Multi-column integrated biological fixation partial femoral head replacement device

Abstract

The invention provides a multi-column integrated biological fixation partial femoral head replacement device, and relates to the field of medical instruments. The device comprises a bone nail, an auxiliary fixing piece and a joint prosthesis, the bone nail is provided with a first end part and a second end part nailed into a femoral neck medullary cavity, and the first end part, the auxiliary fixing piece and the joint prosthesis are integrally formed; the auxiliary fixture has a first surface and a second surface in contact with the conical osteotomy femoral head to prevent sinking and lateral rotation. The joint prosthesis only replaces the cut part of the necrotic femoral head, more normal sclerotin can be reserved, trauma is small, femoral head supporting and bearing are not affected or changed, long-term stability of the joint prosthesis is guaranteed, and meanwhile future rebuilding is facilitated. In addition, the first end part, the auxiliary fixing piece and the joint prosthesis are integrally formed, so that joint prosthesis failure caused by looseness or corrosion among the first end part, the auxiliary fixing piece and the joint prosthesis can be avoided.

Description

Cross-references to related applications

[0001] This application claims priority to Chinese Patent Application No. CN202411942520.4, filed on December 27, 2024, entitled “An Integrated Patient-Matching Partial Femoral Head Replacement Device”, the contents of which are incorporated herein by reference in whole or in part. Technical Field

[0002] This invention relates to the field of medical devices, and more particularly to a multi-column integrated biological fixation partial femoral head replacement device. Background Technology

[0003] Avascular necrosis of the femoral head (ANFH) is a common orthopedic disease, frequently occurring in patients with a history of hip trauma, long-term high-dose use of glucocorticoids, or alcoholism. It can occur at any age, with approximately 800,000 new cases annually, making it a leading cause of disability in young and middle-aged adults. The Association for Research and Circulation Osseous (ARCO) classifies ANFH into four stages: Stage I: Necrosis area less than 30%, usually asymptomatic, but with local ischemia. Stage II: Necrosis area 30%, femoral head not collapsed, may have mild pain. Stage III: Necrosis area 30%, femoral head collapse, significant joint pain and stiffness. Stage IV: Necrosis area greater than 30%, severe femoral head collapse. Current treatments for Stage II and III ANFH include hip resurfacing, partial hip replacement, or total hip replacement.

[0004] In femoral head replacement surgery, the entire surface cartilage, including the normal portion, is removed, leaving only a small amount of cancellous bone. This often leads to long-term adverse events such as femoral head prosthesis subsidence and loosening. Surface replacement surgery can easily damage the blood supply to the femoral head, leading to secondary necrosis and affecting prosthesis stability. Because the diameter of the surface replacement prosthesis is the same as the femoral head, the larger the prosthesis diameter, the more significant the increase in postoperative serum metal ion levels. Many studies have shown that prolonged exposure to excessively high metal ion concentrations may increase the risk of teratogenicity, mutagenicity, and immunodeficiency. These adverse events are closely related to defects in prosthesis structural design, surface treatment methods, and material selection.

[0005] Furthermore, hemiarthroplasty and total hip replacement are highly invasive procedures, involving the removal of the entire femoral head and most of the femoral neck. For active young patients, the reduced bone volume supporting the prosthesis during future revision surgeries leads to poor initial stability, higher risks, and exorbitant costs. Hemiarthroplasty uses a complete metal head to replace the femoral head, which rubs against the physiological acetabular cartilage, easily causing wear and collapse of the acetabular cartilage, increasing the difficulty of future revision surgeries.

[0006] In summary, existing treatment methods all suffer from problems such as low bone preservation, poor long-term stability, and difficulty in future revision surgery. Summary of the Invention

[0007] To address the problems of insufficient bone preservation, poor long-term stability, and difficulty in future revision treatments in existing methods, the purpose of this invention is to provide a multi-column integrated biological fixation partial femoral head replacement device.

