A high lateral tibial closed osteotomy internal fixation device and a preparation method thereof

Abstract

The embodiment of the present invention discloses a high lateral closed tibial osteotomy internal fixation device, including a steel plate and a locking mechanism, wherein the steel plate includes a plate body and an inward-angled head, so that the convex surface of the steel plate at the bend fits the change of the tibial curvature, and the locking mechanism includes a fixing screw and a locking piece, wherein the fixing screw is a self-tapping screw, and the locking piece is arranged in a fixing hole provided in the steel plate to form an inner five-star locking adjustment hole, and a locking piece is arranged in a manner that the angle can be adjusted to be inserted into the locking hole formed between the locking piece and the steel plate to lock the fixing screw. The present invention also discloses a method for preparing a fixing device, including separately preparing a steel plate and a fixing screw. The present invention improves the original Link condylar steel plate, utilizes the inward-angled head to make the steel plate fit the change of the tibial curvature, and through the cooperation of the self-tapping screw and the locking piece, the driving angle of the fixing screw can be adjusted to fully fix the bone, while reducing the tapping steps and avoiding skin cutting damage in the tapping steps.

Description

Technical Field

[0001] The embodiments of the present invention relate to the technical field of orthopedic medical devices, and in particular to a high lateral tibial closed osteotomy internal fixation device and a preparation method thereof. Background Art

[0002] High tibial osteotomy is a common method for treating knee osteoarthritis, and is mainly suitable for patients with varus-type knee osteoarthritis. The internal fixation method currently used in clinical practice is to use the condylar plate system produced by Link Company of Germany, which uses the Link condylar plate with a right-angle L-shaped design. After the plate is placed in the human tibia, it is driven into the proximal part of the tibial osteotomy.

[0003] However, through years of clinical experience, it is found that the system has the following problems and shortcomings:

[0004] 1. The original Link condylar plate is designed in a right-angle L-shape. After the plate is placed in the human tibia, the tail end of the plate cannot completely fit the tibia bone, causing the local soft tissue to be obviously propped up, the appearance is bloated and unsightly, and there is a local friction feeling when wearing tight clothes;

[0005] 2. The original Link condylar plate was designed for Europeans, who have large bones, so the plate size is larger, and the length of each model differs by 1 cm. However, Chinese people have relatively small bones, and most patients with genu varum are women, whose bones are even smaller. The original plate size is generally larger, and the span between adjacent specifications is large, which is inconvenient for clinical use;

[0006] 3. The original Link condylar plate fixing holes are ordinary holes with average fixing effects. The adjustment range of the screws after they are screwed into the holes is limited. There is a problem that the rear screws cannot be fully fixed to the bone at the maximum adjustment angle, which affects the fixing strength.

[0007] 4. During the insertion and removal of the original steel plate, the holder is too large, which is inconvenient to operate and has high requirements for the surgical incision. The surgical incision needs to be longer than the required length of the surgery itself, which increases the scope of trauma;

[0008] 5. The original Link plate system is equipped with ordinary screws, which require drilling and tapping during surgery. The operation steps are redundant and it is easy to cause cutting damage to the incision skin during the tapping process.

[0009] 6. The original Link condylar plate has a large screw length span, and it is often difficult to select the correct screw length after intraoperative depth measurement. Summary of the invention

[0010] To this end, an embodiment of the present invention provides a high lateral tibial closed osteotomy internal fixation device and a preparation method thereof, so as to solve the problem of difficult fixation of the Link condylar plate system in the prior art during high lateral tibial closed osteotomy internal fixation.

[0011] In order to achieve the above purpose, the embodiment of the present invention provides the following technical solutions:

[0012] According to a first aspect of an embodiment of the present invention, a high lateral tibial closed osteotomy internal fixation device comprises:

[0013] A steel plate, the steel plate comprising an integrally formed plate body and a head, wherein the connecting position of the plate body and the head is bent, wherein the head is angled inward so that the convex surface of the bent portion of the steel plate fits the curvature change of the tibia;

[0014] A locking mechanism, the locking mechanism includes a fixing screw and a locking piece, two laterally arranged fixing holes are provided on the head of the steel plate, and two fixing screws are arranged corresponding to the two fixing holes one by one, the locking piece is arranged in the fixing hole, and the locking piece is an annular structure with both the outer contour and the inner contour of the ring being a five-pointed star, the five vertices of the locking piece are integrally formed on the inner wall of the fixing hole, so that the inner hole of the ring of the locking piece can be screwed in for the fixing screw to cooperate with, and a locking hole is formed between the outer wall between two adjacent vertices of the locking piece and the inner wall of the fixing hole, and a locking sheet is inserted in the locking hole to lock the fixing screw in a manner that the angle can be adjusted, wherein the locking piece is an elastic piece.

