BONE FIXATION PLATE

Abstract

A fixation plate comprising a head section for fixation to a first bone segment; a leg section extending from said head section for fixation to a second bone segment; wherein at least one of said head section and said leg section comprises at least one aperture configured to receive a screw for said fixation, and wherein said aperture is configured to receive said screw such that said screw can be inserted at varying angles.

Claims

1-40. (canceled)

41. A fixation plate comprising: a head section for fixation to a first bone segment; a leg section extending from said head section for fixation to a second bone segment; wherein at least one of said head section and said leg section comprises at least one aperture configured to receive a screw for said fixation, and wherein said aperture is configured to receive said screw such that said screw can be inserted at varying angles.

42. The fixation plate of claim 41, wherein said aperture is a threadless aperture and said aperture is made from a material that deforms to form a screw thread within said aperture upon insertion of a threaded screw into said threadless aperture.

43. The fixation plate of claim 41, wherein said aperture includes a plurality of interrupted threads, and wherein the thread interrupts are not equidistant apart.

44. The fixation plate of claim 42, wherein said material comprises a polymer.

45. The fixation plate of claim 43, wherein the plate is made from stainless steel or titanium.

46. A fixation plate comprising a head section for fixation to a first bone segment; a leg section for fixation to a second bone segment; said head section extending from a first end of the fixation plate to said leg section, and said leg section extending from said head section to a second end of the fixation plate, said leg section having lateral sides extending between said head section and said second end of the fixation plate; and wherein one of said lateral sides comprises a protrusion that protrudes laterally away from said leg section of the plate.

47. The fixation plate of claim 46 wherein said leg section extends along a first longitudinal axis L1 between said head section and said second end of the fixation plate and wherein the lateral protrusion extends along a second axis L2 that intersects the axis L1, and wherein said second axis L2 intersects said rst axis L1 at an angle of between 30-60 degrees, 40-50 degrees, and preferably 45 degrees.

48. The fixation plate of claim 46 wherein said leg section comprises at least one aperture configured for receiving a screw for fixation of said plate to said second bone segment and wherein said aperture has a center that is aligned with said first axis L1, and further comprising a second aperture that has a center that is aligned with said first axis L1.

49. The fixation plate of claim 48 wherein said leg section comprises a third aperture that comprises two overlapping circular sections to provide said third aperture with an internal shape of the figure of 8.

50. The fixation plate of claim 47 further comprising an aperture in said lateral protrusion, and wherein said aperture in said lateral protrusion has a center that is aligned with said second axis L2, and wherein said aperture in said lateral protrusion is elongated along said second axis L2.

51. A fixation plate comprising: a head section for fixation to a first bone segment; a leg section extending from said head section for fixation to a second bone segment; wherein at least one of said head section and said leg section comprises at least one aperture configured to receive a screw for said fixation.

52. The fixation plate of claim 51, wherein a screw thread is preformed in the at least one aperture.

53. The fixation plate of claim 51 wherein said head section extends along an axis L3 from a first end of said head section to a second end of said head section that from which the leg section extends.

54. The fixation plate of claim 53 wherein said head section comprises first and second apertures that each has a center point that is aligned with said axis L3.

55. The fixation plate of claim 53 wherein said axis L3 is parallel to said axis L1 and laterally offset to said axis L1.

56. The fixation plate of claim 51 wherein said leg section extends in a plane P and wherein said head section extends away from said plane P.

57. The fixation plate of claim 51 wherein said plate comprises a first side and an opposing second side and a sidewall having a thickness t1 therebetween, wherein said thickness is non-uniform across the plate.

58. The fixation plate of claim 55 wherein said second side of said plate comprises a recessed channel, and wherein in the area of said recessed channel the sidewall has a thickness t2 that is less than said thickness t1 of said plate.

