WO2017087957A1

WO2017087957A1 - Bone fixation assembly, implants and methods of use

Info

Publication number: WO2017087957A1
Application number: PCT/US2016/063124
Authority: WO
Inventors: Douglas K. BLACKLIDGE; John Mullins
Original assignee: Paragon 28, Inc.
Priority date: 2015-11-19
Filing date: 2016-11-21
Publication date: 2017-05-26

Abstract

Bone fixation assemblies, implant and methods for using the bone fixation devices and implants are disclosed. The bone fixation assembly includes an implant and a fastener. The bone fixation device may also include at least one bone screw. In one embodiment, the implant may include a central portion, a first arm extending away from the central portion in a first direction, and a second arm extending away from the central portion in a second direction, wherein the second direction is opposite the first direction. In one embodiment, the fastener may include a head portion and a shaft portion coupled to and extending away from an inferior end of the head portion. Finally, methods for using the bone fixation devices and implants are disclosed.

Description

BONE FIXATION ASSEMBLY, IMPLANTS AND METHODS OF USE

CROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims priority benefit under 35 U S C. § 119(e) of U.S. provisional application No. 62/257,327 filed November 19, 2015, which is incorporated herein by reference in its entirety.

FIELD OF INVENTION

[0002] The present invention relates generally to general surgery and orthopaedic implants used for achieving bone fusion. More specifically, but not exclusively, the present invention relates to surgical devices for fixation of human bones, such as, the foot bones, and to the internal fixation of the proximal portion of metatarsal bones to the bones of the mid-foot and rear-foot to stabilize realignment of a fracture, dislocation, fusion or the like of the tarsometatarsal j oints, mid-foot and rearfoot.

BACKGROUND OF THE INVENTION

[0003] The proximal metatarsal base at its articulation with the mid tarsus of the human foot is a common site of fracture and/or dislocation especially in persons with neuropathy (neuropathic arthropathy or Charcot joints). The metatarsals at the mid tarsal articulation displace dorsally and lead to progressive deformity and instability of the foot. Ultimately this can progress to deformity that leads to excessive soft tissue pressures of the plantar foot and result in wound development. This type of wound is difficult to heal due to the pressures in this area from weight bearing. Instability and deformity of the mid -foot can lead to infection-prone wounds that often result in amputation. Realignment and stabilization of the j oints can provide a more anatomic alignment to the foot, provide stability, and dramatically decrease wound and associated amputation risk.

[0004] Stable fixation of the metatarsus, mid tarsus and tarsus can be challenging with current devices available. A variety of bone screws serving as "beams" have been used in attempt to provide fixation of these foot bone segments. They are most effective at providing stability to the bones of the tarsus and mid tarsus. The smaller metatarsal bones are particularly difficult to include in "beam" screw fixation. The first metatarsal bone can be fixated by axial "beam" screw due to its size and alignment with respect to the mid tarsus and tarsus, however, the smaller metatarsals do not lend themselves to this type of fixation. Alternatively, dorsal plates and screws are used to maintain realignment of the metatarsal bases to the mid tarsus. Bone fixation plates in this area cannot span the metatarsal, mid tarsal, and tarsal foot segments well without excessive bulk and soft tissue disruption. [0005] The challenge for "beam" screw fixation of the smaller metatarsals is the size of beam screw needed to prevent screw failure as compared the size of the metatarsal being fixated. Significant violation of the metatarsal base would occur with insertion of a large screw from the proximal metatarsal extending through the mid tarsus and ending in the tarsus. An ideal "beam" screw construct for stabilization of a relocated metatarsal to mid-tarsal to tarsal foot bone segments would include multiple large diameter screws spanning all three of these bone segments. "Beam" screw fixation inclusive of metatarsal bases 2-5 is suboptimal with current device options.

[0006] It is therefore an obj ect of the present invention to provide a "beam" screw construct that corrects the deficiencies of the prior art. It is further an object of the present invention to provide a "beam" screw construct for internal fixation of the proximal portion of metatarsal bones (base) to the bones of the mid-foot and rear-foot to stabilize realignment of a fracture, dislocation, fusion or the like of the tarso-metatarsal joints, mid-foot and rearfoot that overcomes the deficiencies of the prior art. The present invention achieves these objectives.

SUMMARY OF THE INVENTION

[0007] Aspects of the present invention provide bone fixation devices for use in a method of fusing bones.

[0008] In one aspect, provided herein is a bone fixation assembly, including: an implant and a fastener.

[0009] In another aspect, provided herein is an implant, including: a central portion, a first arm extending away from the central portion in a first direction, and a second arm extending away from the central portion in a second direction, wherein the second direction is opposite the first direction.

[0010] In a further aspect, provided herein is a method for internal fixation of a proximal portion of at least two metatarsal bones to bones of a mid-foot and rear-foot to stabilize realignment of a fracture, dislocation, or fusion of the tarso-metatarsal joints, mid-foot and rearfoot, including: obtaining bone fixation device and surgically implanting the bone fixation device into a patient.

