US20160213405A1 - Vertebral plate systems and methods of use - Google Patents
Vertebral plate systems and methods of use Download PDFInfo
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- US20160213405A1 US20160213405A1 US15/007,348 US201615007348A US2016213405A1 US 20160213405 A1 US20160213405 A1 US 20160213405A1 US 201615007348 A US201615007348 A US 201615007348A US 2016213405 A1 US2016213405 A1 US 2016213405A1
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- bone
- vertebral plate
- bone screw
- orifices
- bottom surfaces
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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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
- A61B17/7059—Cortical plates
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- A—HUMAN NECESSITIES
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- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
- 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
- A61B17/8625—Shanks, i.e. parts contacting bone tissue
-
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- 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
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- A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
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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
- 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
- A61F2/4465—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 having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
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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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- A61F2/44—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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- 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
- 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
- A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30593—Special structural features of bone or joint prostheses not otherwise provided for hollow
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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
- A61F2/30—Joints
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30621—Features concerning the anatomical functioning or articulation of the prosthetic joint
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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
- A61F2/30—Joints
- A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
- A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
- A61F2002/30772—Apertures or holes, e.g. of circular cross section
- A61F2002/30784—Plurality of holes
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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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- 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
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- A61F2002/3092—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth having an open-celled or open-pored structure
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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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- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
- A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
Definitions
- the present disclosure relates generally to devices and methods for treating spinal conditions, and in particular, to vertebral plate systems and methods for fixation and stabilization of the spine.
- the human spinal column is a highly complex structure. It includes more than twenty discrete bones, known as vertebrae, coupled sequentially to one another to house and protect critical elements of the nervous system.
- the cervical portion of the spine which comprises the top of the spine up to the base of the skull, includes the first seven vertebrae.
- the intervertebral discs may begin to deteriorate and weaken, potentially resulting in chronic pain, degenerative disc disease, or even tearing of the disc.
- the disc may deteriorate or weaken to the point of tearing and herniation, in which the inner portions of the disc protrude through the tear.
- a herniated disc may press against, or pinch, the spinal nerves, thereby causing radiating pain, numbness, tingling, and/or diminished strength or range of motion.
- a vertebral plate system having one or more apertures and one or more bone screws is affixed to the vertebrae and oriented to prevent such protrusion.
- a common problem associated with the use of such a vertebral plate system is the tendency of the bone screws to “back out” or pull away or otherwise withdraw from the bone into which they are mounted. This problem occurs, primarily, due to the normal torsional and bending motions of the body and spine. As the screws become loose and pull away or withdraw from the bone, the heads of the screws can rise above the surface of the vertebral plate, which results is pain and discomfort for the patient or possibly the separation of the vertebral plate from one or more vertebrae.
- a vertebral plate including a top and bottom surface, a plurality of orifices defined through at least one of the top and bottom surfaces, and a plurality of bone screw openings defined through the top and bottom surfaces.
- the plurality of orifices defined through the top surface including a different cross-section than a plurality of orifices defined through the bottom surface.
- the vertebral plate may include a lip defined within each bone screw opening of the plurality of bone screw openings, wherein the lip is configured to engage a corresponding bone screw to retain the corresponding bone screw therein.
- the top and bottom surfaces may include concave curvatures.
- the concave curvatures of the top and bottom surfaces may extend in the cephalad/caudal direction.
- the concave curvatures of the top and bottom surfaces may extend in a medial/lateral direction.
- the concave curvatures of the top and bottom surfaces may extend in both a cephalad/caudal direction and a medial/lateral direction.
- the vertebral plate may be formed using an additive manufacturing process.
- the vertebral plate may be formed using Selective Laser Powder Processing.
- the plurality of orifices defined through the top surface may be offset from the plurality of orifices defined through the bottom surface.
- a vertebral plate system including a vertebral plate and a plurality of bone screws.
- the vertebral plate includes a top and bottom surface, a plurality of orifices defined through at least one of the top and bottom surfaces, and a plurality of bone screw openings defined through the top and bottom surfaces.
- the plurality of orifices defined through the top surface includes a different cross-section than the plurality of orifices defined through the bottom surface.
- the plurality of bone screws are configured to be advanced within the plurality of bone screw openings and driven into a bone.
- the plurality of bone screws may be semi-constrained bone screws.
- the plurality of semi-constrained bone screws may include a shank having a first helical thread disposed thereon and a second helical thread disposed on a head portion thereof.
- the pitch of the first helical thread may be different than the pitch of the second helical thread, such that the first helical thread threads into vertebral bone whereas the second helical thread engages a lip disposed within each one of the plurality of bone screw openings, thereby retaining the semi-constrained bone screw within the vertebral plate.
- the plurality of orifices defined through the top surface may be offset from a plurality of orifices defined through the bottom surface.
- a method of performing spinal surgery includes inserting a vertebral plate into an incision of a patient, the vertebral plate including a top and a bottom surface, a plurality of orifices defined through at least one of the top and bottom surfaces, and a plurality of bone screw openings defined through the top and bottom surfaces.
