Patent ID: 12256965

DETAILED DESCRIPTION

Embodiments of the disclosure are generally directed to devices, systems, and methods for bone stabilization, especially radius stabilization. Specifically, embodiments are directed to volar distal radius stabilization systems including a bone plate configured to sit against the volar side of the radial bone. The fasteners may be configured to secure the bone plate to the radius. Still other embodiments are directed to different types of holes and fasteners configured to provide locking and/or compression to the bone.

The bone plate may be comprised of titanium, stainless steel, cobalt chrome, carbon composite, plastic or polymer—such as polyetheretherketone (PEEK), polyethylene, ultra high molecular weight polyethylene (UHMWPE), resorbable polylactic acid (PLA), polyglycolic acid (PGA), combinations or alloys of such materials or any other appropriate material that has sufficient strength to be secured to and hold bone, while also having sufficient biocompatibility to be implanted into a body. Similarly, the fasteners may be comprised of titanium, cobalt chrome, cobalt-chrome-molybdenum, stainless steel, tungsten carbide, combinations or alloys of such materials or other appropriate biocompatible materials. Although the above list of materials includes many typical materials out of which bone plates and bone fasteners are made, it should be understood that the bone plates and fasteners comprised of any appropriate material are contemplated.

The embodiments of the disclosure and the various features and advantageous details thereof are explained more fully with reference to the non-limiting embodiments and examples that are described and/or illustrated in the accompanying drawings and detailed in the following description. The features of one embodiment may be employed with other embodiments as the skilled artisan would recognize, even if not explicitly stated herein. Descriptions of well-known components and processing techniques may be omitted so as to not unnecessarily obscure the embodiments of the disclosure. The examples used herein are intended merely to facilitate an understanding of ways in which the disclosure may be practiced and to further enable those of skill in the art to practice the embodiments of the disclosure. Accordingly, the examples and embodiments herein should not be construed as limiting the scope of the disclosure, which is defined solely by the appended claims and applicable law. Moreover, it is noted that like reference numerals represent similar features and structures throughout the several views of the drawings.

Volar Distal Radius Plate System

Referring now to the drawing,FIGS.1A-1Kdepict embodiments of a volar distal radius stabilization system100including a bone plate110configured to sit against the volar side of the radial bone and one or more bone fasteners130configured to be received in the bone plate110and secured to the radius102. The radius102or radial bone is one of the two large bones of the forearm, the other being the ulna. The radius102extends from the lateral side of the elbow to the thumb side of the wrist and runs parallel to the ulna, which exceeds it in length and size. Near the wrist, the distal end104of the radius102is large and of quadrilateral form. Although generally described with reference to the radius102, it will be appreciated that the stabilization systems described herein may be used or adapted to be used for the fixation of other long bones as well, such as the humerus, femur, tibia, etc.

The bone plate110extends from a first end112configured to be positioned proximate to a shaft portion of radius102to a second end114configured to be positioned proximate to the distal end104of the radius102. The plate110includes a top surface116and an opposite, bottom surface118configured to contact adjacent bone. The top and bottom surfaces116,118are connected by opposite side surfaces extending from the first to second ends112,114of the plate110. The bottom surface118of the plate110includes an anatomic contour configured to follow the best approximation of average distal radial anatomy, flaring up slightly along the radial column and more significantly along the intermediate column of the plate110. The plate110is designed to sit low and have a generally low profile proximal portion. The thickness of the plate110may generally be about 2 mm along the shaft and distal intermediate column, tapering to a thickness of 2.5 mm along the distal radial column which allows for the severe angle of the radial styloid fastener. The watershed line of the volar distal radius defines the border between the radiocarpal (RC) joint and the volar surface of the radius102. A chamfer at the second end114on the distal radius column of the plate110may help to ensure minimal tendon disruption, for example of the flexor pollicus longus and flexor carpi radialis, by maintaining a lower profile over the tendon sites.

The bone plate110includes an elongated portion140extending along a longitudinal axis L, having a length greater than its width. The elongated portion140is configured to contact the shaft of the radius102. The elongated portion140may terminate at the first end112with a taper such that it has a width and/or thickness less than the remainder of the elongated portion140. A transition region144may connect the elongated portion140to an enlarged head portion142. The transition region144may extend along an axis T which is generally angled relative to the axis L of the elongated portion140. The transition region144may extend at an angle X relative to the elongated portion140. The angle X of the transition region144relative to the elongated portion140may range from about 10-60°, about 20-50°, about 30-40°, about 40-50°, or another appropriate angle. The transition region144may generally form a curve from the elongated portion140to an end of the enlarged head portion142.

The transition region144may connect to an end portion of the enlarged head portion142and the other end portion of the enlarged head portion142may be a free end. In other words, the opposite end portion of the enlarged head portion142, not connected to the transition region144, is not connected to any other portion of the plate110. The free end of the enlarged head portion142may be separated a distance from the transition region144and the elongated portion140of the plate110.

The enlarged head portion142or a portion thereof is configured to contact the distal end104of the radius102. The enlarged head portion142has a width greater than the width of the elongated portion140. The enlarged head portion142extends along an axis A at an angle Y relative to the transition region144. The angle Y of the head portion142relative to the transition region144may range from about 10-60°, about 20-50°, about 30-40°, about 40-50°, or another appropriate angle. Accordingly, the axis A of the enlarged head portion142may be transverse to the axis L of the elongated portion140. In some embodiments, the axis A of the enlarged head portion142may be generally perpendicular to the axis L of the elongated portion140. As best seen inFIG.1C, the bone plates110may be available in a variety of lengths and sizes based on the anatomy of the patient. The plates110are configured to sit against the volar side of the radial bone102. The plates110are configured in both left and right designs, in a mirrored configuration, in order to address the anatomy of both the left and right arms of the patient.

As best seen inFIGS.1I and1J, the bottom surface118of the plate110may include a plurality of recesses119located along the elongated portion140between the fastener openings120. In the embodiment shown inFIG.1I, the recesses119are in the form small partial bores in the lateral surface, which are configured to facilitate bending of the plate110. The recesses119remove material such that the plate110shield stress from the fastener openings120, discouraging hole warping effect during recontouring of the plate110. The recesses119may also provide attachment points for plate placement instrumentation (not shown). In the embodiment shown inFIG.1J, the recesses119are in the form of scallop cuts having partially cylindrical valleys cut around a periphery of the bottom surface118of the plate110. This again shields stress from the fastener openings120during bending, discouraging hole warping effects while recontouring the plate110. This also reduces contact between the plate110and the bone surface, thereby helping to preserve blood supply to the bone and prevent osteonecrosis. In addition to or in place of the recesses119, a plurality of dimples, best seen inFIG.1K, may be positioned along the bottom surface118of the plate110(e.g., along the entire bottom surface118or a portion thereof) to further reduce contact between the plate110and bone surface, further helping to preserve blood supply and prevent osteonecrosis.

The plate110includes one or more through openings120configured to receive one or more bone fasteners130. The openings120extend through the body of the plate110from the top surface116to the bottom surface118. The openings120may include cylindrical openings, conical openings, elongated openings, threaded openings, textured openings, non-threaded and/or non-textured openings, and the like. The openings120may allow for locking of the fastener130to the plate110or may allow for movement and dynamic compression of the bone. The plate110may comprise any suitable number of openings120in any suitable configuration. These openings120allow surgeons more flexibility for fastener placement, based on preference, anatomy, and fracture location. Surgeons may have differing opinions as to the number, location, and types of fasteners130. Further, complexity of fracture location and shape makes having as many locations for fasteners130as possible necessary. This design offers surgeons a versatile method to achieve higher accuracy in placement of the fasteners130.