[0008] This invention provides the following technical solution: A multi-column integrated biological fixation partial femoral head replacement device includes bone screws, auxiliary fixation components, and a joint prosthesis; The bone screw has a first end and a second end that is inserted into the femoral neck medullary canal. The auxiliary fixation member is located on the side of the first end. The joint prosthesis is located at the end of the first end and the auxiliary fixation member opposite to the second end. The first end, the auxiliary fixation member and the joint prosthesis are integrally formed. The auxiliary fixation member has a first surface and a second surface that contact the femoral head after conical osteotomy. The first surface is located at one end of the auxiliary fixation member facing the second end to prevent sinking. The second surfaces are arranged in pairs on both sides of the auxiliary fixation member along the circumference of the first end to prevent lateral rotation. The joint prosthesis is used to replace the resected portion of the necrotic femoral head.

[0009] As a further optional embodiment of the multi-column integrated biological fixation partial femoral head replacement device, a reinforcing screw is provided on the first surface, the reinforcing screw being perpendicular to the first surface, and the reinforcing screw being used to insert into the femoral head after conical osteotomy.

[0010] As a further alternative to the multi-column integrated biological fixation partial femoral head replacement device, the reinforcing screw has multiple wings arranged around the axis of the reinforcing screw, and the wings extend in a direction away from the axis of the reinforcing screw; and / or The reinforcing nails are provided in multiple quantities, and the multiple reinforcing nails are evenly distributed on the first surface.

[0011] As a further optional feature of the multi-column integrated biological fixation partial femoral head replacement device, the diameter of the bone screw is D1, 6mm≤D1≤18mm, to accommodate the maximum or minimum diameter of the femoral neck among different individuals, thereby achieving stable fixation; and / or The bone screw extends beyond the auxiliary fixation member by a length L, where 0mm < L ≤ 80mm, to provide stable support for osteoporosis patients.

[0012] As a further alternative to the multi-column integrated biological fixation femoral head replacement device, the bone screw is tapered, and the cross-sectional area of ​​the first end is larger than that of the second end. The cone angle of the bone nail is α, where 0° < α ≤ 45°.

[0013] As a further alternative to the multi-column integrated biological fixation partial femoral head replacement device, the bone screw is arranged in a pyramidal shape, and the bone screw is suitable for osteoporotic femoral heads; or The bone screw is conical in shape and is suitable for femoral heads without osteoporosis; or The surface of the bone screw is provided with multiple stepped portions to enhance pull-out resistance, and the multiple stepped portions are arranged along the length direction of the bone screw.

[0014] As a further alternative to the multi-column integrated biological fixation partial femoral head replacement device, the surface of the bone screw is provided with a groove that extends along the length of the bone screw.

[0015] As a further alternative to the multi-column integrated biological fixation femoral head replacement device, the joint prosthesis has an outwardly convex articular surface located at one end of the joint prosthesis opposite to the first end and the auxiliary fixation member. A flange is provided circumferentially at the edge of the articular surface, and the width of the flange increases with the severity of osteoporosis of the femoral head to prevent subsidence.

[0016] As a further optional feature of the multi-column integrated biological fixation partial femoral head replacement device, the articular surface is spherical, and the diameter of the articular surface is D2, 36mm≤D2≤58mm, to match patients of different heights and body types; or The articular surface is a non-spherical surface, and the articular surface is formed by simulating the defect and necrotic area based on the patient's imaging data. The surface of the articular surface is polished to form a wear-resistant layer.

[0017] As a further alternative to the multi-column integrated biological fixation partial femoral head replacement device, the area of ​​the articular surface is less than 60% of the surface area of ​​the femoral head.