- the plurality of orifices defined through the top surface includes a different cross-section than a plurality of orifices defined through the bottom surface.
- the method further includes advancing a plurality of bone screws within each bone screw opening of the plurality of bone screw openings and driving each bone screw of the plurality of bone screws into a bone.
- the method may include applying a material to the vertebral plate to promote bone ingrowth within the plurality of orifices.
- driving each bone screw of the plurality of bone screws into a bone may include driving a plurality of semi-constrained bone screws into a bone.
- driving each bone screw of the plurality of bone screws into a vertebra may include threading a first helical thread disposed on a shank of the semi-constrained bone screw into a vertebra and engaging a second helical thread disposed on a head of the semi-constrained bone screw with a lip disposed within each bone screw opening of the plurality of bone screw openings, thereby retaining the plurality of semi-constrained bone screws within the vertebral plate.
- the method may include advancing an interbody spacer within a prepared intervertebral space.
- applying a material to the vertebral plate may include applying a bone growth putty to the vertebral plate to promote bone ingrowth within the plurality of orifices.
- FIG. 1 is a perspective view of a vertebral plate provided in accordance with the present disclosure
- FIG. 2 is a top view of the vertebral plate of FIG. 1 ;
- FIG. 2A is a cross-sectional view of the vertebral plate of FIG. 1 , taken along line 2 A- 2 A;
- FIG. 3 is a side view of the vertebral plate of FIG. 1 ;
- FIG. 4A is a bottom, perspective view, of a semi-constrained bone screw capable of use with the vertebral plate of FIG. 1 ;
- FIG. 4B is a side view of the semi-constrained bone screw of FIG. 4A ;
- FIG. 5A is a perspective view of the vertebral plate of FIG. 1 shown as aligned with a spinal column of a patient having a vertebral spacer interposed between adjacent vertebral bodies;
- FIG. 5B is perspective view of the vertebral plate of FIG. 5A shown as being fastened to a plurality of vertebral bodies
- FIG. 6 is a cross-sectional view of the vertebral plate of FIG. 1 illustrating an orifice defined through an upper surface being offset from an orifice defined through a bottom surface;
- FIG. 7 illustrates various cross-sectional configurations of an orifice defined through the vertebral plate of FIG. 1 .
- the term “clinician” refers to a doctor, a nurse or any other care provider and may include support personnel.
- proximal will refer to the portion of the device or component thereof that is closer to the clinician and the term “distal” will refer to the portion of the device or component thereof that is farther from the clinician.
- distal will refer to the portion of the device or component thereof that is farther from the clinician.
- cephalad is used in this application to indicate a direction toward a patient's head, whereas the term “caudal” indicates a direction toward the patient's feet.
- the term “lateral” indicates a direction toward a side of the body of the patient, i.e., away from the middle of the body of the patient
- the term “medial” indicates a direction toward the inside of the body of the patient, i.e., toward the middle of the body of the patient.
- FIG. 1 illustrates an embodiment of a vertebral plate 100 provided in accordance with the present disclosure.
- Vertebral plate 100 includes a top surface 102 and a bottom surface 104 defining a thickness of vertebral plate 100 .
- Vertebral plate 100 may be substantially planar or contoured in either or both the cephalad/caudal and/or medial/lateral planes.
- top surface 102 and bottom surface 104 may include concave contours having the same or different radius of curvature, depending on the application or needs of the patient.
- top surface 102 and bottom surface 104 of vertebral plate are configured to include concave contours having the same radius of curvature.
- vertebral plate 100 may include any suitable profile capable of securing adjacent vertebra thereto, such as square, oval, circular or the like.
- vertebral plate 100 includes a plurality of bone screw openings 106 defined therethrough configured to receive a corresponding plurality of bone screws or bone fixation elements 200 ( FIG. 4A ), as will be described in further detail hereinbelow.
- Each bone screw opening 106 is similar in construction, and therefore, only one will be described in detail hereinbelow.
- Bone screw opening 106 includes an annular sidewall 106 a extending downwards from the top surface 102 of vertebral plate 100 .
- a lip 106 b is disposed in bone screw opening 106 and extends inwards from annular sidewall 106 a , forming a generally frusto-conical configuration on an upper and lower side thereof.
- lip 106 b may include any suitable profile, such as convex, concave, or the like.
- the lip 106 b is disposed within bone screw opening 106 medially between top and bottom surfaces 102 , 104 and is configured to engage a bone screw 200 ( FIGS. 4A and 4B ) such that rotating bone screw 200 causes the threads of an independent locking head 212 of bone screw 200 to engage lip 106 b .
- lip 106 b is located in proximity to the bottom surface 104 of vertebral plate 100 .
- Vertebral plate 100 is constructed of a biocompatible material, such as commercially pure titanium or titanium alloy and includes a porosity capable of promoting bone ingrowth with vertebral plate 100 .
- top and bottom surfaces 102 , 104 have a surface roughness that can promote bone ingrowth.
- the surface roughness may be in a range of about 0.10-50 ⁇ m, and preferably in a range of about 3-4 ⁇ m.
