CERVICAL PLATE

Abstract

A bone plate for use as a orthopedic implant.

Claims

1. A bone plate for use as a orthopedic implant comprising a body that has a plurality of openings therethrough; a maximum cross-sectional area in a region of said body of said bone plate that is widest is greater than a maximum cross-sectional area in a region of said body of said bone plate that is narrowest.

2. The bone plate as defined in claim 1, wherein said cross-sectional area in a region of said body of said bone plate that is widest is 10-40% greater than said cross-sectional area in a region of said body of said bone plate that is narrowest.

3. The bone plate as defined in claim 1, wherein said body is at least partially formed of a refractory alloy or a metal alloy that includes at least 10 awt. % rhenium.

4. The bone plate as defined in claim 1, wherein said bone plate has a maximum width of 10-17 mm, a minimum width of 3-9 mm, a maximum thickness of 0.8-3 mm, a cross-sectional area of 6.0-16 mm.sup.2, and wherein said cross-sectional area of said bone plate varies along a longitudinal length of said bone plate.

5. The bone plate as defined in claim 1, wherein said bone plate includes a plurality of screw openings, a width of each of said screw openings is 2.0-5 mm; each of said screw openings is located 0.7-2.5 mm from an outer peripheral edge of said bone plate.

6. The bone plate as defined in claim 9, wherein a distance of two adjacently positioned screw openings is 0.7-4 mm.

7. The bone plate as defined in claim 1, wherein an angle of a screw set in said screw opening to the top surface of the bone plate is 0-25° relative to a central longitudinal axis of said screw opening; two or more screw openings are configured to cause said angle of said screw set in said screw openings to be different from one another.

8. The bone plate as defined in claim 1, wherein said bone plate includes at least one cam recess that is configured to releasably engage a cam; a portion of the cam recess includes a cam opening that passes fully through the bone plate; a diameter of said cam opening is 2-5 mm; 10-50% of said cam recess does not fully penetrate said bone plate; said portion of said cam recess that does not fully penetrate said bone plate is recessed from said top surface of said bone plate at about 0.1-0.6 mm; said portion of said cam recess that does not fully penetrate said bone plate has a thickness of 0.2-0.6 mm; said cam recess is located 1-3 mm from said outer peripheral edge of said bone plate.

9. The bone plate as defined in claim 8, wherein a portion of said cam recess terminates at at least one screw opening that is located adjacent to said cam recess.

10. The bone plate as defined in claim 8, wherein said cam recess includes a sloped surface positioned between two of said screw openings that are located adjacent to said cam recess; said slope surface is configured and oriented so said slope surface does not engage a cam during rotation of a cam in said cam recess.

11. The bone plate as defined in claim 8, wherein said cam recess includes one or more cam stops to limit rotation of a cam in said cam recess.

12. The bone plate as defined in claim 11, wherein said cam recess includes two of said cam stops; one of said cam stops limits rotation of a cam in a clockwise direction, and another of said cam stops limits rotation of a cam in a counter-clockwise direction.

13. The bone plate as defined in claim 1, wherein said bone plate includes one or more undulations on an outer side peripheral edge of said bone plate; an angle of curvature of said undulation along said outer side peripheral edge is 6-40°.

14. The bone plate as defined in claim 1, wherein said screw openings allow for dual angulation of a screw in said screw opening along a longitudinal axis of the bone plate and along a lateral axis of said bone plate.

15. The bone plate as defined in claim 1, wherein one or more of said screw openings includes one or more concavely indented surfaces; said concavely indented surfaces extend into said screw openings; said concavely indented surfaces are not threaded surfaces.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0066] The above and other features and advantages of the disclosure will become apparent from a consideration of the subsequent detailed description presented in connection with the accompanying drawings in which:

[0067] FIG. 1 is a side elevation view of a Cervical Plate in accordance with the new design;

[0068] FIG. 2 is a top plan view of the Cervical Plate of FIG. 1;

[0069] FIG. 3 is a bottom plan view of the Cervical Plate of FIG. 1;

[0070] FIG. 4 is a front plan view of the Cervical Plate of FIG. 1;

[0071] FIG. 5 is a rear plan view of the Cervical Plate of FIG. 1;

[0072] FIG. 6 is a side plan view of the Cervical Plate of FIG. 1;

[0073] FIG. 7 is an opposite side plan view of the Cervical Plate of FIG. 1;

[0074] FIG. 8 is a cross-sectional view along lines B-B of FIG. 2;

[0075] FIG. 9 is a cross-sectional view along lines A-A of FIG. 2;

[0076] FIG. 10 is a cross-sectional view along lines C-C of FIG. 2;

[0077] FIG. 11 illustrates a fastener inserted through a portion of the Cervical Plate;

[0078] FIGS. 12-13 illustrate non-limiting dimensions of the axial orientation of the openings in the Cervical Plate;

[0079] FIGS. 14-16 illustrated various non-limiting fastener or screw orientations that can be used to fasten the Cervical Plate to a body structure;

[0080] FIG. 17 is a top plan view of another non-limiting the Cervical Plate in accordance with the present disclosure; and

[0081] FIG. 18 is a top plan view of another non-limiting the Cervical Plate in accordance with the present disclosure.

