SYSTEMS AND METHODS OF BONE PLATING

Abstract

An orthopedic fixation device and bone plating system for fracture fixation and methods for using the bone plating systems.

Claims

1. An orthopedic fixation device for use in fracture fixation comprising a bone plate body that has a plurality of screw openings therethrough; at least one of said screw openings as viewed along a central longitudinal axis of said screw opening has a plurality of plastically deformable protruding surfaces and a plurality of arcuate recessed regions; each arcuate recessed region located between two protruding surfaces; an interior of said screw openings absent threads.

2. The orthopedic fixation device as defined in claim 1, wherein each of said protruding surfaces extend no more than 10% about a perimeter of said screw opening; each of said arcuate recessed regions extends no more than 10% about said perimeter of said screw opening.

3. The orthopedic fixation device as defined in claim 1, wherein one or more of said protruding surfaces are formed of top and bottom sloped surfaces; each of said top sloped surfaces slopes downwardly from a top edge or a top region of said screw opening and terminates at a location that is ±0-20% a mid-depth of said screw opening; each of said bottom sloped surfaces slopes upwardly from a bottom edge or a bottom region of said screw opening and terminates at a location that is ±0-20% said mid-depth of said screw opening.

4. The orthopedic fixation device as defined in claim 1, wherein each of said top sloped surfaces is positioned above said top sloped surfaces; said top and bottom sloped surfaces having a same shape and size.

5. The orthopedic fixation device as defined in claim 1, wherein each of said top and bottom sloped surfaces have three sides; each of said intermediate sloped surfaces have four sides.

6. The orthopedic fixation device as defined in claim 1, wherein a thickness of an end of each of said protruding surface is thinner than at other regions of said protruding surface; a thickest region of said protruding surface is located adjacent an inner wall of said screw opening: a thickness of said protruding surface progressively decreases from a location adjacent said inner wall of said screw opening to said end of said protruding surface located closest to a central axis of said screw opening.

7. The orthopedic fixation device as defined in claim 1, wherein said deformable protruding surfaces and said arcuate recessed regions are symmetrically oriented about an outer perimeter of said screw opening.

8. The orthopedic fixation device as defined in claim 1, wherein said bone plate body includes multiple arcuate regions on each side of said bone plate body such that a width of said bone plate body varies along a longitudinal length of said bone plate body; a location of said screw openings in said bone plate body represents a larger width of said bone plate body than regions of said bone plate body that are absent said screw openings.

9. The orthopedic fixation device as defined in claim 1, wherein said bone plate body is at least partially formed of a refractory alloy or a metal alloy that includes at least 15 awt. % rhenium.

10. An orthopedic fixation device for use in fracture fixation comprising a bone plate body that has a plurality of screw openings therethrough; at least one of said screw openings includes a lead thread plate and at least one bottom thread located below said lead thread plate; said lead thread plate includes a plurality of lead recesses, each of said lead recesses are spaced from one another by a wide portion; a top surface of said lead thread plate is positioned parallel to a top surface of said bone plate body.

11. The orthopedic fixation device as defined in claim 10, wherein said bone plate body is planar along the longitudinal axis of bone plate body; said bone plate body has a curved profile along a lateral axis of said bone plate body and about a central longitudinal axis of said bone plate body.

12. The orthopedic fixation device as defined in claim 10, wherein a minimum width of one or more of said lead recesses is less than a maximum width of said bottom threads located below said lead thread plate.

13. The orthopedic fixation device as defined in claim 10, wherein a maximum width of one or more of said wide portions of said lead thread plate is greater than a maximum width of said bottom threads located below said lead thread plate.

14. The orthopedic fixation device as defined in claim 10, wherein lead recesses are spaced symmetrically about said screw opening from one another; and said wide portions are spaced symmetrically about said screw opening from one another.

15. The orthopedic fixation device as defined in claim 10, wherein said top surface of said lead thread plate is recessed from said top surface of said bone plate body; a recess wall extends upwardly from said top surface of said lead thread plate to said top surface of said bone plate body.

16. The orthopedic fixation device as defined in claim 15, wherein a maximum cross-sectional area of said top surface of said lead thread plate is greater than a maximum cross-sectional area of a region under said lead thread plate.

17. The orthopedic fixation device as defined in claim 10, wherein said bone plate body includes multiple arcuate regions on each side of said bone plate body such that a width of said bone plate body varies along a longitudinal length of said bone plate body; a location of said screw openings in said bone plate body represents a larger width of said bone plate body than regions of said bone plate body that are absent said screw openings.

18. The orthopedic fixation device as defined in claim 10, wherein said bone plate body is at least partially formed of a refractory alloy or a metal alloy that includes at least 15 awt. % rhenium.

19. The orthopedic fixation device as defined in claim 10, wherein said bone plate body includes a non-threaded screw opening; said non-threaded screw opening is absent a lead thread plate and threading; said non-threaded screw opening is positioned between two screw openings; said non-threaded screw opening includes a sloped surface that slopes downwardly from said top surface of said bone plate body; said sloped surface does not fully encircle said non-threaded screw opening.