- top and bottom surfaces 102 , 104 may include the same or different surface roughness's (i.e., the surface roughness of top surface 102 may be different than the surface roughness of bottom surface 104 ), or top and bottom surfaces 102 , 104 may not include a surface roughness; rather, top and bottom surfaces 102 , 104 may be smooth. In embodiments, top and bottom surfaces 102 , 104 may include any combination of surface roughness or smooth surface.
- vertebral plate 100 includes a plurality of orifices 110 defined therethrough configured to promote bone ingrowth.
- orifices 110 may include any suitable cross-section capable of promoting bone ingrowth, such as oval, square, hexagonal, diamond, rectangular, or the like ( FIG. 6 ).
- the circular cross-section of orifices 110 mimic bone growth along Haversian canals and lamellar structures of bone. In this manner, orifices 110 may pass entirely through top surface 102 and bottom surface 104 of vertebral body 100 .
- orifices 110 may be offset in relation to one another ( FIG. 7 ). In this manner, an orifice 110 defined through bottom surface 104 will be offset from a corresponding orifice 110 defined through top surface 102 .
- orifices 110 may be defined through top and bottom surfaces 102 , 104 normal thereto, at angles relative thereto. In one non-limiting embodiment, orifices 110 are defined through top and bottom surfaces at angles incident relative to each other, thereby forming a chevron configuration. As can be appreciated, each of the orifices 110 formed through top and bottom surfaces 102 , 104 forms a respective channel therebetween, thereby interconnecting an orifice formed through top surface 102 and an orifice formed through bottom surface 104 . It is contemplated that the density of orifices 110 may be different on top surface 102 than on bottom surface 104 , or may increase or decrease in density at various locations on each of top and bottom surfaces 102 , 104 .
- Orifices 110 include a diameter in a range of about 50-1000 ⁇ m, although a diameter between 300-700 ⁇ m is preferable. As can be appreciated, for shapes other than circular, orifices 110 include a cross-sectional area in a range of about 0.0019 ⁇ m 2 -0.785 ⁇ m 2 , although a cross-sectional area between 0.0707 ⁇ m 2 -0.385 ⁇ m 2 is preferable. As can be appreciated, the plurality of orifices 110 may include orifices 110 having varying sizes and shapes relative to each other.
- the orifices 110 defined through top surface 102 may include a different cross-section that those orifices 110 defined through bottom surface 104 (i.e., circular on top surface 102 while square on bottom surface 104 , or vice versa).
- the plurality of orifices 110 reduce the density and stiffness of vertebral plate 100 to enable the application of bone putty or the like (e.g., bone morphogenetic proteins (BMP), etc.) to vertebral plate 100 to promote bone ingrowth within vertebral plate 100 .
- Bone ingrowth strengthens vertebral plate 100 and reduces the load applied to bone screws 200 . In this manner, the probability that vertebral plate 100 would fracture would be reduced, and the likelihood that micromotion would occur would likewise be reduced.
- vertebral plate 100 may be manufactured by means of additive manufacturing methods (e.g., SDM, SLPP, DMLS (i.e., EOS), SLS, SLM, SHS, EBM, VAT photopolymerisation, material jetting, binder jetting, or the like).
- SLPP Selective Laser Powder Processing
- SLPP utilizes powdered metal and a laser which sinters or cures the metal in a selective fashion according to the design intent in thin layers.
- the layers may have a thickness of about 250 Vertebral plate 100 is built layer by layer to allow for more design options and features which would be difficult to be machined using conventional methods. Specifically, a first layer of powder is applied to a specialized build plate, at which point the laser cures portions of the powder according to the design intent. At this point, a second layer is applied to the build plate and the laser is again used to cure selective portions of this second layer. This process is repeated until vertebral plate 100 is fully formed. Once vertebral plate 100 is fully formed, uncured powder is removed using compressed air or other similar means. Next, post machining is performed on vertebral plate 100 to remove any burrs or similar imperfections embedded within vertebral plate 100 during the additive manufacturing process.
- the burrs are removed by means of buffer wheels, clipper, files, or the like.
- One de-burred, vertebral plate 100 is heat treated, and thereafter, media blasted using aluminum oxide. Thereafter, vertebral plate 100 is immersed in a hydrofluoric bath to strip the aluminum oxide therefrom. Finally vertebral plate 100 is inspected by quality control personnel (or using automated means), cleaned via ultrasonic cleaning, dried, and packaged. Additionally, using SLPP, it is contemplated that vertebral plate 100 may be customized for a designated patient.
- U.S. Pat. No. 8,590,157 issued on Nov. 26, 2013 to Kruth et al., the entire contents of which are hereby incorporated by reference herein.
- Vertebral plate 100 may be constructed from titanium, titanium alloy, cobalt-chrome, ceramic, polyetheretherketone (PEEK), or any other suitable biocompatible material.
- vertebral plate 100 may be manufactured using a three-dimensional printer utilizing a biocompatible polymer.
- Bone screw 200 includes an elongated shank 202 , which is mechanically coupled to a removable tapered locking screw head 212 .