DETAILED DESCRIPTION OF VARIOUS NON-EMBODIMENTS OF DISCLOSURE

[0082] A more complete understanding of the articles/devices, processes and components disclosed herein can be obtained by reference to the accompanying drawings. These figures are merely schematic representations based on convenience and the ease of demonstrating the present disclosure, and are, therefore, not intended to indicate relative size and dimensions of the devices or components thereof and/or to define or limit the scope of the exemplary embodiments.

[0083] Although specific terms are used in the following description for the sake of clarity, these terms are intended to refer only to the particular structure of the embodiments selected for illustration in the drawings and are not intended to define or limit the scope of the disclosure. In the drawings and the following description below, it is to be understood that like numeric designations refer to components of like function.

[0084] The singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise.

[0085] As used in the specification and in the claims, the term “comprising” may include the embodiments “consisting of” and “consisting essentially of.” The terms “comprise(s),” “include(s),” “having,” “has,” “can,” “contain(s),” and variants thereof, as used herein, are intended to be open-ended transitional phrases, terms, or words that require the presence of the named ingredients/steps and permit the presence of other ingredients/steps. However, such description should be construed as also describing compositions or processes as “consisting of” and “consisting essentially of” the enumerated ingredients/steps, which allows the presence of only the named ingredients/steps, along with any unavoidable impurities that might result therefrom, and excludes other ingredients/steps.

[0086] Numerical values in the specification and claims of this application should be understood to include numerical values which are the same when reduced to the same number of significant figures and numerical values which differ from the stated value by less than the experimental error of conventional measurement technique of the type described in the present application to determine the value.

[0087] All ranges disclosed herein are inclusive of the recited endpoint and independently combinable (for example, the range of “from 2 grams to 10 grams” is inclusive of the endpoints, 2 grams and 10 grams, and all the intermediate values).

[0088] The terms “about” and “approximately” can be used to include any numerical value that can vary without changing the basic function of that value. When used with a range, “about” and “approximately” also disclose the range defined by the absolute values of the two endpoints, e.g. “about 2 to about 4” also discloses the range “from 2 to 4.” Generally, the terms “about” and “approximately” may refer to plus or minus 10% of the indicated number.

[0089] Percentages of elements should be assumed to be percent by weight of the stated element, unless expressly stated otherwise.

[0090] Referring now to the drawings, FIGS. 1-18 illustrate a cervical plate assembly 10 that includes a cervical plate 20 made in accordance with the present disclosure. In one non-limiting configuration, the cervical plate 20 can be configured and dimensioned for attachment on the anterior portion of a cervical spine (not shown). The cervical plate 20 can be manufactured from any suitable biocompatible material, including metal, such as titanium, stainless steel, cobalt-chromium-molybdenum alloy, titanium-aluminum vanadium alloy, molybdenum titanium alloy, molybdenum rhenium alloy, molybdenum alloy, rhenium alloy, rhenium-chromium alloy, a rhenium containing metal alloy (e.g., metal alloy that includes at least 15 awt. % rhenium), or other suitable metallic alloys.

[0091] The cervical plate 10 is configured to provide a bone fixation assembly that can accept and fix fasteners 100 (e.g., screws, etc.).

[0092] Cervical plate 20 has a body 21 that has a lower surface 24 and an upper surface 22 and one or more screw openings 30 that extend from the upper surface 22 to the lower surface 24. Cervical plate 20 also includes a smaller tool opening 40 and end indents 42 that pass fully through the cervical plate. One or more tool openings 40 and one or more end indents 42 can be used by a physician to orient cervical plate 20 in position relative to the spine using various type of instruments and tools (not shown). The size, shape, and/or configuration of one or more tool openings 40 and one or more end indents 42 are non-limiting. As illustrated in FIGS. 1-3, tool opening 40 has a smaller diameter (e.g., 5-80% smaller in diameter and all values and ranges therebetween) than the diameter of screw openings 30. As illustrated in FIGS. 1-3, the radius of the one or more end indents 42 has a smaller radius (e.g., 5-80% smaller in radius and all values and ranges therebetween) than the radius of screw openings 30. The one or more end indents 42 are illustrated as being located at one or both ends of cervical plate 20 (e.g., generally about the mid-end of cervical plate 20). It will be appreciated that more than two or less than two end indents 42 can be used and one or more end indents 42 can be located in additional or different locations on cervical plate 20. At least one of tool openings 40 is generally located in the mid-region of cervical plate 20 and spaced form the side edges of cervical plate 20. It will be appreciated that more than one tool opening 40 can be used and one or more tool openings 40 can be located in additional or different locations on cervical plate 20.

[0093] In one non-limiting embodiment, tool openings 40 are a circular or generally circular opening and have a maximum diameter of 1-4 mm (and all values and ranges therebetween, and typically 1.5-2.5 mm. Generally, the cross-sectional area of tool openings 40 is less than the openings in cam recesses 50 and screw openings 30. Generally, tool openings 40 are spaced from the outer perimeter of cervical plate 20 and also spaced from screw openings 30 and cam recesses 50.

