# Patent

## Title
Carbon fiber reinforced PEEK bone plate with titanium fixation screws

## Abstract

A bone plate configured to accommodate fixation devices (such as screws, for example) inserted at various angles. The bone plate is formed of a material softer than the material of the fixation devices, and is provided with fixation holes with rounded, curved interior walls (i.e., non-threaded holes) that allow the fixation devices to be inserted at various angles. The fixation holes have a diameter smaller than that of the fixation devices. As a result of the difference between the materials of the plate and of fixation devices, and of the difference between the diameters of the fixation holes and of the fixation devices, the fixation devices deform the interior walls of the fixation holes, therefore self-threading the holes at an advantageous angle.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This is a divisional of U.S. application Ser. No. 12/504,130, filed Jul. 16, 2009, which claims the benefit of U.S. Provisional Application No. 61/082,408, filed Jul. 21, 2008, the entire disclosure of which is incorporated by reference herein.


FIELD OF THE INVENTION
The present invention relates to a carbon fiber reinforced PEEK bone plate with titanium fixation screws, and to a method for performing high tibial open wedge osteotomy using the bone plate.
BACKGROUND OF THE INVENTION
Treatment of pain or instability associated with lower extremity misalignment may require surgical interventions, such as osteotomy. High tibial osteotomies are indicated by early, medial joint-space narrowing, by early arthritis in patients who have had previous medial meniscectomy, or following rupture of the anterior cruciate ligament in patients with pre-existing varus deformity, for example.
Two osteotomy methods are known in the art: the closed wedge method, and the open wedge method. In the closed wedge method, removal of a bone wedge creates an angled gap in the bone. Part of the bone is left as a hinge at the apex of the angle. The hinge allows the gap to narrow, and the bone material on either side of the closed gap joins together. In the open wedge method, a cut is made across the bone. Part of the bone is left as a hinge, as in the closed wedge method. In contrast to the closed wedge method, however, the hinge allows the cut gap to open. The open wedge is filled with graft material. The two osteotomy methods are performed on opposite sides of the bone to give equivalent results. For example, when a given deformity would be corrected by performing the open wedge procedure on the medial side of a bone, an equivalent closed wedge correction would be performed laterally.
The closed wedge method is the current standard, although several disadvantages are associated with this technique. The most significant disadvantages of the closed wedge method are: (1) disruption of the tibial-femoral joint; (2) possible damage to neurovascular structures; and (3) disruption of the medial cortex, resulting in instability and nonunion between the upper and lower bone because of possible soft tissue interference. It is also difficult to compute the correct amount of bone to remove and, therefore, several extra cuts may be required.
The open wedge method avoids or mitigates many of the disadvantages associated with the closed wedge method. Additionally, the medial, open-wedge high tibial osteotomy has the following advantages over the closed, lateral-wedge high tibial osteotomy: (1) speed; (2) simplicity; (3) ability to quickly change angle at any time during the procedure; and (4) no requirement for fibular osteotomy. Open wedge osteotomy procedures are disclosed, for example, in U.S. Pat. Nos. 5,620,448 and 5,749,875, both of which are assigned to Arthrex, Inc. and incorporated herein by reference.
Because the open wedge method leaves a gap in the bone, a brace is necessary to fix the portions on either side of the gap relative to each other and bear weight until new bone grows to fill the gap. Conventionally, the brace is a bone plate formed of stainless steel or titanium. The bone plate is typically affixed to the bone portions on either side of the gap with steel or titanium screws inserted through pre-formed screw holes in the bone plate. One such bone plate is disclosed in U.S. Pat. No. 5,749,875 referenced above.
Because conventional bone plates are formed of a hard metallic material (e.g., stainless steel or titanium), they offer sufficient strength but the angle at which screws must be inserted is fixed, either by threading or by providing a tapered portion on the interior of the screw holes. This is disadvantageous because it may prevent a surgeon from adjusting the insertion angle of the fixation screws to better accommodate the curvature of a patient's bone. Thus, there is a need in the art for a bone plate that can accommodate fixation screws inserted at different angles.
SUMMARY OF THE INVENTION
The present invention provides apparatus and methods for tissue fixation using a bone plate configured to accommodate fixation devices (such as screws, for example) inserted at various angles.
The bone plate is formed of a material softer than the material of the fixation devices, and is provided with fixation apertures or holes with rounded, curved interior walls (i.e., non-threaded holes) that allow the fixation devices to be inserted at various angles. The fixation apertures or holes have a diameter smaller than that of the fixation devices. As a result of the differences between the materials of the plate and of fixation devices, and between the diameters of the fixation holes and of the fixation devices, the fixation devices deform the interior walls of the fixation holes, therefore “self-threading” the holes at an advantageous angle. The “self-threading” of the fixation holes of the plate by the fixation devices eliminates the need for prior threading or tapering of the fixation holes.
Other features and advantages of the present invention will become apparent from the following description of the invention, which refers to the accompanying drawings.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of a bone plate according to a first embodiment of the present invention.
FIG. 2 is a perspective view of the underside of the bone plate illustrated in FIG. 1.
FIG. 3 is a plan view of the bone plate illustrated in FIG. 1.
FIG. 4 is cross section of the bone plate along line A-A of FIG. 3.
FIG. 5 is cross section of the bone plate along line B-B of FIG. 3.
FIG. 6 is a perspective view of a screw used to fix the bone plate of FIG. 1 to a bone, in accordance with a disclosed embodiment.
FIG. 7 is longitudinal cross section of the screw illustrated in FIG. 6.
FIG. 8 is a plan view of the socket end of the screw illustrated in FIG. 6.
FIG. 9 is a plan view of the cutting end of the screw illustrated in FIG. 6.
FIG. 10 is a flow chart of a method for performing high tibial open wedge osteotomy in accordance with a disclosed embodiment.
FIG. 11 illustrates the bone plate of FIG. 1 positioned over the medial opening during a high tibial open wedge osteotomy.
FIG. 12 illustrates temporary fixation of the bone plate of FIG. 1 over the medial opening and preparation of a proximal hole of the bone plate of FIG. 1 with a unidirectional drill sleeve.
FIG. 13 illustrates preparation of a distal hole of the bone plate of FIG. 1 with a multidirectional drill sleeve.
FIG. 14 illustrates the bone plate of FIG. 1 fixed over the medial opening with a plurality of the screws illustrated in FIG. 7.
FIG. 15 illustrates the insertion of bone grafts into the medial opening.
FIG. 16 is a top plan view of a bone plate according to a second embodiment of the present invention.
FIG. 17 is a top view of the underside of the bone plate of FIG. 16.
FIG. 18 is a side view of the bone plate of FIG. 16.
FIG. 19 is a cross-sectional view of the bone plate of FIG. 18 taken along line A-A.
FIG. 20 is a cross-sectional view of the bone plate of FIG. 16 taken along line C-C.
FIG. 21 is a cross-sectional view of the bone plate of FIG. 20 taken along line B-B.
FIG. 22 is a cross-sectional view of the bone plate of FIG. 20 taken along line D-D.



DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
In the following detailed description, reference is made to various specific embodiments in which the invention may be practiced. These embodiments are described with sufficient detail to enable those skilled in the art to practice the invention, and it is to be understood that other embodiments may be employed, and that structural and logical changes may be made without departing from the spirit or scope of the present invention.
The present invention provides apparatus and methods for tissue fixation (for example, tissue to bone fixation) using a bone plate configured to accommodate fixation devices (such as screws, for example) inserted at various angles. The bone plate is formed of a material softer than the material of the fixation devices, and is provided with fixation apertures or holes with rounded, curved interior walls (i.e., non-threaded holes) that allow the fixation devices to be inserted at various angles. As a result of the difference between the material of the plate and that of the fixation devices, the “self-threading” of the fixation holes of the plate by the fixation devices (i.e., by the threaded screws) eliminates the need for prior threading or tapering of the fixation holes.
According to exemplary embodiments of the present invention, the bone plates of the present invention are configured to accommodate fixation screws inserted at various angles, by forming the bone plate of a softer material than the screws, and rounding the interior walls of the screw holes in the bone plate. Because the bone plate is softer than the fixation screws, the harder fixation screws will deform the interior walls of the screw holes during insertion. This “self-threading” of the screw apertures or holes by the fixation screws eliminates the need for prior threading or tapering of the screw apertures or holes. The curvature (i.e., rounding) of the interior walls of the screw holes (which is described in greater detail below with reference to FIG. 5, for example) allows fixation screws to be inserted at a range of angles. Thus, the surgeon is free to select a preferable screw insertion angle during the osteotomy based, for example, on the shape of the patient's bone.
The bone plate and fixation screws must be sufficiently strong to endure post-operative forces exerted upon them by a patent's weight and movement. In an exemplary embodiment only, the bone plate is formed of polyetheretherketone (“PEEK”) reinforced with a biocompatible fiber filler. In a preferred embodiment, the bone plate is formed of carbon fiber reinforced PEEK (also known as “CF-PEEK”).
The formation of the bone plate of ordinary PEEK (i.e., without carbon fiber reinforcement) would cause the bone plate to be too soft and unable to bear sufficient weight. Similarly, fixation devices (for example, fixation screws) formed of PEEK, or even CF-PEEK, would not be sufficiently strong. Therefore, metallic fixation devices (such as metallic screws) are preferred. In an exemplary embodiment, the fixation devices include at least one screw that comprises titanium, most preferably in the form of TiAl6V4 (i.e., a titanium alloy comprising about 6% aluminum and about 4% vanadium) which provides high strength, light weight, and corrosion resistance. In an exemplary embodiment, all fixation devices are screws.
Referring now to the drawings, where like elements are designated by like reference numerals, FIGS. 1-22 illustrate embodiments of bone plates 100, 200 of the present invention that comprise carbon fiber reinforced PEEK and are provided with fixation apertures or holes with rounded, curved interior walls (i.e., non-threaded holes) that allow corresponding fixation devices (such as fixation screws, for example) to be inserted at various angles. The fixation devices used in conjunction with the bone plates 100, 200 of the present invention are preferably formed of a material stronger than the material of the bone plates (i.e., stronger than carbon fiber reinforced PEEK). Exemplary materials for the fixation devices are, for example, titanium, titanium alloys, stainless steel, or combinations of such materials.