[001 1] These, and other obj ects, features and advantages of this invention will become apparent from the following detailed description of the various aspects of the invention taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The accompanying drawings, which are incorporated in and constitute a part of the specification, illustrate embodiments of the invention and together with the detailed description herein, serve to explain the principles of the invention. The drawings are only for purposes of illustrating preferred embodiments and are not to be construed as limiting the invention. It is emphasized that, in accordance with the standard practice in the industry, various features are not drawn to scale. In fact, the dimensions of the various features may be arbitrarily increased or reduced for clarity of discussion. The foregoing and other objects, features and advantages of the invention are apparent from the following detailed description taken in conjunction with the accompanying drawings in which:

[0013] FIG. 1 is a perspective top side view of a plate, in accordance with an aspect of the present invention;

[0014] FIG. 2 is a perspective bottom side view of the plate of FIG. 1, in accordance with an aspect of the present invention;

[0015] FIG. 3 is a front view of the plate of FIG. 1, in accordance with an aspect of the present invention;

[0016] FIG. 4 is a back view of the plate of FIG. 1, in accordance with an aspect of the present invention;

[0017] FIG. 5 is a bottom view of the plate of FIG. 1, in accordance with an aspect of the present invention;

[0018] FIG. 6 is a top view of the plate of FIG. 1, in accordance with an aspect of the present invention;

[001 ] FIG. 7 is a first side view of the plate of FIG. 1, in accordance with an aspect of the present invention;

[0020] FIG. 8 is a second side view of the plate of FIG. 1, in accordance with an aspect of the present invention;

[0021] FIG. 9 is a cross-sectional view of the plate of FIG. 1 taken along line 9—9 in FIG. 6, in accordance with an aspect of the present invention;

[0022] FIG. 10 is a cross-sectional view of the plate of FIG. 1 taken along line 10—10 in FIG. 3, in accordance with an aspect of the present invention;

[0023] FIG. 11 is a cross-sectional view of the plate of FIG. 1 taken along line 11—11 in FIG. 3, in accordance with an aspect of the present invention;

[0024] FIG. 12 is a bottom, front perspective view of the plate of FIG. 1 and a fastener, in accordance with an aspect of the present invention;

[0025] FIG. 13 is a top, front perspective view of the plate and fastener of FIG. 12, in accordance with an aspect of the present invention;

[0026] FIG. 14 is a front view of the plate and fastener of FIG. 12, in accordance with an aspect of the present invention; [0027] FIG. 15 is a side view of the plate and fastener of FIG. 12, in accordance with an aspect of the present invention;

[0028] FIG. 16 is a top view of the plate and fastener of FIG. 12, in accordance with an aspect of the present invention;

[0029] FIG. 17 is a bottom view of the plate and fastener of FIG. 12, in accordance with an aspect of the present invention;

[0030] FIG. 18 is a front perspective view of a bone fixation device, in accordance with an aspect of the present invention;

[0031] FIG. 19 is a side perspective view of the bone fixation device of FIG. 18, in accordance with an aspect of the present invention;

[0032] FIG. 20 is a bottom perspective view of the bone fixation device of FIG. 18, in accordance with an aspect of the present invention;

[0033] FIG. 21 is an exploded side perspective view of the bone fixation device of FIG. 18, in accordance with an aspect of the present invention;

[0034] FIG. 22 is an exploded front perspective view of the bone fixation device of FIG. 18, in accordance with an aspect of the present invention;

[0035] FIG. 23 is an exploded back perspective view of the bone fixation device of FIG. 18, in accordance with an aspect of the present invention;

[0036] FIG. 24 is a perspective top view of a plate or washer, in accordance with an aspect of the present invention;

[0037] FIG. 25 is a perspective bottom view of the plate of FIG. 24, in accordance with an aspect of the present invention;

[0038] FIG. 26 is a front view of the plate of FIG. 24, in accordance with an aspect of the present invention;

[0039] FIG. 27 is a bottom view of the plate of FIG. 24, in accordance with an aspect of the present invention;

[0040] FIG. 28 is an end view of the plate of FIG. 26, in accordance with an aspect of the present invention;

[0041] FIG. 29 is a cross-sectional view of the plate of FIG. 26 taken along line 29-29, in accordance with an aspect of the present invention;

[0042] FIG. 30 is a cross-sectional view of the plate of FIG. 26 taken along line 30-30, in accordance with an aspect of the present invention;

[0043] FIG. 31 is a cross-sectional view of the plate of FIG. 26 taken along line 31— 31, in accordance with an aspect of the present invention; [0044] FIG. 32 is a perspective view of the plate of FIG. 26 and a beam screw, in accordance with an aspect of the present invention;

[0045] FIG. 33 is a top perspective view of the device of FIG. 32 engaging transparent portions of bone, in accordance with an aspect of the present invention;

[0046] FIG. 34 is a front view of the bone fixation device installed on transparent portions of adjacent bones, with the fastener, in accordance with an aspect of the present invention;

[0047] FIG. 35 is a cross-sectional view of the bone fixation device of FIG. 34 taken along line 35—35, in accordance with an aspect of the present invention;

[0048] FIG. 36 is a side view of the installed bone fixation device of FIG. 34, in accordance with an aspect of the present invention;

[0049] FIG. 37 is a cross-sectional view of the installed bone fixation device of FIG. 34 taken along line 37—37, in accordance with an aspect of the present invention;

[0050] FIG. 38 is a top view of the bone fixation device installed on portions of adjacent bones, in accordance with an aspect of the present invention;

[0051] FIG. 39 is a bottom view of the bone fixation device installed on portions of the adjacent bones, in accordance with an aspect of the present invention;

[0052] FIG. 40 is a cross-sectional view of the installed bone fixation device of FIG. 38 taken along line 40—40, in accordance with an aspect of the present invention;

[0053] FIG. 41 is a bottom view of the installed bone fixation device of FIG. 33, in accordance with an aspect of the present invention;

[0054] FIG. 42 is a side perspective view of the bone fixation assembly of FIG. 18 implanted into a foot with a transparent cuboid and calcaneus, in accordance with an aspect of the present invention;

[0055] FIG. 43 is a front perspective view of FIG. 42, in accordance with an aspect of the present invention;

[0056] FIG. 44 is a side perspective view of the bone fixation assembly of FIG. 18 implanted into a foot with a transparent cuboid, calcaneus, fourth metatarsal and fifth metatarsal, in accordance with an aspect of the present invention; and

[0057] FIG. 45 is a front perspective view of FIG. 44, in accordance with an aspect of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

[0058] Generally stated, disclosed herein are embodiments of bone fixation devices.