20. The orthopedic fixation device as defined in claim 10, further including a fastener arrangement configured to be secured to one of said screw openings; said fastener arrangement includes a head portion and a body portion that is connected to the bottom of said head portion and extends downwardly from said head portion; said head portion includes head threading on an outer surface of head portion; said body portion including body threading on an outer surface of said body portion; one or more of a) a pitch of said body threading is different from a pitch of said head threading, b) a thread length of said body threading is different from a thread length of said head threading, c) a thread angle of said body threading is different from a thread angle of said head threading, d) a root depth of said body threading is different from a root depth of said head threading, and/or e) a lead of said body threading is different from a lead of said head threading,

21. The orthopedic fixation device as defined in claim 20, wherein said head portion of said fastener arrangement includes a tapered portion that forms a tapered profile of said head portion along a central axis of said head portion; said head threading at least partially located on said tapered portion; said tapered portion constitutes 20-100% of a longitudinal length of said head portion, an angle of taper of said tapered portion is constant along 60-100% of said tapered portion, said head threading on said tapered portion also having a tapered profile.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0088] 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:

[0089] FIG. 1 is an illustration of a prior art bone plate.

[0090] FIG. 2 is a top plan view of a one non-limiting embodiment of the bone plate in accordance with the present disclosure.

[0091] FIG. 3 is a cross-sectional view of the bone plate along line 3-3 of FIG. 2.

[0092] FIG. 4 is an enlarged end portion of the bone plate of FIG. 1 and includes an upper portion of a screw positioned in the screw opening of the bone plate.

[0093] FIG. 5 is a top plan view of FIG. 4.

[0094] FIG. 6 is a cross-sectional view of the bone plate along line 6-6 of FIG. 4.

[0095] FIG. 7 illustrates the bone plate of FIG. 2 positioned on a bone structure.

[0096] FIG. 8 illustrates the bone plate of FIG. 2 positioned and screwed by screws on a bone structure.

[0097] FIG. 9 is an elevation top view of another non-limiting embodiment of the bone plate in accordance with the present disclosure.

[0098] FIG. 10 is a top plan view of the bone plate of FIG. 9.

[0099] FIG. 11 is a bottom plan view of the bone plate of FIG. 9.

[0100] FIG. 12 is a cross-sectional view of the bone plate along line 12-12 of FIG. 9.

[0101] FIG. 13 is a cross-sectional view of the bone plate along line 13-13 of FIG. 9.

[0102] FIG. 14 is a side elevation view of a screw in accordance with the present disclosure.

[0103] FIG. 15 is a top view of the screw of FIG. 14.

[0104] FIG. 16 is a bottom view of the screw of FIG. 14.

[0105] FIG. 17 is a side view of the screw of FIG. 14.

[0106] FIG. 18 is an enlarged side view of a top portion of the screw of FIG. 14.

[0107] FIG. 19 is a cross-sectional view of the head of the screw along line 19-19 of FIG. 18.

[0108] FIG. 20 is an enlarged top plan view of one opening in the bone plate of FIG. 9.

[0109] FIG. 21 is a side cross-sectional view of the top portion of the bone plate of FIG. 9 with a screw partially inserted in the screw openings of the bone plate.

[0110] FIG. 22 is a side cross-sectional view of the top portion of the bone plate of FIG. 9 with a screw fully inserted in the screw openings of the bone plate.

[0111] FIG. 23 is a side cross-sectional view of the top portion of the bone plate of FIG. 9 with a screw fully inserted in the screw openings of the bone plate at a different orientation than in FIG. 22.

DESCRIPTION OF NON-LIMITING EMBODIMENTS

[0112] 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.

[0113] 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.

[0114] The singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise.

[0115] 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.

[0116] 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.

[0117] 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).

[0118] 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.

[0119] Percentages of elements should be assumed to be percent by weight of the stated element, unless expressly stated otherwise.

[0120] Referring now to FIG. 1, there is illustrated a prior art bone plate 100 that has seven star-shaped screw openings 110 that are cut uniformly through the fully thickness of the bone plate 100.

[0121] Referring new to FIGS. 2-23, there is illustrated a novel bone plate and fastener arrangement that can be used on various bones such as, but not limited to, a radius, an ulna, spinal bones, maxillofacial bones, a fibula, metatarsal bones, calcaneus bones, ankle bones, femur, distal tibia, proximal tibia, proximal humerus, distal humerus, a clavicle, bones of the foot, bones of the hand, etc. The bone plate can be shaped to match a particular bone surface (e.g., I-shaped, L-shape, T-shape, Y-shape, S-shape, C-shaped, E-shaped, F-shaped, J-shaped, U-shaped, etc.) and any other appropriate shape to fit the bone to be treated. In one non-limiting embodiment the bone plate can have a planar or non-planar profile along the longitudinal length of the bone plate. In another non-limiting embodiment, the bone plate can have a planar or non-planar profile along lateral axis of the bone plate along one or more locations or along the complete longitudinal length of the bone plate. The thickness of the bone plate can be constant or vary along the longitudinal length of the bone plate. In one non-limiting embodiment, the thickness of the bone plate is generally constant along 80-100% (and all values and ranges therebetween) of the longitudinal length of the bone plate. One or more surface of the bone plate can optionally be formed by a cutting process, stamping process, 3D printer, molding process, etc.