The openings120may be configured to receive one or more bone fasteners130. The fasteners130may include locking fasteners, non-locking fasteners, or any other fasteners known in the art. The fasteners130may comprise bone screws or the like. The fasteners130may also include other fasteners or anchors configured to be secured or engaged with bone, such as nails, spikes, staples, pegs, barbs, hooks, or the like. The fasteners130may include fixed and/or variable angle bone screws. The fastener130may include a head portion132and a shaft portion134configured to engage bone. For a locking fastener130, the shaft portion134may be threaded such that the fastener130may be threaded into the bone. The head portion132may include a textured area, such as threads, around its outer surface sized and configured to engage with the opening120, for example, and corresponding threads in the opening120in order to lock the fastener130to the plate110. In the alternative, for a non-locking fastener130, the head portion132may be substantially smooth to allow for dynamic compression of the bone.

In one embodiment, the enlarged head portion142of the plate110includes a plurality of holes120A are aligned so that their nominal trajectories follow the articular surfaces of both the radio-carpal joint and the distal radio ulnar-joint. This allows the fasteners130A to buttress and support the articular surfaces during fracture reconstruction. As shown in the embodiment inFIGS.1A-1C, the plate110may have a single row of holes120A generally in alignment and a secondary hole120A positioned on the transition region144.FIG.1Cdepicts one embodiment of the plate110(right most plate110) having a first, distal row of holes120A generally in alignment and a second row of holes120A generally in alignment. The second row of holes120A may receive fasteners130A with trajectories converging with the distal row screw trajectories. In an alternative version of the stabilization system100, shown inFIGS.1D and1E, the elongated portion140directly transitions into the enlarged head portion142and the enlarged head portion142is increased in dimension in order to receive the second row of the fasteners130A.

The holes120A may be fixed openings configured to accept fixed angle fasteners130A that can be secured into the distal end104of the radius102. The screw holes120A and screw heads132may have mating conical threads that lock the screw130A in both angular and axial alignment to prevent collapse and backout. The fasteners130A may have predetermined trajectories based on the orientations of the openings120A. An upper portion of the holes120A may be tapered128to allow for the proper positioning of each of the fasteners130A. Each of the fasteners130A may be angled along a different trajectory than the other respective fasteners130A. Some of the fasteners130A may have a greater angulation than other respective fasteners130A.

The enlarged head portion of the plate110further include a hole120B configured to receive fastener130B with a trajectory having the severe angle necessary to reach the tip of the radial styloid. An upper portion of the hole120B may be tapered128and a portion of the plate110around the hole120B may be enlarged or increased in thickness to allow for the proper angle of the fasteners130B to be achieved. The fastener130B may be in the form of a polyaxial bone screw, which may be generally larger (e.g., in length and/or diameter) than the other fasteners130securing the plate110to the bone. The fasteners130A,130B are optionally cannulated to allow for precise placement with a k-wire (not shown) if desired by the surgeon. In some embodiments, the fasteners130A,130B may include polyaxial screws having self-forming threads that work by displacement of the plate material, which are described in more detail herein.

The plate110also include one or more holes120C present along the elongated portion140of the plate110and configured to accommodate a compression fastener130C. As best seen inFIG.1G, the holes120C may offer a sliding slot for proximal-distal adjustment of the plate110during provisional placement. The slot120C may allow for proximal adjustment, distal adjustment, and/or medial-lateral adjustment of the plate110. This allows surgeons to optimally center the plate position along the bone prior to locking screw insertion. The hole or holes120C may be elongated along the longitudinal axis L of the elongated portion140as well as elongated, relative to the fastener130C, from lateral side to lateral side. The elongated hole or holes120C may have varying lengths and/or widths. Preferably, the length is greater than the width of the slot120C. In the alternative embodiment of the slot120C′ illustrated inFIG.1H, adjustment markings125are provided along each longitudinal side of the slot120C′. The adjustment markings125may include be applied via ink, etching, for example, via laser etching, or other suitable means. The adjustment markings125are spaced in increments, for example, equally spaced increments, such as 1 mm increments, to assist with accurate proximal/distal adjustment of the plate110.

The hole120C may be configured to accommodate non-locking, compression screws130C, the heads of which have a spherical underside, so the screw130C may be placed at varying angles. The compression screw130C can be inserted and preliminarily tightened to secure the plate110to the bone. As the screw130C is inserted eccentrically in to the hole120C, the screw130C slides down the slot120C, displacing the plate110and the bone as well. The compression screw130C may have a shorter length and/or a smaller diameter than the screws130A and/or130B. If the plate110needs to be adjusted later, the screw130C can be loosened and the plate110can be shifted in the proximal, distal, and/or medial-lateral directions. This slot120C also accommodates reduction of the radius102by inserting a longer compression screw130C and pulling the bone to the plate110.

The plate110may include one or more holes120D present along the elongated portion140of the plate110configured to secure the plate110to the shaft of the radius102. The holes120D may be configured to accommodate fixed and/or variable angle fasteners130D. For locking fasteners130D, the screw holes120D and screw heads132may have mating conical threads that lock the screw130D in both angular and axial alignment to prevent collapse and backout. An upper portion of the holes120D may be tapered128, for example, around the perimeter of the hole120D, to allow for the proper positioning of each of the fasteners130D. For non-locking fasteners130D, the head portion132may be substantially smooth to allow for dynamic compression of the bone.

The plate110including head portion142and/or the elongated portion140may further comprise a plurality of openings124configured to receive one or more k-wires (not shown). The k-wire holes124may comprise small diameter holes (e.g., having a diameter significantly smaller than the fastener openings120). The k-wire holes124may allow preliminary placement of the plate110against the bone and/or to aid in reduction of the fracture. The distal k-wire holes124on the head portion142may ensure a trajectory to follow the RC joint and provide direction during insertion of the distal locking screws. The proximal k-wire holes in the elongated portion140of the plate110are arrange between fastener openings120and may be angled relative to the surface of the plate110to avoid intrusion into areas where instrumentation must pass during screw insertion.

In the embodiment shown inFIGS.1D and1E, the plate110may also comprise a window126. The window126may provide visualization of the plate110with respect to the radius102in the operating environment and on imaging (e.g., fluoroscopy). The window126is show as generally an asymmetrical triangle, but it envisioned that the window126, if present, may be of any suitable shape, size, and dimension.

The bone plate110may be attached to a proximal humerus to fixate one or more bone fractures or fragments and thereby promote healing of the bone. In one embodiment, the plate110further restores the anatomic alignment of the radius102. The plate110may be positioned against the volar side of the radial bone. One or more k-wires may be supplied through the k-wire holes124to assist with preliminary placement of the plate110. Pilot holes may be drilled through the fastener openings120to prepare to receive the respective fasteners130. The fasteners130A,130B,130C,130D may be positioned through the respective openings120A,120B,120C,120D and into the radius102. The fasteners130may be affixed to the bone in any suitable order, number, and orientation depending on the anatomy of the bone and the fracture.

Alternative Hole Configurations

The fixed and variable angle, locking and non-locking openings120,220(e.g., including openings120A,120B,120C,120D) and respective fasteners130,230(e.g., including130A,130B,130C,130D) described herein may be substituted with or include one or more of the following openings20and/or fasteners30,40. The openings20and/or fasteners30,40are generally described with reference to a generic plate10, which may include plate110,210,310,410,510,610, or any other suitable plate design.

Referring now to the drawing,FIGS.2-18depict alternative openings20in plate10. The openings20extending through the plate10are configured to accept locking fasteners30, non-locking fasteners40, or a combination of both locking and non-locking fasteners30,40that are able to dynamically compress the bone and/or affix the plate10to the bone. When plating diaphyseal bone, surgeons may use a combination of both locking and non-locking fasteners30,40that are able to dynamically compress bone and to connect the bone and the plate10. Dynamic compression may also be desirable to create interfragmental compression while tightening the fasteners30,40.

