Patent Grant
10905480
The present invention relates to a bone plate and a bone plate system.
Heretofore, in order to fix bone fractures and osteotomy sites and to accelerate healing and joining of bones, a bone plate system that includes a bone plate and screws for fixing the bone plate to the bone has been used (for example, see PTL 1).
Such a bone plate system is, for example, used in high tibial osteotomy (HTO) to treat knee osteoarthritis. High tibial osteotomy is a surgical procedure that involves cutting a patient's own bone to induce a slight angular change so as to change the direction of the load, which is biased toward the medial side due to a varus deformity, to the lateral side and correct the alignment.
There are several types of high tibial osteotomy: an open wedge HTO technique that involves incising a bone from the medial side to the lateral side of the tibia, expanding the incision, and inserting a trapezoidal or wedge-shaped artificial bone or the like thereinto so as to carry out angular correction, and a closed wedge HTO technique that involves cutting out a wedge-shaped block from the bone, from the lateral side of the tibia, so as to shorten the bone and carry out angular correction.
In recent years, a procedure called hybrid HTO that has the advantages of both the open wedge technique and the closed wedge technique has been performed to treat advanced medial osteoarthritis cases involving large correction angles or accompanied by osteoarthritis in the patella or femoral joint.
International Publication No. 2015/146866 discloses a bone plate system used in the open wedge technique.
Furthermore, Japanese Patent Publication No. 4368560 discloses a bone plate system used to mend and fix fractured segments in the case of fracture of a long bone, such as the femur or tibia. In the bone plate system described in Japanese Patent Publication No. 4368560, when the bone plate is fixed to an epiphyseal region with screws, the axis directions of the screws can be changed by turning the screws.
An object of the present invention is to provide a bone plate and a bone plate system that have an optimized structure in view of conformance to the corrected tibial shape after hybrid HTO.
According to one aspect of the present invention, there is provided a bone plate comprising: a strip-shaped body portion to be fixed to a portion of the lateral surface of the tibia below an osteotomy surface formed in the lateral surface of the tibia, the body portion extending along a longitudinal direction of the tibia; a wide portion wider than the body portion and to be fixed along an outer peripheral surface of the head of the tibia at a higher position than the osteotomy surface; a connecting portion that connects the body portion and the wide portion; and a plurality of screw holes arrayed in the wide portion, the body portion, and the connecting portion with spaces between one another and penetrate therethrough in a plate thickness direction, wherein an inner surface that extends from the wide portion to the connecting portion and faces the tibia has a curved shape that substantially fits a three-dimensional contour of the tibia in a continuous manner while being twisted about an axis along the longitudinal direction of the tibia, the wide portion is offset in an outward plate thickness direction with respect to the body portion, and when the bone plate is attached to the tibia, a curvature of a side surface of the connecting portion that follows the posterior surface of the tibia is larger than a curvature of a side surface of the connecting portion that follows the anterior surface of the tibia.
In the aspect described above, the plurality of screw holes may include a plurality of first screw holes formed in the wide portion with spaces between one another, and a plurality of second screw holes formed in the connecting portion with spaces between one another, and a first axis, which is an axis of one of the plurality of the first screw holes that is located at a tibial posterior surface-side position when the bone plate is attached to the tibia, and a second axis, which is an axis of one of the plurality of the second screw holes that is located at a tibial anterior surface-side position when the bone plate is attached to the tibia, may lie along substantially the same plane.
In the aspect described above, an angle formed between a straight line connecting an upper end portion and lower end portion of the bone plate in the longitudinal direction and a first plane that includes a straight line that defines an arraying direction of the plurality of first screw holes and an axis direction of the first screw holes may be 80° or more and 90° or less.
In the aspect described above, an offset amount of the offset may be 15 mm or more and 25 mm or less.
In the aspect described above, a total length in the longitudinal direction may be 100 mm or more and 120 mm or less and preferably 95 mm or more and 105 mm or less.
According to another aspect of the present invention, there is provided a bone plate system comprising: any of the bone plates described above and a plurality of screws to be respectively fastened to the plurality of screw holes in the bone plate so as to fix the bone plate to the tibia.
In the aspect described above, the bone plate may have a plate thickness of 3±1 mm, and the bone plate system may be configured such that, in a state in which the bone plate is fastened with the plurality of screws, an amount of deflection of the bone plate when a vertical load is applied in a longitudinal axis direction of the bone plate is 0.5 mm±0.3 mm/kgf.
In the aspect described above, the bone plate and the screws may contain a highly biocompatible material.
