG. 2 is a front view of the example spacer shown in FIG. 1 ;
- FIG. 3 is a side view of the example spacer shown in FIG. 1 ;
- FIG. 4 is a perspective view of an example fixation element of the intervertebral fusion with fixation device
- FIG. 5 is a cross-sectional side view of the example fixation element show in FIG. 4 ;
- FIG. 6 is a side view of an example integrated drill and screwdriver driving instrument
- FIG. 7 is a perspective exploded view of a tip of the example integrated drill and screwdriver drilling tip shown in FIG. 6 ;
- FIG. 8 is a perspective view of an example intervertebral fusion with fixation device with the example fixation elements shown in FIG. 4 preloaded in the example spacer shown in FIG. 1 ;
- FIG. 9 is a perspective view of the example intervertebral fusion with fixation device of FIG. 8 with the example integrated drill and screwdriver of FIG. 6 actuating a fixation element shown in FIG. 4 .
- FIG. 10 is a translucent perspective view of an example intervertebral fusion with fixation device with the example fixation element of FIG. 4 in a locked position within a vertebra.
- FIG. 1 is a perspective view of an example spacer 100 of an intervertebral fusion with fixation device.
- the intervertebral fusion with fixation device is illustrated in FIG. 8 .
- the spacer 100 is made of a weight-bearing material, such as a polymer, metal, ceramic, biological material, or composite thereof, that is capable of withstanding the normal stresses of bodily movement and positioning, while also allowing sufficient elasticity.
- the material can have a flexural modulus and tensile strength comparable to bone.
- the spacer 100 can be made of polyetheretherketone (PEEK), a thermoplastic with a flexural modulus of 4.2 GPa and a tensile strength of 95 MPa.
- PEEK polyetheretherketone
- Another benefit of PEEK is its high level of biocompatibility in a dynamic and immunoreactive environment. Other materials and combinations of materials are possible.
- the spacer 100 includes an insertion wall 110 , trailing wall 112 , lateral walls 106 , 108 , top surface 102 , bottom surface 104 , and through opening 114 extending between and through the top surface 102 and bottom surface 104 for bone graft insert.
- the dimensions of the spacer 100 are approximately the following: the length of the spacer 100 between an insertion wall 110 and trailing wall 112 is between about 10 mm and 80 mm; the width of the spacer 100 between a first lateral wall 106 and second lateral wall 108 is between about 10 mm and 80 mm; and the height of the spacer 100 between a top surface 102 and bottom surface 104 is between about 4 mm and 30 mm.
- the foregoing dimensions are non-limiting and are intended to be adjusted depending on the specific spinal anatomy of the patient.
- the trailing wall 112 includes a plurality of through holes 202 (shown in FIG. 2 ) extending from the central opening 114 to the exterior of the spacer 100 to receive, secure, and guide plural fixation elements 400 (shown in FIG. 4 ).
- Each of the foregoing holes 202 is oriented to provide a trajectory for a fixation element (shown in FIG. 4 ).
- the trajectories of the holes 202 can be oriented in directions lateral, medial, superior, inferior, or any combination thereof to the spacer to provide multi-axial fixation to the vertebrae.
- the holes 202 can direct the fixation elements 400 in divergent trajectories to counterbalance one another from any opposing torques or shear stresses initiated by vertebral motion.
- the dimensions of the holes 202 are approximately the following: the medial and/or lateral angle in respect to lateral walls 106 , 108 is between about 0 degrees and 25 degrees, and the superior and/or inferior angle in respect to surfaces 102 , 104 is between about 30 degrees and 50 degrees.
- the diameters of the foregoing holes 202 are approximately between 0.5 mm and 10 mm.
- FIG. 2 is a front view of the example spacer 100 shown in FIG. 1 .
- the spacer 100 includes ridges 116 on surfaces 102 , 104 proximate the holes 202 to reinforce the spacer 100 during advancement of the fixation elements 400 .
- ridges 116 can be provided about the exits to the outside of the spacer 100 and can be of various dimensions and tapers along the surfaces 102 , 104 .
- the ridges 116 can be omitted.
- the spacer 100 further includes ridges 118 along the surfaces 102 , 104 that penetrate surrounding vertebrae during implantation and provide stability to the spacer 100 through micro-scale contact with the vertebral plates.
- the spacer 100 can include plural radiopaque markers 120 to enhance radiographic visualization of the spacer 100 .
- the markers 120 can be made of a biocompatible radiopacic material, such as tantalum, platinum alloys, gold alloys, or palladium alloys. Other applicable materials may also be employed.