[0015] Furthermore, the head is set at a right angle of 90° perpendicular to the plate body and is retracted 5° toward one side of the plate body.

[0016] Furthermore, the fixing screw is a locking self-tapping screw.

[0017] Furthermore, a holder hole for the holder to be screwed into is provided on the convex surface of the bent portion of the steel plate, and the holder hole is located on the symmetry axis of the two fixing holes.

[0018] Furthermore, the tail end of the plate body away from the head is arranged in a pointed shape.

[0019] Furthermore, the fixing screw includes an integrally formed screw head and a screw rod, the screw head presents a conical structure whose outer contour dimension increases gradually from the direction close to the screw rod to the direction away from the screw rod, and a conical thread is provided on the outer side wall of the screw head, and a serrated thread is provided on the outer side wall of the screw rod, so that the conical thread on the screw head and the serrated thread on the screw rod are integrally arranged through a milling process.

[0020] According to a second aspect of the embodiments of the present invention,

[0021] Furthermore, a method for preparing a high lateral tibial closed osteotomy internal fixation device is provided, using the high lateral tibial closed osteotomy internal fixation device according to claims 1-6, characterized in that the preparation method comprises:

[0022] S1. Select Link condylar plate and use Link condylar plate as sample. Use mechanical process to bend the head of original Link condylar plate from the initial right angle of 90° to the plate body, and retract 5° to one side of the plate body, so that the convex surface of the bending part of the plate fits the change of tibial curvature.

[0023] S2. On the head of the steel plate that is angled inward, two transversely arranged fixing holes are first opened through a mechanical process, and then elastic locking pieces are respectively formed in the two fixing holes, and an inner hole of the ring is opened in the middle of the locking piece for the fixing screw to be screwed in, so that the locking piece has a ring structure with both the outer and inner contours of the ring being a five-pointed star, so as to form two inner five-pointed star locking adjustment holes on the head of the steel plate, and on the convex surface of the curved part of the steel plate and located on the symmetric axis of the two fixing holes, and a holder hole is opened for the holder to be screwed in;

[0024] S3. After the structure of the steel plate is formed, the surface of the steel plate is subjected to wire drawing, polishing and passivation treatment in sequence through the process;

[0025] S4. Synchronously prepare self-tapping fixing screws. First, make a straight serrated thread on the screw rod through a milling process. Then make a tapered thread on the screw head with the diameter increasing from close to the screw rod to away from the screw rod. The tapered thread and the serrated thread are integrated into one piece to be assembled in the five-star locking adjustment hole. A locking plate is provided at the locking hole to lock the fixing screw.

[0026] Furthermore, the length of the steel plate is divided into four specifications according to the width of the tibia bone of Chinese people, and the length specifications of the four steel plates are, from small to large, 50mm, 55mm, 60mm, and 65mm.

[0027] Furthermore, the span variation of the length of the fixing screws is divided into thirteen specifications, and the length specifications of the thirteen fixing screws are from small to large: 60mm, 62mm, 64mm, 66mm, 68mm, 70mm, 72mm, 74mm, 76mm, 78mm, 80mm, 85mm, and 90mm.