59. The fixation plate of claim 51 wherein said plate is made from a polymer, and wherein said polymer is bioabsorbable.

60. The fixation plate of claim 59 wherein said plate comprises a blend of said polymer with an additive, and wherein said additive comprises biphasic calcium phosphate, said biphasic calcium phosphate comprising 70% hydroxyapatite and 30% tricalcium phosphate, and a binding agent.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Various embodiments of the present invention will now be described, by way of example only, and with reference to the drawings, in which:

[0029] FIG. 1 is a schematic front view of a bone fixation plate in accordance with the prior art and as described in U.S. Pat. No. 5,304,180;

[0030] FIG. 2 is a schematic top view of one example of a bone fixation plate in accordance with the present invention;

[0031] FIG. 3 shows two bottom views of a bone fixation plate in accordance with the present invention, showing the underside of the plate that is to be affixed to the bone;

[0032] FIG. 4 shows a side cross sectional view of a bone fixation plate in accordance with the present invention;

[0033] FIG. 5 shows a cross sectional view of the head section of a fixation plate, showing the concave underside of the head section.

[0034] FIG. 6 shows a schematic top view of another example of a bone fixation plate in accordance with the present invention.

[0035] FIG. 7 shows a bottom view of the bone fixation plate of FIG. 6.

[0036] FIG. 8 shows a side cross sectional view of the bone fixation plate of FIG. 6 in accordance with the present invention.

DETAILED DESCRIPTION

[0037] FIG. 1 is a schematic front view of a bone fixation plate in accordance with the prior art and as described and shown in U.S. Pat. No. 5,304,180.

[0038] The tibial osteotomy fixation plate 10 of U.S. Pat. No. 5,304,180 is shown spanning curvilinear cut C wherein triangular portion 12 is to be attached to the metaphysis and leg portion 14 is to be attached to the tibia using bone screws (not shown) seated in apertures 16a-f. Plate 10 is cast from surgical grade stainless steel and thus is relatively thick (approximately 5 mm) and possibly toxic. Also, the somewhat sharp transition at area 18 between triangular portion 12 and leg 14 results in a weak area in region 19.

[0039] In some embodiments, the fixation plate of the present invention may be machined out of surgical implant grade 316L stainless steel or titanium. In other embodiments, the plate may be made from a bioabsorbable blend of Poly Lacitdes specifically Poly L/D/L Lactide (PLDLA). In some embodiments, the implant may comprise the addition of further additives and in some embodiments may be a blend of PLDLA and biphasic calcium phosphate with a proprietary binding agent, with the inclusion of further additives, e.g. 60% PLDLA/40% biphasic calcium phosphate. The 40% biphasic calcium phosphate is 70% hydroxyapatite and 30% TCP. For example, in some embodiments, the blend of PLDLA may include TCP (tricalcium phosphate) which supports and stimulates bone growth. In other examples, bioglass may be added to increase the strength of the implant. In other embodiments, pharmaceuticals or other healing compounds may be added and used within the material. As the fixation plate implant is absorbed by the body the pharmaceutical will then slowly be released at the implant site. By using a bioabsorbable polymer, the implant may be at least partially absorbed into the body after the bone has healed. Such bioabsorbable polymers are also more biocompatible than metal implants and by using such materials the chance of infection is also reduced, because the surface of a bioabsorbable implant is constantly changing and so it is difficult for the bacteria to grow.

[0040] In the embodiments described herein, the screws that may be used with the fixation plate may be made from a polymer such as a bioabsorbable polymer, or may be made from a biocompatible metal, including examples such as titanium or stainless steel. Other biocompatible materials as are known in the art may also be used.

[0041] In some embodiments, the fixation plate may be made from a radiolucent material so that when x-rayed, only the bone growth would show up and not the implant itself. This would give the surgeon a clear and unobstructed view of the bone growth during healing.

[0042] One example of a fixation plate 40, in accordance with the present invention, is shown in FIG. 2 and includes two distinct sections, a head section 42 comprising apertures 44a, 44b, 44c and 44d for fixation to one bone segment (e.g. the medial segment), and a leg (or tail) section 46, extending from the head section, the leg section 46 including apertures 48a, 48b, 48c and 48d for fixation to another bone segment, e.g. distal segment (diaphysis). The fixation plate extends between a first, proximal end 60 and a second, distal end 50.

[0043] The uniquely shaped head section 42 of the present invention as described below allows the plate to be placed in multiple locations on the bone to get the desired fixation.