[0094] As illustrated in FIGS. 1-2, top surface 22 of cervical plate 20 includes three cam recesses 50 that are configured to receive a cam (not shown) that can be releasably connected to top surface 22 of cervical plate 20. The number of cam recesses 50 on he cervical plate 20 and the shape, size, and/or configuration of cam recess 50 on cervical plate 20 are non-limiting. For example. FIG. 17 illustrates cervical plate 20 including two earn recesses 50, and FIG. 18 illustrates a cervical plate 20 including six cam recesses 50. Generally, cervical plate 20 includes 2-8 cam recesses 50.

[0095] Each of cam recesses 50 includes a cam opening 52. As illustrated in FIGS. 1, 2, 17 and 18, the cross-sectional area of can opening 52 is less than the cross-sectional area of cam recesses 50 (e.g., the cross-sectional area of the cam opening 52 is 5-70% less and all values and ranges therebetween of the cross-sectional area of cam recesses 50). In one non-limiting embodiment, a non-limiting size of cam opening 52 can be 2-6 mm (and all values and ranges therebetween), and typically about 3.8-4.2 mm. Cam opening 52 is generally spaced from the side edges of cam recesses 50. The general shape of cam opening 52 is generally circular. The shape and size of each of cam recess 50 is non-limiting. Cam openings 52 in cam recesses 50 are generally spaced from screw openings 30 and the outer perimeter of cervical plate 20. One or more of cam recesses 50 can border with or terminate at one or more of screw openings 30 as illustrated in FIGS. 1, 2, 17 and 18. Cam opening 52 is generally spaced an equal distance from the two adjacently positioned screw openings 30 as illustrated in FIGS. 1, 2, 17 and 18. As illustrated in FIGS. 1, 2, 17 and 18, the cross-sectional area of cam opening 52 is less than the cross-sectional area of te screw openings 30 (e.g., the cross-sectional area of cam opening 52 is 5-50% less and all values and ranges therebetween of the cross-sectional area of screw openings 30). As illustrated in FIGS. 1, 2 and 18, the cross-sectional area of cam opening 52 is greater than the cross-sectional area the tool opening 40 (e.g., the cross-sectional area of cam opening 52 is 10-200% greater and all values and ranges therebetween of the cross-sectional area of tool openings 40).

[0096] Cervical plate 20 in accordance with the present disclosure can be curved, contoured, straight, flat, undulating, etc. The cervical plate can be a periarticular plate or a straight plate. The cervical plate can be shaped to match a particular spinal bone surface to be treated.

[0097] The one or more screw openings 30 in cervical plate 20 are shown having a central axis X as illustrated in FIGS. 12-16, and are adapted to receive a fastener system 100.

[0098] Fastener system 100 can be any typical, standard locking fastener or a non-locking fastener system. Fastener system 100, such as a screw, includes a body 120 that optionally includes threads 122 or other arrangement on at least a portion of body 120. For example, body 120 can be fully threaded, partially threaded, comprise a helical blade, and/or may comprise one or more tacks, deployable talons, expanding elements, or so forth. As can be appreciated, body 120 of fastener system 100 can be a peg or pin shape. The end of body 120 can optionally include a self-tapping or self-drilling tip (not shown); however, this is not required. The screw can be optionally formed of a refractory metal alloy and/or a metal ally that includes at least 15 awt. % rhenium.

[0099] Fastener system 100 can include a head portion 110. Generally, the cross-section size of head portion 110 is greater than body 120. The shape of head portion 110 is non-limiting. The cross-sectional shape of the top region of head portion 110 is generally circular shaped; however, other shapes can be used. Head portion 110 can optionally include a cavity 112 to facilitate in inserting fastener system 100 into a bone and securing the cervical plate to the bone. The configuration of cavity 112 is non-limiting. Generally, cavity 112 is specially shaped to receive a tool to rotate and/or otherwise cause fastener system 110 to be inserted into a bone. Non-limiting shapes that can be used in cavity 112 include one or more dimples, ridges, bumps, textured areas, star shaped, polygonal shaped, or any other surface or shape. As can be appreciated, cavity 112 can include a threaded inner surface and a circular-cross-sectional shape.

[0100] As can be appreciated, the configuration of fastener system 100 is non-limiting. Many different configurations of head portion 110 and body portion 120 of fastener system 100 can be used with cervical plate 20 in accordance with the present disclosure. Generally the maximum cross-sectional area of head portion 110 is greater than the maximum cross-sectional area of screw openings 30 to prevent head portion 110 from fully passing through screw openings 30 when securing cervical plate 20 to a bone.

[0101] As illustrated in FIGS. 2, 17 and 18, screw openings 30 have a generally circular cross-sectional shape. In one non-limiting embodiment, the diameter of the one or more screw openings is 3-6 mm (and all values and ranges therebetween), and typically 4-5 mm. It will be appreciated that the screw openings 30 can have other cross-sectional shapes (e.g., oval, square, polygonal, etc.) and diameters. The spacing of two adjacently positioned screw openings 30 is generally 1.5-4.5 mm (and all values and ranges therebetween), and typically 2.5-4 mm. As illustrated in FIGS. 2, 17 and 18, screw openings 30 are spaced from the outer perimeter of cervical plate 20. In one non-limiting embodiment, two adjacently positioned screw openings 30 are spaced from the longitudinal central axis of cervical plate 20, and are positioned along the same lateral axis of the of cervical plate 20. Generally, the two adjacently positioned screw openings 30 are spaced generally an equal distance (e.g., ±0-5% and all values and ranges therebetween)) from the longitudinal central axis of cervical plate 20. As illustrated in FIGS. 2, 17 and 18, cam opening 52, the one or more tool openings 40, and/or one or more end indents 42 intersect the longitudinal central axis of cervical plate 20.