- Shank 202 includes a uniform outer diameter and a first continuous helical thread 210 formed thereon for threaded insertion into bone.
- a second continuous helical thread 224 is formed on the independent head portion 212 for engaging lips 106 b of vertebral plate 100 .
- the pitch of the first thread 210 is greater than the pitch of the second thread 224 .
- Each of the first and second threads 210 , 224 includes a substantially uniform pitch.
- bone screws 200 are constructed of a material which is harder than the material of lips 106 b of vertebral plate 100 .
- bone screws 200 may be formed of titanium alloy (e.g., Ti-6Al-4V) and the lips 106 b of vertebral plate being formed from a softer material, such as commercially pure titanium.
- titanium alloy e.g., Ti-6Al-4V
- the lips 106 b of vertebral plate being formed from a softer material, such as commercially pure titanium.
- bone screws 200 may be monolithically formed such that head portion 212 of bone screws 200 is rigidly constrained in relation to shank 202 .
- bone screw 200 may be of a semi-constrained variety wherein the head portion is pivotable with respect to a longitudinal axis of the shank, thereby allowing the head portion to pivot while the shank remains stationary.
- exemplary semi-constrained bone screws reference may be made to U.S. Pat. No. 8,574,272, issued Nov. 5, 2013 to Wallenstein et al., and U.S. Pat. No. 9,095,390, issued Aug. 4, 2015 to Wallenstein et al., the entire contents of each of which are hereby incorporated by reference herein.
- vertebral plate 100 and bone screws 200 may be provided in the form of a system or kit.
- the system or kit may include any suitable interbody spacer 300 ( FIG. 5A ).
- Interbody spacer 300 includes a body portion extending between distal and proximal end surfaces, respectively, to define top and bottom vertebral engaging surfaces and opposed side surfaces.
- the top and bottom surfaces each include a plurality of ridges disposed thereon to aid in securing interbody spacer 300 to each respective adjacent vertebral body and stability against fore and aft, oblique or side to side movement of interbody spacer 300 within the intervertebral space.
- vertebral plate 100 is inserted within an incision and aligned with adjacent vertebra ( FIGS. 5A and 5B ).
- bone screws 200 are advanced within each of the plurality of bone screw openings 106 of vertebral plate 100 .
- Each bone screw 200 is driven into the vertebral body using a suitable tool or driver (not shown).
- threads 224 of head portion 212 engage the lip 106 b disposed within each bone screw opening 106 .
- screw shank 202 varies in angular orientations with respect to the axis of the bone screw opening 106 .
- the screw shank 202 remains free to articulate relative to the screw head 212 and, hence, vertebral plate 100 .
- bone growth putty or other suitable compositions e.g., BMP, etc.
- an interbody spacer 300 is first advanced within a prepared intervertebral space. In this manner, the vertebral plate 100 helps prevent the interbody spacer 300 from being forced out of the intervertebral space ( FIGS. 5A and 5B ).
- This process may be repeated as many times as the procedure requires, whether it be for the same vertebral plate 100 or for a plurality of vertebral plates 100 as required by the procedure being performed.
- the manufacturing processes and orifice designs detailed above may be utilized to form various other medical devices known in the art.
- the additive manufacturing process detailed above may be employed to form corpectomy devices, fixed spinal implants, expandable spinal implants, bone screws, cervical implants, and the like.
- the orifice designs detailed above may be formed in any of the beforementioned medical devices that would benefit from an increased ability to fuse with bone. Examples of such devices may be found in the following commonly owned references: U.S. Pat. No. 8,585,761 to Theofilos, U.S. Pat. No. 8,673,011 to Theofilos et al., U.S. application Ser. No. 14/936,911 to Sutterlin et al., U.S. Pat. No.
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Abstract
Description
- This application claims priority to, and the benefit of, U.S. Provisional Patent Application Ser. No. 62/108,197, filed on Jan. 27, 2015 and U.S. Provisional Patent Application Ser. No. 62/196,371, filed on Jul. 24, 2015. The entire contents of each of these prior applications are hereby incorporated by reference herein.
- 1. Technical Field
- The present disclosure relates generally to devices and methods for treating spinal conditions, and in particular, to vertebral plate systems and methods for fixation and stabilization of the spine.
- 2. Background of the Disclosure
- The human spinal column is a highly complex structure. It includes more than twenty discrete bones, known as vertebrae, coupled sequentially to one another to house and protect critical elements of the nervous system. The cervical portion of the spine, which comprises the top of the spine up to the base of the skull, includes the first seven vertebrae.
- For many reasons, such as aging and trauma, the intervertebral discs may begin to deteriorate and weaken, potentially resulting in chronic pain, degenerative disc disease, or even tearing of the disc. Ultimately, the disc may deteriorate or weaken to the point of tearing and herniation, in which the inner portions of the disc protrude through the tear. A herniated disc may press against, or pinch, the spinal nerves, thereby causing radiating pain, numbness, tingling, and/or diminished strength or range of motion.