[0044] The head section 42 may be described as being generally square, or diamond shaped, with rounded corner edges and extends from the first end 60 of the plate to a second end 61 of the head section 42. In particular, the head section 42 extends from a first corner and first end 60 of the square or diamond at the proximal end 60 of the plate in the direction of the leg section as can be seen in FIG. 2. The head section 42 has a width w1 that initially increases with distance away from this first end 60 of the head section, in the direction of the leg section 46. The width w1 then reaches a maximum distance e.g. 18-25 mm at the approximate middle of the head section 42 (i.e. the middle of the square or diamond) before it begins to gradually decrease again in the direction of the second end 61 of the head section, as shown in FIG. 2. The head section 42 can be seen in FIG. 2 as gradually tapering at its second end 61 to smoothly join a first end 51 of the leg section 46, as shown in FIG. 2, from where the leg section begins.

[0045] The leg section of the fixation plate also has and extends between a first end 51 (which is joined to the second end of the head section 42) and a second end 50, which corresponds to the second, distal end 50 of the plate itself. The leg section can be seen as being asymmetrical in that, as it extends from the head section towards the distal end, it has a lateral protrusion 54 on one side 53, whereas the other lateral side 52 does not have this protrusion. For example, one lateral side 52 of the leg section (shown as being on the right hand side of FIG. 2) extends linearly from the first end 51 of the leg section 46 (and also away from the head section 42) in the direction of the second, distal end 50 of the leg section and terminates by smoothly tapering to form the distal rounded end 50 of the fixation plate. The other opposing, lateral side 53 of the leg section does not extend linearly from the head section, but instead comprises a protrusion 54 that extends laterally away from the first end 51 of the main body of the leg section 46 as shown in FIG. 2.

[0046] This protrusion therefore helps to provide the bone fixation plate 40 with an anatomically pre-contoured shape, to thereby closely fit the bone surface to which it is applied and to reduce the amount of bending prior to fixation. This detail goes towards the center of the tibia and allows the surgeon to take advantage of a lot of bone stock when placing that screw.

[0047] As mentioned above, and as can be seen in FIG. 2, the bone fixation plate has a first end 60 and an opposite second end 50. A first longitudinal axis L1 extends from the center of the distal second end 50 of the fixation plate and along the length of the main body of the leg section 46. The leg section further comprises means for fixing the leg section to a bone. In the example shown in FIG. 2, the means for fixing the plate to the bone comprise apertures that are configured to receive locking or fixing means such as screws. The example shown in FIG. 2 comprises four apertures in the leg section. Two of the apertures 48b and 48c of the leg section 46 may be generally circular in shape and can be seen in FIG. 2 as being positioned so that so that the center points of these apertures both lie on this first longitudinal axis L1. All of the apertures can accept a locking screw or a standard non locking screw.

[0048] As can be seen in FIG. 2, a third aperture 48a is positioned closer to the head section than the apertures 48b and 48c. This aperture 48a of the leg section of the implant may be shaped so as to comprise a first circular section 62 and an overlapping second circular section 63. The second section 63 in this example is smaller than the first section 62 to facilitate use with a locking screw of a non-locking screw. The first, larger section is for a locking screw as, generally, locking screws have a larger head; the smaller second section is for a standard non-locking screw which has a smaller head. The second section is closest to the aperture 48b. Both sections 62 and 63 comprise circular apertures that overlap to result in the overall aperture 48a having an elongated shape that comprises an aperture having a figure of 8 internal shape, as shown in FIG. 2. This feature of the invention provides a combination aperture which may be used for either compression, or for locking/fixing, but not both at the same time, as described below. This feature also allows a screw to be placed more cranially which is central to the long axis of the tibia and a much better place to put a screw. The compression aperture in this section is at 45 degrees to the long axis of the plate so that compression can be put on the cut at two locations 45 degrees from each other. This gives more uniform compression across the radial cut. The center point of this combination aperture 48a is also aligned with the axis L1 and the two circular sections may be overlapped so that the overall aperture is therefore elongated along the axis L1, as shown in FIG. 2.

[0049] The minimum and maximum spacing between any two apertures 48a-48c in the main body of the leg section 46 may be, respectively, 7 mm and 12 mm.

[0050] The fourth aperture 48d of the leg section 46 of the plate is not aligned on the same longitudinal axis L1 as the other apertures of the leg section but instead is offset laterally to the main body of the leg section and the axis L1 as shown in FIG. 2. Specifically, the fourth aperture 48d of the leg section is positioned within the lateral protrusion 54, as described above. This laterally offset protrusion and therefore aperture 48d of the leg section is correctly placed to take advantage of a large portion of bone on the medial side of the bone to which the plate is being fixed. This aperture is offset to the other holes in the leg section, or tail of the implant. All other implants used in this procedure up until now only have the holes in the leg section aligned. Many times, however, the screws are placed and they are too close to the caudal aspect of the tibia with a concern that they might fracture out.