- Plural markers 120 can be provided near the walls 106 , 108 , 110 , 112 and surfaces 102 , 104 to provide additional visual references of the spacer 100 for clinicians during radiographic imaging.
- the markers 120 can assume various geometries and volumes within the spacer 100 depending on visualization requirements. In various embodiments, the markers 120 can be omitted.
- FIG. 3 is a side view of an example spacer 100 of an intervertebral fusion with fixation device of FIG. 8 .
- the trailing height 302 gradually decreases to the insertion height 304 at a taper to approximate natural lordosis.
- the ridges 116 can be also tapered to minimize friction during insertion and facilitate smooth entry of the spacer 100 into the intervertebral space.
- FIG. 4 is a perspective view of an example fixation element 400 .
- the fixation element 400 can be made of a biocompatible metal, such as a titanium alloy. Other applicable materials may also be employed.
- the fixation element 400 includes a tip 405 that locks into and interfaces with the holes 202 during assembly to maintain a preloaded position, and penetrates bone during engagement with vertebral endplates.
- the fixation element 400 has a minor diameter 402 that is between about 1 mm and 10 mm.
- the fixation element 400 also includes a major diameter 404 of threading that is between 2 mm and 15 mm to provide cutting during engagement.
- the tip 405 includes flutes 406 to facilitate penetration into the vertebra during initial engagement.
- the fixation element 400 further includes a head 407 with a conically shaped body 408 to pressure-fit into the holes 202 after advancement via an instrument receiver 410 .
- the instrument receiver 410 can interface with a driving instrument (shown in FIG. 6 ).
- the head 407 includes a hook protrusion 412 with a sharp edge that can cut into the hole 202 after the fixation element 400 is advanced (e.g., fully) into the vertebra and the head 407 is in contact with the spacer 100 .
- the contact between the sharp edge of the hook protrusion 412 and the hole 202 functions as a locking mechanism to prevent extrusion of the fixation element 400 .
- FIG. 5 is a cross-sectional side view of an example fixation element 400 of FIG. 4 .
- the fixation element 400 includes a cannula 502 that allows a drilling tip of the driving instrument (shown in FIG. 6 ) to pass into and through the fixation element 400 to facilitate vertebral endplate pre-drilling and preparation for advancement of the fixation element 400 .
- the fixation element 400 further includes a platform 504 that connects or interfaces the driving instrument receiver 410 and cannula 502 to contact and limit the depth of motion of the driving instrument (shown in FIG. 6 ) in relation to the fixation element 400 .
- FIG. 6 is a side view of an example integrated drill and screwdriver driving instrument (driving instrument) 600 .
- the driving instrument 600 can be made of a metal, such as titanium. Other applicable materials may also be employed.
- the driving instrument 600 includes an integrated tip 614 that can penetrate and pre-drill vertebral endplates with a drill tip 606 as well as engage the driving instrument receiver 410 of a fixation element 400 with a fixation element interface 604 .
- the drill tip 606 of the integrated tip 614 can pass into and through the cannula 502 of the fixation element 400 in order to penetrate and pre-drill a vertebral endplate.
- the fixation element interface 604 can contact the driving instrument receiver 410 once the drill tip 606 has penetrated through the vertebral endplate into the softer bony layer.
- both the fixation element interface 604 and corresponding driving instrument receiver 410 are of a quadrilateral shape to facilitate rigid contact between the surfaces and allow engagement of the fixation element 400 .
- the driving instrument 600 includes a body 602 to increase operational distance from the spacer 100 and provide access under various angulations.
- the body 602 is smoothly mated to the integrated tip 614 with a conical transition element 610 .
- the driving instrument 600 includes a handle 612 that can be operated manually or by an electrical or mechanical tool.
- the handle 612 can be constructed as a hexagonal bit to fit a standard screwdriver.
- the handle 612 is smoothly mated to the body 602 with a conical transition element 603 .
- FIG. 7 is an exploded perspective view of the example integrated tip 614 .
- the integrated tip 614 includes cutting blades 702 to facilitate vertebral penetration during advancement.
- the integrated tip 614 further includes a rounded transition element 704 between the fixation element interface 604 and the drill tip 606 to allow smooth contact between the fixation element interface 604 and driving instrument receiver 410 during the initial engagement of the fixation element 400 .
- FIG. 8 is a perspective view of an example intervertebral fusion with fixation device 800 with the plural example fixation elements 400 of FIG. 4 preloaded in the example spacer 100 of FIG. 1 .
- the fixation elements 400 can be preloaded into the spacer 100 via holes 202 .
- the flutes 406 and threading 404 cut into and secure the fixation elements 400 to the spacer 100 via holes 202 to maintain a preloaded assembly.