[0122] The novel bone plate and/or novel fastener arrangement can be made of a metal alloy (e.g., refractory metal alloy, metal alloy that includes at least 15 awt. % rhenium, etc.). The novel bone plate and/or novel fastener arrangement can be configured to penetrate and affix the bone plate to a bone while enabling multiple directions of the fastener arrangement axis relative to the normal vector of the bone plate, which facilitates fusion by stabilizing sections of bone together. The novel bone plate allows for a wide range of fastener arrangement locking angulation, thus providing greater surgical options during bone repairing procedures.

[0123] Referring now to FIGS. 2-8, there is illustrated bone plate 200 in accordance with the present disclosure. The bone plate 200 is configured to provide a bone fixation assembly that can accept a fastener arrangement 290 (e.g., screws, etc.). Bone plate 200 has a body 210 that has a lower surface 214 and an upper surface 212, a central longitudinal axis, a lateral axis that is traverse to the central longitudinal axis, and one or more screw openings 220 that extend from lower surface 214 to upper surface 212. The shape and/or size of the screw openings 220 can be the same or different. As illustrated in FIG. 2, the shape and size of all of the screw openings 220 are the same. The spacing of adjacently positioned screw openings 220 can be the same or different. As illustrated in FIG. 2, the spacing of adjacently positioned screw openings 220 are the same. The screw openings 220 are spaced from the peripheral edge of the bone plate 200.

[0124] The one or more screw openings 210 in body 210 of bone plate 200 are shown as having a central axis, and the screw openings 220 are adapted to receive the fastener arrangement 290.

[0125] The geometry of the screw openings 220 in the body 210 of bone plate 200 optionally allows for plastic deformation of the screw opening geometry to lock a portion of the head portion of the fastener arrangement 290 in the screw opening 220. This locked construct of the head portion of the fastener arrangement 290 and screw opening 220 in bone plate 200 can be used to stabilize the bones relative to bone plate 200 and facilitate fusion.

[0126] The screw openings 220 generally have a circular cross-sectional shape and the inner surface of screw openings 220 include a series of inwardly-protruding surfaces 230. The plurality of protruding surfaces 230 extend into screw opening 220 toward the central axis A of screw opening 220 and are spaced from central axis A of screw opening 220. The plurality of protruding surfaces 230 are illustrated as forming smooth and non-threaded surfaces One non-limiting purpose of plurality of protruding surfaces 230 is to engage one or more portions of the head of a fastener arrangement (e.g., screw, etc.) to facilitate in securing head portion 292 of fastener arrangement 290 to bone plate 200. The protruding surfaces 230 are configured to be plastically deformed when head portion 292 of fastener arrangement 290 is partially or fully inserted into screw opening 220. The plastic deformation and frictional engagement between head portion 292 of fastener arrangement 290 and protruding surfaces 230 results in head portion 292 of fastener arrangement 290 to be secured to bone plate 200 when fastener arrangement 290 is partially or fully inserted into screw openings 220. As illustrated in FIGS. 3, 4 and 6, screw opening 220 is absent threads and only the plastic deformation and frictional engagement between head portion 292 of fastener arrangement 290 and protruding surfaces 230 in screw opening 220 are used to secure head portion 292 of fastener arrangement 290 to bone plate 200. In such an arrangement, head portion 292 of fastener arrangement 290 may or may not include threading since any threading on head portion 292 of fastener arrangement 290 will not be engaging any thread in screw opening 220.

[0127] As illustrated in FIG. 2, each of the screw openings 220 includes eight (8) protruding surfaces 230 when screw opening 220 is viewed along its central axis. When screw opening 220 is along the central axis A, an arcuate recessed region 240 is located on both sides of protruding surface 230 as illustrated in FIG. 5.

[0128] Each protruding surfaces 230 is formed by a top sloped surface 232 and a bottom sloped surface 234. Positioned between each set of top and bottom sloped surfaces 232, 234 is an intermediate sloped surface 236 that partially or fully forms the arcuate recessed region 240. Each of sloped surfaces 232, 234, 236 extend no more than 20% (e.g., 2-20% and all values and ranges therebetween) about a perimeter of screw opening 220.

[0129] As illustrated in FIGS. 3, 4 and 6, top sloped surfaces 232 slope downwardly from a top edge or a top region of screw opening 220 and terminate at a location that is ±0-20% (and all values and ranges therebetween) of the mid-depth of screw opening 220. As also illustrated in FIGS. 3, 4 and 6, bottom sloped surfaces 234 slope upwardly from a bottom edge or a bottom region of screw opening 220 and terminate at a location that is ±0-20% (and all values and ranges therebetween) the mid-depth of screw opening 220.