[0051] The lateral protrusion 54 extends away from the main body of the leg section along a second axis L2, as shown in FIG. 2. The fourth aperture 48d of the leg section 46 may be circular but in some embodiments may be elongated (as shown in FIG. 2) with the elongation also extending along a second axis L2. This second axis L2 extends at an angle to said first axis L1 and so that it intersects the first axis L1 at point 70 at an angle of between 30-60 degrees, 40-50 degrees, and preferably 45 degrees. In some embodiments, the fourth, elongated aperture 48d of the leg section of the plate may have at least one beveled end and/or beveled sides.

[0052] Circular apertures 48a-c in leg section 46 may also be beveled evenly around their circumferences. For strength, the minimum spacing between any two adjacent apertures in head section 42 may be 8 mm.

[0053] As can also be seen in FIG. 2, the head section 42 also has means for fixing the plate to a bone, which comprise apertures 44a-44c that are configured to receive fixing, or locking means, such as screws. Although the centers of the apertures 48a, 48b and 48c of the leg section 46 are aligned with each other on the first axis L1, their centers are not aligned with the center points of the apertures 44a, 44b, 44c and 44d of the head section. This offset puts the tail more cranial and closer to the long axis of the tibia. This allows the surgeon to place the plate as caudal as possible above the cut at the same time keeping the tail more cranial below the cut.

[0054] The center points of two of the apertures 44a and 44c of the head section that are closest to the first 60 and second end 61 of the head section are aligned on a further longitudinal axis L3 that is parallel to the axis L1, but which is slightly offset laterally in the opposite direction to the lateral protrusion 54 by e.g. 1-3 mm. This longitudinal axis L3 extends from the furthermost tip 60 of the first end of the fixation plate in the direction of the leg section. The center points of the apertures 44b and 44d which are at the widest parts of the head section are aligned on a fourth axis L4 which is perpendicular to both L1 and L3.

[0055] The center axis L3 of the apertures in the head section of the plate converge and would intersect at approximately 70 mm away. This ensures that the screw ends do not collide with any other screw end inside the bone or 2-5 mm outside the far side of the bone. If they were to collide in the bone they would not be able to be fully seated. The converging apertures increase the holding power of the implant so that if the implant was pulled off the bone, the material between the screws would need to break out, which would require more force than is possible to apply. Because the screw heads lock into the plate they cannot change their angle in the plate once fully seated. Standard non locking screws can change their angle if a load was applied to the implant (because they do not lock). Therefore, when using locking screws that have their heads fixed inside the plate, the loads required to get the plate to be pulled off the bone are significantly higher.

[0056] All of the apertures of the fixation plates described herein, except for the elongated aperture 48d in the protruding part of the leg section of the plate, may be used for fixing or locking the implant into position on the bone. The aperture 48d in the protruding section of the leg section, however, is intended to be used for compression.

[0057] Compression may be necessary or useful in some cases to push the two segments of bone together.

[0058] The aperture 48a of the leg section is a combination aperture in that it may be used for either locking (e.g. when the screw is inserted into the section 63), or for compression (when the screw is inserted into the section 62). Due to the fact that these individual circular sections overlap to form one elongated aperture makes it is impossible for the surgeon to insert both a locking and compression screw into this location at the same time. By applying compression along two axes that are 45 degrees apart, a more uniform compression is provided across the entire cut line. The aperture combining a locking and a non-locking screw allows the surgeon to choose to apply more compression or not.

[0059] In some embodiments of the invention, the aperture 48d provided in the lateral protrusion of the leg section may be angled so that compression is applied at a different angle than compression applied via section 62 of the aperture 48a. This gives a more uniform compression across the cut in the bone than if just one point of compression is used.

[0060] The fixation plates described herein have a first surface 80 which is the uppermost surface in use, and an opposing surface 81 which is generally facing the bone and so in contact with the bone when in use (i.e. fixed in place on the bone). A side wall 82 extends there between which dictates the thickness t1 of the implant. Some examples of plate thickness are set out in the table below.