Further, surgical methods for using the bone fixation devices are discussed.

[0059] In this detailed description and the following claims, the words proximal, distal, anterior, posterior, medial, lateral, superior and inferior are defined by their standard usage for indicating a particular part of a bone or implant according to the relative disposition of the natural bone or directional terms of reference. For example, "proximal" means the portion of a device or implant nearest the torso, while "distal" indicates the portion of the device or implant farthest from the torso. As for directional terms, "anterior" is a direction towards the front side of the body, "posterior" means a direction towards the back side of the body, "medial" means towards the midline of the body, "lateral" is a direction towards the sides or away from the midline of the body, "superior" means a direction above and "inferior" means a direction below another object or structure.

[0060] Similarly, positions or directions may be used herein with reference to anatomical structures or surfaces. For example, as the current devices and methods are described herein with reference to use with the bones of the foot, the bones of the foot, ankle and lower leg may be used to describe the surfaces, positions, directions or orientations of the devices,

instrumentation and methods. Further, the devices and methods, and the aspects, components, features and the like thereof, disclosed herein are described with respect to one side of the body for brevity purposes. However, as the human body is relatively symmetrical or mirrored about a line of symmetry (midline), it is hereby expressly contemplated that the devices and methods, and the aspects, components, features and the like thereof, described and/or illustrated herein may be changed, varied, modified, reconfigured or otherwise altered for use or association with another side of the body for a same or similar purpose without departing from the spirit and scope of the invention. For example, the devices and methods, and the aspects, components, features and the like thereof, described herein with respect to the right foot may be mirrored so that they likewise function with the left foot. Further, the devices and methods, and the aspects, components, features and the like thereof, disclosed herein are described with respect to the foot for brevity purposes, but it should be understood that the devices and methods may be used with other bones of the body having similar structures, for example the upper extremity, and more specifically, with the bones of the wrist, hand, and arm.

[0061] Referring to the drawings, wherein like reference numerals are used to indicate like or analogous components throughout the several views, and with particular reference to FIGS. 1- 23, there is illustrated a bone fixation device, implant or assembly 100. The bone fixation assembly 100 may be, for example, an orthopedic fixation device or implant, such as a foot bone fixation device or implant. The bone fixation device 100 may be used for internal fixation of bones to stabilize realignment of a fracture, dislocation, fusion or the like. The bone fixation device 100 may fix, for example, the proximal portion of metatarsal bones to the mid-foot and rear -foot, to stabilize realignment of the tarso-metatarsal joints, mid-foot and rearfoot. In an embodiment, the bone fixation device 100 may include an implant or plate 1 10. The bone fixation device 100 may also include a fastener 150 and at least one bone screw 170. Each component of the bone fixation device 100 may be made from, for example, a biocompatible material, including but not limited to a metal, polymer, composite, etc.

[0062] As shown in FIGS. 1-11, the implant, plate or washer 110 may include a top surface 102, a bottom surface 104 opposite the top surface 102, a first end 106, and a second end 108 opposite the first end 106. The terms "implant," "plate," and "washer" may be used

interchangeably herein as they essentially describe the same type of device. The plate 110 may include a body 112 with a central portion 1 18, a first arm 1 14 extending out from the central portion 118 in a first direction, and a second arm 116 extending out from the central portion 1 18 in a second direction. The first direction being opposite the second direction. The plate having length extending between the first end 106 and the second end 108 (i.e., x-direction), a height extending between the top surface 102 to the bottom surface 104 (i.e., y-direction), and a width extending between a front side and a back side of the plate 110 (i.e., z-direction). The central portion 118, first arm 1 14, and second arm 116 have a generally uniform width and the flanges 126, 128, 134, 136 extending out from the generally uniform width. The central portion 118 having a length larger than the length of the first arm 114 and the second arm 116 in the x- direction.

[0063] The central portion 1 18 may be, for example, generally flat on the top surface 102 of the plate 1 10 and curved on the bottom surface 104 of the plate 1 10, as shown in FIGS. 1-4. Then central portion 1 18 may also be tapered from the front side of FIG. 3 to the back side of FIG. 4 forming a generally tapered or angled bottom surface 104 of the central portion 118. The central portion 118 may include a center opening 120 for receiving a fastener 150. The center opening 120 may include an inset portion which may be curved to correspond to the curvature of an inferior surface 156 of the head 152 of the fastener 150, as shown in FIG. 9. Although not shown, the center opening 120 may be threaded. The threads may be positioned on an interior surface of the center opening 120. The threads in the center opening 120 may include, for example, at least one scallop or cutout (not shown) forming a break in the threads of the center opening 120. The threads and at least one cutout may be shaped to lock the fastener or screw 150 in the opening 120.