The plate10includes a top surface16and an opposite, bottom surface18configured to contact adjacent bone. The plate10includes one or more through openings20configured to receive one or more bone fasteners30,40. The openings20extend through the body of the plate10from the top surface16to the bottom surface18. In the embodiments depicted inFIGS.2-3, for example, the openings20may be in the form of a combination opening that has at least two overlapping holes. As shown inFIG.2, the combination opening20includes a first hole22overlapping a second hole24. One of the holes22may be configured to be the locking hole22, thereby able to receive and secure the locking fastener30to the plate10, and the other of the holes24may be configured to be the dynamic compression hole24, thereby allowing the non-locking fastener40to freely move in the hole24and apply dynamic compression. The locking hole22may have one or more locking features designed to engage with a locking fastener30, and the dynamic compression hole24may be elongated, for example, along the central longitudinal axis of the plate10. The screw holes22,24are not constrained to parallel axes. This hole geometry may be used in bone plates10to utilize either fixed angle or variable angle locking screws30and/or polyaxial non-locking screws40that can achieve dynamic compression.

These openings20allow surgeons more flexibility for fastener placement, based on preference, anatomy, and fracture location. Surgeons may have differing opinions as to whether non-locking or locking screws30,40(or some combination of the two) should be used in diaphyseal bone. Further, complexity of fracture location and shape makes having as many locations for fasteners30,40as possible necessary. This design offers surgeons a versatile method to achieve higher accuracy in placement of locking and/or non-locking screws30,40.

As best seen inFIG.2, the locking and non-locking fasteners30,40are shown. The locking and non-locking fasteners30,40may include traditional fasteners known in the art. The locking and non-locking fasteners30,40may comprise bone screws or the like. The fasteners30,40may also include other fasteners or anchors configured to be secured or engaged with bone, such as nails, spikes, staples, pegs, barbs, hooks, or the like. The fasteners30,40may include fixed and/or variable angle bone screws.

The locking fastener30may include a head portion32and a shaft portion34configured to engage bone. The shaft portion34may be threaded such that the fastener30may be threaded into the bone. The head portion32of the locking fastener30includes a textured area36around its outer surface sized and configured to engage with the locking hole22of the combination opening20. The textured area36may include threads, ridges, bumps, dimples, serrations, or other types of textured areas. As shown, the texture area36preferably includes a threaded portion extending substantially from the top of the head portion32to the bottom of the head portion32proximate to the shaft portion34. Thus, when the textured area36engages the locking hole22, the locking fastener30is thereby locked to the plate10.

The non-locking fastener40includes a head portion42and a shaft portion44configured to engage bone. The shaft portion44may be threaded such that the fastener40may be threaded into the bone. The head portion42of the non-locking fastener40is substantially smooth around its outer surface such that is able to slide along the elongated compression hole24. Thus, the non-locking fastener30may be coupled to the plate10, but not locked thereto to enable dynamic compression of the bone. It will be recognized that the head portions32,42of the fasteners30,40may include a recess configured to receive a driver or the like.

The locking hole portion22of the combination opening20includes a textured portion26. The textured portion26may include threads, ridges, bumps, dimples, serrations, knurls, or other types of textured areas. The textured portion26may be of the same type (e.g., mating surfaces) or different from the textured area36of the locking fastener30. As shown, the textured portion26is serrated or knurled along an inner portion of the hole22. The knurled surface may include straight, angled, or crossed lines cut or rolled into the material. In the embodiment shown inFIG.2, the textured portion26extends along substantially the entire inner surface of the hole22. With reference to the embodiment shown inFIG.3, the combination hole20is substantially the same as that shown inFIG.2except that the textured portion26the locking hole22now includes a thin centralized textured ribbon of material. For example, the textured portion26takes up about half or less of the surface area of the hole22. In this instance, only a portion of the textured area36of the head portion32of the locking fastener30engages with and locks to the textured portion26of the hole22.

An upper portion of the hole22may be tapered28, without texturing, for example, to facilitate alignment of the fastener30with the opening20. As shown inFIG.3, this tapered portion28is enlarged in area relative to the embodiment inFIG.2. The hole22may be configured to receive a fixed or variable angle fastener30. The hole22may be generally conical in shape such that it is wider near the top surface16of the plate10and narrower toward the bottom surface18of the plate10. The tapered portion28and/or the textured area26may be conical in shape. In this embodiment, the locking hole22is a textured fixed angle conical hole configured to receive locking fastener30. The textured holes22may deform as the fastener head32interferes with the textured portion26of the hole22, thereby providing a positive lock between the fastener30and the plate10.

The second hole portion24of the combination opening20may be an elongated dynamic compression hole. The dynamic compression hole24may be elongated such that it has a length greater than its width. The hole24may be elongated along the longitudinal axis of the plate10. In the alternative, the hole24may be generally cylindrical such that the hole24only permits polyaxial movement of the fastener40. The inner surface of the hole24may be substantially smooth such that the non-locking fastener40is able to freely pivot and/or slide along the hole24. This provides for at least two directions of compressive force (e.g., along the longitudinal axis and perpendicular to the longitudinal axis of the plate10). The head portion42of the non-locking fastener40may be substantially smooth around its outer surface. The head portion42is sized and configured to engage with and be retained within the hole portion24of the combination opening20. The hole24may be configured to receive a fixed or variable angle fastener40. In one embodiment, the hole24may be generally conical in shape and/or tapered such that it is wider near the top surface16of the plate10and narrower toward the bottom surface18of the plate10. In this embodiment, the hole24is a smooth variable angle conical hole configured to receive the non-locking fastener40. The hole24may receive the fastener head42allowing movement of the fastener40, for example, in a polyaxial fashion and/or along the length of the hole22, thereby providing dynamic compression of the bone.

Turning now toFIGS.4-7, alternative types of openings20A-20G, which provide for locking and/or non-locking, dynamic compression are provided. As many of the features of these openings are similar to the combination openings20described already forFIGS.2-3, only the different features will be further explained.

With reference toFIGS.4A-4C, the combination opening20A is similar to combination opening20except that the dynamic compression hole24A has the same general diameter as the locking hole22A, and the locking hole22A includes a different type of textured portion26A. In this embodiment, the locking hole22A has a first diameter D1, and the dynamic compression hole24A has a second diameter D2. Unlike the elongated hole24described earlier, dynamic compression hole24A has substantially same diameter as the locking hole22A. Thus, the first and second diameters D1, D2are substantially the same. The hole24A may be formed by milling or drilling a sphere out of the plate10in the center of the circle with tapers or ramps on either side. The hole24A is not elongated, but is generally circular and the non-locking fastener40will be allowed to translate in the hole24A because the diameter of the head portion42and/or shaft (e.g., bone thread) will be smaller than the size of the hole24A in the plate10. With respect to hole22A, the textured portion26A of the hole22A may be in the form of a tapered thread. This tapered thread may generally correspond to a similar tapered thread on the locking fastener30. This hole22A also does not include a tapered portion, and the textured portion26A begins at the intersection with the top surface16of the plate10. This alternative opening20A also provides for the use of both locking and non-locking fasteners30,40that are able to dynamically compress bone and/or lock the plate10to the bone.

Turning now toFIGS.5A-5C, the combination opening20B is similar to other combination openings except that the locking hole22B includes a different type of textured portion26B. The textured portion26B includes a series of alternating recesses and protrusions around a central portion of the hole22B. The recesses may be in form of a wave of alternating cutouts extending around the inner perimeter of the hole22B. The textured portion26B may lock the fastener30with a friction fit or may be modified during insertion of the fastener30to form a lock in situ. In this embodiment, the locking hole may allow for polyaxial locking. The plate10and the locking fastener30may be made of dissimilar materials having dissimilar hardness values. For example, the fastener30may have a higher hardness (e.g., on the Rockwell scale) relative to the plate10, which may be formed of a material having a lower relative hardness value. Due to the increased hardness, the head portion32of the locking fastener30may create a thread in the plate10as the fastener30is inserted (e.g., threaded) into the hole22B, thereby locking the fastener30to the plate10.