- This preloaded assembly ensures fixed trajectories for the fixation elements 400 during delivery of the device 800 and eliminates the need for alignment post-implantation.
- FIG. 9 is a perspective view of an example intervertebral fusion with fixation device of FIG. 8 with an example driving instrument 600 of FIG. 6 actuating a fixation element 400 of FIG. 4 .
- the integrated tip 614 is delivered into and through the cannula 502 of the fixation element 400 to pre-drill the vertebral endplate with the cutting blades 702 of the fixation element 400 .
- the penetration of the integrated tip 614 through the vertebral endplate combined with the linear force applied to the handle 612 drives the fixation element interface 604 into contact with the driving instrument receiver 410 of the fixation element 400 .
- the torque from the handle 612 engages the fixation element interface 604 , which in turn actuates the driving instrument receiver 410 and advances the fixation element 400 into vertebral endplate. Additionally, the fixation element flutes 406 and major threading 404 penetrate and secure the fixation element 400 to the endplate of the vertebra.
- FIG. 10 is a translucent perspective view of an example intervertebral fusion with fixation device 800 with the plural example fixation elements 400 of FIG. 4 in a locked position and secured to a vertebra 1001 .
- the hook protrusion 412 of the fixation element 400 pressure fits the holes 202 of the spacer 100 to prevent the fixation element 400 from toggling and backing-out.
- the hook protrusion 412 rigidly cut into the spacer 100 via its sharp edge to limit the ability of the fixation element 400 to torque towards the trailing wall 112 of the device 800 and away from the vertebra 1001 .
- the ridges 118 penetrate adjacent vertebral endplates and provide ancillary stability.
Abstract
A system, device, and method are disclosed for anterior intervertebral fusion with fixation. An intervertebral fusion with fixation device includes a spacer configured to fit into a disc space between plural vertebrae, the spacer including through holes between and through plural sidewalls. A first fixating element is rigidly preloaded in a first portion of the spacer along a first linear trajectory. A second fixating element is rigidly preloaded in a second portion of the spacer along a second linear trajectory. An integrated drill and screwdriver instrument is adapted to extend through a cannula of the first fixating element and second fixating element and penetrate the vertebra. The instrument is further adapted to drive the head of the first fixating element and second fixating element into the vertebra and lock the first fixating element and second fixating element with respect to the spacer to prevent extrusion from the spacer.
Description
- This application claims the benefit of U.S. Provisional Application No. 61/463,239, filed on Feb. 15, 2011, and U.S. Provisional Application No. 61/517,717, filed on Apr. 25, 2011, which are incorporated herein by reference in their entirety.
- The present disclosure relates to spinal implants and associated instrumentation. Various embodiments are directed to an anterior intervertebral fusion with fixation system, device and method.
- A healthy spinal disc (intervertebral disc) is a fibroelastic structure with a non-compressible viscous center that articulates adjacent vertebrae. Due to its deformable geometry, the disc not only supports normal functional loads of the human body, but also evenly distributes the stresses applied during body movement and positioning. The disc interfaces with associated superior and inferior vertebrae via large surface areas known as vertebral endplates. Normally, vertebral endplates are thin regions of dense bone (e.g. 1 mm-3 mm) that support high stresses at articulating junctions.
- Intervertebral discs and adjacent articulations progressively deteriorate with age. This natural degenerative process results in various degrees of pathological changes, mostly affecting the geometry and elasticity of a vertebral disc. In severe cases, reduced disc volume results in foraminal compression that mechanically irritates nerve roots and causes neurocompressive syndrome. This often causes severe chronic pain that can only be resolved surgically.
- Historically, surgical treatment of degenerative spinal disc disease required fusion, which immobilizes two adjacent vertebral bodies (vertebrae) to prevent motion-sensitive pain and inflammation. This is accomplished by distracting the vertebrae to a healthy disc height, inserting a disc implant and allowing bone to grow between and through the disc implant until the vertebrae fuse into a solid bony structure. To facilitate proper healing under normal conditions of motion, the disc implant is used to maintain temporary positioning until the bone achieves fusion. The implant is secured to the vertebrae using fixation elements.
- The effectiveness of the disc implant can be evaluated with the following criteria: (i) its ability to restore and maintain normal disc height and curvature; (ii) its ease of delivery and fixation to the disc space; (iii) its ability to facilitate fusion of associated vertebrae; and (iv) its ability to restrict movement of associated vertebrae.