[0028] The embodiments of the present invention have the following advantages:

[0029] 1. By improving the original Link condylar plate, the right angle of the head of the original Link condylar plate is changed to an inward angle. After the plate is inserted into the tibial osteotomy laterally, the head of the plate can better fit the change of the tibial curvature, avoiding local protrusion after surgery, improving the fixation effect and achieving aesthetics;

[0030] 2. The ordinary fixing hole of the original Link condylar plate is improved to an inner five-star locking adjustment hole. After the fixing screw is driven into the tibial osteotomy along the fixing hole, the locking piece can be inserted into the locking hole to enhance the combined fixing strength of the plate and the fixing screw to lock the fixing screw. The structure of the elastic locking piece and the locking hole can be used to adjust the driving angle of the fixing screw according to the needs of the operation when the fixing screw is driven in, so that the fixing screw is behind the tibial osteotomy and the bone can be fully fixed by adjusting the angle, thereby improving the fixation efficiency.

[0031] 3. The ordinary screws of the original Link steel plate system are replaced with self-tapping screws, which can be directly screwed in after drilling, thereby reducing the number of tapping steps and effectively avoiding skin cutting injuries during the tapping step. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] In order to more clearly illustrate the implementation methods of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for the implementation methods or the description of the prior art. Obviously, the drawings in the following description are only exemplary, and for ordinary technicians in this field, other implementation drawings can be derived from the provided drawings without creative work.

[0033] The structures, proportions, sizes, etc. illustrated in this specification are only used to match the contents disclosed in the specification so as to facilitate understanding and reading by persons familiar with the technology. They are not used to limit the conditions under which the present invention can be implemented, and therefore have no substantial technical significance. Any structural modification, change in proportion or adjustment of size shall still fall within the scope of the technical contents disclosed in the present invention without affecting the effects and purposes that can be achieved by the present invention.

[0034] Figure 1 A schematic diagram of the overall structure of a high lateral tibial closed osteotomy internal fixation device provided in Example 1 of the present invention;

[0035] Figure 2 A schematic diagram of the structure of the head of a high lateral tibial closed osteotomy internal fixation device provided in Example 1 of the present invention;

[0036] Figure 3 A schematic diagram of the structure of a fixing screw of a high lateral tibial closed osteotomy internal fixation device provided in Example 1 of the present invention;

[0037] Figure 4 This is a schematic diagram of the osteotomy fixation state of a high lateral tibial closed osteotomy internal fixation device provided in Example 1 of the present invention.

[0038] In the figure: 1, steel plate; 11, plate body; 12, head; 121, fixing hole; 13, holder hole; 2, locking mechanism; 21, fixing screw; 211, screw head; 212, screw rod; 22, locking piece; 23, locking hole. DETAILED DESCRIPTION

[0039] The following is a description of the implementation of the present invention by specific embodiments. People familiar with the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0040] Example 1

[0041] like Figure 1 and Figure 2 As shown, an embodiment of the present invention provides a high lateral tibial closed osteotomy internal fixation device, including a steel plate 1 and a locking mechanism 2, and the specific configuration is as follows:

[0042] The steel plate 1 is based on the Link condylar steel plate in the condylar steel plate system produced by Link Company of Germany, and includes an integrally formed plate body 11 and a head 12. The plate body 11 is a straight plate structure, and its tail end away from the head 12 is set at a pointed tip, so that the tail end of the plate body 11 can be laterally driven into the human tibia. At the same time, the connection position of the plate body 11 and the head 12 is set in a curved manner, so that the head 12 is angled inward. Specifically, the head 12 is set at a 90° right angle perpendicular to the plate body 11 in the original Link condylar steel plate, and is retracted to one side of the plate body 11. According to the actual use effect during the operation, it is preferred that the head 12 is retracted 5°, so that after the plate body 11 is driven into the tibial osteotomy, the head 12 of the steel plate 1 can better fit the change in the curvature of the tibia, effectively avoiding the situation of local protrusion of the original Link condylar steel plate after surgery, effectively improving the fixation effect, and having both aesthetics.