- Many treatments are available to remedy these conditions, including surgical procedures in which one or more damaged intervertebral discs are removed and replaced with a prosthetic. However, should the prosthetic protrude from between the adjacent vertebrae and thereby contact the surrounding nerves or tissues, the patient may experience additional discomfort. In procedures for remedying this problem, a vertebral plate system having one or more apertures and one or more bone screws is affixed to the vertebrae and oriented to prevent such protrusion.
- A common problem associated with the use of such a vertebral plate system is the tendency of the bone screws to “back out” or pull away or otherwise withdraw from the bone into which they are mounted. This problem occurs, primarily, due to the normal torsional and bending motions of the body and spine. As the screws become loose and pull away or withdraw from the bone, the heads of the screws can rise above the surface of the vertebral plate, which results is pain and discomfort for the patient or possibly the separation of the vertebral plate from one or more vertebrae.
- Therefore, a need exists for a vertebral plate that inhibits separation of the vertebral plate from a vertebral body.
- In accordance with an embodiment of the present disclosure, there is provided a vertebral plate including a top and bottom surface, a plurality of orifices defined through at least one of the top and bottom surfaces, and a plurality of bone screw openings defined through the top and bottom surfaces. The plurality of orifices defined through the top surface including a different cross-section than a plurality of orifices defined through the bottom surface.
- In embodiments, the vertebral plate may include a lip defined within each bone screw opening of the plurality of bone screw openings, wherein the lip is configured to engage a corresponding bone screw to retain the corresponding bone screw therein.
- In embodiments, the top and bottom surfaces may include concave curvatures. The concave curvatures of the top and bottom surfaces may extend in the cephalad/caudal direction. Alternatively, the concave curvatures of the top and bottom surfaces may extend in a medial/lateral direction. Further still, the concave curvatures of the top and bottom surfaces may extend in both a cephalad/caudal direction and a medial/lateral direction.
- In embodiments, the vertebral plate may be formed using an additive manufacturing process. The vertebral plate may be formed using Selective Laser Powder Processing.
- In embodiments, the plurality of orifices defined through the top surface may be offset from the plurality of orifices defined through the bottom surface.
- In accordance with an embodiment of the present disclosure, a vertebral plate system is provided, including a vertebral plate and a plurality of bone screws. The vertebral plate includes a top and bottom surface, a plurality of orifices defined through at least one of the top and bottom surfaces, and a plurality of bone screw openings defined through the top and bottom surfaces. The plurality of orifices defined through the top surface includes a different cross-section than the plurality of orifices defined through the bottom surface. The plurality of bone screws are configured to be advanced within the plurality of bone screw openings and driven into a bone.
- In embodiments, the plurality of bone screws may be semi-constrained bone screws. The plurality of semi-constrained bone screws may include a shank having a first helical thread disposed thereon and a second helical thread disposed on a head portion thereof. The pitch of the first helical thread may be different than the pitch of the second helical thread, such that the first helical thread threads into vertebral bone whereas the second helical thread engages a lip disposed within each one of the plurality of bone screw openings, thereby retaining the semi-constrained bone screw within the vertebral plate.
- In embodiments, the plurality of orifices defined through the top surface may be offset from a plurality of orifices defined through the bottom surface.
- In accordance with another embodiment of the present disclosure, a method of performing spinal surgery is disclosed. The method includes inserting a vertebral plate into an incision of a patient, the vertebral plate including a top and a bottom surface, a plurality of orifices defined through at least one of the top and bottom surfaces, and a plurality of bone screw openings defined through the top and bottom surfaces. The plurality of orifices defined through the top surface includes a different cross-section than a plurality of orifices defined through the bottom surface. The method further includes advancing a plurality of bone screws within each bone screw opening of the plurality of bone screw openings and driving each bone screw of the plurality of bone screws into a bone.
- In embodiments, the method may include applying a material to the vertebral plate to promote bone ingrowth within the plurality of orifices.
- In embodiments, driving each bone screw of the plurality of bone screws into a bone may include driving a plurality of semi-constrained bone screws into a bone.
- In embodiments, driving each bone screw of the plurality of bone screws into a vertebra may include threading a first helical thread disposed on a shank of the semi-constrained bone screw into a vertebra and engaging a second helical thread disposed on a head of the semi-constrained bone screw with a lip disposed within each bone screw opening of the plurality of bone screw openings, thereby retaining the plurality of semi-constrained bone screws within the vertebral plate.
- In embodiments, the method may include advancing an interbody spacer within a prepared intervertebral space.
- In embodiments, applying a material to the vertebral plate may include applying a bone growth putty to the vertebral plate to promote bone ingrowth within the plurality of orifices.