In the aspect described above, the screws may be hollow screws each having a through hole through which a guide pin can pass, a thread diameter of the screws may be ϕ5.0 mm or more and 5.8 mm or less, a root diameter may be ϕ4.5 mm or more and 5.3 mm or less, and a hollow shaft diameter of the hollow screws may be ϕ1.8 mm or more and 2.8 mm or less.
A bone plate 1 and a bone plate system 2 according to one embodiment of the present invention will now be described with reference to the drawings.
As illustrated in
The bone plate 1 of this embodiment is used in a so-called hybrid HTO that has advantages of both the open wedge technique and the closed wedge technique performed to treat advanced medial osteoarthritis involving large correction angles or accompanied by osteoarthritis in the patella or femoral joint, and is an elongated strip-shaped component to be fixed to a high position of the lateral surface of the tibia X after the osteotomy.
As illustrated in
The body portion 1a is formed to have a strip shape so as to follow a lower position of the lateral surface of the tibia X. In addition, as illustrated in
Furthermore, as illustrated in
As illustrated in
As illustrated in
As illustrated in
Furthermore, as illustrated in
The effects of the bone plate 1 and the bone plate system 2 of this embodiment having the above-described structures are described below.
In order to perform high tibial osteotomy for knee osteoarthritis by the hybrid HTO technique using the bone plate system 2 of this embodiment, an incision is formed from a high position of the lateral surface of the tibia X toward the medial side in a direction oblique with respect to the longitudinal axis of the tibia X so as to form a first osteotomy surface, and then another incision is formed from the lateral surface of the tibia X at a position remote from the osteotomy surface in the longitudinal axis direction toward the medial side so as to form a second osteotomy surface, and then a wedge-shaped bony block between the first osteotomy surface and the second osteotomy surface is removed with a particular tool. Then, the first osteotomy surface and the second osteotomy surface are brought together to close the wedge so as to turn the axis direction of the tibia outward, and subsequently, the bone plate 1 is placed along a transition portion of the lateral surface of the tibia X between the shaft portion and the end portion, and is fixed thereat. Specifically, as illustrated in
Subsequently, the screws 3 are passed from the lateral side toward the medial side in the plate thickness direction through the screw holes 4 in the bone plate 1 and are fastened to the tibia X. As a result, the tibia X, after correction by osteotomy, can support a vertical load through the bone plate 1 bridging the incision and fixed with the screws 3.
The screws 3b inserted into the screw holes 4b in the wide portion 1b are fastened so as to lie on a plane substantially parallel to the tibial articular surface. Thus, the bone plate can be fixed while preventing the tips of screws 3b from being directed toward the tibial articular surface. Moreover, since the tips of the screws 3b can be directed toward a thick portion of the tibia X with a high bone density, the fixability can be improved while maintaining the integrity of the cancellous bone even under poor fixing conditions and degraded bone quality caused by osteoporosis etc.
The bone plate 1 of this embodiment is formed so that the curvature of the side surface of the connecting portion 1c on the side that follows the posterior surface of the tibia X (
Furthermore, the threading angles of the respective screw holes are set so that axis A of the screw 3b fastened to the screw hole 4b, which is one of the screw holes 4b formed in the wide portion 1b on the side where the side surface curvature is large, and axis B of the screw 3c fastened to the screw hole 4c, which is one of the screw holes 4c formed in the connecting portion 1c on the side where the side surface curvature is large, lie on substantially the same plane; thus, the screws can be placed closer to one another in a direction orthogonal to the direction in which the screws 3 extend, the number of engaging threads can be increased, and thus a more secure fixation is made possible. In addition, when the bone plate 1 is fastened and fixed to the tibia with the screws 3, the tips of the screws 3 can be accurately delivered to a posterior portion of the tibia X where the bone density of the tibia X is high; thus, the fixability of the bone plate 1 to the tibia X can be enhanced.
As illustrated in
Furthermore, the fittability of the bone plate 1 to the tibia X can be enhanced while preventing interference between the tips of the screws 3c inserted into the screw holes 4c in the connecting portion 1c and the tips of the screws 3b inserted into the screw holes 4b in the wide portion 1b.
In this embodiment, as illustrated in
The total length of the bone plate 1 in the longitudinal direction is set to 100 mm or more and 120 mm or less and preferably to 95 mm or more and 105 mm or less so that the bone plate 1 can closely follow the lateral surface of the tibia X despite the differences in the correction amount and the length of the tibia X attributable to differences in patient physical builds.