[0102] The top region of the inner surface of one or more screw openings 30 optionally has one or more concavely indented surfaces 32. Concavely indented surfaces 32 extend into screw openings 30. Concavely indented surfaces 32 can optionally be smooth and non-threaded. Such an arrangement can be used to form a non-locking arrangement for fastener system 100 with cervical plate 20. In one non-limiting arrangement, there is no thread to thread contact between the head of fastener system 100 with cervical plate 20 when the fastener system is fully connected to the bone. One non-limiting purpose of concavely indented surfaces 32 is to orient the longitudinal axis of fastener system 100 at a particular angle relative to body 21 of cervical plate 20 when body portion 120 of fastener system 100 in inserted into screw openings 30 during the securing of cervical plate 20 to the spine. Head portion 110 of fastener system 100 is configured to engage one or more concavely indented surfaces 32 can cause the central longitudinal axis of fastener system 100 to be oriented a) normal (e.g., 90°) to top surface 22 of body 21 of cervical plate 20 when fastener system 100 is fully inserted into screw openings 30 during the securing of cervical plate 20 to the spine, or b) a some angle from normal (e.g., 0.001°-30° and all values and ranges therebetween) to top surface 22 of body 21 of cervical plate 20 when fastener system 100 is fully inserted into screw openings 30 when securing of cervical plate 20 to the spine.

[0103] Concavely indented surfaces 32 can be formed of one or more partially circular or arcuate recess regions. Concavely indented surfaces 32 can be formed by a cutting process, stamping process, 3D printer, molding process, etc. The radius of curvature of the partially circular or arcuate recess regions is non-limiting. The depth of the partially circular or arcuate recess regions is less than the thickness of cervical plate 20. As can be appreciated, the size, shape, and configuration of concavely indented surfaces 32 in one or more of screw openings 30 are non-limiting.

[0104] Referring now to FIGS. 12-16, screw openings 30 and concavely indented surfaces 32 in screw openings 30 can be selected to enable the central longitudinal axis of fastener system 100 to be oriented in screw opening 30 at various angles to the longitudinal axis of screw opening 30 when viewed from either the lateral or longitudinal axis of cervical plate 20. FIGS. 13-15 illustrate the central longitudinal axis of screw openings 30 and/or fastener system 100 along the lateral axis of cervical plate 20 as viewed from the end of cervical plate 20, and FIGS. 12 and 16 illustrate the central longitudinal axis of screw openings 30 and/or fastener system 100 along the longitudinal axis of cervical plate 20 as viewed from the side of the cervical plate.

[0105] Referring now to FIGS. 13, 14 and 15, the longitudinal axis line X represents the central longitudinal axis of screw opening 30 that is normal to top surface 22 of body 21 of cervical plate 20 along the lateral axis of cervical plate 20. The longitudinal axis line CA represents the central longitudinal axis of cervical plate 20 along the longitudinal central axis of cervical plate 20. The dashed longitudinal axis lines Y and Z represent a longitudinal axis through screw opening 30 that is not normal to the top surface 22 of te body 21 of cervical plate 20 when viewed along the lateral axis of cervical plate 20. For example, FIG. 14 illustrates that the central longitudinal axis of fastener system 100 is oriented along longitudinal axis Z that is oriented inwardly at an angle of about 0.50 to 8° from longitudinal axis line X. Longitudinal axis Y that is oriented outwardly at an angle of about −0.5-8° from longitudinal axis line X. Concavely indented surfaces 32 in screw opening 30 are configured to enable the central longitudinal axis of fastener system 100 to be oriented in screw opening 30 at an angle of −8-8° relative to central longitudinal axis X of screw opening 30.

[0106] As illustrated in FIG. 13, central longitudinal axis X of screw opening 30 along the lateral axis of cervical plate 20 as viewed from the end of cervical plate 20 are at a non-parallel angles B.sup.1 and B.sup.2 to longitudinal axis line CA of cervical plate 20. The end profile of cervical plate 20 illustrates a curved profile that results in central longitudinal axis X of screw opening 30 being non-parallel to longitudinal axis line CA of cervical plate 20. The angle of curvature is generally 0.1-10° (and all values and ranges therebetween). For example, if the angle of curvature of cervical plate 20 along the lateral axis of cervical plate 20 is 3.1°, then angles B.sup.1 and B.sup.2 would also be about 3.1°.

[0107] Referring to FIG. 16, the solid longitudinal axis line K represents the central longitudinal axis of screw opening 30 that is normal to top surface 22 of body 21 of cervical plate 20 along the longitudinal axis of cervical plate 20 when viewed from the side of cervical plate 20. The dashed longitudinal axis lines J and L represent a longitudinal axis through screw opening 30 that is not normal to top surface 22 of body 21 of cervical plate 20 along the longitudinal axis of cervical plate 20 when viewed from the side of cervical plate 20. The central longitudinal axis of fastener system 100 is oriented along longitudinal axis J which is oriented outwardly at an angle of about −10-−25° from longitudinal axis line K. Longitudinal axis L is oriented inwardly at an angle of about 0.5-6° from longitudinal axis line K. Concavely indented surfaces 32 in screw opening 30 is configured to enable the central longitudinal axis of fastener system 100 to be oriented in screw opening 30 at an angle of −25-6° relative to central longitudinal axis K of screw opening 30.