FIG. 1 illustrates the top and side of a bone plate 100 (i.e., the side facing away from the bone after installation) constructed in accordance with a first embodiment of the present invention. The bone plate 100 is preferably constructed of carbon fiber reinforced PEEK. Proximal apertures or holes 101, 102, 103 (proximal fixation holes or proximal screw holes 101, 102, 103) are provided at one end. Distal apertures or holes 105, 106, 107 (distal fixation holes or distal screw holes 105, 106, 107) are provided at the opposite end. An intermediate apertures or hole 104 (intermediate fixation hole or intermediate screw hole 104) is provided between the proximal and distal holes, but nearer to the proximal end of the bone plate 100 (i.e., nearer to the proximal screw holes 101, 102, 103).
In an exemplary high tibial open wedge osteotomy, the bone plate 100 is secured to the proximal portion of the tibia (i.e., the portion “above” the medial opening) with fixation devices (screws) inserted through the proximal holes 101, 102, 103 and the intermediate hole 104. Similarly, the bone plate 100 is secured to the distal portion of the tibia (i.e., the portion “below” the medial opening) with fixation devices (screws) inserted through distal holes 105, 106, 107.
FIG. 2 illustrates the underside of the bone plate 100 (i.e., the side facing the bone after installation). FIG. 3 is a plan view of the top of the bone plate 100. FIG. 4 is a cross section of the bone plate 100 along line A-A of FIG. 3. FIG. 5 is a cross section of the bone plate 100 along line B-B of FIG. 3. In a preferred embodiment, lines drawn through the center axis of proximal screw holes 101 and 102 form a 20° angle, as shown in FIG. 5. Also in a preferred embodiment, lines drawn tangent to opposite sides of the uppermost portion of the interior curved surface of the screw holes form a 60° angle. FIG. 5 illustrates this angle with respect to proximal screw hole 102, though the same angle can be formed in any or all of the other distal, intermediate, or proximal screw holes. The diameter of the screw holes in the bone plate is preferably less than the diameter of the fixation devices (screws) intended to be inserted through them. In this manner, the fixation screws can deform the interior walls of the screw holes, thereby “self-threading” the holes at an advantageous angle, as described above.
FIG. 6 illustrates a fixation device 600 (screw 600) that can be used to fasten a bone plate of the present invention (such as bone plate 100, 200) to a bone. The fixation device 600 comprises a socket end 601 and a cutting end 603. The body of the fixation device 600 contains threads 602. FIG. 7 is a partial cross section along the longitudinal axis of the fixation device 600. FIG. 8 illustrates the socket end 601 of the fixation device 600. The socket end 601 comprises an interior portion 604 shaped to accommodate a tool for rotating the fixation device 600. In a preferred embodiment, the interior portion 604 defines a substantially hexagonal region. FIG. 9 illustrates the cutting end 603 of the fixation device 600. The threaded portion of the fixation device 600 is preferably 5.0 mm in diameter with 1.0 mm pitch between threads. In an exemplary embodiment, the fixation devices (such as screw 600) comprise titanium, most preferably in the form of TiAl6V4 (i.e., a titanium alloy comprising about 6% aluminum and 4% vanadium).
FIG. 10 is a flow chart illustrating steps of a method for performing high tibial open wedge osteotomy using the bone plate and fixation devices disclosed in this application. At step 1001, a medial opening is formed using conventional surgical techniques, such as described in U.S. Pat. No. 5,620,448 referenced above, for example. At step 1002, the bone plate 100 is positioned over the medial opening. FIG. 11 illustrates a femur 1101 and tibia 1102 at this stage of the osteotomy (i.e., after step 1002). Pliers 1103 may be used to hold the medial opening 1105 at an appropriate angle while the bone plate 100 is positioned over the medial opening 1105. Kirschner wires (also known as “K wires”) 1104 may be used to provide orientation around the joint during the procedure.
At step 1003, guide holes are drilled into the tibia 1102 through the proximal screw holes 101, 102, 103 of the bone plate 100 using the unidirectional end 1106a of a drill sleeve 1106, as illustrated in FIG. 12. The unidirectional end 1106a acts as a guide for the drill bit 1107 and maintains the drill bit 1107 at a fixed angle with respect to the bone plate 100. K wires 1104 can be inserted into the tibia through any of the screw holes in bone plate 100 to temporarily fix the bone plate 100 in position, as also illustrated in FIG. 12. At step 1004, fixation screws, such as those described above with reference to FIGS. 6-9, are inserted through the proximal holes 101, 102, 103 and into the guide holes drilled at step 1003 to permanently fix the bone plate 100 to the proximal portion of the tibia 1102.