[0043] The locking mechanism 2 includes a fixing screw 21 and a locking member 22. Two fixing holes 121 arranged transversely are provided on the head 12 of the steel plate 1, and two fixing screws 21 are provided corresponding to the two fixing holes 121 one by one, and the fixing screws 21 pass through the fixing holes 121 and are driven into the human tibial osteotomy, thereby fixing the steel plate 1. The locking member 22 is arranged in the fixing hole 121, and the locking member 22 is an annular structure with both the outer contour and the inner contour of the ring being a five-pointed star. The five vertices of the locking member 22 are integrally formed on the inner wall of the hole of the fixing hole 121, so that the inner hole of the ring of the locking member 22 is screwed in with the fixing screw 21, and a locking hole 23 is formed between the outer wall between two adjacent vertices of the locking member 22 and the inner wall of the hole of the fixing hole 121, thereby forming two inner five-star locking adjustment holes on the head 12 of the steel plate 1, and a locking sheet is also inserted in the locking hole 23 to lock the fixing screw 21 in an angle-adjustable manner, wherein the locking member 22 is an elastic member. Since the fixing hole of the original Link condylar steel plate is an ordinary round hole, the fixing effect is general, and the adjustment range is limited after the screw is screwed into the nail hole. There is a problem that the rear screw still cannot have sufficient bone fixation at the maximum adjustment angle, which affects the fixation strength. Therefore, this embodiment improves the ordinary hole of the original Link condylar steel plate into an internal five-star locking adjustment hole. After the fixing screw 21 is driven into the tibial osteotomy along the inner hole of the ring of the locking piece 22, it can be inserted into the locking hole 23 through the locking piece to improve the combined fixing strength of the steel plate 1 and the fixing screw 21 to lock the fixing screw 21. The structure of the elastic locking piece 23 and the locking hole 23 can be used to adjust the driving angle of the fixing screw 21 according to the surgical needs when the fixing screw 21 is driven in, and allow the fixing screw 21 to have a larger angle adjustment range (increased from 15°~30° of the original Link condylar steel plate ordinary hole to 15°~45°). Preferably, a holder hole 13 for a holder to be screwed into is opened on the convex surface of the curved part of the steel plate 1, and the holder hole 13 is located on the symmetry axis of the two fixing holes 121. By setting the holder hole 13, the outer surrounding holder of the original Link condylar steel plate is changed to a center hole holder, and the holder only needs to be screwed into the holder hole 13 for fixing, so that the steel plate 1 can be inserted and removed conveniently and quickly, and the surgical incision can be reduced.

[0044] As mentioned above, combined Figure 3As shown in the figure, since the original Link plate system supporting screws are ordinary screws, the surgical operation needs to be followed by tapping after drilling, which is redundant and can easily cause cutting damage to the incision skin during the tapping process. Therefore, the fixing screw 21 of this embodiment is a locking self-tapping screw, which can be directly screwed into the steel plate 1 after drilling, reducing the tapping steps and effectively avoiding skin cutting damage during the tapping steps. Specifically, the fixing screw 21 includes an integrally formed screw head 211 and a screw rod 212. The screw rod 212 is a straight rod, and a straight serrated thread is provided on the outer wall of the screw rod 212. The serrated thread can effectively reduce stress concentration, and the screw head 211 is a conical structure with an outer contour dimension that increases gradually from the direction close to the screw rod 212 to the direction away from the screw rod 212, and a conical thread is provided on the outer wall of the screw head 211. The conical thread setting of the screw head 211 can improve the combined fixing strength of the steel plate 1 and the fixing screw 21 after the screw is screwed into the steel plate 1, thereby achieving the purpose of locking the steel plate 1, and the conical thread on the screw head 211 and the serrated thread on the screw rod 212 are integrally arranged through a milling process.

[0045] The embodiment of the present invention improves the original Link condylar plate by changing the right angle of the head 12 of the original Link condylar plate to an angle of inward retraction. After the plate body 11 is inserted into the tibial osteotomy laterally, the head 12 of the plate 1 can better fit the change of the tibial curvature (refer to Figure 4 ), avoiding local protrusion after surgery, improving the fixation effect and making it beautiful. In addition, the ordinary fixing hole 121 of the original Link condylar steel plate is improved to an internal five-star locking adjustment hole. After the fixing screw 21 is driven into the tibial osteotomy along the fixing hole 121, the locking piece can be inserted into the locking hole 23 to improve the combined fixing strength of the steel plate 1 and the fixing screw 21 to lock the fixing screw 21. By utilizing the structure of the elastic locking piece 22 and the locking hole 23, when the fixing screw 21 is driven in, the driving angle of the fixing screw 21 can be adjusted according to the needs of the operation, so that the fixing screw 21 can be fully fixed to the bone behind the tibial osteotomy by adjusting the angle, thereby improving the fixation efficiency. At the same time, the ordinary screws supporting the original Link steel plate system are changed to self-tapping screws, which can be directly screwed into the fixing screw 21 after drilling, thereby eliminating the tapping step and effectively avoiding skin cutting damage during the tapping step.