With reference toFIGS.6A-6C, the opening20C includes locking hole22C and dynamic compression hole24C with a more open configuration. The locking portion22C has a textured portion26C in the form of a tapered thread. This tapered thread may generally correspond to a similar tapered thread on the locking fastener30. The opposite portion24C of the opening20C is oblong with a ramp25C milled into the top surface16of the plate10to allow for dynamic compression. As best seen inFIG.6C, the ramp may be partially spherical in shape and extend from the top surface16of the plate10and connect to the textured portion26C. When viewed from above inFIG.6B, the ramp25C creates a square-like, key-hole, and/or non-hole geometry that sweeps into the tapered threaded locking hole22C. This alternative opening20C also provides for the use of both locking and non-locking fasteners30,40that are able to dynamically compress bone and/or lock the plate10to the bone.

Turning now toFIGS.7A-7C, the opening20D includes locking hole22D and dynamic compression hole24D. These holes22D,24D are connected and close together but are not overlapping. The holes22D,24D are separated by a small portion or sliver of plate material proximate to the lower portion of the holes22D,24D (e.g., at bottom surface18of the plate10and partially extending between the holes22D,24D). The locking portion22D has a textured portion26D in the form of a tapered thread. The textured portion26D extends around almost the entire circumference of the hole22D except where connected to hole24D. The dynamic compression hole24D is elongated and has ramped portions25D on opposite sides of the hole24D to receive fastener40. This configuration allows for a very close population of holes22D,24D on the plate10while giving structural stability at the holes22D,24D.

With reference toFIGS.8A-8C, locking hole22E and dynamic compression hole24E are adjacent, but separate from one another. The holes22E,24E are completely separated from one another by a wall56of plate material. The locking portion22E has a textured portion26E in the form of a tapered thread extends around the entire perimeter of the hole22E. The dynamic compression hole24E is elongated and has ramped portions25E on opposite sides of the hole24E. This configuration also allows for a very close population of holes22E,24E on the plate10while giving options for both locking and/or dynamic compression.

Turning now toFIGS.9A-9D, an alternative version of opening20F is provided. In this embodiment, the hole construct20F is comprised of at least three overlapping conical threaded holes in the plate10. The opening20F includes a first, locking hole22F, a second hole24F, and a third hole23F arranged along a longitudinal axis of the plate10. The third hole23F is the mirror image of hole24F across the first locking hole22F. The conically threaded holes22F,23F,24F may or may not have parallel axes. Each hole22F,23F,24F may include a textured portion26F, for example, in the form of one or more threaded portions. Thus, the locking fastener30may lock to any of the holes22F,23F,24F. Although each of the holes22F,23F,24F are shown in with the textured portion26F, it will be appreciated that one or more of the holes22F,23F,24F may have a substantially smooth inner portion instead of the textured portion26F. The upper part of the hole construct at the first and second ends of the hole20F each have a ramped feature25F (e.g., adjacent to holes23F and24F) to allow for dynamic compression of the plate10. In addition, the ramped feature25F may span the three or more conical holes22F,23F,24F (e.g., around the entire perimeter of the opening20F).

The non-locking compression fasteners40may have a major bone thread diameter such that the fastener40can translate between overlapping holes22F,24F,23F without interference. As best seen inFIG.9D, the locking fastener30may include a textured area36, for example, in the form of a thread, configured to engage with the textured portion26F of any of the holes22F,23F,24F. The hole geometry of opening20F can be applied to bone plates10to utilize either fixed angle and/or variable angle locking screws30and/or polyaxial non-locking screws40that can achieve dynamic compression. This allows surgeons more flexibility for screw placement, based on preference, anatomy, and fracture location.

Turning now toFIGS.10A-10B, another embodiment of opening20G is provided. This opening20G may be comprised of one elongate hole or slot extending from the top surface16to the bottom surface18of the plate10. A locking portion22G of the opening20G may include a textured portion26G having straight machine threads. The threads may extend more than 180 degrees to retain the locking fastener30. A non-locking portion24G of the opening20G may be positioned opposite the locking portion22G to complete the opening20G. The upper part of the opening20G may have one or more ramped features25G to allow for dynamic compression of the plate10. The ramp25G may span along the entire upper perimeter of the elongated slot20G or a portion thereof. The compression screws40may have a major bone thread diameter such that the screws40are able to translate along the opening20G without interference.

With reference toFIGS.11A-11E, alternative embodiments of the locking fastener30may be used with any plate10. The head portion32of the fastener30may include a textured area36in the form of a thread, for example, to lock the fastener30to the plate10. The fastener30and/or plate10may also include one or more mechanisms to prevent back out of the fastener30from the plate10. InFIG.11A, the head portion32includes at threaded portion36A (e.g., having straight threads) that interface with the plate10and the top of the head extends larger than the threads. The head portion32bottoms out when the fastener30is fully inserted and creates preload in the fastener30, thus locking the fastener30rotationally. InFIG.11B, the head portion32includes threaded portion36B. The head portion32has a constant major diameter while the minor diameter is tapered. The thread depth may go to zero at the top of the head portion32of the screw30. The first few turns smoothly insert, but as the tapered portion of the male thread engages with the plate10, interference occurs, jamming and/or locking the screw30and preventing backout. InFIG.11C, a screw thread36C on the head portion32, similar to the design inFIG.11B, except the minor diameter of the screw30stays constant while the major diameter of the head portion32gets larger toward the top of the screw30. A similar jamming and locking mechanism results through tightening of the screw30in the plate10. InFIG.11D, the threaded portion36D has areas of varying pitch. In particular, a straight screw thread on the head portion32of the screw30has a similar pitch to that of the plate10at the bottom of the head portion32of the screw30. The pitch then increases or decreases towards the top of the head portion32, which thereby results in jamming of the threads and preventing unwanted backout of the screw30. In an alternative variation of the concept ofFIG.11D, shown inFIG.11E, the opening in the plate10is provided with areas of varying pitch while the pitch of the threaded portion36D remains constant. For example, the head portion32may include a straight thread with a constant pitch. The upper surface of the plate10may include a thread pitch is similar to that of the screw10, but towards the bottom surface of the plate10, the thread pitch would either increase or decrease to lock the screw30to the plate10.

Turning now toFIGS.12A and12B, the plate10includes an additional anti-backout feature. In this embodiment, the plate10includes cylindrical holes or openings20H configured to accept either the compression fastener40or the locking fastener30. Each opening20H may include a ramped portion25H extending around a portion or the entire perimeter of the opening20H to allow for dynamic compression with a compression fastener40. Each opening20H may include a cylindrical feature to provide angular stability with a locking fastener30. The opening20H may also include an angular taper28to cause compressive tightening between the locking fastener30and the cylindrical opening20H. Each opening20H has an accompanying blocking screw46that can be actuated to block the fastener30,40from backing out. The blocking screw46may extend from a first end at the top surface16to a second end at the bottom surface18of the plate10. The first end of the blocking screw46may include a recess sized to receive an instrument to rotate the blocking screw46from an unblocked position to a blocked position. The blocked position may include a portion of the blocking screw46covering a portion of the head portion42of the fastener40, thereby further preventing backout of the fastener40from the plate10.

According to yet another embodiment, the plate10may include one or more openings20configured to receive the locking fastener30having self-forming threads that work by displacement of the plate material to lock the fastener30to the plate10. Turning now toFIGS.13-18, the locking fastener30and alternative embodiments of the openings20in the plate10are shown. In these embodiments, the locking mechanism of the fastener30(e.g., bone screw) to the internal fixation plate10may allow for variable angle screw insertion. The fastener30may be inserted within an angular cone where the force required to dislodge the head portion32of the fastener30is substantially equivalent to the force required when the fastener30is inserted perpendicular to the plate10. The holes or openings20in the plate10may be shaped such that the fastener30may be inserted at different angles. The geometry of the opening20is conducive to catching the threads on the head portion32of the fastener30and to reduce the axial force necessary to initiate the thread formation.