[0064] The first arm 1 14 may include a first finger 122 that generally curves, arches, or slopes downwardly relative to and from the top surface 102 of the central portion 118 in a first direction, as shown in FIGS. 1 -4. The first finger 122 may be, for example, made of a generally pliant material, such as titanium or the like, to allow for the first finger 122 to be manipulated during implantation in order to match the shape of the received bone. The first arm 114 may also include a first opening 124 positioned along the first finger 122. The first opening 124 may be positioned anywhere along the first finger 122 that allows the first opening 124 to extend from an outer surface of the plate 1 10 through the plate 110 into the first recess 138. In the illustrated embodiment, the opening 124 is positioned on the curved or angled portion of the first finger 122, as shown in FIG. 4. The first opening 124 may include, for example, threads positioned on an interior surface of the opening 124. The threads in the opening 124 may include, for example, at least one scallop or cutout 125 forming a break in the threads of the opening 124, as shown in FIG. 5. The opening 124 may be, for example, a screw hole for receiving a fastener or screw 170. The threads and at least one cutout 125 are shaped to lock the fastener or screw 170 in the opening 124. The first arm 1 14 may also include a first flange, lobe, or lip 126 extending out from the body 1 12 in a first direction, adjacent to the opening 124. The first arm 1 14 may also include a second flange, lobe, or lip 128 extending out from the body 1 12 in a second direction, adjacent to the opening 124. The first direction being opposite the second direction.

[0065] The second arm 1 16 includes a second finger 130 that generally curves, arches or slopes downwardly from the top surface 102 of the central portion 1 18 in a second direction, as shown in FIGS. 1 -4. The second finger 130 may be, for example, made of a generally pliant material, such as titanium or the like, to allow for the second finger 130 to be manipulated during implantation in order to match the shape of the received bone. The second arm 116 may also include a second opening 132 positioned along the second finger 130. The second opening 132 may be positioned anywhere along the second finger 130 that allows the second opening 132 to extend from an outer surface of the plate 1 10 through the plate 1 10 into the second recess 140. In the illustrated embodiment, the opening 132 is positioned on the curved or angled portion of the second finger 130. The second opening 132 may include, for example, threads positioned on an interior surface of the opening 132. The threads in the opening 132 may include, for example, at least one scallop or cutout 133, as shown in FIG. 6, forming a break in the threads of the opening 124. The opening 124 may be, for example, a screw hole for receiving a fastener or screw 1 70. The threads and at least one cutout 133 are shaped to lock the fastener or screw 170 in the opening 124. The second arm 116 may also include a third flange, lobe, or lip 134 extending out from the body 1 12 in a first direction, adjacent to the opening 132. The second arm 116 may also include a fourth flange, lobe, or lip 136 extending out from the body 1 12 in a second direction, adjacent to the opening 132. The first direction being opposite the second direction.

[0066] The body 112 may also include a first recess 138 positioned between the central portion 118 and the first arm 114, as shown in FIGS. 1-4. The first finger 122 forms an outer side of the first recess 138. The central portion 1 18 forms an inner side of the first recess 138. The top surface 102 of the plate 110 forms the end of the first recess 138. The first recess 138 is opened at the bottom surface 104 of the plate 1 10 and extends into the plate 110. The first recess 138 having a shape generally in the form of a bone, for example, a metatarsal bone or base. The first recess 138 may be curved, curvilinear or otherwise arced to match the shape of the bone that it will engage.

[0067] The body 1 12 may further include a second recess 140 positioned between the central portion 118 and the second arm 1 16, as shown in FIGS. 1-4. The second finger 130 forms an outer side of the second recess 140. The central portion 1 18 forms an inner side of the second recess 140. The top surface 102 of the plate 1 10 forms an end of the second recess 140. The second recess 140 is opened at the bottom surface 104 of the plate 1 10 and extends into the plate 110. The second recess 140 having a shape generally in the form of a bone, for example, a metatarsal bone or base. The second recess 140 may be curved, curvilinear or otherwise arced to match the shape of the bone that it will engage.

[0068] As best shown in FIGS. 3 and 4, the first and second recesses 138, 140 have different sizes to accommodate the different sizes of a patient' s bones, for example, the different sizes of adjacent metatarsal bones. Although not shown, it is also contemplated that the first and second recesses 138, 140 may have the same size or any sizes that correspond to the bones that will mate with the recesses 138, 140.

[0069] The body 1 12 may also include, for example, a first retention lip, flange, spike or the like (collectively and hereinafter, first retention lip) (not shown) on a lower inside surface of the first finger 122 such that that the first retention lip extends into the first recess 138. A second retention lip, flange, spike or the like (collectively and hereinafter, second retention lip) (not shown) may be positioned on a lower outside surface of the central portion 1 18 such that the second retention lip extends into the first recess 138. The first and second retention lips (not shown) may be of the type described below with reference to lips 230, 228 and will not be described here for brevity sake. The body 1 12 may also include a third retention lip, flange, spike or the like (collectively and hereinafter, third retention lip) (not shown) on a lower inside surface of the second finger 130 such that that the third retention lip extends into the second recess 140. A fourth retention lip, flange, spike or the like (collectively and hereinafter, second retention lip) (not shown) may be positioned on a lower outside surface of the central portion 1 18 such that the fourth retention lip extends into the second recess 140. The third and fourth retention lips (not shown) may be of the type described below with reference to lips 224, 226, which will not be described here for brevity sake. [0070] In one embodiment, the body 1 12 may also include a step-off (not shown) between the first arm 1 14 and the second arm 1 16. The step-off may be sized and shaped to account for the medial to lateral arch of the metatarsals. The step-off would be positioned to offset the first recess 138 from the second recess 140. The offset could positi on the first recess 138 such that the first arm 1 14 is positioned higher in the y-direction than the second arm 116 and the second recess 140, or vice versa.