[0108] As illustrated in FIGS. 14 and 15, the majority (e.g., 51-100% and all values and ranges therebetween) of the top surface of head portion 110 of fastener system 100 is positioned level with or below top surface 22 of body 21 of cervical plate 20. As illustrated in FIG. 16, when the central longitudinal axis of fastener system 100 is oriented at an extreme angle (e.g., greater than +8° from longitudinal axis X, 25-90% (and all values and ranges therebetween)); the top surface of head portion 110 of fastener system 100 is positioned above top surface 22 of body 21 of cervical plate 20. However, in all of fastener system 100 orientations illustrated in FIGS. 14-16 and described above, concavely indented surfaces 32 in screw opening 30 are configured such that a least a portion of head portion 110 of fastener system 100 is seated in concavely indented surfaces 32 in screw opening 30 to form a stable and rigid connection between fastener system 100 and cervical plate 20 when fastener system 100 is fully inserted into screw openings 30 during the securing cervical plate 20 to the spine. In one non-limiting embodiment, 80-100% of the top surface of head portion 110 of fastener system 100 is positioned level with or below top surface 22 of body 21 of cervical plate 20 when fastener system 100 is fully inserted into screw openings 30 located inwardly from screw openings 30 located at each end of cervical plate 20. In one non-limiting embodiment, 5-70% of the top surface of head portion 110 of fastener system 100 is positioned above top surface 22 of body 21 of cervical plate 20 when fastener system 100 is fully inserted into screw openings 30 located at each end of cervical plate 20.

[0109] Referring again to FIGS. 12, 17 and 18, the longitudinal central axis of concavely indented surfaces 32 in screw opening 30 can have the same or different longitudinal central axis as screw opening 30. As illustrated in FIG. 12, the longitudinal central axis of concavely indented surfaces 32 in center screw opening 30 is the same or substantially the same (e.g. ±0-3°) as longitudinal central axis K of center screw opening 30. As also illustrated in FIG. 12, longitudinal central axis J of concavely indented surfaces 32 in screw openings 30 on the left and right sides of center screw opening 30 are not aligned with the longitudinal central axis of center screw opening 30. In one non-limiting embodiment, longitudinal central axis J of concavely indented surfaces 32 in screw openings 30 on the left and right sides of center screw opening 30 have an angle A.sup.1 and A.sup.2 that is 3-25° (and all values and ranges therebetween) from the central axis of screw openings 30 on the left and right sides of center screw opening 30. In another non-limiting embodiment, concavely indented surfaces 32 in screw openings 30 on one or both ends of cervical plate 20 have a longitudinal central axis that is not aligned with the longitudinal central axis of screw openings 30. In another non-limiting embodiment, one or more or all of longitudinal central axis of concavely indented surfaces 32 in screw openings 30 that are positioned inwardly of screw openings 30 that are positioned on the ends of cervical plate 20 have a longitudinal central axis that is aligned with the longitudinal central axis of screw openings 30.

[0110] As discussed above with regard to FIG. 16, the longitudinal central axis of fastener system 100 (when viewed from the side of cervical plate 20) when fully inserted into screw openings 30 may or may not be aligned with a) the longitudinal central axis of concavely indented surfaces 32 in the screw opening, and/or b) the longitudinal central axis of screw opening 30. As illustrated in FIG. 16, the longitudinal central axis of fastener system 100 in central screw openings 30 is illustrated as both aligned with the longitudinal central axis of concavely indented surfaces 32 in the screw opening 30, and the longitudinal central axis of screw opening 30. As also illustrated in FIG. 16, the longitudinal central axis of the fastener system 100 in screw openings 30 located at each end of cervical plate 20 are illustrated as aligned with the longitudinal central axis of concavely indented surfaces 32 in screw opening 30, but not aligned with the longitudinal central axis of screw opening 30. FIG. 16 further illustrates that the longitudinal central axis of fastener system 100 in each screw openings 30 can be adjusted as required.

[0111] Referring again to FIG. 12, the central longitudinal central axis of concavely indented surfaces 32 in central screw opening 30 (which is spaced inwardly of screw openings 30 that are located at the two ends of cervical plate 20) is the same or substantially the same as the longitudinal central axis central screw opening 30, and the central longitudinal central axis of concavely indented surfaces 32 in screw openings 30 on each end of cervical plate 20 have a longitudinal central axis that is not aligned with the longitudinal central axis of screw openings 30.

[0112] Referring to FIG. 17, cervical plate 20 only includes two sets of screw openings 30 that are positioned at each end of cervical plate 20. As such, since screw openings 30 are located at the ends of cervical plate 20, the central longitudinal central axis of concavely indented surfaces 32 in the two sets of screw openings 30 have a longitudinal central axis that is not aligned with the longitudinal central axis of screw openings 30.