- Disc implants share the same fundamental characteristics to meet the effectiveness criteria. Implants aim to restore disc height through the use of variable geometries. Lordotic curvature is preserved through the use ergonomic designs that conform to spinal curvature and height between the vertebrae. Also, the disc implants are sufficiently porous or hollow to promote the growth of vertebral bone into and through the implant. However, independently, these implants can only restrict spinal flexion and intervertebral compression. Any excessive lateral, sliding, or extension motion may cause device failure and/or extrusion. To avoid this risk, it is customary to provide additional fixation of the disc implant to the vertebrae.
- Devices and systems may integrate fixating members directly into the disc implant. These implants have garnered the nickname “standalone” due to their ability to self-fixate without the use of secondary fixation elements. In the foregoing standalone implants, obtrusive fixation elements are delivered directly through implant pilot openings into the vertebra, which fixate the implant to the vertebrae and prevent implant failure under remaining ranges of motion (e.g., lateral, sliding, extension). Nevertheless, during these motions, connectivity between fixation elements and vertebrae may become weakened causing the fixation elements to slip or extrude out of the implant. To prevent unwanted fixation element slipping or extrusion, it is customary to include a locking mechanism for the implant.
- In a particular embodiment, an intervertebral fusion with fixation device is disclosed. The device includes a spacer with an insertion wall, a trailing wall opposite to the insertion wall, a first lateral wall, a second lateral wall opposite to the first lateral wall, a top surface, and a bottom surface opposite to the top surface. The intervertebral fusion with fixation device further includes a first fixating element rigidly preloaded in a first portion of the spacer along a first linear trajectory, the first fixating element configured to penetrate and secure to a first vertebra by advancing along the first linear trajectory. The device also includes a second fixating element rigidly preloaded in a second portion of the spacer along a second linear trajectory that is different from the first linear trajectory, the second fixating element configured to penetrate and secure to a second vertebra by advancing along the second trajectory. Further, the intervertebral fusion with fixation device includes a through opening having an entrance proximate the top surface and an exit proximate the bottom surface to facilitate contact and in-growth of bone fusion material with the first vertebra and second vertebra.
- In another particular embodiment, an integrated drill and screwdriver instrument is disclosed. The integrated drill and screwdriver includes a handle, a driving element configured to engage a head of a bone screw and rotate the bone screw into a vertebra, and a drilling element extending from the from the driving element. The drilling element is configured to extend through a cannula of the bone screw and to penetrate the vertebra. The driving element is configured to engage the head of the bone screw as the drilling element penetrates through a vertebral endplate.
- In a further particular embodiment, an intervertebral fusion with fixation system is disclosed. The system includes an intervertebral fusion with fixation device configured to be implanted between plural vertebrae. The device includes a spacer with an insertion wall, a trailing wall opposite to the insertion wall, a first lateral wall, a second lateral wall opposite to the first lateral wall, a top surface, and a bottom surface opposite to the top surface. The device further includes a first fixating element rigidly preloaded in a first portion of the spacer along a first linear trajectory, the first fixating element configured to penetrate and secure to a first vertebra by advancing along the first linear trajectory. Additionally, the device also includes a second fixating element rigidly preloaded in a second portion of the spacer along a second linear trajectory that is different from the first linear trajectory, the second fixating element configured to penetrate and secure to a second vertebra by advancing along the second trajectory. The system also includes an integrated integrated drill and screwdriver instrument. The integrated instrument includes a handle, a driving element configured to engage a head of a bone screw and rotate the bone screw into a vertebra, and a drilling element extending from the from the driving element. The drilling element is configured to extend through a cannula of the bone screw and to penetrate the vertebra. The driving element is configured to engage the head of the bone screw as the drilling element penetrates through a vertebral endplate.
- In yet another particular embodiment, a method to secure plural vertebrae is disclosed. The method includes implanting an intervertebral fusion with fixation device between plural vertebrae. The fusion with fixation device includes a spacer, a first fixating element rigidly preloaded in a first portion of the spacer along a first linear trajectory, and a second fixating element rigidly preloaded in a second portion of the spacer along a second linear trajectory that is different from the first linear trajectory. The method further includes driving the first fixating element along the first linear trajectory to penetrate the first vertebra and to secure the spacer to a first vertebra, and driving the second fixating element along the second linear trajectory to penetrate the second vertebra and to secure the spacer to a second vertebra. The method also includes extending an integrated drill and screwdriver instrument through a cannula of the first fixating element and a cannula of the second fixating element, drilling the plural vertebrae with a drilling element, engaging the first fixating element and second fixating element with a driving element as the drilling element penetrates through a vertebral endplate of the plural vertebrae, and rotating the first fixating element and second fixating element via the driving element to penetrate the plural vertebrae and to secure the spacer to the plural vertebrae. The method further includes locking the first fixation element and second fixation element with respect to the spacer to prevent the first fixation element and second fixation element from extruding from the plural vertebrae and from the spacer.