[0071] As shown in FIGS. 21-23, the fastener 150 may include a head portion 152 and a shaft portion 160. The terms "bone screw," "fastener," "beam screw," "fixator," "elongate member," and "screw" may be used interchangeably herein as they essentially describe the same type of device. The head portion 152 may include a superior end 154 and an inferior end 156. The superior end 154 of the head portion 152 may have a tool engagement opening 158, as shown in FIGS. 21-23. The tool engagement opening 158 may have a multi-lobed shape as shown in FIGS. 12-14 and 18-23, although other polygonal shapes are also contemplated, including a hexagonal shape. The fastener 150 may also have a cannulated opening extending from the tool engagement opening 158 through the entire length of the fastener 150. Although not shown, the inferior end 156 of the head portion 152 may be threaded to engage

corresponding threads in the opening 120. The inferior end 156 of the head portion 152 is coupled to an end of the shaft portion 160. The shaft portion 160 may include a smooth section 162 and a threaded section 164 for engaging a patient's bone, as seen in FIGS. 12-23. The fastener 150 may be, for example, available in multiple sizes with threaded sections 164 of various lengths, including, for example, a fully threaded shaft portion 160. The length of the threaded section 164 may correspond to the orientation of insertion into the patient' s bones and the bones that the fastener 150 is inserted through and into. The threaded section 164 of the shaft portion 160 may also include a tip 166. The tip 166 may be, for example, blunt or include at least one cutting tip 166, as shown in FIG. 23, to assist in insertion into the patient's bone. Although any number of cutting tips 166 are contemplated, in the illustrated embodiment of FIG. 23, the threaded end 160 includes, for example, three cutting tips 166.

[0072] With continued reference to FIGS. 21-23, at least one bone screw 170 is shown. The at least one bone screw 170 may include a head portion 172 coupled to one end of a shaft portion 180. The terms "bone screw," "fastener," "fixator," "elongate member," and "screw" may be used interchangeably herein as they essentially describe the same type of device. The head portion 172 may include a superior end and an inferior end. The superior end of the head portion 172 may have a tool engagement opening 174, as shown in FIGS. 19 and 21. The tool engagement opening 174 may have a multi-lobed shape as shown in FIGS. 19 and 21, although other polygonal shapes are also contemplated, including a hexagonal shape. The inferior end of the head portion 172 may include threads 176 to engage the corresponding threads in the opening 124, 132. The inferior end of the head portion 172 is also coupled to an end of the shaft portion 180. The shaft portion 180 may include a threaded section 182 along at least a portion of the shaft portion 180 for engaging a patient's bone, as seen in FIGS. 12-23. The fastener 150 may be, for example, available in multiple sizes with threaded sections 182 of various lengths. The length of the threaded section 182 and size of the at least one bone screw 170 may correspond to the size of the patient's bones, for example, the metatarsal bones. The threaded section 182 of the shaft portion 180 may also include a tip 184. The tip 184 may be, for example, blunt or include at least one cutting tip 184, as shown in FIGS. 20 and 21, to assist in insertion into the patient' s bone. Although any number of cutting tips 184 is contemplated, in the illustrated embodiment of FIGS. 20 and 21, the threaded end 182 includes, for example, three cutting tips 184.

[0073] Referring now to FIGS. 18-20, the bone fixation device 100, including the plate 1 10, the fastener 150, and two bone screws 170, is shown. The plate 1 10 may be sized and shaped to engage adjacent bones, for example, adjacent metatarsal bones. The fastener 150 may be selected to span from the plate 110 through at least one bone of the patient. In one embodiment, the fastener 150 may extend through the cuboid and thread into the calcaneus. The two bone screws 170 may be selected to be inserted into the bones engaged by the plate 1 10, for example, the metatarsal bones, to secure the plate 110 to the bones.

[0074] In one embodiment, as shown in FIGS. 42-45, the bone fixation assembly 100 is implanted on a patient's foot 400. The plate 1 10 is positioned on the fourth metatarsal 404 and fifth metatarsal 402. The fastener 150 is inserted through the center opening 120, between the fourth and fifth metatarsals 404, 402, through the cuboid 406, and into the calcaneus 408. A first bone screw 170 is inserted through the first opening 124 of the plate 1 10 and into the fifth metatarsal 402. A second bone screw 170 is inserted through the second opening 132 and into the fourth metatarsal 404.

[0075] With continued reference to FIGS. 42-45, one embodiment of a surgical method of using the bone fixation assembly 100, 300 includes preparing the patient's foot for surgery and exposing the bones for realignment. The method may also include inserting a guide wire (not shown) into the patient' s bones to realign the foot. Next, the plate 1 10, 200 may be slid over the guide wire (not shown) and positioned on the bones. The fastener 150, 240 may then be inserted over the guide wire (not shown), through the center opening 120, 214 of the plate 1 10, 200, and into at least one bone, for example, the cuboid 406 and/or calcaneus 408. The fastener 150, 240 may also engage at least a portion of the fourth and/or fifth metatarsals 404, 402. As the fastener 150, 240 is inserted into the patient' s bones 406, 408, the plate 1 10, 200 is translated along the metatarsals 402, 404 until the plate 1 10, 200 grips the bones 402, 404 and the desired realignment is achieved. If the desired correction is achieved the patient may be closed.