TABLE-US-00001 Plate size/dim Thickness Length Width 1 Width 2 2.4 mm 2.5 30 15 17 2.7 mm 3.0 35 20 22 3.5 mm 3.5 46.5 24 27 3.5 mm big 4.0 80.00 25 28

[0061] In any of the embodiments described herein, the fixation implant may further comprise sections of reduced thickness t2. As can be seen in FIG. 3, this may be achieved by providing recessed channels 83 or scollops in one of the sides 80, 81 of the implant. The recessed channels are preferably provided in the second, underside 81 of the fixation plate (i.e. that which is facing the bone when the implant is attached thereto). In some examples, these recessed channels 83 in the underside 81 of the implant may extend all the way across the entire width of the base and/or leg section. For example, the recessed channel(s) may extend from a first lateral side 52 of the leg section of the implant to the second lateral side 53 of the leg section of the implant.

[0062] An advantage of providing these recessed channels 83 on the underside 81 of the implant is that it helps to reduce the amount of contact that the underside of the implant has with the bone when the plate is fixed in place. A further advantage of the fixation plate having these recessed channels 83 is that any bending forces that may be being applied to the implant would be concentrated at these areas of reduced thickness, instead of being concentrated in areas of the implant that would normally be subject to bending force, such as at the apertures containing the locking screws. This helps to reduce loosening or possible fracture of the screws and/or apertures. The recessed channels under the plate are placed between the apertures so that if the plate is further contoured all bending will occur there instead of through the screw holes.

[0063] The implants described herein may also be shaped so as to have a non-uniform cross-sectional profile, as shown in FIG. 4. For example, in some embodiments, the main body of the leg section of the implant (i.e. containing the apertures 48a-48c) may have a generally uniform linear cross section or profile that extends in a first plane P. In some embodiments, however, the head section 42 may extend away from this plane at an angle such as shown in FIG. 4. In FIG. 4 the head section extends in the upper direction (e.g. away from the bone) away from the leg section at an angle of 15 degrees to the plane P of the leg section 46, however, other angles within the range of e.g. 12-20 degrees may also be used.

[0064] The upper 80 and lower surface 81 of the head section 42 may also be curved, so that the upper surface 80 of the head section is convex whereas the lower surface 81 of the head section is concave, as shown in FIG. 5. Angles of curvature may be in the range of 18-28 mm depending on the size plate and the size patient. Due to fact that the head section has a curved profile with a convex upper surface and concave lower surface, the angles of the apertures 44a-44c in the head section of the plate may be set at particular angles that make it then impossible for the surgeon to place a screw into the aperture that would enter the joint. For example, the aperture angles may be 94 degrees for aperture 44a, 86 degrees for aperture 44b and 82 degrees for aperture 44c.

[0065] The profile of the protruding section 54 of the leg section may also extend and curve away from this plane P of the leg section as shown in FIG. 4. In particular, the protruding section 54 of the leg section may extend away from the plane P at an angle of 18-28 mm in the opposite direction to the head section, i.e. in the downward direction, towards the bone.

[0066] FIGS. 6-8 show an alternative example to the fixation plate shown in FIGS. 2-5. FIG. 6 shows a top view of the fixation plate of this alternative example. The fixation plate has the same geometry as the fixation plate shown in FIGS. 2-5, but includes only three apertures 44a, 44b, 44d in the head section 42. Further, the fixation plate shown in FIGS. 6-8 does not include the protrusion portion 54 of FIGS. 2-5. In this example, the leg section can be seen as being symmetrical and the lateral sides 52 and 53 extend linearly from the first end 51 of the leg section (and also away from the head section 42) in the direction of the second, distal end 50. In the example shown in FIGS. 6-8, the fixation plate may be made from a bioabsorbable material or a biocompatible metal, as described above in relation to FIGS. 2-5. In particular, it has been found that stainless steel has been an optimal material for the configuration in FIGS. 6-8.

[0067] Fixation plates such as these, having this non-uniform cross sectional profile more closely fit the contour of the bone to which they are affixed.