- In a further embodiment, a method to assemble an intervertebral fusion with fixation device is disclosed. The method includes rigidly preloading a first fixating element in a first portion of a spacer along a first linear trajectory and a second fixating element in a second portion of the spacer along a second linear trajectory, the first linear trajectory being different from the second linear trajectory.
-
FIG. 1 is a perspective view of an example spacer of an intervertebral fusion with fixation device; -
FIG. 2 is a front view of the example spacer shown inFIG. 1 ; -
FIG. 3 is a side view of the example spacer shown inFIG. 1 ; -
FIG. 4 is a perspective view of an example fixation element of the intervertebral fusion with fixation device; -
FIG. 5 is a cross-sectional side view of the example fixation element show inFIG. 4 ; -
FIG. 6 is a side view of an example integrated drill and screwdriver driving instrument; -
FIG. 7 is a perspective exploded view of a tip of the example integrated drill and screwdriver drilling tip shown inFIG. 6 ; -
FIG. 8 is a perspective view of an example intervertebral fusion with fixation device with the example fixation elements shown inFIG. 4 preloaded in the example spacer shown inFIG. 1 ; -
FIG. 9 is a perspective view of the example intervertebral fusion with fixation device ofFIG. 8 with the example integrated drill and screwdriver ofFIG. 6 actuating a fixation element shown inFIG. 4 . -
FIG. 10 is a translucent perspective view of an example intervertebral fusion with fixation device with the example fixation element ofFIG. 4 in a locked position within a vertebra. -
FIG. 1 is a perspective view of anexample spacer 100 of an intervertebral fusion with fixation device. The intervertebral fusion with fixation device is illustrated inFIG. 8 . Thespacer 100 is made of a weight-bearing material, such as a polymer, metal, ceramic, biological material, or composite thereof, that is capable of withstanding the normal stresses of bodily movement and positioning, while also allowing sufficient elasticity. The material can have a flexural modulus and tensile strength comparable to bone. For example, thespacer 100 can be made of polyetheretherketone (PEEK), a thermoplastic with a flexural modulus of 4.2 GPa and a tensile strength of 95 MPa. Another benefit of PEEK is its high level of biocompatibility in a dynamic and immunoreactive environment. Other materials and combinations of materials are possible. - The
spacer 100 includes aninsertion wall 110, trailingwall 112,lateral walls top surface 102,bottom surface 104, and throughopening 114 extending between and through thetop surface 102 andbottom surface 104 for bone graft insert. - In various embodiments, the dimensions of the
spacer 100 are approximately the following: the length of thespacer 100 between aninsertion wall 110 and trailingwall 112 is between about 10 mm and 80 mm; the width of thespacer 100 between a firstlateral wall 106 and secondlateral wall 108 is between about 10 mm and 80 mm; and the height of thespacer 100 between atop surface 102 andbottom surface 104 is between about 4 mm and 30 mm. The foregoing dimensions are non-limiting and are intended to be adjusted depending on the specific spinal anatomy of the patient. - The
opening 114 can have a volume approximately between 0 cm3 and 8 cm3. Other volumes can be provided. While theinsertion wall 110, trailingwall 112, andlateral walls top surface 102 andbottom surface 104 may be tapered or curved with respect to one another to conform to intervertebral lordosis or curvature. Thelateral walls lateral surfaces - The trailing
wall 112 includes a plurality of through holes 202 (shown inFIG. 2 ) extending from thecentral opening 114 to the exterior of thespacer 100 to receive, secure, and guide plural fixation elements 400 (shown inFIG. 4 ). Each of the foregoing holes 202 is oriented to provide a trajectory for a fixation element (shown inFIG. 4 ). The trajectories of theholes 202 can be oriented in directions lateral, medial, superior, inferior, or any combination thereof to the spacer to provide multi-axial fixation to the vertebrae. In some embodiments, theholes 202 can direct thefixation elements 400 in divergent trajectories to counterbalance one another from any opposing torques or shear stresses initiated by vertebral motion. The dimensions of theholes 202 are approximately the following: the medial and/or lateral angle in respect tolateral walls surfaces holes 202 are approximately between 0.5 mm and 10 mm. -
FIG. 2 is a front view of theexample spacer 100 shown inFIG. 1 . Now with reference toFIGS. 1 and 2 , thespacer 100 includesridges 116 onsurfaces holes 202 to reinforce thespacer 100 during advancement of thefixation elements 400. For example,ridges 116 can be provided about the exits to the outside of thespacer 100 and can be of various dimensions and tapers along thesurfaces ridges 116 can be omitted. Thespacer 100 further includesridges 118 along thesurfaces spacer 100 through micro-scale contact with the vertebral plates. - The