[0076] Another embodiment of the surgical method of using a bone fixation assembly 100, 300 with openings 124, 132 includes positioning the plate 1 10, 200 on two adj acent bones, for example, the fourth and fifth metatarsals 404, 402. Next, a guide wire (not shown) may be inserted through the center opening 120, 214 of the plate 1 10, 200 and into at least one bone, for example, into the cuboid 406 and calcaneus 408. Once the plate 110, 200 is positioned on the patient' s bones, a first bone screw 170 may be inserted into a metatarsal, for example, the fifth metatarsal 402, through the first opening 124. Next, a second bone screw 170 may be inserted into an adj acent metatarsal, for example, the fourth metatarsal 404, through the second opening 132. After the bone screws 170 couple the plate 1 10, 200 to the metatarsals 402, 404, the fastener 150, 240 may be inserted through the center opening 120, 214 and into at least one bone, for example, the cuboid 406 and/or calcaneus 408. The fastener 150, 240 may also engage at least a portion of the fourth and/or fifth metatarsals 404, 402 as it extends between the metatarsals 402, 404. If the desired correction is achieved the patient may be closed.

[0077] Referring to FIGS. 24-41 , and particularly to FIGS. 24-31 , there is shown another embodiment of one component of a fixation device or implant 300, for example, a foot bone (orthopedic) fixation device or implant. The bone fixation device 300 may be used for internal fixation of, for example, the proximal portion of metatarsal bones or bases to the bones of the foot, for example, the mid-foot and rear-foot, to stabilize realignment of a fracture, dislocation, fusion or the like of the tarso-metatarsal joints, mid-foot and rearfoot. In one embodiment, the bone fixation device 300 may include a plate or washer 200 and a fastener 240. In another embodiment the bone fixation device 300 may include the plate or washer 200 by itself.

[0078] The plate 200 is characterized by a body 210 having a central portion or section 212 with a central opening 214, the body 210 may be made from a biocompatible material, such as titanium, stainless steel, an alloy thereof, or another biocompatible material . The opening 214 is sized to allow a portion of a fastener, for example, the shank of a beam screw, to pass through the opening 214 while preventing the head of the fastener from passing through the opening 214. The opening 214 may be, for example, threaded or non- threaded. The fastener may be of the type shown in FIGS. 32-36, 38 and 41, which will be described in greater detail below with reference to fastener 240. The head of the fastener is thus retained by the body 210, the details of which are provided below with reference to FIGS. 33-41. The body 210 is formed generally in a semi-circular shape having a first arm or wing 232 and a second arm or wing 234, the nomenclature first and second being arbitrary. The first arm 232 may extend away from the central portion 212 in a first direction and the second arm 234 may extend away from the central portion 212 in a second direction. The first direction may be opposite to the second direction. The shape may be changed or modified as desired in keeping with the principles of the disclosed embodiments . The first arm 232 generally arches or slopes downwardly from the central portion 212 in a first direction while the second arm 234 generally arches or slopes downwardly from the central portion 212 in a second direction, the nomenclature first and second again being arbitrary. In one embodiment, the body 210 may also include a step-off (not shown) between the first arm 232 and the second arm 234. The step-off may be sized and shaped to account for the medial to lateral arch of the metatarsals.

[0079] The body 210 also has a first recess 218 formed in the first arm 232 with its opening at the bottom of the first arm 232. The first recess 218 having a shape generally in the form of a bone, for example, a metatarsal bone or base. The body 210 further has a second recess 222 formed in the second arm 234 with its opening at the bottom of the second arm 234. The second recess 222 having a shape generally in the form of a bone, for example, a metatarsal bone or base. As such, the plate 200 is fashioned to fit onto adjacent bones, such as, adj acent metatarsal bones or bases. As best seen in FIG. 26, the first and second recesses 218, 222 are sized differently to accommodate the adjacent bones, for example, the metatarsal bones of the foot, which are naturally differently sized. While not shown, the first and second recesses 218, 222 may be sized the same or sized as desired to accommodate the bones being fixed.

[0080] The first arm 232 has a first finger 216 that forms an outer side of the first recess 216, while the second arm 234 has a second finger 220 that forms an outer side of the second recess 222. The central portion 212 forms an inner side of the first recess 218 and an inner side of the second recess 222. The central portion 212 may have, for example, a flat bottom extending between the inner side of the first recess 218 and the inner side of the second recess 222. In another embodiment, the central portion 212 may be sized and sloped to fit between two bones, for example two metatarsal bones. In addition, the bottom of the central portion 212 may be, for example, pointed, "V" shaped or the like to fit between two bones, such as, two metatarsal bones. The first finger 216 is preferably, but not necessarily, at least somewhat pliant to allow the first finger 216 to be manipulated during implantation in order to match the metatarsal onto which the plate 200 is being installed. Likewise, the second finger 220 is preferably, but not necessarily, at least somewhat pliant to allow the second finger 220 to be manipulated during implantation in order to match the metatarsal onto which the plate 200 is being installed.