- The above and other aspects, features, and advantages of the present disclosure will become more apparent in light of the following detailed description when taken in conjunction with the accompanying drawings in which:
-
FIG. 1 is a perspective view of a vertebral plate provided in accordance with the present disclosure; -
FIG. 2 is a top view of the vertebral plate ofFIG. 1 ; -
FIG. 2A is a cross-sectional view of the vertebral plate ofFIG. 1 , taken alongline 2A-2A; -
FIG. 3 is a side view of the vertebral plate ofFIG. 1 ; -
FIG. 4A is a bottom, perspective view, of a semi-constrained bone screw capable of use with the vertebral plate ofFIG. 1 ; -
FIG. 4B is a side view of the semi-constrained bone screw ofFIG. 4A ; -
FIG. 5A is a perspective view of the vertebral plate ofFIG. 1 shown as aligned with a spinal column of a patient having a vertebral spacer interposed between adjacent vertebral bodies; -
FIG. 5B is perspective view of the vertebral plate ofFIG. 5A shown as being fastened to a plurality of vertebral bodies -
FIG. 6 is a cross-sectional view of the vertebral plate ofFIG. 1 illustrating an orifice defined through an upper surface being offset from an orifice defined through a bottom surface; and -
FIG. 7 illustrates various cross-sectional configurations of an orifice defined through the vertebral plate ofFIG. 1 . - Embodiments of the present disclosure are now described in detail with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the several views. As used herein, the term “clinician” refers to a doctor, a nurse or any other care provider and may include support personnel. Throughout this description, the term “proximal” will refer to the portion of the device or component thereof that is closer to the clinician and the term “distal” will refer to the portion of the device or component thereof that is farther from the clinician. In addition, the term “cephalad” is used in this application to indicate a direction toward a patient's head, whereas the term “caudal” indicates a direction toward the patient's feet. Further still, for the purposes of this application, the term “lateral” indicates a direction toward a side of the body of the patient, i.e., away from the middle of the body of the patient, and the term “medial” indicates a direction toward the inside of the body of the patient, i.e., toward the middle of the body of the patient. Additionally, in the drawings and in the description that follows, terms such as front, rear, upper, lower, top, bottom, and similar directional terms are used simply for convenience of description and are not intended to limit the disclosure. In the following description, well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail.
- Referring now to the drawings,
FIG. 1 illustrates an embodiment of avertebral plate 100 provided in accordance with the present disclosure.Vertebral plate 100 includes atop surface 102 and abottom surface 104 defining a thickness ofvertebral plate 100.Vertebral plate 100 may be substantially planar or contoured in either or both the cephalad/caudal and/or medial/lateral planes. As can be appreciated,top surface 102 andbottom surface 104 may include concave contours having the same or different radius of curvature, depending on the application or needs of the patient. In one non-limiting embodiment,top surface 102 andbottom surface 104 of vertebral plate are configured to include concave contours having the same radius of curvature. - Although generally illustrated as including a rectangular profile, it is contemplated that
vertebral plate 100 may include any suitable profile capable of securing adjacent vertebra thereto, such as square, oval, circular or the like. - As best illustrated in
FIGS. 2 and 2A ,vertebral plate 100 includes a plurality ofbone screw openings 106 defined therethrough configured to receive a corresponding plurality of bone screws or bone fixation elements 200 (FIG. 4A ), as will be described in further detail hereinbelow. Eachbone screw opening 106 is similar in construction, and therefore, only one will be described in detail hereinbelow. Bone screw opening 106 includes anannular sidewall 106 a extending downwards from thetop surface 102 ofvertebral plate 100. Alip 106 b is disposed inbone screw opening 106 and extends inwards fromannular sidewall 106 a, forming a generally frusto-conical configuration on an upper and lower side thereof. As can be appreciated,lip 106 b may include any suitable profile, such as convex, concave, or the like. Thelip 106 b is disposed within bone screw opening 106 medially between top andbottom surfaces FIGS. 4A and 4B ) such thatrotating bone screw 200 causes the threads of anindependent locking head 212 ofbone screw 200 to engagelip 106 b. In one non-limiting embodiment,lip 106 b is located in proximity to thebottom surface 104 ofvertebral plate 100. -
Vertebral plate 100 is constructed of a biocompatible material, such as commercially pure titanium or titanium alloy and includes a porosity capable of promoting bone ingrowth withvertebral plate 100. In this manner, top andbottom surfaces bottom surfaces top surface 102 may be different than the surface roughness of bottom surface 104), or top andbottom surfaces bottom surfaces bottom surfaces vertebral plate 100 includes a plurality oforifices 110 defined therethrough configured to promote bone ingrowth. Although generally illustrated as including a circular cross-section,orifices 110 may include any suitable cross-section capable of promoting bone ingrowth, such as oval, square, hexagonal, diamond, rectangular, or the like (FIG. 6 ). The circular cross-section oforifices 110 mimic bone growth along Haversian canals and lamellar structures of bone. In this manner,orifices 