[0113] Referring to FIG. 18, cervical plate 20 includes six sets of screw openings 30. The central longitudinal central axis of concavely indented surfaces 32 in the sets of screw openings 30 located at each end of cervical plate 20 have a longitudinal central axis that is not aligned with the longitudinal central axis of screw openings 30. The four sets of screw openings 30 that are located inwardly of screw openings 30 that are located at each end of cervical plate 20 have concavely indented surfaces 32 that have a longitudinal central axis that is aligned with the longitudinal central axis of screw openings 30.

[0114] As illustrated in FIGS. 12-16, the central longitudinal axis of fastener system 100 can be oriented at different angles relative to the central longitudinal axis of concavely indented surfaces 32 and/or screw opening 30 depending on the view from the lateral or longitudinal axis of cervical plate 20.

[0115] The number of screw openings 30 in cervical plate 20 is non-limiting. The shape, length, width, and/or thickness of cervical plate 20 is non-limiting.

[0116] As illustrated in FIGS. 1-3, 17 and 18, each side of cervical plate 20 can optionally have multiple arcuate regions that create a generally wavy side or sinusoidal-shaped edges of cervical plate 20; however, it can be appreciated that such arcuate regions are not required. The radius of curvature of the wavy side edges is generally 5-10 mm (and all values and ranges therebetween), and typically 7-9 mm. Due to these arcuate regions, the width of cervical plate 20 varies along the longitudinal length the cervical plate. Generally, the location of screw openings 30 in cervical plate 20 represents a larger width region of cervical plate 20 than the regions absent screw openings 30. In one non-limiting embodiment, the maximum width of the cervical plate (as measured along the lateral axis of cervical plate 20) that includes one or more screw openings 30 is 20-60% greater (and all values and ranges therebetween) than the minimum width of cervical plate 20 at a location between two screw openings 30. For example, as illustrated in FIG. 2, the maximum width of cervical plate 20 is along cross-sectional line A-A and the minimum width of cervical plate 20 is along cross-sectional line C-C.

[0117] As illustrated in FIGS. 9 and 10, the thickness of cervical plate 20 can vary along the longitudinal length of cervical plate 20. In one non-limiting configuration, the thickness of the cervical plate at the location of screw openings 30 is generally thicker than at the regions that are absent screw openings 30. For example, as illustrated in FIG. 9, the maximum cross-sectional area MA1 of the cervical plate at the location between screw openings 30 and at the central longitudinal axis of cervical plate 20 is greater (10-50% greater and all values and ranges therebetween) than the minimum cross-sectional area MA2 of cervical plate 20 that is not located between screw openings 30 and is located along the central longitudinal axis of cervical plate 20. For example, as illustrated in FIG. 2, maximum cross-sectional area MA1 of cervical plate is along cross-sectional line A-A at the central longitudinal axis of cervical plate 20 and the minimum width of cervical plate 20 is along cross-sectional line C-C at the central longitudinal axis of cervical plate 20.

[0118] In one specific non-limiting configuration of cervical plate 20, the cross-sectional area of the cervical plate along the longitudinal length of the cervical plate is 8-16 mm.sup.2 (and all values and ranges therebetween); the cross-sectional area of the cervical plate optionally varies along the longitudinal length of the cervical plate; the maximum thickness of the cervical plate is 1-3 mm (and all values and ranges therebetween); the thickness of the cervical plate varies along the longitudinal length and/or latitudinal length of the cervical plate; the width of the cervical plate is 5-18 mm (and all values and ranges therebetween); and the width of the cervical plate varies along the longitudinal length of the cervical plate.

[0119] In another specific configuration of cervical plate 20, the cross-sectional area of the cervical plate along the longitudinal length of the cervical plate is 8.5-14 mm.sup.2; the cross-sectional area of the cervical plate optionally varies along the longitudinal length of the cervical plate; the maximum thickness of the cervical plate is 1-3 mm; the thickness of the cervical plate varies along the longitudinal length and/or latitudinal length of the cervical plate; the width of the cervical plate is 7-17 mm; and the width of the cervical plate varies along the longitudinal length of the cervical plate; the maximum cross-sectional area and/or the thickness of the cervical plate at and/or about the region of the screw openings is greater than the minimum cross-sectional area and/or thickness of the cervical plate in the region of the cervical plate that is absent the screw openings and located between two sets of screw openings; the maximum cross-sectional area of the cervical plate at and/or about the region between of the screw openings of a set of screw openings is 10-14 mm.sup.2, the minimum cross-sectional area of the cervical plate is 8.5-11 mm.sup.2; the width of the cervical plate at and/or about the region of the screw openings is greater than the width of the cervical plate that is absent the screw openings; the maximum width of the cervical plate at and/or about the region of the screw openings is 10-17 mm; and the minimum width of the cervical plate is 7-9.5 mm.

[0120] In another specific configuration of cervical plate 20, the maximum width of the cervical plate along the longitudinal axis of the cervical plate is 14-16.5 mm and the minimum width along the longitudinal axis of the cervical plate is 7.2-8.5 mm.

[0121] As illustrated in FIGS. 2 and 18, when cervical plate 20 includes three of more sets of screw openings, the maximum width of the cervical plate at the location of the screw openings at the ends of the cervical plate is less (e.g., 5-20% and all values and ranges therebetween) than the maximum width of the cervical plate at the location of the screw openings that are spaced inwardly from the screw openings located at the ends of the cervical plate. For example, as illustrated in FIG. 2, the maximum width of the cervical plate along line A-A is greater than the maximum width of the cervical plate along line D-D. When the cervical plate includes two of more sets of screw openings located between the screw openings located at each end of the cervical plate, the maximum width of the cervical plate at the two of more sets of screw openings located between the screw openings located at each end of the cervical plate can be the same.