[0130] As illustrated in FIGS. 3, 4 and 6, top sloped surfaces 232 and bottom sloped surfaces 234 have a similar shape and a similar size. Each of top sloped surfaces 232 is positioned above a bottom sloped surface 234 and each set of top and bottom slope surfaces 232, 234 form first protruding surface 230. An intermediate sloped surface 236 is positioned between each pair of top and bottom slope surfaces 232, 234. Each of the top and bottom sloped surfaces 232, 234 have three sides, and each of intermediate sloped surfaces 236 have four sides. As illustrated FIGS. 3, 4 and 6, each of intermediate sloped surfaces 236 extends from the top edge or the top region of screw opening 220 to the bottom edge or the bottom region of screw opening 220.

[0131] Protruding surfaces 230 can be formed by a cutting process, stamping process, 3D printer, molding process, etc. The radius of curvature of a top sloped surface 232, a bottom slope surface 234, and an intermediate sloped surfaces 236 is non-limiting.

[0132] The thickness of the end of protruding surface 230 is thinner than the other portions of protruding surface 230 to enable the end region of the protruding surface 230 to at least partially plastically deform when a head portion 292 of a fastener arrangement 290 is secured to bone plate 200.

[0133] As illustrated in FIGS. 2 and 5, protruding surfaces 230 are symmetrically oriented about the inner surface of screw opening 220.

[0134] The shape, length, width, and/or thickness of body 210 of bone plate 200 is non-limiting. As illustrated in FIGS. 2, 7 and 8, each side of body 210 of bone plate 200 has multiple arcuate regions that create generally wavy side or sinusoidal-shaped edges of the body 210 of bone plate 200. 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.

[0135] The width of body 210 of bone plate 200 can optionally vary along the longitudinal length of body 210 of bone plate 200 as illustrated in 2. The location of screw openings 220 in body 210 of bone plate 200 represents the larger width regions of body 210 of bone plate 200 than the regions absent screw openings 220. In one non-limiting embodiment, the maximum width of body 210 of bone plate 200 (as measured along the lateral axis of the body 210 of bone plate 200) that includes one or more screw openings 220 is 5-40% greater (and all values and ranges therebetween) than the minimum width of the body 210 of bone plate 200 at a location between two screw openings 220.

[0136] Fastener arrangement 290 can be any typical, standard locking fastener or a non-locking fastener system. As illustrated in FIGS. 4-6, fastener arrangement 290 is in the form of a screw that includes a head portion 292 and a body portion 294. Body portion 294 includes threads 296. Body portion 294 can be fully or partially threaded. The end of body portion 294 (not shown) can optionally include a self-Lapping or self-drilling tip.

[0137] The maximum cross-sectional size of head portion 292 of the screw is greater than the maximum cross-sectional size of body portion 294. The cross-sectional shape of the top region of head portion 292 is generally circular shaped. Head portion 292 can optionally include a cavity 298 to facilitate in inserting the screw into a bone and securing bone plate 200 to bone B as illustrated in FIGS. 7-8. The configuration of cavity 298 is non-limiting. Generally, cavity 298 is specially shaped to receive a tool to rotate and/or otherwise cause the screw to be inserted into a bone B. Non-limiting shapes that can be used in the cavity 298 include one or more dimples, ridges, bumps, textured areas, or any other surface. As illustrated in FIGS. 5 and 6, cavity 298 has a star shape. The depth of cavity 298 is generally less the longitudinal length of head portion 292 as illustrated in FIG. 6.

[0138] Referring now to FIGS. 9-23, another embodiment of the bone plate and fastener arrangement is illustrated. As illustrated in FIGS. 9-13, there is illustrated bone plate 300 in accordance with the present disclosure. Bone plate 300 is configured to provide a bone fixation assembly that can accept a fastener arrangement 400 (e.g., screws, etc.). Bone plate 300 has a body 302 that has a lower surface 306 and an upper surface 304, a central longitudinal axis as represented by dashed line 12 of FIG. 10, a lateral axis that is traverse to the central longitudinal axis as represented by dashed line 13 of FIG. 10, and one or more screw openings 310 that extend from lower surface 306 to upper surface 304. Each of the screw openings 310 has a central longitudinal axis. The central longitudinal axis C of the far-right screw opening 350 of FIGS. 10 and 12 is represented by the intersection of axis lines 12 and 13 in FIG. 10 and line C of FIG. 12. Bone plate 300 is illustrated has including five (5) screw openings 310 and a central opening 350 which can be formed into a screw opening or can be formed into an opening that temporarily secures bone plate 300 in place and/or facilitates in the positioning of the bone plate 300 in position on a bone. The number of screw openings 310 in bone plate 300 is non-limiting (e.g., 2-10 and all values and ranges therebetween).

[0139] The shape and/or size of screw openings 310 can be the same or different. As illustrated in FIGS. 9-12, the shape and size of all of screw openings 310 are the same. The spacing of adjacently positioned screw openings 310 can be the same or different. As illustrated in FIGS. 9-12, the spacing of adjacently positioned screw openings 310 are the same. The screw openings 310 are spaced from the peripheral edge of bone plate 300. As best illustrated in FIG. 10, screw openings 310 are aligned along the central longitudinal axis of bone plate 300; however, this is not required. The spacing of adjacently positioned screw openings 310 can be the same; however, this is not required. The minimum spacing of each of screw openings 310 from the outer perimeter edge of bone plate 300 can be the same; however, this is not required. Generally, the spacing of the screw openings 310 from the outer perimeter edge of bone plate 300 is at least 0.015 inches (e.g., 0.015-0.1 inches and all values and ranges therebetween), and typically at least 0.03 inches.