The locking mechanism includes a fastener30having a head portion32with self-forming threads that displace the plate material. The plate10may be made of a material softer than the fastener30to facilitate displacement. For example, the plate10may be comprised of titanium, alloys, polymers, or other materials having a lower material hardness (e.g., Rockwell hardness). The fastener30may be made of a harder relative material, for example, comprised of cobalt chrome, tungsten, alloys, or other materials having a higher material hardness. Preferably, the fastener30is comprised of a material having a strong, stiff, and high surface hardness which facilitates the thread forming process. The forming mechanism works by displacement of material rather than removal of the material of the plate10, thereby minimizing fragments or chips which are created from tapping.

InFIGS.13A-13B, the locking fastener30includes a head portion32and a shaft portion34configured to engage bone. Although not shown, the shaft portion34may be threaded such that the fastener30may be threaded into the bone. The head portion32may be tapered (e.g., at an angle of about 20°) such that the fit within the opening20in the plate10becomes tighter as the fastener30is advanced in to the bone. The head portion32of the locking fastener30includes a textured area36around its outer surface sized and configured to engage an opening20in the plate10. The textured area36may include threads, ridges, bumps, dimples, serrations, or other types of textured areas. As shown, the textured area36preferably includes a threaded portion extending substantially from the top of the head portion32to the bottom of the head portion32proximate to the shaft portion34. The threads36may run generally perpendicular to the conical surface of the head portion32. The threaded portion36is in the form of self-forming threads configured to displace the plate material and create threads in the opening20of the plate10. The threaded portion has an exaggerated sharp thread peak to facilitate cutting or forming of the plate material.

Turning now toFIGS.13C-17, alternative versions of the openings20are shown before being tapped with the fastener30. Once the fastener30is inserted, these openings20are modified based on the self-forming threads. The geometry of the openings20are conducive to catching the threads36and designed to reduce the axial force necessary to initiate the thread formation. An upper portion of the hole20may be tapered28, for example, with a conical straight tapered surface cut through the top surface16of the plate10for clearance of the head portion32of the fastener30during off angle insertion. A lower portion of hole20may further be tapered29, for example, with a conical straight tapered surface cut through the bottom surface18of the plate10for clearance of the shaft portion34during off angle insertion. The upper tapered portion28may be larger, for example, with a larger degree of taper than the lower tapered portion29. For example, the upper tapered portion28may have a taper in a range from about 60-90°, 70-80°, or 72-78°, preferably about 70°, 75°, or 80° whereas the lower tapered portion29may have a taper in a range from about 50-70°, 55-65°, or 57-63°, preferably about 55°, 60°, or 65°. The upper and/or lowered tapered portions28,29may be substantially conical (e.g.,FIGS.14B,15B,15C,16B) or may be segmented with more than one section, such as two separate conical sections having different diameters or degrees of taper (e.g.,FIGS.17A and17B).

At the intersection between the upper tapered portion28and the lower tapered portion29, a narrowed central portion, as indicated by the area31within the dashed lines ofFIG.13Cdefines the area where thread forming takes place. The area31provides a concentric ring of material for material displacement and thread forming. The area31may have the untextured surface illustrated inFIG.13Cor may have a textured portion26. As described herein, the textured portion26may include threads, ridges, bumps, dimples, serrations, or other types of textured areas. In the embodiment shown inFIGS.14A-14B, the textured portion26includes a windswept cut design comprised of a plurality of shallow cuts where each cut overlaps the next. For example, the windswept design may include a plurality of threadlike helical cut sweeps. Each cut has a smooth transition into the inner diameter of the hole20(e.g., into the upper and lower tapered portions28,29). The windswept cuts provide a positive surface for the self-forming threads to cut into, thereby helping to prevent peeling of the newly formed threads into the plate10.

InFIGS.15A-15D, the textured portion26includes a knurled cut design. In the embodiment illustrated inFIGS.15A-15B, a rounded transition between the upper tapered portion28and the lower tapered portion29(e.g., the two conical cuts) provides a workable surface for the knurling process as well as a surface for the head portion32to be able to roll over during off-axis locking. The knurled design may include a plurality of shallow knurled grooves set in a diamond pattern (e.g., about 45°) where each cut overlaps the next. The knurled grooves allow for the self-forming threads to cut more deeply into the material and reduce the necessary axial force to begin the thread forming process. In the embodiment illustrated inFIGS.15C-15D, the area31has a textured portion26defined by a plurality of 360° circular swept cuts. Additionally, a series of 60° triangular cuts is made at a 17° trajectory from a plane normal to hole axis, with the same number of cuts being applied in both a clockwise and counter-clockwise fashion, creating a pattern on the inside ring of material. The cuts create “plateaus” of material protruding into the hole, as shown. While specific angles are described, the disclosure is not limited to the specific angles. The resultant geometry from the cuts provides positive surfaces to cut into, dramatically reducing the axial force necessary to lock the screw to the plate. As such, the mechanism does not rely on bone purchase to engage the threads in the head of the screw. Secondly, the material removed by the cuts allow the head threads to cut deeper by reducing the amount of material which must be formed, and reducing friction between the screw30and plate10during the forming process.

FIGS.16A-16Bdepict a polygon form cut design. In this design, there is no textured portion at the transition between the upper tapered portion28and the lower tapered portion29. Instead, the narrowed central region has an overall polygonal form such that the hole20is neither cylindrical nor conical. The polygonal shape includes a number of sides with distinct linear section of material and rounded corners around which the form cut is allowed to sweep. For example, the polygonal shape may be substantially hexagonal (6-sided), heptagonal (7-sided), octagonal (8-sided), etc. The hole20may also be represented without lobe cuts, as a single concentric ring with the same geometry.

InFIG.17A, the upper tapered portion28includes a conical straight tapered surface cut for clearance of the head portion32of the fastener30during off angle insertion. The upper tapered portion28is segmented to have an upper area with a larger area relative to a lower area proximate the transition to the lower tapered portion29having a narrower diameter. The central area between the upper and lower tapered portions28,29, where the thread forming process occurs, includes two peaks or concentric rings of material (e.g., a superficial ring60and a deep ring62) with a groove27being locating in between for material removal and thread forming relief. The groove27between the rings60,62may be angled, for example, in the range of about 40-80°, about 50-70°, or about 60°. The superficial ring60is of a slightly smaller inner diameter than the deep ring62, as the superficial ring60is responsible for supporting a majority of the cantilever loads. The deep ring62provides additional fixation and support during off-angle insertion as well as additional support during nominal trajectory insertion. The lower tapered portion29includes a straight tapered surface that provides clearance for the shaft34of the fastener30when inserted off angle.

The embodiment of the opening20inFIG.17Bis similar toFIG.17A, but further includes textured portion26in the form of a plurality of helical swept cuts at the transition between the upper tapered portion28and the lower tapered portion29. The shallow helical cuts or windswept cuts may include a series of cuts at a steep pitch. The windswept cuts may be angled, for example, at about 50-70°, or about 60°. The same number of cuts may be made in both a clockwise and counter-clockwise fashion. The cuts may create plateaus of material protruding into the opening20. The resultant geometry provides positive surfaces for the fastener30to cut into, which can dramatically reduce the axial force necessary to lock the fastener30to the plate10. Thus mechanism does not need to rely on bone purchase in order to engage the threads in the head portion32of the fastener30. The material removed during insertion of the fastener30allows the self-forming threads to cut deeper by removing material which much be formed and reducing friction between the fastener30and the plate10during the forming process.

FIGS.18A-18Ddepict a screw-plate assembly. The assembly, inFIG.18C, shows the locking fastener30placed at an angle, other than perpendicular, to the upper surface16of the plate10. InFIG.18D, a non-locking fastener40is placed generally perpendicular to the plate10. It will be appreciated that the locking fastener30and non-locking fastener40may be oriented at any appropriate angle relative to the plate10. The section view inFIG.18Cshows the thread engagement with the plate10in which material of the plate10is displaced around the threads of the fastener30. By using the self-forming threads, the fastener30is able to be inserted into the plate10at variable angles and engages with the plate10with one-step locking requiring no additional steps to lock the fastener30to the plate10. The section view inFIG.18Dshow the compressive, non-locking screw40received in the opening20, without threadedly locking thereto. The non-locking screw40may provide for dynamic compression of the bone. Accordingly, the fasteners and openings described herein provide a wide variety of options for the surgeon, thereby providing appropriate locking and/or unlocking capability for dynamic compression depending on the desired treatment of the fracture and the bone.