[0122] In another specific configuration, the width of each of the screw openings is 3.5-5 mm (and all values and ranges therebetween).

[0123] In another specific configuration, the distance between each of the screw openings is from the outer peripheral edge of the cervical plate is 1.2-2.5 mm (and all values and ranges therebetween).

[0124] In another specific configuration, the distance between the two adjacently positioned screw openings is 1.5-4 mm (and all values and ranges therebetween). The two adjacently positioned screw openings can be located at the same distance from the central longitudinal axis of the cervical plate.

[0125] In another specific configuration, when the screws are inserted into screw openings 30, the screw opening can be shaped to cause the longitudinal axis of the screw to be at some non-tangential angle relative to top surface of the cervical plate adjacent the particular screw opening. In one non-limiting configuration, the screw openings located nearest to the end of the cervical plate are configured such that the longitudinal axis of the screw when fully placed into the screw opening is oriented ±2-15° (and all values and ranges therebetween) from a right angle to the top surface of the cervical plate (e.g., 75-88° relative to the top surface of the cervical plate). In one non-limiting configuration, the screw openings located in the mid-region of the cervical plate are configured such that the longitudinal axis of the screw when fully placed into the screw opening is oriented ±0-8° (and all values and ranges therebetween) from a right angle to the top surface of the cervical plate (e.g., 82-90° relative to the top surface of the cervical plate). Generally, the screw openings located in the mid-region of the cervical plate are configured differently from the screw openings located nearest to the end of the cervical plate such that the longitudinal axis of the screw when fully placed into the screw opening located in the mid-region of the cervical plate is different from the longitudinal axis of the screw when fully placed into the screw opening located nearest to the end of the cervical plate.

[0126] In another specific configuration, the cervical plate can have dual angulation of the screw openings as illustrated in FIGS. 12-16 wherein two or more adjacently positioned screw openings along a longitudinal axis of the cervical plate have a central axis that is not parallel to one another, and two or more pairs of adjacently positioned screw openings along the transverse axis (e.g., axis that is perpendicular to the longitudinal axis) have a central axis that is not parallel to one another. Such an arrangement can be caused by the orientation of the screw openings in the cervical plate and/or by the curvature of the cervical plate along the longitudinal and/or transverse axis of the cervical plate. For example, FIGS. 4, 5, 9, 10, and 13 illustrate a cervical plate that is curved along the longitudinal axis (e.g., 2-4°) and the pair of screw openings at the two ends have a central axis that has an angle (e.g., 9°) that is greater than the angle of curvature of the cervical plate along the longitudinal axis.

[0127] In another non-limiting configuration as illustrated in FIG. 16, the central axis of the pair of screw openings centrally located along the longitudinal axis of the cervical plate is generally perpendicular to the top surface of the cervical plate and the two pair of screw openings located at the end portions of the cervical plate have a central axis that is not generally perpendicular to the top surface of the cervical plate.

[0128] In another non-limiting configuration as illustrated in FIGS. 14-15, the central axis of the pair of screw openings centrally located along the transverse axis or lateral axis of the cervical plate is generally perpendicular to the top surface of the cervical plate and the two pair of screw openings located at the end portions of the cervical plate have a central axis that is also generally perpendicular to the top surface of the cervical plate. As such, when looking at the central axis of the screw openings along the longitudinal axis of the cervical plate, two or more of the adjacently positioned screw openings have central axis that are non-parallel to one another; and, when looking at the central axis of the screw openings along the transverse axis of the cervical plate, two or more of the adjacently positioned screw openings have central axis that are also non-parallel to one another.

[0129] In another specific configuration as illustrated in FIG. 16, the central axis of two or more adjacently positioned screw openings along the longitudinal axis of the cervical plate is such that the bottom portion of the fastener, when fully inserted into the screw opening, angles away from one another; and the central axis of two or more adjacently positioned screw openings along the transverse axis of the cervical plate is such that bottom portion of the fastener, when fully inserted into the screw opening, angle toward one another.

[0130] In another specific configuration as illustrated in FIGS. 14-16, the screw openings and the top portion of the fasteners (e.g., screw, etc.) are configured so at least a portion or all of the top of the fastener is flush or slightly recessed in the screw opening when the fastener is fully inserted into the screw opening. Such slightly recessed or flush mounting can be desirable in applications wherein the sharp edges of the fastener are not exposed after the cervical plate is secured to the bone or tissue. In one non-limiting embodiment, the screw opening has a shape that is the same or substantially similar to the top or upper portion of the fastener so the top portion of the fastener is flush with the top surface of the cervical plate that the top portion of the fastener contacts and sits on the screw opening when the fastener is fully inserted into the screw opening.