Stress shielding (the phenomenon in which the load is not smoothly exerted on the bone) of the tibia X under correction with the bone plate 1 attached thereto can be suppressed if a design is implemented such that the amount of deflection of the bone plate 1 when a vertical load W (the arrow direction indicated in
The bone plate 1 and the screws 3 are formed of a metal material having a high biocompatibility. Such a material has a relatively high safety to the human body even when it is installed in the human body.
The optimum biocompatible material used in the bone plate 1 and the screws 3 is a titanium alloy, which can maintain sufficient strength and elasticity over a long term. Naturally, the biocompatible material is not limited to titanium alloys, and other materials, such as cobalt chromium alloys, stainless steel, etc., can also be used.
As illustrated in
The screws 3 of this embodiment are designed to have a diameter such that even when the screws 3 are fastened and fixed to the tibia X for a long time, the screws 3 sufficiently absorb the load in the vertical direction and remain unbroken. Moreover, by setting the diameters within these ranges, for example, in the epiphyseal region, the bone enters tip portions of the hollow holes, and thus the fixability can be improved.
Furthermore, since the diameters of the screws 3 are not excessively large, adverse effects caused by screw holes in the cancellous bone of the tibia X after removal of the bone plate 1 can be minimized.
Furthermore, since the screws 3 of this embodiment have through holes 6 through which the guide pins 5 can pass, the screws 3 can be fastened by using the through holes 6 in the screws 3 and the guide pins 5 as guides, and thus the operational ease of the fastening operation can be improved.
As a result, the following aspect is read from the above described embodiment of the present invention.
According to one aspect of the present invention, there is provided a bone plate comprising: a strip-shaped body portion to be fixed to a portion of the lateral surface of the tibia below an osteotomy surface formed in the lateral surface of the tibia, the body portion extending along a longitudinal direction of the tibia; a wide portion wider than the body portion and to be fixed along an outer peripheral surface of the head of the tibia at a higher position than the osteotomy surface; a connecting portion that connects the body portion and the wide portion; and a plurality of screw holes arrayed in the wide portion, the body portion, and the connecting portion with spaces between one another and penetrate therethrough in a plate thickness direction, wherein an inner surface that extends from the wide portion to the connecting portion and faces the tibia has a curved shape that substantially fits a three-dimensional contour of the tibia in a continuous manner while being twisted about an axis along the longitudinal direction of the tibia, the wide portion is offset in an outward plate thickness direction with respect to the body portion, and when the bone plate is attached to the tibia, a curvature of a side surface of the connecting portion that follows the posterior surface of the tibia is larger than a curvature of a side surface of the connecting portion that follows the anterior surface of the tibia.
According to the aspect described above, since the inner surface of the bone plate facing the tibia has a curved shape that substantially fits the three-dimensional contour of the tibia after hybrid HTO, the bone plate can be placed to follow the shape of the side surface of the tibia after the surgery.
Since the bone plate is designed for hybrid HTO, there is no need to preoperatively perform bending, sterilization treatment, etc., on the bone plate for fracture fixation, and preoperative preparation can be carried out easily.
Furthermore, since the curvature of the side surface of the connecting portion that follows the posterior surface of the tibia when the bone plate is attached to the tibia is larger than the curvature of the side surface of the connecting portion that follows the anterior surface of the tibia, the screws can be brought closer to one another in a direction orthogonal to the direction of the screws, and the number of engaging threads can be increased so as to enable more secure fixation. In addition, the tips of the screws inserted into the screw holes in the connecting portion can be assuredly delivered to the posterior portion of the tibia where the bone density of the tibia is large. As a result, even the portions that do not receive support from the osteotomy surface can be securely fixed.
In the aspect described above, the plurality of screw holes may include a plurality of first screw holes formed in the wide portion with spaces between one another, and a plurality of second screw holes formed in the connecting portion with spaces between one another, and a first axis, which is an axis of one of the plurality of the first screw holes that is located at a tibial posterior surface-side position when the bone plate is attached to the tibia, and a second axis, which is an axis of one of the plurality of the second screw holes that is located at a tibial anterior surface-side position when the bone plate is attached to the tibia, may lie along substantially the same plane.
In this manner, when the screws are inserted into the screw holes in the bone plate and fastened and fixed to the tibia, the tips of the screws can be accurately delivered to a posterior portion of the tibia where the bone density of the tibia is high. Thus, the fixability of the bone plate to the tibia can be enhanced. Moreover, even when a load is exerted in the vertical direction, the osteotomy surface of the tibia does not immediately receive the torque, and stable fixation can be achieved.