[0046] Example 2

[0047] The embodiment of the present invention provides a method for preparing a high lateral tibial closed osteotomy internal fixation device, using the high lateral tibial closed osteotomy internal fixation device of embodiment 1, and the preparation method comprises:

[0048] S1. Select a Link condylar plate and use the Link condylar plate as a sample. Use a mechanical process to bend the head 12 of the original Link condylar plate from the initial right angle of 1190° to the plate body 11, and retract 5° to one side of the plate body 11, so that the convex surface of the bending part of the plate 1 fits the change of the tibial curvature;

[0049] S2. On the head of the steel plate 1 which is retracted at an angle, two transversely arranged fixing holes 121 are firstly opened through a mechanical process, and then elastic locking members 22 are respectively formed in the two fixing holes 121, and an inner hole of the ring for the fixing screw 21 to be screwed into is opened in the middle of the locking member 22, so that the locking member 22 is an annular structure with both the outer contour and the inner contour of the ring being a five-pointed star, so as to form two inner five-pointed star locking adjustment holes on the head of the steel plate 1, and on the convex surface of the curved part of the steel plate 1 and located on the symmetric axis of the two fixing holes 121, a holder hole 23 for the holder to be screwed into is opened at the same time;

[0050] Furthermore, since the original Link condylar plate was designed for Europeans, who have large bones, the design size of the plate is relatively large, while Chinese people have relatively small bones, and most patients with genu varum are females with even smaller bones. Therefore, during the preparation of the steel plate 1, the length of the steel plate 1 can be divided into four specifications according to the variation in the width of the Chinese tibia bone, and the length specifications of the four steel plates 1 are, from small to large, 50mm, 55mm, 60mm, and 65mm, respectively, to make it more in line with the variation in the width of the Chinese tibia bone.

[0051] S3, after the structure of the steel plate is formed, the surface of the steel plate 1 is subjected to wire drawing, polishing and passivation treatment in sequence through the process;

[0052] S4. Synchronously prepare a self-tapping fixing screw 21. First, a straight serrated thread is made on the screw rod 212 through a milling process. Then, a tapered thread with a diameter increasing gradually from the direction close to the screw rod 212 to the direction away from the screw rod 212 is made on the screw head 211. The tapered thread and the serrated thread are integrally arranged to be assembled in the five-star locking adjustment hole, and a locking plate is provided at the locking hole 23 to lock the fixing screw 21.

[0053] Furthermore, since the length span of the screws of different specifications in the original Link condylar plate is relatively large (including only eight specifications: 76mm, 78mm, 80mm, 85mm, 90mm, 95mm, 100mm, and 110mm), it is not easy to accurately fix the bone. Therefore, in this embodiment, the span variation of the length of the fixing screw 21 is optimized to thirteen specifications, and the length specifications of the thirteen fixing screws 21 are from small to large: 60mm, 62mm, 64mm, 66mm, 68mm, 70mm, 72mm, 74mm, 76mm, 78mm, 80mm, 85mm, and 90mm, so as to provide more precise length screw fixation for surgical fixation.

[0054] Although the present invention has been described in detail above by general description and specific embodiments, it is obvious to those skilled in the art that some modifications or improvements can be made on the basis of the present invention. Therefore, these modifications or improvements made on the basis of not departing from the spirit of the present invention all belong to the scope of protection claimed by the present invention.