spacer 100 can include pluralradiopaque markers 120 to enhance radiographic visualization of thespacer 100. Themarkers 120 can be made of a biocompatible radiopacic material, such as tantalum, platinum alloys, gold alloys, or palladium alloys. Other applicable materials may also be employed.Plural markers 120 can be provided near thewalls spacer 100 for clinicians during radiographic imaging. Furthermore, themarkers 120 can assume various geometries and volumes within thespacer 100 depending on visualization requirements. In various embodiments, themarkers 120 can be omitted. -
FIG. 3 is a side view of anexample spacer 100 of an intervertebral fusion with fixation device ofFIG. 8 . In a particular embodiment, the trailingheight 302 gradually decreases to theinsertion height 304 at a taper to approximate natural lordosis. Additionally, theridges 116 can be also tapered to minimize friction during insertion and facilitate smooth entry of thespacer 100 into the intervertebral space. -
FIG. 4 is a perspective view of anexample fixation element 400. In a particular embodiment, thefixation element 400 can be made of a biocompatible metal, such as a titanium alloy. Other applicable materials may also be employed. Thefixation element 400 includes atip 405 that locks into and interfaces with theholes 202 during assembly to maintain a preloaded position, and penetrates bone during engagement with vertebral endplates. Thefixation element 400 has aminor diameter 402 that is between about 1 mm and 10 mm. Thefixation element 400 also includes amajor diameter 404 of threading that is between 2 mm and 15 mm to provide cutting during engagement. - Additionally, the
tip 405 includesflutes 406 to facilitate penetration into the vertebra during initial engagement. Thefixation element 400 further includes ahead 407 with a conically shapedbody 408 to pressure-fit into theholes 202 after advancement via aninstrument receiver 410. Theinstrument receiver 410 can interface with a driving instrument (shown inFIG. 6 ). In a particular embodiment, thehead 407 includes ahook protrusion 412 with a sharp edge that can cut into thehole 202 after thefixation element 400 is advanced (e.g., fully) into the vertebra and thehead 407 is in contact with thespacer 100. The contact between the sharp edge of thehook protrusion 412 and thehole 202 functions as a locking mechanism to prevent extrusion of thefixation element 400. -
FIG. 5 is a cross-sectional side view of anexample fixation element 400 ofFIG. 4 . As illustrated, thefixation element 400 includes acannula 502 that allows a drilling tip of the driving instrument (shown inFIG. 6 ) to pass into and through thefixation element 400 to facilitate vertebral endplate pre-drilling and preparation for advancement of thefixation element 400. Thefixation element 400 further includes aplatform 504 that connects or interfaces the drivinginstrument receiver 410 andcannula 502 to contact and limit the depth of motion of the driving instrument (shown inFIG. 6 ) in relation to thefixation element 400. -
FIG. 6 is a side view of an example integrated drill and screwdriver driving instrument (driving instrument) 600. In a particular embodiment, the drivinginstrument 600 can be made of a metal, such as titanium. Other applicable materials may also be employed. The drivinginstrument 600 includes anintegrated tip 614 that can penetrate and pre-drill vertebral endplates with adrill tip 606 as well as engage the drivinginstrument receiver 410 of afixation element 400 with afixation element interface 604. - The
drill tip 606 of theintegrated tip 614 can pass into and through thecannula 502 of thefixation element 400 in order to penetrate and pre-drill a vertebral endplate. Thefixation element interface 604 can contact the drivinginstrument receiver 410 once thedrill tip 606 has penetrated through the vertebral endplate into the softer bony layer. In a particular embodiment, both thefixation element interface 604 and corresponding drivinginstrument receiver 410 are of a quadrilateral shape to facilitate rigid contact between the surfaces and allow engagement of thefixation element 400. - The driving
instrument 600 includes abody 602 to increase operational distance from thespacer 100 and provide access under various angulations. Thebody 602 is smoothly mated to theintegrated tip 614 with aconical transition element 610. Furthermore, the drivinginstrument 600 includes ahandle 612 that can be operated manually or by an electrical or mechanical tool. In a particular embodiment, thehandle 612 can be constructed as a hexagonal bit to fit a standard screwdriver. Thehandle 612 is smoothly mated to thebody 602 with aconical transition element 603. -
FIG. 7 is an exploded perspective view of the example integratedtip 614. Theintegrated tip 614 includes cuttingblades 702 to facilitate vertebral penetration during advancement. Theintegrated tip 614 further includes arounded transition element 704 between thefixation element interface 604 and thedrill tip 606 to allow smooth contact between thefixation element interface 604 and drivinginstrument receiver 410 during the initial engagement of thefixation element 400. -