[0081] Additionally, a first retention lip, flange, spike or the like (collectively and hereinafter, first retention lip) 230 is provided on a lower inside surface of the first finger 216 such that that the first retention lip 230 extends into the first recess 218. A second retention lip, flange, spike or the like (collectively and hereinafter, second retention lip) 228 is provided on a lower outside surface of the central portion 212 such that the second retention lip 228 extends into the first recess 218. The first and second retention lips 230, 228 are structured and situated such that they will bite into opposite sides of a bone, for example, the metatarsal surface of a metatarsal M2 base (see e.g., FIGS. 33, 34, and 39-41). A third retention lip, flange, spike or the like (collectively and hereinafter, third retention lip) 224 is provided on a lower inside surface of the second finger 220 such that that the third retention lip 224 extends into the second recess 222. A fourth retention lip, flange, spike or the like (collectively and hereinafter, second retention lip) 226 is provided on a lower outside surface of the central portion 212 such that the fourth retention lip 226 extends into the second recess 222. The third and fourth retention lips 224, 226 are structured and situated such that they will bite into opposite sides of a bone, for example, the metatarsal surface of a metatarsal Ml base (see e.g., FIGS. 33, 34, and 39-41).

[0082] As shown in FIG. 37, the walls of the second recess 222, formed by the inside surface of the second finger 220 and the outside surface of the central portion 212 are angled to match or mimic the natural angle of a bone, for example, a metatarsal. The walls of the second recess 222 may be angled and angle a of, for example, approximately 4° or like angle which mimics or matches the natural angle of the bone engaging the plate 200. Likewise, the walls of the first recess 218, formed by the inside surface of the first finger 216 and the outside surface of the central portion 212 may also be angled to match or mimic the natural angle of a bone, for example, a metatarsal.

[0083] Referring now to FIG. 32, a foot bone fixation device 300 is shown that includes the plate 200 and a fastener 240. The fastener 240 may be, for example, a beam screw 240. The beam screw 240 is a bone screw that may be fashioned to span from the plate 200 through at least one bone, for example, the cuboid and into the calcaneus, as well as other bones of the foot. The beam screw 240 is fashioned from a biocompatible material. The beam screw 240 may have a head 246 with a shank 242 extending from the head 246. The shank 242 has threads or threading 244 on its distal end that are pitched such as is known in the art for anchoring into a bone. The threads 244 may extend, for example, along the entire length of the shank 242 or along only a portion of the shank 242. The head 246 includes a socket 248 configured for receiving a like driving tool (not shown) such as is known in the art.

[0084] The shank 242 and threading 244 are sized to extend through the opening 214 of the plate 200. The head 246 is sized to not be able to extend through the opening 214 and to be retained by the opening 214. Particularly, the head 246 is shaped and sized to abut the plate 200 about the opening 214 and to pull against the plate 200 during tightening of the beam screw 240 when implanting the present foot bone fixation device 300, as further explained below.

[0085] FIGS. 33-41 show various views of the present foot bone fixation device 300 implanted onto adj acent metatarsal bones/bases M l , M2. Metatarsal bones naturally taper as best seen in FIGS. 38, 39 and 41. Once placed onto the adjacent metatarsal bases Ml, M2, the beam screw 240 is tightened. As the head 246 of the beam screw 240 abuts the plate 200, the head 246 pulls against the plate 200 to move the plate 200 along the metatarsal bases Ml, M2 to wedge the plate 200 onto the metatarsal bases Ml, M2. The respective lips of the recesses 218, 222 bite or grip against the surface of the metatarsal bases Ml, M2.

[0086] The bone fixation devices 100, 300 are configured to provide better fixation between the metatarsal bases to the mid-tarsal and the tarsus in a beam screw construct. The foot bone fixation devices 100, 300 provide a means of capturing the metatarsal bases so they can be incorporated into the beam screw fixation construct or bone fixation device 100, 300 without sacrificing beam screw diameter. The foot bone fixation device s 100, 300 function as plates or washers 1 10, 200 with anatomic shapes to capture two adjacent metatarsal bases so a large diameter beam screw 150, 240 can be inserted between the metatarsal bases. The beam screw 150, 240 can span the metatarsal to mid-tarsal to tarsal foot bone segments while capturing without separating the adjacent metatarsal bases due to the anatomic arms or wings 1 14, 1 16, 232, 234 of the plate 1 10, 200 that extend from an opening 120, 214 in the plate 110, 200 for screw insertion and screw head reception.

[0087] In an embodiment, the foot bone fixation devices 100, 300 are characterized by a rigid, preferably but not necessarily metallic, bone fixation plate or washer 1 10, 200 having a central hole 120, 214 with arched anatomic arms 114, 116, 232, 234 extending in opposite directions from the top 102 of the plate 1 10, 200. Each arm 114, 116, 232, 234 is anatomically shaped to capture adj acent metatarsal bases and afford large diameter beam screw 150, 240 insertion.

[0088] The opening 120, 214 of the plate 100, 300 is configured to allow the threaded shank 160, 242 of the beam screw 150, 340 to extend through the opening 120, 214 while concurrently capturing and retaining the head 152, 246 of the beam screw 150, 340. Alternatively, the opening 120, 214 can contain threads (not shown) that move with the screw threads.

[0089] Each arched arm 114, 116, 232, 234 has a recess 138, 140, 218, 222 shaped in general to receive a metatarsal base. An outer finger 122, 130, 216, 220 of each arched arm 1 14, 1 16, 232, 234 may be manipulated to shape the corresponding recess 138, 140, 218, 222 for a particular metatarsal base.