[0140] Referring now to FIGS. 10-11, the sides of bone plate 300 are illustrated as including indent regions 360 located in between screw openings 310, thereby causing the width of bone plate 300 to vary along the longitudinal length of the bone plate. The depth of the indent regions (when used) is non-limiting. As illustrated in FIGS. 9-11, a non-indented region exists between one of screw openings 310 and central opening 350; however, this is not required.

[0141] The thickness of bone plate 300 is at least 0.02 inches (e.g., 0.02-0.1 inches and all values and ranges therebetween), and typically at least 0.3 inches

[0142] As illustrated in FIGS. 9 and 12, bone plate 300 is substantially linear (e.g., 0-5° and all values and ranges therebetween) along the longitudinal axis of bone plate 300; however, this is not required.

[0143] As illustrated in FIGS. 9-11, the width of bone plate 300 varies along the longitudinal length of bone plate 300. Both sides of the bone plate are illustrated as having multiple arcuate regions 360 that create a generally wavy side or sinusoidal-shaped edges of bone plate 300. 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 360, the width of bone plate 300 varies along the longitudinal length of bone plate 300. Generally, the location of screw openings 310 in bone plate 300 represents a larger width region of bone plate 300 than the regions absent screw openings 310. Generally, the maximum width of bone plate 300 (as measured along the lateral axis of the bone plate) that includes one or more screw openings 310 (e.g., along line 13 of FIG. 10) is 5-40% greater (and all values and ranges therebetween) than the minimum width of bone plate 300 at a location between two screw openings 310 (e.g., along line D of FIG. 10).

[0144] As illustrated in FIG. 13, bone plate 300 has a curved profile (e.g., 1-15 and all values and ranges therebetween) along the lateral axis of the bone plate and about the central longitudinal axis of bone plate 300; however, this is not required.

[0145] The one or more screw openings 350 in body 302 of bone plate 300 are shown as having a central longitudinal axis C as illustrated in FIG. 12, and screw openings 350 are adapted to receive fastener arrangement 400 as illustrated in FIGS. 21-23.

[0146] Referring now to FIGS. 9-13 and 20-23, the inner surface of the one or more screw openings 310 has a special threaded configuration that enables head portion 410 of fastener arrangement 400 to be locked in screw opening 310 once head portion 410 of fastener arrangement 400 is partially or fully inserted into screw opening 310.

[0147] Screw openings 310 include a lead thread plate 320 that includes a plurality of lead recesses 322 (e.g., 2-6 lead recesses, 3 lead recesses, etc.), and wherein lead recesses 322 are spaced from one another by wide portions 324. The plurality of lead recesses 322 are configured to facilitate in the threading of head portion 410 of the fastener arrangement 400 to screw opening 310. As illustrated in FIG. 20, the minimum width of one or more of the lead recesses 322 is less than a maximum width of bottom threads 330 located below lead thread plate 320. Generally, the maximum width of wide portions 324 of lead thread plate 320 is greater than a maximum width of a bottom thread 330 located below the lead thread plate as illustrated in FIG. 20. The lead recesses 322 and wide portions 324 are illustrated as being spaced at equal distances about screw opening 310; however, this is not required.

[0148] As illustrated in FIGS. 12, 13 and 20, lead thread plate 320 is recessed from upper surface 304 of bone plate 300. A recess wall 340 extends upwardly from the upper surface of lead thread plate 320 to upper surface 304 of bone plate 300. The shape of the recessed region having an outer perimeter as defined by recess wall 340 is generally cylindrical; however, this is not required. The depth of the recessed region is at least 0.002 inches (e.g., 0.002-0.025 and all values and ranges therebetween), and typically at least 0.005 inches. Generally, the depth of the recessed region is at least 5% (e.g., 5-60% and all values and ranges therebetween) of the thickness of screw opening 310, and typically the depth of the recessed region is at least 15% of the thickness of screw opening 310. The recessed region has a generally circular cross-sectional shape; however, this is not required. As illustrated in FIGS. 12 and 13, the maximum cross-sectional area of the recessed region is greater than the maximum cross-sectional area of the recessed region under the lead thread plate that include bottom threads 330. As such, the diameter or cross-sectional area of screw opening 310 located above lead thread plate 320 is greater than the maximum diameter or cross-sectional area of the region that includes threads 330 located below lead thread plate 320. The depth of the recessed region formed by lead thread plate 320 is generally uniform throughout the recessed region. The thickness of lead thread plate 320 is generally the same. In one non-limiting configuration, the top surface of lead thread plate 320 is generally parallel to upper surface 304 of bone plate 300.