[0018] The embodiments of the present invention have the following beneficial effects: When using the aforementioned multi-column integrated biological fixation partial femoral head replacement device, the second end of the bone screw is inserted into the femoral neck medullary canal through the top of the femoral head. Since the first end of the bone screw, the auxiliary fixation component, and the joint prosthesis are integrally formed, the device is fixed to the femoral head after the conical osteotomy. The first surface of the auxiliary fixation component contacts the femoral head along the length of the bone screw to prevent sinking, while the second surface contacts the femoral head circumferentially along the first end to prevent lateral rotation. This ensures sufficient initial axial and rotational stability even when the joint prosthesis only replaces the resected necrotic portion of the femoral head, minimizing the risk of displacement during long-term use. Furthermore, replacing only the resected necrotic portion of the femoral head with the joint prosthesis helps preserve more normal bone, resulting in less trauma, no impact on or alteration of the femoral head's load-bearing capacity, and ensuring long-term stability of the joint prosthesis, while also facilitating future revision surgery. In addition, the integral formation of the first end, auxiliary fixation component, and joint prosthesis avoids joint prosthesis failure caused by loosening or corrosion between these components.

[0019] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, preferred embodiments are described below in detail with reference to the accompanying drawings. Attached Figure Description

[0020] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0021] Figure 1 This diagram illustrates the overall structure of a multi-column integrated biological fixation femoral head replacement device according to an embodiment of the present invention. Figure 2 This diagram illustrates the overall structure of a multi-column integrated biological fixation femoral head replacement device according to another embodiment of the present invention. Figure 3 This diagram illustrates the overall structure of a multi-column integrated biological fixation femoral head replacement device according to another embodiment of the present invention. Figure 4 This figure shows a front view of a multi-column integrated biological fixation partial femoral head replacement device according to an embodiment of the present invention; Figure 5 This figure shows a front view of a multi-column integrated biological fixation partial femoral head replacement device according to another embodiment of the present invention; Figure 6 This diagram illustrates the overall structure of a multi-column integrated biological fixation femoral head replacement device according to another embodiment of the present invention. Figure 7 This diagram illustrates the overall structure of a multi-column integrated biological fixation femoral head replacement device according to another embodiment of the present invention. Figure 8 This diagram illustrates the overall structure of a multi-column integrated biological fixation femoral head replacement device according to another embodiment of the present invention. Figure 9 This diagram illustrates the overall structure of a multi-column integrated biological fixation femoral head replacement device according to another embodiment of the present invention. Figure 10 This diagram illustrates the overall structure of a multi-column integrated biological fixation femoral head replacement device according to another embodiment of the present invention. Figure 11 This diagram illustrates the overall structure of a multi-column integrated biological fixation femoral head replacement device according to another embodiment of the present invention. Figure 12 This diagram illustrates the overall structure of a multi-column integrated biological fixation femoral head replacement device according to another embodiment of the present invention. Figure 13 This diagram illustrates the overall structure of a multi-column integrated biological fixation femoral head replacement device according to another embodiment of the present invention. Figure 14 This diagram illustrates the overall structure of a multi-column integrated biological fixation femoral head replacement device according to another embodiment of the present invention.

[0022] Explanation of key component symbols: 100-Bone screw; 110-First end; 120-Second end; 130-Step portion; 140-Groove; 200-Auxiliary fixation component; 210-First surface; 220-Second surface; 230-Reinforcing screw; 231-Wing portion; 300-Joint prosthesis; 310-Articular surface; 320-Flange. Detailed Implementation

[0023] Embodiments of the present invention are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, and should not be construed as limiting the present invention.

[0024] It should be noted that when an element is said to be "fixed" to another element, it can be directly on the other element or there may be an intervening element. When an element is said to be "connected" to another element, it can be directly connected to the other element or there may be an intervening element. Conversely, when an element is said to be "directly" on another element, there is no intervening element. The terms "vertical," "horizontal," "left," "right," and similar expressions used in this document are for illustrative purposes only.

[0025] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0026] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this invention, "a plurality of" means two or more, unless otherwise explicitly specified.

[0027] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein in the template description is for the purpose of describing particular embodiments only and is not intended to limit the invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0028] Example Please see Figure 1 This embodiment provides a multi-column integrated biological fixation partial femoral head replacement device, hereinafter referred to as "femoral head replacement device", which consists of a bone screw 100, an auxiliary fixation component 200 and a joint prosthesis 300.