[0090] In one embodiment, each finger 216, 220 may include one or more lips, flanges or spikes 230, 224 to aid in retaining the arm 232, 234 onto the metatarsal base. The recess 218, 222 of each arm 232, 234 may also include one or more lips, flanges or spikes 228, 226 to further aid in retaining the arm 232, 234 onto the metatarsal base. Each finger 122, 130 may contain at least one hole 124, 132 for receiving a screw 170 that inserts into each metatarsal base.

[0091] The recess of each arm 138, 140, 218, 222 may be, for example, angled to match a metatarsal base angle.

[0092] In one form, metatarsal base recesses 138, 140, 218, 222 of the plate 110, 200 are sized differently to accommodate size difference of adjacent metatarsal bases. Other variations are also contemplated.

[0093] The terminology used herein is for the purpose of describing particular

embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprise" (and any form of comprise, such as "comprises" and "comprising"), "have" (and any form of have, such as "has", and "having"), "include" (and any form of include, such as "includes" and "including"), and "contain" (and any form of contain, such as "contains" and

"containing") are open-ended linking verbs. As a result, a method or device that

"comprises," "has," "includes," or "contains" one or more steps or elements possesses those one or more steps or elements, but is not limited to possessing only those one or more steps or elements. Likewise, a step of a method or an element of a device that "comprises," "has," "includes," or "contains" one or more features possesses those one or more features, but is not limited to possessing only those one or more features. Furthermore, a device or structure that is configured in a certain way is configured in at least that way, but may also be configured in ways that are not listed.

[0094] The invention has been described with reference to the preferred embodiments. It will be understood that the architectural and operational embodiments described herein are exemplary of a plurality of possible arrangements to provide the same general features, characteristics, and general system operation. Modifications and alterations will occur to others upon a reading and understanding of the preceding detailed description. It is intended that the invention be construed as including all such modifications and alterations.

Claims

CLAIMS Having thus described the preferred embodiments, the invention is now claimed to be:

1. A bone fixation assembly, comprising:

an implant; and

a fastener.

2. The bone fixation assembly of claim 1, wherein the implant comprises a body and wherein the body comprises :

a central portion;

a first arm extending away from the central portion in a first direction; and a second arm extending away from the central portion in a second direction, wherein the second direction is opposite the first direction.

3. The bone fixation assembly of claim 2, wherein the central portion comprises a center opening sized to receive the fastener.

4. The bone fixation assembly of claim 3, wherein the center opening comprises at least one of an inset curved portion and a plurality of threads.

5. The bone fixation assembly of claim 2, wherein the first arm comprises:

a first finger extending away from the center portion in a first direction and is curved; and

a first opening positioned along the first finger.

6. The bone fixation assembly of claim 5, wherein the first arm further comprises: a first flange positioned adj acent to the first opening and extending in a first direction; and

a second flange positioned adj acent to the first opening and extending in a second direction, wherein the second direction is opposite the first direction .

7. The bone fixation assembly of claim 2, wherein the second arm comprises: a second finger extending away from the center portion in a second direction, wherein the second finger is curved; and

a second opening positioned through the second finger.

8. The bone fixation assembly of claim 7, wherein the second arm further comprises:

a first flange positioned adj acent to the first opening and extending in a first direction; and

9. The bone fixation assembly of claim 2, wherein the body further comprises: a first recess positioned between the central portion and the first arm; and a second recess positioned between the central portion and the second arm.

10. The bone fixation assembly of claim 9, wherein the first recess is curvilinear and the second recess is curvilinear.

1 1. The bone fixation assembly of claim 9, wherein the body further comprises: a first lip extending from the first finger into the first recess;

a second lip extending from the central portion into the first recess;

a third lip extending from the second finger into the second recess; and a fourth lip extending from the central portion into the second recess .

12. The bone fixation assembly of claim 9, wherein the first recess and second recess extend into the body from a bottom side.

13. The bone fixation assembly of claim 1, further comprising:

at least one bone screw, wherein the at least one bone screw engages at least one opening in the implant.

14. The bone fixation assembly of claim 2, wherein the central portion is tapered.

15. An implant, comprising:

a central portion;

16. The implant of claim 15, wherein the central portion comprises:

a center opening, the center opening having at least one of an inset curved portion and a plurality of threads.

17. The implant of claim 16, wherein the first arm comprises a first finger extending away from the center portion in a first direction, and wherein the first finger is curved and wherein the second arm comprises a second finger extending away from the center portion in a second direction, and wherein the second finger is curved.

18. The implant of claim 17, further comprising:

a first opening positioned along the first finger, wherein the first opening comprises:

a plurality of threads on an inner surface of the first opening; and at least one cutout positioned along the plurality of threads; and a second opening positioned along the second finger, wherein the second opening comprises:

a plurality of threads on an inner surface of the second opening; and at least one cutout positioned along the plurality of threads.

19. The implant of claim 15, further comprising:

a first cavity defined by the central portion, the first finger and the first arm; and

a second cavity defined by the central portion, the second finger, and the second arm.

20. A method for internal fixation of a proximal portion of at least two metatarsal bones to bones of a mid-foot and rear-foot to stabilize realignment of a fracture, dislocation, or fusion of the tarso-metatarsal j oints, mid-foot and rearfoot, comprising:

obtaining bone fixation assembly; and

surgically implanting the bone fixation assembly into a patient.