[0149] Referring now to FIGS. 9, 12 and 13, the inner surface of the one or more screw openings 310 located below lead thread plate 320 includes one or more sets of lower threading 330. The lower threading 320 forms a spiral surface that has a generally uniform thread width and thickness along the depth of the screw opening. In another non-limiting embodiment, one or more of lower threading 320 does not fully encircle the screw opening 310 (e.g., lower threading encircles 30-90% of the screw opening and all values and ranges therebetween) In one non-limiting arrangement, one or more screw openings 310 includes a lead thread plate 320 that includes first, second, and third lead recesses 322 and a first lower thread that begins below the first lead recess, a second lower thread begins below the second lead recess, and a third lower thread begins below the third lead recess, and wherein the first, second, and/or third lower threads optionally do not fully encircle screw opening 310, and wherein lead recesses 322 are optionally spaced equal distances from adjacently positioned lead recesses 322. The longitudinal length of one or more lower threads 330 along central axis C of screw opening 310 is at least 25% (e.g., 25-90% and all values and ranges therebetween) of the thickness of screw opening 310.

[0150] As illustrated in FIGS. 12 and 13, the angle between lead thread plate 320 and the beginning of lower thread 330 located below lead thread plate 320 is about 10-40° (e.g., and all values and ranges therebetween); however, other angles can be used.

[0151] As illustrated in FIGS. 9 and 10, bone plate 300 includes a non-threaded screw opening 350. Non-threaded screw opening 350 is absent a lead thread plate and a lower thread. Non-threaded screw opening 350 can have a maximum cross-sectional area along the longitudinal length of bone plate 300 that is greater than a maximum cross-sectional area of one or more of screw openings 310 that include a lead thread plate 320 and one or more lower threads 330. Non-threaded screw opening 350 is illustrated as positioned between screw openings 310 that include a lead thread plate 320 and one or more lower threads 330. Non-threaded screw opening 350 has a sloped surface 352 that slopes downwardly from an upper surface 304 of body 302 of bone plate 300. Sloped surface 352 has a thickness of 50-100% (and all values and ranges therebetween) of the thickness of body 302 of bone plate 300, and slope surface 352 does not fully encircle non-threaded screw opening 350.

[0152] The configuration of bone plate 300 and/or screw openings 310 in bone plate 300 can be configured to enable a fastener arrangement 400 to be oriented a) along central axis C of screw opening 310 when fully inserted into the screw opening 310, or b) be oriented off-center from central axis C of screw opening 310 when fully inserted into the screw opening. Bone plate 300 having a plurality of screw openings 310 with the same size and configuration can enable a) all of the fastener arrangements 400 to be oriented in the same way relative to central axis C of screw opening 310 when fully inserted into the screw openings 310, or b) one or more of fastener arrangements 400 have a different orientation to other fastener arrangements 400 when fully inserted into screw openings 310.

[0153] Bone plate 300 having a plurality of screw openings 310 with the same size and configuration can also enable a) central axis C of all of fastener arrangements 400 to be parallel with one another when fully inserted into screw openings 310, or b) central axis C of one or more of fastener arrangements 400 to be non-parallel (e.g., oriented inwardly toward one another, oriented outwardly from one another, etc.) with central axis C of one or more other fastener arrangements 400 when fully inserted into screw openings 310.

[0154] The ability to enable the fastener arrangements to have the ability to be secured to the bone plate in various orientations relative to the central axis of the bone while using the same screw opening configuration on the bone plate is a significant advantage when attempting to secure the bone plate to a bone since the desired location of insertion of the fastener arrangement to the bone when the bone plate is positioned on the bone is not always along the central axis of the screw opening. The ability to custom orient the fastener arrangement relative to the central axis of one or more or all of the screw openings enables the proper insertion of the fastener arrangement in the bone once the bone plate is properly positioned on the bone.

[0155] Referring now to 14-23, fastener arrangement 400 is in the form of a screw. The fastener arrangement 400 includes a head portion 410 and a body portion 440 connected to the bottom of head portion 410 and extends downwardly from head portion 410.

[0156] Head portion 410 includes a top opening 420 and head threading 430 on the outer surface of head portion 410.

[0157] Top opening 420 generally includes a non-circular cross-sectional shape or a threaded inner surface. As illustrated in FIGS. 14 and 15, top opening 420 has a hexagonal cross-sectional shape along at least a portion of the central axis of opening 420. As can be appreciated, other non-circular cross-sectional shapes can be used (e.g., triangular, square, polygonal, oval, etc.). As illustrated in FIGS. 21-22, the depth of top opening 420 along the central axis of top opening 420 is generally at least 30% (e.g., 30-100% and all values and ranges therebetween) the depth of head portion 410 along the central axis of head portion 410. Top opening 420 is generally spaced from the other perimeter of head portion 410.

[0158] Head portion 410 has a tapered profile along the central axis of head portion 410. The angle α of taper is generally at least 1° (e.g., 1-25° and all values and ranges therebetween) In one non-limiting configuration, the angle of taper of head portion 410 is 10-20°. As such, the cross-sectional area and/or diameter of the top of head portion 410 is greater than the cross-sectional area and/or diameter of the bottom of head portion 410. As illustrated in FIGS. 17, 18, 21 and 22, the cross-sectional area and/or diameter of head threading 430 from the top to the bottom of head 410 portion also progressively reduces due to the taper of the head portion.