At step 1005, guide holes are drilled into the tibia 1102 through the intermediate screw hole 104 and distal screw holes 105, 106, 107 of the bone plate 100 using the multidirectional end 1106b of the drill sleeve 1106, as illustrated in FIG. 13. Like the unidirectional end 1106a, the multidirectional end 1106b also acts as a guide for the drill bit 1107. However, the multidirectional end 1106b allows the drill bit 1107 to pivot within the intermediate screw hole 104 and distal screw holes 105, 106, 107. At step 1006, fixation screws are inserted through the intermediate screw hole 104 and distal screw holes 105, 106, 107 and into the guide holes drilled at step 1005 to permanently fix the bone plate 100 to the distal portion of the tibia 1102.
The sequence of drilling and screw insertion steps described herein is merely exemplary. The order can be varied based on the professional judgment of the surgeon performing the osteotomy. For example, a guide hole could be drilled through one of the distal screw holes 105, 106, 107 before guide holes are drilled through all of the proximal screw holes 101, 102, 103. Similarly, a screw might be inserted through one or more of the distal screw holes 105, 106, 107 before additional screws are inserted through all of the proximal holes 101, 102, 103. In addition, the multidirectional end 1106b of the drill sleeve 1106 may be used in conjunction with the proximal screw holes 101, 102, 103 of the bone plate 100, and the unidirectional end 1106a of the drill sleeve 1106 may be used in conjunction with the intermediate hole 104 and distal holes 105, 106, 107 of the bone plate 100, as necessary to achieve advantageous alignment of the fixation devices (screws).
FIG. 14 illustrates the tibia 1102 and the bone plate 100 after completion of step 1006. As shown, fixation screws 600 have been inserted into the guide holes drilled at steps 1003 and 1005 to permanently fix the bone plate 100 to the tibia 1102. At step 1007, bone grafts may be inserted into the medial opening to promote bone growth. U.S. Pat. No. 6,823,871, which is assigned to Arthrex, Inc. and incorporated herein by reference, discloses example grafts and graft materials suitable for insertion into osteotomy openings. In general, local tibial cancellous grafts may be used for defects measuring 7.5 mm of less. Bi- or tri-cortical iliac crest autografts or allografts or synthetic bone void filler could be used for defects larger than 7.5 mm. FIG. 15 illustrates the tibia 1102 after completion of step 1007. As shown, bone grafts 1108 have been inserted into the medial opening 1105.
FIGS. 16-22 illustrate a bone plate 200 according to another embodiment of the present invention. Bone plate 200 may be also employed in conjunction with fixation devices such as fixation device (screw) 600 described above. Bone plate 200 is similar in part to bone plate 100 in that bone plate 200 also comprises carbon fiber reinforced PEEK and is also provided with fixation apertures or holes with rounded, curved interior walls (i.e., non-threaded holes) that allow corresponding fixation devices (such as fixation screws 600, for example) to be inserted at various angles. Bone plate 200 has a more convex configuration, however, as illustrated in FIG. 18, for example, where proximal portion 210a of body plate 210 is curved inwardly to allow through hole or aperture 201 to be visible when the plate 200 is viewed from the lateral side. In this manner, bone plate 200 is designed to better accommodate the curvature of a patient's bone, while allowing the fixation devices to be inserted at different angles as described above with reference to bone plate 100.
While embodiments have been described in detail in connection with the examples known at the time, it should be readily understood that they are not limited to such disclosed embodiments. Rather, they can be modified to incorporate any number of variations, alterations, substitutions, or equivalent arrangements not heretofore described. Accordingly, it is not intended that the present invention be limited to the illustrated embodiments, but only by the appended claims.