Dia-Meta Volar Distal Radius Plate System

FIG.19depicts embodiments of a dia-meta volar distal radius stabilization system200including a bone plate210configured to sit against the volar side of the radial bone and one or more bone fasteners are configured to be received in the bone plate210and secured to the radius and radial shaft of a bone. Although generally described with reference to the radius and radial shaft, it will be appreciated that the stabilization system200described herein may be used or adapted to be used for the fixation of other long bones as well, such as the humerus, femur, tibia, etc.

The bone plate210extends from a first end212configured to be positioned on a shaft portion of radial bone to a second end214configured to be positioned proximate to the distal end of the radius. The plate210includes a top surface216and an opposite, bottom surface218configured to contact adjacent bone. The top and bottom surfaces216,218are connected by opposite side surfaces extending from the first to second ends212,214of the plate210. The bottom surface218of the plate210includes an anatomic contour configured to follow the best approximation of average distal radial anatomy, flaring up slightly along the radial column and more significantly along the intermediate column of the plate210. The plate210is designed to sit low and have a generally low profile proximal portion. The thickness of the plate210may generally be about 2 mm along the shaft and distal intermediate column, tapering to a thickness of 2.5 mm along the distal radial column which allows for the severe angle of the radial styloid fastener. The thickness of the plate210may generally increase towards the first end212when compared to the second end214. In addition, the width of the plate210proximate the first end212and along the elongate portion240may be thicker than the width of the plate at the second end214. The design of plate210allows for an easy transition from the second end214of the plate210to the elongate portion240to the first end212of the plate210to address fractures proximal to the second end of the plate214while also providing adequate support in the radial shat of the bone.

The second end214of the bone plate210toward the elongate portion240of the bone plate210is very similar to the bone plate110, thus the features and disclosures set forth above relating to the bone plate110are equally applicable to bone plate210and are incorporated in their entirety herein.

Looking at the elongate portion or dia-meta portion240of the plate210, the plate210includes one or more through openings220configured to receive one or more bone fasteners. The openings220extend through the body of the plate210from the top surface216to the bottom surface218. The openings220may include cylindrical openings, conical openings, elongated openings, threaded openings, textured openings, non-threaded and/or non-textured openings, and the like. The openings220may allow for locking of the fastener to the plate210or may allow for movement and dynamic compression of the bone. The plate210may comprise any suitable number of openings220in any suitable configuration. These openings220allow surgeons more flexibility for fastener placement, based on preference, anatomy, and fracture location. Surgeons may have differing opinions as to the number, location, and types of fasteners. Further, complexity of fracture location and shape makes having as many locations for fasteners as possible necessary. This design offers surgeons a versatile method to achieve higher accuracy in placement of the fasteners.

The openings220may be configured to receive one or more bone fasteners. The fasteners may include locking fasteners, non-locking fasteners, or any other fasteners known in the art. The fasteners may comprise bone screws or the like. The fasteners may also include other fasteners or anchors configured to be secured or engaged with bone, such as nails, spikes, staples, pegs, barbs, hooks, or the like. The fasteners may include fixed and/or variable angle bone screws. The fastener may include a head portion and a shaft portion configured to engage bone. For a locking fastener, the shaft portion may be threaded such that the fastener may be threaded into the bone. The head portion may include a textured area, such as threads, around its outer surface sized and configured to engage with the opening220, for example, and corresponding threads in the opening220in order to lock the fastener to the plate210. In the alternative, for a non-locking fastener, the head portion may be substantially smooth to allow for dynamic compression of the bone.

The plate210may further comprise a plurality of openings224configured to receive one or more k-wires (not shown). The k-wire holes224may comprise small diameter holes (e.g., having a diameter significantly smaller than the fastener openings220). The k-wire holes224may allow preliminary placement of the plate210against the bone and/or to aid in reduction of the fracture. The distal k-wire holes224on the head portion242may ensure a trajectory to follow the RC joint and provide direction during insertion of the distal locking screws. The proximal k-wire holes in the elongated portion240of the plate210are arrange between fastener openings220and may be angled relative to the surface of the plate210to avoid intrusion into areas where instrumentation must pass during screw insertion.

Dorsal Plate System

FIGS.20-24depict embodiments of a dorsal stabilization system300including bone plates310,410which are configured to sit against the dorsal portion of bone. One or more bone fasteners320C are configured to be received in the bone plates310,410to secure the plates310,410to the dorsal portion of a bone. Although generally described with reference to the dorsal portion of bone, it will be appreciated that the stabilization system300described herein may be used or adapted to be used for the fixation of other bones as well, such as other portions of the identified bones. It should be noted that the same reference numerals are being used for plates310,410because the plates are similar except for their respective first ends312which show different opening320configurations.FIG.20shows an acute configuration andFIG.22shows an oblique configuration.

As shown inFIGS.20-22, the plates310,410each have a body that extends from a first end312to a second end314. The plates310,410each include a top surface316and an opposite, bottom surface318configured to contact adjacent bone. The top and bottom surfaces316,318are connected by opposite side surfaces extending from the first to second ends312,314of the plate310. Although the plate310,410are shown having a generally longitudinal body, it will be appreciated that any suitable shape and contouring of the plates may be provided depending on the location and type of fracture to be plated.

The bone plates310,410include one or more openings320. The openings320extend through the plate310,410from the upper surface316to the bottom surface318and are configured to accept locking fasteners and non-locking fasteners320C. When using the plates310,410with bone, surgeons may use only locking, only non-locking or a combination of both locking and non-locking fasteners to connect the bone and the plates310,410. The openings320may be in the form of any of the openings discussed above with respect to the volar distal radial plate system, the dia-meta plate system, and the alternative hole configurations.

The plates310,410also include one or more slots320C present along the elongated portion340of the plates310,410and configured to accommodate a sliding fastener322C, shown inFIGS.23and24. As best seen inFIGS.20-24, the slot320C may offer a sliding slot for proximal-distal adjustment of the plates310,410during provisional placement. The slot320C may allow for proximal adjustment, distal adjustment, and/or medial-lateral adjustment of the plates310,410. This allows surgeons to optimally center the plate position along the bone prior to locking screw insertion. The slot320C may be elongated along a longitudinal axis of the elongated portion340as well as elongated, perpendicular to the longitudinal axis, from lateral side to lateral side. The elongated slot320C may have varying lengths and/or widths. Preferably, the length is greater than the width of the slot320C. The plates310,410may include etch lines adjacent to slot320C for more accurate adjustment of the plate310when being positioned on bone.

As best seen inFIGS.20and22, plates310,410also may include a plurality of side relief cuts or scalloped edging322along the length of the plates310,410which allows the plates310,410to be bent, for example, in three dimensions. The side relief cuts or scalloped edges322may be in the form of one or more curves having a widened portion along the sides of the plates310,410and a narrowed portion towards the center of the plates310,410. The side relief cuts or scalloped edges322may be positioned between consecutive openings320. The plurality of relief cuts or scalloped edges322may form a scalloped or wavy profile along the side edges of the plates310,410. As a result, the plates310,410are able to be shaped to a multi-contour surface without warping the openings320.

The plates310,410may further comprise a plurality of openings324configured to receive one or more k-wires (not shown). The k-wire holes324may comprise small diameter holes (e.g., having a diameter significantly smaller than the fastener openings320). The k-wire holes324may allow preliminary placement of the plates310,410against the bone and/or to aid in reduction of the fracture.