[0159] The tapered profile includes head threading 430 along 60-100% (and all values and ranges therebetween) of the central axis of the tapered portion of the head portion. The tapered portion of the head portion is generally 20-100% (and all values and ranges therebetween) of the longitudinal length of the head portion. The angle of taper of the head portion can be constant along 60-100% (and all values and ranges therebetween) of the taper. Head threading 430 on the head portion 410 is spirally shape and has a) a constant width along 60-100% (and all values and ranges therebetween) the length of the threading, b) a constant shape along 60-100% (and all values and ranges therebetween) the length of the threading, c) a constant lead along 60-100% (and all values and ranges therebetween) the length of the threading, and/or d) a constant pitch along 60-100% (and all values and ranges therebetween) the length of the threading.

[0160] The use of the tapered region on the head portion of the fastener arrangement can optionally facilitate in enabling in the fastener arrangement to be oriented in the screw opening at a desired angle relative to the central axis of the screw opening. When the screw opening includes a lead thread plate that has two or more recesses, the bottom narrower portion of the taper region of the head portion of the fastener arrangement can be used to allow the fastener arrangement to be angled and positioned in the desired recess of the lead thread plate of the screw opening before the threads on the taper region fully engage the lead thread plate and/or the threads below the lead thread plate.

[0161] Head threading 430 generally has the same or similar pitch as lower threads 330 in screw opening 310 of bone plate 300. The lead of head threading 430 is generally greater than the pitch of head threading 430; however, this is not required. In one non-limiting embodiment, the lead of head threading 430 is about 0.04-0.1 inches (and all values and ranges therebetween), and the pitch of head threading 430 is about 0.01-0.05 inches (and all values and ranges therebetween). In one non-limiting specific configuration, the lead is about 0.06 inches and the pitch is about 0.02 inches. Head threading 430 is illustrated as encircling head portion 410 at least once (e.g., 1-6 encirclements of head portion 410 and all values and ranges therebetween).

[0162] The angle of head threading 430 is generally the same or similar to the angle of lower thread 330 located below lead thread plate. In one non-limiting configuration, the angle of head threading 430 is about 60° (e.g., 60°±20° and all values and ranges therebetween); however, other angles can be used.

[0163] Head portion 410 generally has a maximum cross-sectional area that is greater than a maximum cross-sectional area of body portion 440. The shape of head portion 410 is non-limiting. In one non-limiting configuration, the cross-sectional shape of the top region of head portion 410 is generally circular shaped.

[0164] As illustrated in FIGS. 14, 17 and 18, fastener arrangement 400 can optionally include a transition portion 450 that is located from the bottom portion of head portion 410 to the top of body portion 440; however, this is not required. Transition portion 450 (when used) can include one or more curved regions; however, this is not required. The non-threaded transition region of the head portion (when used) is generally 5-80% (and all values and ranges therebetween) of the longitudinal length of the head portion. In one non-limiting configuration, the minimum cross-sectional area of the non-threaded transition region is less than the maximum cross-sectional area of the head portion and/or the body portion, and the non-threaded transition region has a generally circular cross-sectional shape along 60-100% (and all values and ranges therebetween) of the longitudinal length of non-threaded transition region 450. The use of the non-threaded transition region on the head portion of the fastener arrangement optionally facilitate in enabling the fastener arrangement to be oriented in the screw opening at a desired angle relative to the central axis of the screw opening. When the screw opening includes a lead thread plate that has two or more recesses, the non-threaded transition region of the head portion of the fastener arrangement can be used to allow the fastener arrangement to be angled and positioned in the desired recess of the lead thread plate of the screw opening before the threads on the taper region fully engage the lead thread plate and/or the threads below the lead thread plate.

[0165] Referring now to FIGS. 14 and 17, body portion 440 of fastener arrangement 400 includes body threading 460 that is configured to be secured into a bone. Body threading 460 generally has a different lead and pitch than head threading 430 of fastener arrangement 400. In one non-limiting configuration, head threading 430 of fastener arrangement 400 has a lead of 0.04-0.08 inches (and all values and ranges therebetween) and a pitch of 0.01-0.04 inches (and all values and ranges therebetween) and a thread angle of 30-70° (and all values and ranges therebetween). Head threading 430 is illustrated as being a single thread. The pitch of body threading 460 is generally greater than the pitch of head threading 430 (e.g., at least 20% greater) In one non-limiting configuration pitch of body threading 460 is 0.05-0.12 inches. The lead of body threading 460 is generally greater than the lead of head threading 430 (e.g., at least 20% greater). In one non-limiting configuration lead of body threading 460 is 0.05-0.12 inches.

[0166] Head threading 430 can have the same or similar lead and pitch as lower threading 330 in screw opening 310.

[0167] Body threading 460 on the body portion of the fastener arrangement has a maximum cross-sectional area that is less than the minimum cross-sectional area of screw opening 310 so the body portion of the fastener arrangement can be passed through the screw opening.

[0168] As illustrated in FIG. 17, body threading 460 on the body portion of the fastener arrangement has a maximum cross-sectional area that is less than the maximum cross-sectional area of head threading 430.