FIG. 8 is a perspective view of an example intervertebral fusion withfixation device 800 with the pluralexample fixation elements 400 ofFIG. 4 preloaded in theexample spacer 100 ofFIG. 1 . As illustrated, thefixation elements 400 can be preloaded into thespacer 100 viaholes 202. Theflutes 406 and threading 404 cut into and secure thefixation elements 400 to thespacer 100 viaholes 202 to maintain a preloaded assembly. This preloaded assembly ensures fixed trajectories for thefixation elements 400 during delivery of thedevice 800 and eliminates the need for alignment post-implantation. -
FIG. 9 is a perspective view of an example intervertebral fusion with fixation device ofFIG. 8 with anexample driving instrument 600 ofFIG. 6 actuating afixation element 400 ofFIG. 4 . As illustrated, theintegrated tip 614 is delivered into and through thecannula 502 of thefixation element 400 to pre-drill the vertebral endplate with thecutting blades 702 of thefixation element 400. The penetration of theintegrated tip 614 through the vertebral endplate combined with the linear force applied to thehandle 612 drives thefixation element interface 604 into contact with the drivinginstrument receiver 410 of thefixation element 400. Simultaneously, the torque from thehandle 612 engages thefixation element interface 604, which in turn actuates the drivinginstrument receiver 410 and advances thefixation element 400 into vertebral endplate. Additionally, the fixation element flutes 406 andmajor threading 404 penetrate and secure thefixation element 400 to the endplate of the vertebra. -
FIG. 10 is a translucent perspective view of an example intervertebral fusion withfixation device 800 with the pluralexample fixation elements 400 ofFIG. 4 in a locked position and secured to avertebra 1001. In a particular embodiment, thehook protrusion 412 of thefixation element 400 pressure fits theholes 202 of thespacer 100 to prevent thefixation element 400 from toggling and backing-out. Furthermore, thehook protrusion 412 rigidly cut into thespacer 100 via its sharp edge to limit the ability of thefixation element 400 to torque towards the trailingwall 112 of thedevice 800 and away from thevertebra 1001. Additionally, theridges 118 penetrate adjacent vertebral endplates and provide ancillary stability. - Other apparent modifications and configurations of the invention will be appreciated by those skilled in the art to allow varying applications of the disclosed embodiments without departing from the scope of the embodiments described herein. The disclosed specifications and principles are intended to be used for illustrative purposes only, with the true scope and spirit of the patent document being defined by the following claims.
Claims (14)
1. An intervertebral fusion with fixation device configured to be implanted between plural vertebrae, the device comprising:
a spacer with an insertion wall, a trailing wall opposite to the insertion wall, a first lateral wall, a second lateral wall opposite to the first lateral wall, a top surface, and a bottom surface opposite to the top surface;
a first fixating element rigidly preloaded in a first portion of the spacer along a first linear trajectory, the first fixating element configured to penetrate and secure to a first vertebra by advancing along the first linear trajectory; and
a second fixating element rigidly preloaded in a second portion of the spacer along a second linear trajectory that is different from the first linear trajectory, the second fixating element configured to penetrate and secure to a second vertebra by advancing along the second trajectory.
2. The intervertebral fusion with fixation device of claim 1 , wherein the spacer includes a through opening having an entrance proximate the top surface and an exit proximate the bottom surface to facilitate contact and in-growth of bone fusion material with the first vertebra and second vertebra.
3. The intervertebral fusion with fixation device of claim 1 , wherein the spacer is made of polyetheretherketone (PEEK), other polymers, metal, ceramics, or composites.
4. The intervertebral fusion with fixation device of claim 1 , wherein at least one of the first fixating element and the second fixating element is a cannulated bone screw.
5. The intervertebral fusion with fixation device of claim 4 , wherein the cannulated bone screw includes a head that is configured to integrate with a driving instrument.
6. The intervertebral fusion with fixation device of claim 4 , wherein the cannulated bone screw includes a head that has a locking mechanism configured to penetrate and lock into spacer to prevent screw toggling and extrusion.
7. An integrated drill and screwdriver instrument, the instrument comprising:
a handle;
a driving element configured to engage a head of a bone screw and to rotate the bone screw into a vertebra,
a drilling element extending from the driving element, the drilling element configured to extend through a cannula of the bone screw and to penetrate the vertebra, the driving element engaging the head of the bone screw as the drilling element penetrates through a vertebral endplate.