Lateral Plate

FIGS.25-27depict embodiments of a lateral stabilization system500including bone plate510which is configured to sit against the lateral portion of bone to address fractures on the side of the radius. One or more bone fasteners520C are configured to be received in the bone plate510to secure the plate510to the lateral portion of a radius of a bone. Although generally described with reference to the lateral portion of the radius of the bone, it will be appreciated that the stabilization system500described herein may be used or adapted to be used for the fixation of other bones, such as long bones, as well as other portions of the identified bones.

The plate510has a body that extends from a first end512to a second end514. The plate510includes a top surface516and an opposite, bottom surface518configured to contact adjacent bone. The top and bottom surfaces516,518are connected by opposite side surfaces extending from the first to second ends512,514of the plate510. Although the plate510is shown having a generally longitudinal body, that contours or radius upwardly to accommodate distal radius bony anatomy, it will be appreciated that any suitable shape and contouring of the plates may be provided depending on the location and type of fracture to be plated.

The bone plate510includes one or more openings520. The openings520extend through the plate510from the upper surface516to the bottom surface518and are configured to accept locking fasteners and non-locking fasteners520C. When using the plate510with bone, surgeons may use only locking, only non-locking or a combination of both locking and non-locking fasteners to connect the bone and the plate510. The openings520may be in the form of any of the openings discussed above with respect to the volar distal radial plate system, the dia-meta plate system, the dorsal plates and the alternative hole configurations.

The plate510also includes one or more slots520C present along the elongated portion540of the plate510and configured to accommodate a sliding fastener522C, shown inFIG.27. As best seen inFIGS.25-26, the slot520C may offer a sliding slot for proximal-distal adjustment of the plate510during provisional placement. The slot520C may allow for proximal adjustment, distal adjustment, and/or medial-lateral adjustment of the plate510. This allows surgeons to optimally center the plate position along the bone prior to locking screw insertion. The slot520C may be elongated along a longitudinal axis of the elongated portion540as well as elongated, perpendicular to the longitudinal axis, from lateral side to lateral side. The elongated slot520C may have varying lengths and/or widths. Preferably, the length is greater than the width of the slot520C. The plate510may include etch lines adjacent to slot520C for more accurate adjustment of the plate510when being positioned on bone.

As best seen inFIGS.25and27, plate510also may include a plurality of side relief cuts or scalloped edging522along a portion of the length of the plate510which allows that portion of the plate510to be bent, for example, in three dimensions. The side relief cuts or scalloped edges522may be in the form of one or more curves having a widened portion along the sides of the plate510and a narrowed portion towards the center of the plate510. The side relief cuts or scalloped edges522may be positioned between consecutive openings520. The plurality of relief cuts or scalloped edges522may form a scalloped or wavy profile along the side edges of the plate510. As a result, a portion of the plate510is able to be shaped to a multi-contour surface without warping the openings520.

The plate510may further comprise a plurality of openings524configured to receive one or more k-wires (not shown). The k-wire holes524may comprise small diameter holes (e.g., having a diameter significantly smaller than the fastener openings520). The k-wire holes524may allow preliminary placement of the plate519against the bone and/or to aid in reduction of the fracture.

Bridge Plate

FIG.28depicts an embodiment of a stabilization system600including bone plate610which acts as an internal fixator for high energy comminuted distal radius fractures. The plate610is placed dorsally and extends from the third or second metacarpal to approximately a third to half way down the radius. One or more bone fasteners are configured to be received in the bone plate610to secure the plate610to the desired portions of bone. Although generally described with reference to the radius and metacarpals, it will be appreciated that the stabilization system600described herein may be used or adapted to be used for the fixation of other bones, such as long bones, as well as other portions of the identified bones.

The plate610has a body that extends from a first end612to a second end614. The plate610includes a top surface616and an opposite, bottom surface618configured to contact adjacent bone. The top and bottom surfaces616,618are connected by opposite side surfaces extending from the first to second ends612,614of the plate610. Although the plate610is shown having a generally longitudinal body that is generally planar, it will be appreciated that any suitable shape and contouring of the plates may be provided depending on the location and type of fracture to be plated.

The bone plate610includes one or more openings620. The openings620, which are located proximate the first end612and the second end614, extend through the plate610from the upper surface616to the bottom surface618and are configured to accept locking fasteners and non-locking fasteners. When using the plate610with bone, surgeons may use only locking, only non-locking or a combination of both locking and non-locking fasteners to connect the bone and the plate610. The openings620may be in the form of any of the openings discussed above with respect to the volar distal radial plate system, the dia-meta plate system, the dorsal plates, the lateral plates and the alternative hole configurations.

Lunate Facet Hook Plate

FIGS.29-36depict embodiments of a stabilization system700including hook plate710,710′ which is designed for fracture patterns that involve the volar ulnar corner of the distal radius. The plate710,710′ may be used as a stand-alone stabilization plate, as shown inFIGS.32and34or may be used in combination with a volar distal radius plate110, as shown inFIGS.31,33and35-36.

When the plate710is used alone, the hooks712of the plate are embedded or tapped into bone to prevent the shifting of the plate in a lateral or medial direction. It is contemplated that there may one, two, or more hooks712. The plate710also includes an opening720to receive a fixation screw714, which may aid in further fixation of the plate710the bone and the fracture site.

When the plate710is used with the volar distal radius plate, the plate710is configured and dimensioned such that is can be slidably placed under a pre-positioned volar distal radius plate110. The opening720will align with an opening120on the volar distal radius plate110such that a fastener will pass through the opening120on the volar distal radius plate110and the opening720on the plate710. The opening720can accept a locking screw or a non-locking screw.

Referring toFIGS.32and34A-34E, the plate710′ is similar to the previous embodiment and includes a pair of hooks712′ extending from the body716of the plate710′ with a transition area713therebetween. The hooks712′ have an arcuate configuration such that the hooks712′ complement the curvature of the rim of the lunate facet (seeFIGS.32and34E). The transition area713narrows between the elongate body716and the hooks712′. An elongate slot720extends through the elongate body716and is configured to receive a fixation screw714. As seen inFIG.34E, the elongate body716may have an initial curvature or be bent to complement the contour of the bone102.

Referring toFIGS.34A-34E, an illustrative method of installing the plate710′ as a stand-alone stabilization plate will be described. As shown inFIG.34A, an inserter730is utilized to hold plate710′ and apply the plate710′ to the bone102with the hooks712′ positioned over the lunate facet. A tamp732is struck with a mallet734or the like to tamp the hooks712′ in or over the facet as shown inFIG.34B. With the plate710′ in position, a hole is drilled through the slot720, for example, utilizing a drill738with a bit passing through a soft tissue protector736as illustrated inFIG.34C. It may be desired to position the hole in a proximal portion of the slot720. After the hole is drilled, the desired screw length may be determined utilizing a depth gauge or the like (not shown). The desired fixation screw714may then be inserted into the hole using a driver740or the like, as shown inFIG.34D. Non-locking screws lag the plate710′ to the bone102and help to maintain fracture compression and avoiding last translation of the plate710′ distally.FIGS.32and34Eillustrate the final construct of the stabilization plate. Fluoroscopy, as shown inFIG.34E, may be utilized to confirm proper screw714placement.

Turning toFIGS.35A-35E, a first illustrative method of installing the plate710′ along with a volar distal radius plate110will be described. In this illustrative method, the plate710′ is positioned prior to the volar plate insertion. Initially, the plate710′ is positioned relative to the bone102and the hooks712′ are tamped into position in a manner similar to that described with respect toFIGS.34A and34B. With the plate710′ in position, a k-wire742is inserted through the slot720and into the bone102as shown inFIG.35A. The volar plate110is then positioned such that the k-wire742extends through one of the screw holes120A in the head portion142of the volar plate110as shown inFIG.35B. The inserter730may be utilized to hold and manipulate the volar plate110. The volar plate110is slid along the k-wire742such that the volar plate110is properly positioned on the bone102and is covering the hook plate710′ as shown inFIG.35C. When positioned correctly, the ulnar-most subchondral locking screw hole120A aligns with the slot720of the hook plate710′. With the volar plate110positioned properly, a fixation screw714is inserted through the screw hole120A and the slot720and secured within the bone.FIGS.33and35Eillustrate the final construct of the stabilization assembly. Fluoroscopy, as shown inFIG.35E, may be utilized to confirm proper screw714placement and proper placement of the hook plate710′.