110 may pass entirely throughtop surface 102 andbottom surface 104 ofvertebral body 100. Alternatively,orifices 110 may be offset in relation to one another (FIG. 7 ). In this manner, anorifice 110 defined throughbottom surface 104 will be offset from acorresponding orifice 110 defined throughtop surface 102. In embodiments,orifices 110 may be defined through top andbottom surfaces orifices 110 are defined through top and bottom surfaces at angles incident relative to each other, thereby forming a chevron configuration. As can be appreciated, each of theorifices 110 formed through top andbottom surfaces top surface 102 and an orifice formed throughbottom surface 104. It is contemplated that the density oforifices 110 may be different ontop surface 102 than onbottom surface 104, or may increase or decrease in density at various locations on each of top andbottom surfaces Orifices 110 include a diameter in a range of about 50-1000 μm, although a diameter between 300-700 μm is preferable. As can be appreciated, for shapes other than circular,orifices 110 include a cross-sectional area in a range of about 0.0019 μm2-0.785 μm2, although a cross-sectional area between 0.0707 μm2-0.385 μm2 is preferable. As can be appreciated, the plurality oforifices 110 may includeorifices 110 having varying sizes and shapes relative to each other. In embodiments, theorifices 110 defined throughtop surface 102 may include a different cross-section that thoseorifices 110 defined through bottom surface 104 (i.e., circular ontop surface 102 while square onbottom surface 104, or vice versa). The plurality oforifices 110 reduce the density and stiffness ofvertebral plate 100 to enable the application of bone putty or the like (e.g., bone morphogenetic proteins (BMP), etc.) tovertebral plate 100 to promote bone ingrowth withinvertebral plate 100. Bone ingrowth strengthensvertebral plate 100 and reduces the load applied to bone screws 200. In this manner, the probability thatvertebral plate 100 would fracture would be reduced, and the likelihood that micromotion would occur would likewise be reduced. - As can be appreciated, manufacturing
vertebral plate 100 using standard machining methods (e.g., lathe, mill, EDM, etc.) would be difficult. In view of this, it is contemplated thatvertebral plate 100 may be manufactured by means of additive manufacturing methods (e.g., SDM, SLPP, DMLS (i.e., EOS), SLS, SLM, SHS, EBM, VAT photopolymerisation, material jetting, binder jetting, or the like). In one non-limiting embodiment,vertebral plate 100 may be manufactured using Selective Laser Powder Processing (SLPP). SLPP utilizes powdered metal and a laser which sinters or cures the metal in a selective fashion according to the design intent in thin layers. In embodiments, the layers may have a thickness of about 250Vertebral plate 100 is built layer by layer to allow for more design options and features which would be difficult to be machined using conventional methods. Specifically, a first layer of powder is applied to a specialized build plate, at which point the laser cures portions of the powder according to the design intent. At this point, a second layer is applied to the build plate and the laser is again used to cure selective portions of this second layer. This process is repeated untilvertebral plate 100 is fully formed. Oncevertebral plate 100 is fully formed, uncured powder is removed using compressed air or other similar means. Next, post machining is performed onvertebral plate 100 to remove any burrs or similar imperfections embedded withinvertebral plate 100 during the additive manufacturing process. In embodiments, the burrs are removed by means of buffer wheels, clipper, files, or the like. One de-burred,vertebral plate 100 is heat treated, and thereafter, media blasted using aluminum oxide. Thereafter,vertebral plate 100 is immersed in a hydrofluoric bath to strip the aluminum oxide therefrom. Finallyvertebral plate 100 is inspected by quality control personnel (or using automated means), cleaned via ultrasonic cleaning, dried, and packaged. Additionally, using SLPP, it is contemplated thatvertebral plate 100 may be customized for a designated patient. For a detailed description of exemplary manufacturing methods, reference can be made to U.S. Pat. No. 8,590,157, issued on Nov. 26, 2013 to Kruth et al., the entire contents of which are hereby incorporated by reference herein. -
Vertebral plate 100 may be constructed from titanium, titanium alloy, cobalt-chrome, ceramic, polyetheretherketone (PEEK), or any other suitable biocompatible material. In embodiments,vertebral plate 100 may be manufactured using a three-dimensional printer utilizing a biocompatible polymer. - With reference to
FIGS. 4A-4B , a bone screw provided in accordance with the present disclosure is provided and generally identified byreference numeral 200.Bone screw 200 includes anelongated shank 202, which is mechanically coupled to a removable taperedlocking screw head 212.Shank 202 includes a uniform outer diameter and a first continuoushelical thread 210 formed thereon for threaded insertion into bone. A second continuoushelical thread 224 is formed on theindependent head portion 212 for engaginglips 106 b ofvertebral plate 100. The pitch of thefirst thread 210 is greater than the pitch of thesecond thread 224. Each of the first andsecond threads lips 106 b ofvertebral plate 100. In embodiments, bone screws 200 may be formed of titanium alloy (e.g., Ti-6Al-4V) and thelips 106 b of vertebral plate being formed from a softer material, such as commercially pure titanium. As can be appreciated, bone screws 200 may be monolithically formed such thathead portion 212 of bone screws 200 is rigidly constrained in relation toshank 202. - Alternatively,