[0169] The bottom portion of body portion 440 optionally includes a cut face 480 that can be used to facilitate in the tip of fastener arrangement 400 penetrating into a bone.

[0170] Referring now to FIGS. 21-23, there is illustrated fastener arrangement 400 that has been threaded into bone plate 300. FIGS. 21 and 22 illustrate fastener arrangement 400 as being threadedly secured to bone plate 300 and the central axis of fastener arrangement 400 is generally perpendicular to the longitudinal axis of bone plate 300. FIG. 22 illustrates fastener arrangement 400 as being threadedly secured to bone plate 300 and the central axis of fastener arrangement 400 is non-perpendicular to the longitudinal axis of bone plate 300. In both of these configurations, fastener arrangement 400 is able to be locked in position relative to bone plate 300. The tapered profile of head portion 410 enables fastener arrangement 400 to be inserted along central axis C of screw opening 310, or positioned at some non-parallel angle relative to central axis C of screw opening 310 when initially orienting fastener arrangement 400 relative to screw opening 310. One the desired orientation of fastener arrangement 400 relative to the screw opening is obtained, the fastener arrangement can then be threaded into screw opening 310 to thereby secure and lock the fastener arrangement in position relative to bone plate 300. FIG. 21 illustrates the fastener arrangement inserted into the screw opening prior to full insertion and FIG. 22 illustrated that fastener arrangement fully inserted into the screw opening and locked in the screw opening.

[0171] The locking of fastener arrangement 400 in screw opening 310 is at least in part achieved when the top of body threading 460 is positioned below lead thread plate 320. When head portion 410 of the fastener arrangement 400 is inserted sufficient in the screw opening 310 such that some or all of the top of body threading 460 is positioned below lead thread plate 320, the fastener arrangement becomes locked in the screw opening from lead thread plate 320 resisting fastener arrangement 400 from being threaded out from screw opening 310.

[0172] Turning now to the methods of implantation, the surgeon accesses the surgical site of interest, which can be an internal site at which a bone fracture that requires stabilization to ensure proper healing is located. The fracture may be reduced with conventional forceps and guides (which are known to those in the art), and a bone plate of appropriate size and shape is placed over the fracture site. In some instances, the bone plate may be temporarily secured to the bone using provisional fixation pins. When used, provisional fixation pins may be used through any of the openings in the bone plate. Provisional fixation pins temporarily secure the bone plate to the bone before placing the fastener system (e.g., screws, etc.) through the opening in the bone plate. Thus, the surgeon can be certain that the bone plate is properly positioned before placing the fastener system for permanent fixation of the bone plate to the bone.

[0173] Once the bone plate is secured at a desired location in relation to the fracture, the surgeon then identifies an insertion angle, or the direction along which the fastener system is to be inserted through one or more openings in the bone plate and then driven into the bone material of the bone. If the bone plate includes more than one opening, the surgeon also selects the specific openings in the bone plate to be used. After selecting the desired insertion angle and openings to be used in the bone plate, the surgeon inserts a lower portion of the fastener system through each of the selected openings in the bone plate until the bottom of the fastener system contacts bone material. In some cases, a hole may need to be drilled or tapped into the bone along the insertion angle to facilitate the initial tapping or insertion of the fastener system into the bone. The surgeon then uses an appropriate driving tool in the cavity of the head portion of the fastener system to manipulate the fastener system into place.

[0174] The fastener system can optionally be inserted at angles other than being aligned with the central axis of the opening in the bone plate. In some instance, the surgeon may need to toggle or maneuver the fastener system in order to secure and draw in displaced bone fragments during the securing of the bone plate to the bone.

[0175] Once the bone fragment is secured, the fastener system is ready to be secured to the bone plate. As the fastener system is driven further into bone, it is also drawn further into the bone plate.

[0176] With reference to the non-limiting embodiment of FIGS. 2-8, as the head portion of the fastener system begins to contact protruding surfaces 230 in screw opening 220 in the bone plate, one or more of protruding surfaces 230 are caused to at least partially plastically deform and thereby secure the head portion of the fastener arrangement to the bone plate in the desired angle. The action of engagement between the protruding surfaces and the fastener arrangement rigidly affixes the fastener arrangement to the bone plate. In some embodiments, the surgeon can optionally use traditional locking and/or non-locking screws in one or more other openings in the bone plate. This can potentially help further secure the bone plate to the bone fracture if needed.

[0177] With reference to the non-limiting embodiment of FIGS. 9-23, head portion 410 of fastener arrangement 400 is inserted further into the screw openings of bone plate 300. The angular shape of the head portion in combination with the threading on the head portions and the threading on the bone plate results in the locking screw locking into position relative to the bone plate.

[0178] In one optional procedure, once all fastener systems are inserted into the bone plate, the surgeon may optionally place covers over the unused openings in the bone plate. Additionally or alternatively, the surgeon may use bone graft material, bone cement, bone void filler, and any other material to help heal the bone. Such material (when used) can be placed in one or more unused openings in the bone plate and/or placed one and/or about one or more portions of the bone plate.

[0179] 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.

[0180] 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.

[0181] 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.