In the aspect described above, an angle formed between a straight line connecting an upper end portion and lower end portion of the bone plate in the longitudinal direction and a first plane that includes a straight line that defines an arraying direction of the plurality of first screw holes and an axis direction of the first screw holes may be 80° or more and 90° or less.
In this manner, the bone plate can closely follow the lateral surface of the tibia after correction despite the differences in the correction amount and the length of the tibia attributable to differences in patient physical builds.
Moreover, the screws can be inserted into the optimum range in which the articular surface remains unpierced and interference with artificial bones and defective parts of the bones is avoided.
In the aspect described above, an offset amount of the offset may be 15 mm or more and 25 mm or less.
In this manner, the bone plate can be placed to closely follow the lateral surface of the tibia after correction.
Moreover, the fittability of the bone plate to the tibia can be enhanced while preventing interreference between the tips of the screws inserted into the connecting portion and the tips of the screws inserted into the wide portion.
In the aspect described above, a total length in the longitudinal direction may be 100 mm or more and 120 mm or less and preferably 95 mm or more and 105 mm or less.
In this manner, the bone plate can be placed to appropriately fit the lateral surface of the tibia after the hybrid HTO is performed, despite the differences in the correction amount and the length of the tibia attributable to differences in the patient physical builds. In addition, since the bone plate is set within such dimensional ranges, the screws can be fastened in appropriate directions and at appropriate positions.
According to another aspect of the present invention, there is provided a bone plate system comprising: any of the bone plates described above and a plurality of screws to be respectively fastened to the plurality of screw holes in the bone plate so as to fix the bone plate to the tibia.
According to this aspect, since the inner surface of the bone plate facing the tibia has a curved shape that substantially fits the three-dimensional contour of the tibia after the hybrid HTO, the bone plate can be placed to follow the shape of the side surface of the tibia after the surgery. Moreover, since the screws inserted into the screw holes in the bone plate are fastened so that the tips thereof are placed under the tibial articular surface, the screws can be fastened to a portion having a high bone density while avoiding piercing of the tibial articular surface.
Moreover, since the bone plate is designed not to project outward with respect to the head of the tibia, pain caused by a projecting bone plate stimulating the skin can be avoided.
In the aspect described above, the bone plate may have a plate thickness of 3±1 mm, and the bone plate system may be configured such that, in a state in which the bone plate is fastened with the plurality of screws, an amount of deflection of the bone plate when a vertical load is applied in a longitudinal axis direction of the bone plate is 0.5 mm±0.3 mm/kgf.
Since the amount of deflection of the bone plate is adjusted as such, stress shielding (the phenomenon in which the load is not smoothly exerted on the bone) of the tibia with the bone plate attached thereto can be suppressed.
In the aspect described above, the bone plate and the screws may contain a highly biocompatible material.
In this manner, an implant made of a highly biocompatible material having a sufficient strength and elasticity can be configured.
In the aspect described above, the screws may be hollow screws each having a through hole through which a guide pin can pass, a thread diameter of the screws may be ϕ5.0 mm or more and 5.8 mm or less, a root diameter may be ϕ4.5 mm or more and 5.3 mm or less, and a hollow shaft diameter of the hollow screws may be ϕ1.8 mm or more and 2.8 mm or less.
According to this aspect, the diameters are designed so that even when the bone plate is screwed to the tibia for a long time spanning years, the screws sufficiently absorb the load in the vertical direction and remain unbroken. By setting the diameters within these ranges, for example, in the epiphyseal region, the bone enters tip portions of the hollow holes, and thus the fixability can be improved.
Moreover, adverse effects caused by screw holes in the tibial cancellous bone after removal of the bone plate can be minimized.
Since the inner surface of the bone plate extending from the wide portion to the connecting portion has a twisted continuous curved shape, the screw fastening directions are not uniform, and errors are likely to occur regarding the screw fixing directions. However, according to the aspect described above, the screws have through holes through which guide pins can pass, and thus, the screws can be fastened by using the through holes in the screws and guide pins as the guides. Thus, the operational ease of the fastening operation can be improved.
This is a continuation of International Application PCT/JP2016/065960, with an international filing date of May 31, 2016, which is hereby incorporated by reference herein in its entirety.
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| Number | Date | Country | |
|---|---|---|---|
| 20190090921 A1 | Mar 2019 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/JP2016/065960 | May 2016 | US |
| Child | 16200760 | US |