bone screw 200 may be of a semi-constrained variety wherein the head portion is pivotable with respect to a longitudinal axis of the shank, thereby allowing the head portion to pivot while the shank remains stationary. For a detailed description of exemplary semi-constrained bone screws, reference may be made to U.S. Pat. No. 8,574,272, issued Nov. 5, 2013 to Wallenstein et al., and U.S. Pat. No. 9,095,390, issued Aug. 4, 2015 to Wallenstein et al., the entire contents of each of which are hereby incorporated by reference herein. - In embodiments, it is contemplated that
vertebral plate 100 andbone screws 200 may be provided in the form of a system or kit. As can be appreciated, the system or kit may include any suitable interbody spacer 300 (FIG. 5A ).Interbody spacer 300 includes a body portion extending between distal and proximal end surfaces, respectively, to define top and bottom vertebral engaging surfaces and opposed side surfaces. The top and bottom surfaces each include a plurality of ridges disposed thereon to aid in securinginterbody spacer 300 to each respective adjacent vertebral body and stability against fore and aft, oblique or side to side movement ofinterbody spacer 300 within the intervertebral space. For a detailed description of exemplary interbody spacers, reference can be made to U.S. Pat. No. 8,137,405, issued Mar. 20, 2012 to Kostuik et al., the entire contents of which are hereby incorporated by reference herein. - With reference to
FIGS. 1-5B , in use,vertebral plate 100 is inserted within an incision and aligned with adjacent vertebra (FIGS. 5A and 5B ). At this point, bone screws 200 are advanced within each of the plurality ofbone screw openings 106 ofvertebral plate 100. Eachbone screw 200 is driven into the vertebral body using a suitable tool or driver (not shown). As eachbone screw 200 is further advanced,threads 224 ofhead portion 212 engage thelip 106 b disposed within eachbone screw opening 106. Continued advancement of the plurality of bone screws 200 deforms thelip 106 b ofvertebral plate 100 and secures thebone screw 200 in the corresponding bone screw opening 106 such that eachbone screw 200 is inhibited from backing out of the respectivebone screw opening 106. Further,head portion 212 ofbone screw 200 is dimensioned to engagelip 106 b to prevent further advancement ofbone screw 200 throughvertebral plate 100. This type of screw locking arrangement is disclosed and shown in U.S. Pat. No. 6,322,562, issued Nov. 27, 2001 to Wolter, the entire contents of which are hereby incorporated by reference herein. - As threads 220 of the
screw head 212 engage thecorresponding lip 106 b,screw shank 202 varies in angular orientations with respect to the axis of thebone screw opening 106. Asscrew shank 202 is driven into bone and thescrew head 212 locked tovertebral plate 100, thescrew shank 202 remains free to articulate relative to thescrew head 212 and, hence,vertebral plate 100. At this point, bone growth putty or other suitable compositions (e.g., BMP, etc.) may be applied tovertebral plate 100 to promote bone ingrowth. In embodiments, aninterbody spacer 300 is first advanced within a prepared intervertebral space. In this manner, thevertebral plate 100 helps prevent theinterbody spacer 300 from being forced out of the intervertebral space (FIGS. 5A and 5B ). - For a detailed description of exemplary methods of using a vertebral plate with semi-constrained bone screws, reference may be made to U.S. Pat. No. 8,574,272, incorporated by reference hereinabove.
- This process may be repeated as many times as the procedure requires, whether it be for the same
vertebral plate 100 or for a plurality ofvertebral plates 100 as required by the procedure being performed. - It is envisioned that the manufacturing processes and orifice designs detailed above may be utilized to form various other medical devices known in the art. In this manner, the additive manufacturing process detailed above may be employed to form corpectomy devices, fixed spinal implants, expandable spinal implants, bone screws, cervical implants, and the like. Similarly, the orifice designs detailed above may be formed in any of the beforementioned medical devices that would benefit from an increased ability to fuse with bone. Examples of such devices may be found in the following commonly owned references: U.S. Pat. No. 8,585,761 to Theofilos, U.S. Pat. No. 8,673,011 to Theofilos et al., U.S. application Ser. No. 14/936,911 to Sutterlin et al., U.S. Pat. No. 8,801,791 to Soo et al., U.S. Pat. No. 8,439,977 to Kostuik et al., U.S. Patent Application Publication No. 2010/0100131 to Wallenstein, U.S. Patent Application Publication No. 2012/0179261 to Soo, U.S. Pat. No. 8,449,585 to Wallenstein et al., U.S. Pat. No. 8,814,919 to Barrus et al., U.S. Pat. No. 5,733,286 to Errico et al., U.S. Patent Application Publication No. 2013/0046345 to Jones et al., U.S. Pat. No. 8,961,517 to McClintock et al., U.S. Patent Application Publication No. 2015/0025573 to Abitbol et al., and U.S. Patent Application Publication No. 2015/0142062 to Donald et al.
- It will be understood that various modifications may be made to the embodiments of the presently disclosed vertebral plate. Therefore, the above description should not be construed as limiting, but merely as exemplifications of embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the present disclosure.
Claims (20)
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EP3050540A1 (en) | 2016-08-03 |
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AU2016200443A1 (en) | 2016-08-11 |
US20200237526A1 (en) | 2020-07-30 |
US10660763B2 (en) | 2020-05-26 |
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