## Claims

1. A bone plate to accommodate fixation devices inserted at various angles, the bone plate comprising:
a body with a first surface, a second surface opposed to the first surface, the body comprising carbon fiber reinforced polyetheretherketone, the body having a proximal region and a distal region, the proximal region comprising a first plurality of apertures passing through the plate, and the distal region comprising a second plurality of apertures passing through the plate, wherein each of the first and second plurality of apertures is a through hole with a longitudinal axis and comprising non-threaded, rounded and curved internal walls; and
threaded metallic fixation devices configured to be received in the first and second plurality of apertures, respectively, and inserted at a range of angles relative to the first and second plurality of apertures and non-parallel to the longitudinal axis of each through hole,
wherein the non-threaded, rounded internal walls of the first and second plurality of apertures have a uniform configuration along the longitudinal axis of each through hole, and
wherein a head portion and a threaded portion of each of the threaded fixation devices have a diameter that is larger than a diameter of each of the first and second plurality of apertures to allow the threaded metallic fixation device to deform the non-threaded, rounded internal walls of the first and second plurality of apertures upon insertion, for securing the bone plate to the bone, and
wherein the body is formed of a material softer than a material of the threaded metallic fixation devices so that, when the threaded metallic fixation devices are inserted through the first and second plurality of apertures, threads of the threaded metallic fixation devices deform and thread the non-threaded, rounded internal walls of the first and second plurality of apertures upon insertion and self-thread the through hole at an angle, to secure the bone plate to bone.