Referring toFIGS.36A and36B, another illustrative method of installing the plate710′ along with a volar distal radius plate110will be described. In this illustrative method, the volar plate110has already been installed and thereafter it is determined that a hook plate710′ is desired, for example, when an unstable lunate facet fracture is identified after the volar plate fixation. Initially, at least one of the fixation screws securing the head portion of the volar plate110is removed (not shown). Thereafter, the elongate body716of the hook plate710′ is slid behind the volar plate110and the hooks712′ are tamped into position as shown inFIG.36A. With the plate710′ in position, a k-wire742is inserted through the slot720and into the bone102as shown inFIG.35A. The volar plate110is then positioned such that the k-wire742extends through one of the screw holes120A in the head portion142of the volar plate110as shown inFIG.35B. Once the hook plate710′ positioned properly, a fixation screw714is inserted through the screw hole120A and the slot720and secured within the bone as illustrated inFIG.36B. The final construct of the stabilization assembly will be as shown inFIGS.33and35E. Again, fluoroscopy, as shown inFIG.35E, may be utilized to confirm proper screw714placement and proper placement of the hook plate710′.

FIGS.37and28show a lunate facet hook plate reduction instrument810. The instrument is capable of being connected to any quick connect handle known in the industry, such as the AO quick-connect handle. The reduction instrument810utilizes a two-piece contact surface that is capable of capturing a lunate facet hook plate and releasing the hook plate when it is positioned in the desired location and orientation.

FIGS.39and40depict a drill guide910that can be attached to second end114of the volar distal radius plate110. The drill guide910may include a plurality of cannulated openings912which correspond to each of the respective openings120in the plate110. The drill guide910openings912may be configured in order to drill the pilot holes at the appropriate trajectories for each opening120, and subsequently receive the respective fasteners at the correct trajectories. The drill guide910may also include a plurality of k-wire openings914which match with the k-wire openings in the plate110. The drill guide910may be secured to the plate110with one or more fasteners or may be secured to the plate110through an integrated connection system such as a thumb screw, an interference fit, etc. The fastener may thread into the plate110or otherwise temporarily secure the drill guide910to the plate110. The drill guide910may be pre-assembled to the plate110or may be attached at any other suitable time before or during the surgery. The fastener may be secured, for example, in the operating room, via thumb or hexalobular fastener, to attach the drill guide910to the plate110. After the pilot holes are drilled, the drill guide910may then be removed and the fasteners positioned through the respective openings120. The drill guide910may be relatively slim in thickness, for example, not protruding more than 10 mm above the plate110, to prevent impinging on soft tissue.

Neck and Head Plate

FIGS.41A and41Bdepict an embodiment of a lateral stabilization system1000including bone plate1010which is configured to treat fractures of the ulnar neck and head. One or more bone fasteners1030are configured to be received in the bone plate1010to secure the plate1010to the neck and head portion of the ulna102. The plate1010has a body that extends from a first end1012to a second end1014. The plate1010includes a top surface1016and an opposite, bottom surface1018configured to contact adjacent bone. The top and bottom surfaces1016,1018are connected by opposite side surfaces extending from the first to second ends1012,1014of the plate1010. The first end1012of the plate1010preferably has a chamfer which allows distal placement of the plate1010. The second end1014of the plate1010has an arcuate configuration which complements the curvature of the distal portion of the ulna102. The plate1010has a generally longitudinal body, that contours or radius upwardly slightly to accommodate distal radius bony anatomy, however, it will be appreciated that any suitable shape and contouring of the plates may be provided depending on the location and type of fracture to be plated.

The bone plate1010includes one or more openings1020. The openings1020extend through the plate1010from the upper surface1016to the bottom surface1018and are configured to accept locking fasteners and non-locking fasteners1030. When using the plate1010with bone, surgeons may use only locking, only non-locking or a combination of both locking and non-locking fasteners to connect the bone and the plate1010. The openings1020may be in the form of any of the openings discussed above with respect to the volar distal radial plate system, the dia-meta plate system, the dorsal plates and the alternative hole configurations. The proximal most opening1020A preferably is a polyaxial screw hole which is angled distally. Such a configuration helps to prevent screw impingement on the articular surface.

The plate1010also includes one or more slots1020C present along the elongated portion1040of the plate1010and configured to accommodate a sliding fastener1030C. The slot1020C has a configuration similar to the slot120C′ illustrated inFIG.1Hand may offer a sliding slot for proximal-distal adjustment of the plate1010during provisional placement. The slot1020C may allow for proximal adjustment, distal adjustment, and/or medial-lateral adjustment of the plate1010. This allows surgeons to optimally center the plate position along the bone prior to locking screw insertion. The slot1020C may be elongated along a longitudinal axis of the elongated portion1040as well as elongated, perpendicular to the longitudinal axis, from lateral side to lateral side. The elongated slot1020C may have varying lengths and/or widths. Preferably, the length is greater than the width of the slot1020C. The plate1010may include etch lines adjacent to slot1020C for more accurate adjustment of the plate1010when being positioned on bone.

As best seen inFIG.41A, plate1010also may include a plurality of side relief cuts or scalloped edging1022along a portion of the length of the plate1010which allows that portion of the plate1010to be bent, for example, in three dimensions. The side relief cuts or scalloped edges1022may be in the form of one or more curves having a widened portion along the sides of the plate1010and a narrowed portion towards the center of the plate1010. The side relief cuts or scalloped edges1022may be positioned between consecutive openings1020. The plurality of relief cuts or scalloped edges1022may form a scalloped or wavy profile along the side edges of the plate1010. As a result, a portion of the plate1010is able to be shaped to a multi-contour surface without warping the openings1020.

The plate1010may further comprise a plurality of openings1024configured to receive one or more k-wires (not shown). The k-wire holes1024may comprise small diameter holes (e.g., having a diameter significantly smaller than the fastener openings1020). The k-wire holes1024may allow preliminary placement of the plate1010against the bone and/or to aid in reduction of the fracture. Alternatively, as illustrated inFIG.42A, a drill guide744may be utilized to direct a drill bit of a drill738through the openings1020through the plate1010. For example, the proximal most opening1020A and the distal most opening1020D may be utilized for positioning of k-wires742to provisionally hold the plate1010in place. The placement of the k-wires742may be confirmed utilizing fluoroscopy as illustrate inFIG.42B.

According to one embodiment, the ulna plate1010may be used for fixation of an unstable ulna following distal radius repair. Using a subcutaneous ulnar approach, the patient's arm may be positioned on a hand table with the elbow flexed. The forearm may be positioned to expose the subcutaneous border of the ulna. A longitudinal incision may be created distally and proximally. The interval between the extensor carpi ulnaris (ECU) and the flexor carpi ulnaris (FCU) may be split to expose the ulnar shaft. The plate1010may be applied dorsally if desired. The fracture may be reduced and the reduction may be confirmed, for example, with fluoroscopy. The speed locking drill guide744may be used to place k-wires742in the distal and proximal screw holes to provisionally hold the plate in position. A hole may be drilled through the center of the positioning slot, and a screw may be positioned therein, thereby allowing for adjustment of the plate1010proximal-distal and/or medial-lateral for optimal placement. The remaining screws may be predrilled and placed and the k-wires may be replaced with locking screws.

Although the invention has been described in detail and with reference to specific embodiments, it will be apparent to one skilled in the art that various changes and modifications can be made without departing from the spirit and scope of the invention. Thus, it is intended that the invention covers the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents. It is expressly intended, for example, that all ranges broadly recited in this document include within their scope all narrower ranges which fall within the broader ranges. It is also intended that the components of the various devices disclosed above may be combined or modified in any suitable configuration.