[0068] In embodiments wherein at least the apertures of the plate are made from a polymer, the apertures provided in the plates described herein may or may not be pre-threaded. A feature of some of the embodiments described herein is that the screws may be self-locking. In other words, in some embodiments, the apertures may comprise no threads and the screws may be provided with a screw thread which may then self-tap into the apertures of the plate, thereby forming the screw threads in the polymer plate as they are inserted.

[0069] By providing a plate that has apertures containing no pre-formed screw threads, the plate thereby allows the surgeon to place the screw at whatever angle is necessary and/or appropriate for that particular application. Fixation plates having at least the inner surface of the apertures made from polymers such as poly lactides, specifically poly LDL lactides (PLDLA) allow for this self-tapping feature, as the material is soft enough for the screw threads to be formed in the apertures upon insertion of a screw. In some embodiments, only the inner surface of the apertures need to be made from this deformable material. In other embodiments, the entire implant may be made from this material

[0070] In contrast to this, fixation plates which have apertures that have threads pre-formed therein (e.g. for stainless steel or titanium plates) only allow for a screw to be inserted at a predetermined angle. In some cases, the predetermined angle is not necessarily the desired angle but the surgeon has no choice.

[0071] In some embodiments, wherein the plate is made from a material such as poly LDL lactides the fixation plate may contain no pre-formed apertures at all and the apertures as described above may be replaced by dents or markers on the plate to indicate to the surgeon where to insert the fixing or locking means (e.g. screws). The surgeon can then simply insert the screws into the bone plate at the appropriate place and appropriate angle. The advantages of the plate having only dents or markers are that the anatomy and surgeon's desire is often different than the basic anatomy. This would allow the surgeon to choose which angle is best and which direction to place the screw based on the patient's anatomy and fracture.

[0072] In some embodiments, wherein the fixation plate is made from a metal, specifically designed locking screws may be used in conjunction with the plate which allow the screws to be put into the plate with a plurality of degrees of freedom. The holes in the plate are set at specific angles so that the surgeon can simply use those if that is desired. If the surgeon would then like to alter the angle, they can do so by a plurality of degrees in any direction. This is achieved by the screws comprising a plurality of interrupted threads. In one example, the screw comprises four sets of interrupted threads. This allows them to enter the apertures of the fixation plate by 15 degrees in any direction. By having the interrupts in the threads on the head, the screw thread has 4 starting positions (4 interrupts). With these multiple starting positions the screw threads can enter the plate at four different angles or locations allowing the screw to be placed at multiple angles.

[0073] In other embodiments, wherein the fixation plate is made from a metal, the apertures of the fixation plate may include a plurality of interrupted threads. The interrupted threads in the apertures allow for the surgeon to insert a screw into the plate with a plurality of degrees of freedom. In one example, the aperture comprises four sets of interrupted threads. This allows for the screw to enter the apertures of the fixation plate by 15 degrees in any direction. Preferably, the interrupts are not equidistant apart from each other.

[0074] The fixation plates are preferably made in four different sizes e.g. 2.4 mm, 2.7 mm, 3.5 mm and 3.5 mm big. Smaller sizes may also be used and mirror images of the plates may also be made (e.g. with the protrusion on the opposite to that shown in FIG. 2. The bone fixation plates described herein may, however, be scaled to fit any size dog by increasing the appropriate dimensions. Important dimensions would be overall length (L), thickness (T), width of head (W1) and width of head to laterally protruded section (W2). The sizes of each are based on historical data of patient size.

[0075] In some embodiments, the surface of the plates may comprise a mark which provides an indication of the preferred location of the implant over the bone. In some embodiments, wherein the plate is made from metal, the mark may be machined onto the surface of the plate.

[0076] Preferred materials for the plate are polymer, titanium and stainless steel. In an embodiment using stainless steel the plate may not have the protruding nose and may only have 3 holes in the base (head section) (44a, 44b and 44d) all the angles and geometry are the same as for the above example.

[0077] In a preferred embodiment, hole 44d is placed 2-3 mm higher than hole 44b. This is done to make sure the hole stays above the radial cut. The radial cut is going up so the hole needs to go up.

[0078] The fixation plates described herein therefore provide improved bone fixation and may be useful in tibial osteotomy and other procedures. The fixation plate of this invention is thinner, lightweight, and strong and is better contoured to the shape of the bone to which it is attached.

[0079] Any of the features of the implants described herein may be used in combination with any or all of the other features.