[0131] In another specific configuration as illustrated in FIGS. 1, 2, 17 and 18, a side portion of the cam recess terminates at one or both screw openings located adjacent to the cam recess. The cam recess can optionally include a sloped surface 54 that is located between such screw openings. When a sloped surface exists between the two screw openings, the slope surface is generally configured and oriented so the slope surface does not engage the cam during rotation of the cam in the cam recess. A portion of the can recess includes a cam opening that passes fully through the cervical plate. The diameter of the can openings is generally 2-5 mm (and all values and ranges therebetween). Generally, about 10-50% of the cam recess (and all values and ranges therebetween) does not pass fully through the cervical plate. The cam recess can be configured to include one or more cam stops 56 to limit rotation of a cam in the cam recess. Generally, the cam recess includes one or more cam stops that can a) limit rotation of the cam in a clockwise direction, and/or b) limit rotation of the cam in a counter-clockwise direction. The portion of the cam recess that does not fully penetrate the cervical plate is generally recessed from a top surface of the cervical plate (e.g., recessed about 0.1-0.6 mm and all values and ranges therebetween). The portion of the cam recess that does not fully penetrate the cervical plate has a thickness that is generally 0.2-0.6 mm (and all values and ranges therebetween). The cam recess is generally located 1-3 mm from the outer peripheral edge of the cervical plate.

[0132] In another specific configuration, the outer peripheral edge of the cervical plate can include a plurality of undulations on each of the two longitudinal sides of the cervical plate. In one non-limiting arrangement, the angle of curvature of the undulation along the long axis is 6-15° (and all values and ranges therebetween), and the angle of curvature of the undulation along the short axis is 30-40° (and all values and ranges therebetween).

[0133] In another specific configuration, the cross-sectional area in the region of a cervical plate at its narrowest width that is formed of a refractory metal alloy (e.g., MoTi alloy) or a metal alloy that includes at least 15 awt. % rhenium and the cross-sectional area is 9-11 mm.sup.2 (and all values and ranges therebetween) and the cross-sectional area in the region of the cervical plate at its widest width is 13-15 mm.sup.2 (and all values and ranges therebetween). The maximum thickness of the cervical plate at the center of the cervical plate is about 2-3 mm (and all values and ranges therebetween). The minimum width of the cervical plate is about 5-9 mm (and all values and ranges therebetween), and the maximum width of the cervical plate is 14-16.5 mm (and all values and ranges therebetween).

[0134] In another specific configuration, the cross-sectional area in the region of a cervical plate at its narrowest width that is formed of a refractory metal alloy (e.g., MoRe alloy) or a metal alloy that includes at least 15 awt. % rhenium and the cross-sectional area is 9-10 mm.sup.2 and the cross-sectional area in the region of the cervical plate at its widest width is 11-13 mm.sup.2. The maximum thickness of the cervical plate at the center of the cervical plate is about 1-2.5 mm (and all values and ranges therebetween). The minimum width of the cervical plate is about 7-9 mm (and all values and ranges therebetween), and the maximum width of the cervical plate is 14-16.5 mm (and all values and ranges therebetween).

[0135] The configuration and dimensions of the cervical plate are novel over prior art cervical plates. These novel dimensions are achievable by forming the cervical plate from a refractory alloy (e.g., MoTi, MoRe, etc.) or a metal alloy that includes at least 15 awt. % rhenium.

[0136] The cervical plate and/or fastener system (e.g., screws) can be partially or fully formed of a variety of materials (e.g., titanium, stainless steel, cobalt-chromium, carbon composite, plastic or polymer [e.g., polyetheretherketone (PEEK), polyethylene, ultra-high molecular weight polyethylene (UHMWPE), resorbable polylactic acid (PLA), polyglycolic acid (PGA), etc.], refractory alloys, metal alloy that includes at least 15 awt. % rhenium, etc.

[0137] These and other advantages will become apparent to those skilled in the art upon the reading and following of this description.

[0138] Reference throughout the specification to “various embodiments,” “some embodiments,” “one embodiment,” “some example embodiments,” “one example embodiment,” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with any embodiment is included in at least one embodiment. Thus, appearances of the phrases “in various embodiments,” “in some embodiments,” “in one embodiment,” “some example embodiments,” “one example embodiment, or “in an embodiment” in places throughout the specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures or characteristics may be combined in any suitable manner in one or more embodiments.

[0139] To aid the Patent Office and any readers of this application and any resulting patent in interpreting the claims appended hereto, Applicant does not intend any of the appended claims or claim elements to invoke 35 U.S.C. 112(f) unless the words “means for” or “step for” are explicitly used in the particular claim.

[0140] It will thus be seen that the objects set forth above, among those made apparent from the preceding description, are efficiently attained, and since certain changes may be made in the constructions set forth without departing from the spirit and scope of the disclosure, it is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense. The disclosure has been described with reference to preferred and alternate embodiments. Modifications and alterations will become apparent to those skilled in the art upon reading and understanding the detailed discussion of the disclosure provided herein. This disclosure is intended to include all such modifications and alterations insofar as they come within the scope of the present disclosure. It is also to be understood that the following claims are intended to cover all of the generic and specific features of the disclosure herein described and all statements of the scope of the disclosure, which, as a matter of language, might be said to fall there between. The disclosure has been described with reference to the certain embodiments. These and other modifications of the disclosure will be obvious from the disclosure herein, whereby the foregoing descriptive matter is to be interpreted merely as illustrative of the disclosure and not as a limitation. It is intended to include all such modifications and alterations insofar as they come within the scope of the appended claims.