Claims

1. A device for internal fixation of high lateral tibial closed osteotomy, characterized in that: The high lateral tibial closed osteotomy internal fixation device comprises: A steel plate (1), the steel plate (1) comprising an integrally formed plate body (11) and a head (12), wherein the connection position between the plate body (11) and the head (12) is curved, wherein the head (12) is angled inward so that the convex surface of the curved portion of the steel plate (1) fits the change in the curvature of the tibia; A locking mechanism (2), the locking mechanism (2) comprising a fixing screw (21) and a locking piece (22), the head (12) of the steel plate (1) being provided with two fixing holes (121) arranged transversely, and two fixing screws (21) being arranged corresponding to the two fixing holes (121) one by one, the locking piece (22) being arranged in the fixing hole (121), and the locking piece (22) being an annular structure with both an outer contour and an inner contour of the ring being a five-pointed star, the five vertices of the locking piece (22) being integrally formed on the inner wall of the fixing hole (121), so that the inner hole of the ring of the locking piece (22) is screwed in with the fixing screw (21), and a locking hole (23) is formed between the outer wall between two adjacent vertices of the locking piece (22) and the inner wall of the fixing hole (121), and a locking sheet is inserted in the locking hole (23) to lock the fixing screw (21) in an angle-adjustable manner, wherein the locking piece (22) is an elastic piece; The head (12) is set at a right angle of 90° perpendicular to the plate body (11) and is retracted 5° inwards to one side of the plate body (11); The fixing screw (21) is a locking self-tapping screw; A holder hole (13) for screwing a holder is provided on the convex surface of the curved portion of the steel plate (1), and the holder hole (13) is located on the symmetric axis of the two fixing holes (121); The tail end of the plate body (11) away from the head (12) is arranged in a pointed shape; The fixing screw (21) comprises an integrally formed screw head (211) and a screw rod (212); the screw head (211) is a tapered structure whose outer contour increases in a direction from close to the screw rod (212) to far away from the screw rod (212); a tapered thread is provided on the outer wall of the screw head (211); and a sawtooth thread is provided on the outer wall of the screw rod (212); the tapered thread on the screw head (211) and the sawtooth thread on the screw rod (212) are integrally arranged by a milling process.

2. A method for preparing a high lateral tibial closed osteotomy internal fixation device, using the high lateral tibial closed osteotomy internal fixation device according to claim 1, characterized in that: The preparation method comprises: S1. Select a Link condylar plate and use the Link condylar plate as a sample. Use a mechanical process to bend the head (12) of the original Link condylar plate from an initial right angle of 90° to the plate body (11) and retract 5° to one side of the plate body (11), so that the convex surface of the bending part of the plate (1) fits the change of the tibial curvature; S2. On the head of the steel plate (1) which is inwardly angled, two transversely arranged fixing holes (121) are firstly opened by mechanical technology, and then elastic locking parts (22) are respectively formed in the two fixing holes (121), and an inner ring hole for screwing the fixing screw (21) is opened in the middle of the locking part (22), so that the locking part (22) has a ring structure with both the outer and inner contours of the ring being a five-pointed star, so as to form two inner five-pointed star locking adjustment holes on the head of the steel plate (1), and on the convex surface of the curved part of the steel plate (1) and located on the symmetric axis of the two fixing holes (121), and a holder hole (13) for screwing a holder is opened; S3, after the structure of the steel plate is formed, the surface of the steel plate (1) is subjected to wire drawing, polishing and passivation treatment in sequence through the process; S4. A self-tapping fixing screw (21) is simultaneously prepared. A straight sawtooth thread is first formed on the screw rod (212) by a milling process. Then, a tapered thread with a diameter increasing from the direction close to the screw rod (212) to the direction away from the screw rod (212) is formed on the screw head (211). The tapered thread and the sawtooth thread are integrally arranged to be assembled in the five-star locking adjustment hole. A locking plate is provided at the locking hole (23) to lock the fixing screw (21).

3. The method for preparing a high lateral tibial closed osteotomy internal fixation device according to claim 2, characterized in that: The method further comprises: the length of the steel plate (1) is divided into four specifications according to the width of the tibia bone of Chinese people, and the length specifications of the four steel plates (1) are, from small to large, 50 mm, 55 mm, 60 mm, and 65 mm.

4. The method for preparing a high lateral tibial closed osteotomy internal fixation device according to claim 2, characterized in that: The method further comprises: the span variation of the length of the fixing screw (21) is divided into thirteen specifications, and the length specifications of the thirteen fixing screws (21) are, from small to large, 60mm, 62mm, 64mm, 66mm, 68mm, 70mm, 72mm, 74mm, 76mm, 78mm, 80mm, 85mm, and 90mm.

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