8. An intervertebral fusion with fixation system, the system compromising:
an intervertebral fusion with fixation device configured to be implanted between plural vertebrae, the device comprising:
a spacer with an insertion wall, a trailing wall opposite to the insertion wall, a first lateral wall, a second lateral wall opposite to the first lateral wall, a top surface, and a bottom surface opposite to the top surface;
a first fixating element rigidly preloaded in a first portion of the spacer along a first linear trajectory, the first fixating element configured to penetrate and secure to a first vertebra by advancing along the first linear trajectory; and
a second fixating element rigidly preloaded in a second portion of the spacer along a second linear trajectory that is different from the first linear trajectory, the second fixating element configured to penetrate and secure to a second vertebra by advancing along the second trajectory; and
an integrated drill and screwdriver instrument, the instrument comprising:
a handle;
a driving element configured to engage a head of a bone screw and to rotate the bone screw into a vertebra; and
a drilling element extending from the driving element, the drilling element configured to extend through a cannula of the bone screw and to penetrate the vertebra, the driving element engaging the head of the bone screw as the drilling element penetrates through a vertebral endplate.
9. A method to secure plural vertebrae, the method comprising:
implanting an intervertebral fusion with fixation device between plural vertebrae, the device comprising:
a spacer with an insertion wall, a trailing wall opposite to the insertion wall, a first lateral wall, a second lateral wall opposite to the first lateral wall, a top surface, and a bottom surface opposite to the top surface;
a first fixating element rigidly preloaded in a first portion of the spacer along a first linear trajectory; and
a second fixating element rigidly preloaded in a second portion of the spacer along a second linear trajectory that is different from the first linear trajectory, the second fixating element configured to penetrate and secure to a second vertebra by advancing along the second trajectory;
driving the first fixating element along the first linear trajectory to penetrate the first vertebra and to secure the spacer to the first vertebra; and
driving the second fixating element along the second linear trajectory to penetrate the second vertebra and to secure the spacer to the second vertebra.
10. The method of claim 9 , the method comprising:
introducing an integrated drill and screwdriver instrument to the first fixating element of the intervertebral fusion with fixation device, the instrument comprising:
a handle;
a driving element configured to engage a head of the first fixating element; and
a drilling element extending from the driving element, the drilling element configured to extend through a cannula of the first fixating element; and
drilling the first vertebra with the drilling element;
engaging the first fixating element with the driving element as the drilling element penetrates through a vertebral endplate of the first vertebra; and
rotating the first fixating element via the driving element to penetrate the first vertebra and to secure the spacer to the first vertebra.
11. The method of claim 10 , the method comprising:
locking the first fixating element with respect to the spacer to prevent the first fixating element from extruding from the spacer.
12. The method of claim 9 , the method comprising:
introducing the instrument to the second fixating element of the intervertebral fusion with fixation device;
drilling the second vertebra with the drilling element;
engaging the second fixating element with the driving element as the drilling element penetrates through a vertebral endplate of the second vertebra; and
rotating the second fixating element via the driving element to penetrate the second vertebra and to secure the spacer to the second vertebra.
13. The method of claim 12 , the method comprising:
locking the second fixating element with respect to the spacer to prevent the second fixating element from extruding from the spacer.
14. A method to assemble an intervertebral fusion with fixation device, the method comprising:
providing a spacer that includes an insertion wall, a trailing wall opposite to the insertion wall, a first lateral wall, a second lateral wall opposite to the first lateral wall, a top surface, and a bottom surface opposite to the top surface;
preloading a first fixating element rigidly in a first portion of the spacer along a first linear trajectory, the first fixating element configured to penetrate and secure to a first vertebra by advancing along the first linear trajectory; and
preloading a second fixating element rigidly in a second portion of the spacer along a second linear trajectory that is different from the first linear trajectory, the second fixating element configured to penetrate and secure to a second vertebra by advancing along the second trajectory.
Priority Applications (2)
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US13/371,242 US20120209385A1 (en) | 2011-02-15 | 2012-02-10 | Anterior intervertebral fusion with fixation system, device and method |
US14/492,160 US9138331B2 (en) | 2011-02-15 | 2014-09-22 | Anterior intervertebral fusion with fixation system, device, and method |
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Also Published As
Publication number | Publication date |
---|---|
CN104105460A (en) | 2014-10-15 |
US9138331B2 (en) | 2015-09-22 |
WO2012112406A2 (en) | 2012-08-23 |
EP2675401A4 (en) | 2015-05-20 |
US20150012102A1 (en) | 2015-01-08 |
EP2675401A2 (en) | 2013-12-25 |
WO2012112406A3 (en) | 2014-04-17 |
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