2. The bone plate of claim 1, wherein the fixation device comprises a material selected from the group consisting of titanium, titanium alloy and stainless steel.

3. The bone plate of claim 1, wherein the fixation device comprises TiAl6V4.

4. The bone plate of claim 1, wherein the fixation device comprises TiAl6V4 with about 6% aluminum and about 4% vanadium.

5. The bone plate of claim 1, wherein the internal walls are about parallel to a longitudinal axis of the body.

6. The bone plate of claim 1, wherein the fixation device is a screw, an anchor or a washer.

7. The bone plate of claim 1, wherein the body has a T-shape configuration.

8. The bone plate of claim 1, wherein the proximal region of the body has a convex configuration.

9. The bone plate assembly of claim 1, wherein the body is curved to match a curvature of a tibia.

10. The bone plate assembly of claim 1, wherein portions of the non-threaded, rounded and curved internal walls that extend from the first surface to the second surface of the body are threaded upon insertion of the threaded metallic fixation devices.

11. A bone plate assembly, comprising:
a body with a first surface, a second surface opposed to the first surface, the body having a proximal region and a distal region, at least one aperture passing through the body at either the proximal region or the distal region, the at least one aperture having a longitudinal axis and non-threaded, rounded and curved internal walls that include a length extending from the first surface to the second surface; and
at least one threaded fixation device is configured to be received in the at least one aperture, the threaded fixation device being inserted at an angle relative to the longitudinal axis of the at least one aperture,
wherein the threaded fixation device has a first diameter and the at least one aperture has a second diameter that is smaller than the first diameter, to allow the at least one threaded fixation device to deform the non-threaded, rounded and curved internal walls of the at least one aperture upon insertion, and
wherein the body is formed of a material softer than a material of the at least one threaded fixation device so that, when the at least one threaded fixation device is inserted at an angle through the at least one aperture, threads of the at least one threaded fixation device deform the non-threaded, rounded and curved internal walls of the at least one aperture to cut a threaded pattern into the non-threaded, rounded and curved internal walls, for securing the bone plate to bone, and wherein the threaded pattern extends across the curved internal walls from the first surface to the second surface of the body.

12. The bone plate assembly of claim 11, wherein the body is formed of carbon fiber reinforced polyetheretherketone and the at least one threaded fixation device is formed of titanium, titanium alloy, or stainless steel.

13. The bone plate assembly of claim 11, wherein the non-threaded, rounded and curved internal walls of the at least one aperture have a uniform configuration along the longitudinal axis of the at least one aperture.

14. The bone plate assembly of claim 11, wherein the at least one threaded fixation device is a screw, an anchor or a washer.

15. The bone plate assembly of claim 11, wherein the at least one fixation device is a TiAl6V4 screw.

16. The bone plate assembly of claim 11, wherein the at least one threaded fixation device has rounded edges.

17. The bone plate assembly of claim 11, further comprising a second aperture extending through the body at the other of either the proximal or distal regions; and a second threaded fixation device is received in the second aperture at an angle relative to a longitudinal axis of the second aperture, the angle of the second threaded fixation device being different than the angle of the at least one fixation device.

18. The bone plate assembly of claim 17, wherein a diameter of the second aperture is smaller than a diameter of the second threaded fixation device, to allow the second threaded fixation device to deform non-threaded, rounded and curved internal walls of the second aperture upon insertion therein.

19. The bone plate assembly of claim 17, wherein the second aperture extends non-symmetrically relative to the longitudinal axis of the body.

20. The bone plate assembly of claim 11, wherein the body is curved to match a curvature of a tibia.