[0029] The bone screw 100 has a first end 110 and a second end 120 that is inserted into the medullary canal of the femoral neck. The auxiliary fixation member 200 is located on the side of the first end 110, and the joint prosthesis 300 is located at the end of the first end 110 and the auxiliary fixation member 200 opposite to the second end 120. The first end 110, the auxiliary fixation member 200 and the joint prosthesis 300 are integrally formed.

[0030] The auxiliary fixation member 200 has a first surface 210 and a second surface 220 that contact the femoral head after a conical osteotomy. The first surface 210 is located at one end of the auxiliary fixation member 200 facing the second end 120 to prevent sinking. The second surfaces 220 are arranged in pairs on both sides of the auxiliary fixation member 200 along the circumference of the first end 110 to prevent lateral rotation.

[0031] In addition, the joint prosthesis 300 is used to replace the resected portion of the necrotic femoral head.

[0032] When using the aforementioned femoral head replacement device, the second end 120 of the bone screw 100 is inserted into the femoral neck medullary cavity through the top of the femoral head. Since the first end 110 of the bone screw 100, the auxiliary fixation member 200, and the joint prosthesis 300 are integrally formed, the femoral head replacement device is fixed to the femoral head after the conical osteotomy. Specifically, the first surface 210 of the auxiliary fixation member 200 contacts the femoral head along the length of the bone screw 100 to prevent the femoral head replacement device from sinking, and the second surface 220 of the auxiliary fixation member 200 contacts the femoral head circumferentially along the first end 110 to prevent lateral rotation of the femoral head replacement device. Thus, even when the joint prosthesis 300 only replaces the resected portion of the necrotic femoral head, sufficient initial axial and rotational stability is ensured, and displacement is less likely to occur during long-term use. Furthermore, replacing only the resected portion of the necrotic femoral head with the joint prosthesis 300 helps retain more normal bone, resulting in less trauma, no impact on or alteration of the femoral head's load-bearing capacity, ensuring the long-term stability of the joint prosthesis 300, and facilitating future revision surgery. In addition, the first end 110, the auxiliary fixation member 200 and the joint prosthesis 300 are integrally formed, which can avoid the failure of the joint prosthesis 300 caused by loosening or corrosion between the first end 110, the auxiliary fixation member 200 and the joint prosthesis 300.

[0033] It should be noted that, in some embodiments, the bone interface between the above-mentioned femoral head replacement device and the bone is provided with a microporous layer.

[0034] The microporous layer has a porosity of 30-90%, a pore size of 150-2000 micrometers, and a connectivity of ≥50%.

[0035] Understandably, the microporous design allows bone trabeculae to grow into the micropores, achieving hinged fixation between the bone and the prosthesis, which is also known as biological fixation, thus ensuring the joint prosthesis 300 is securely fixed.

[0036] In some embodiments, the above-mentioned femoral head replacement device is made of metal material by 3D printing or machining, and the metal material includes, but is not limited to, zirconium-niobium alloy, cobalt-chromium-molybdenum alloy, alumina-based ceramic or titanium metal.

[0037] Specifically, when the aforementioned femoral head replacement device is made of zirconium-niobium alloy, its surface is heat-treated to form a zirconium oxide ceramic interface. Alternatively, when the aforementioned femoral head replacement device is made of titanium, its surface is surface-treated to form a ceramic interface.

[0038] In other embodiments, the above-mentioned femoral head replacement device may also be made of PAEK (polyetherketoneketone) and its composite materials by 3D printing or machining.

[0039] Please refer to the following: Figure 2 and Figure 3 Furthermore, in some embodiments, the first surface 210 is provided with a reinforcing screw 230. The reinforcing screw 230 is perpendicular to the first surface 210 and is used to insert into the femoral head after a conical osteotomy.

[0040] On the one hand, the reinforcing screw 230 is driven into the femoral head after the conical osteotomy, and together with the bone screw 100 is driven into the femoral neck medullary cavity, which can more stably fix the above-mentioned femoral head replacement device to the femoral head after the conical osteotomy. On the other hand, the reinforcing screw 230 and the femoral head are relatively fixed to each other in the circumferential direction of the first end 110, which can further prevent the above-mentioned femoral head replacement device from rotating laterally.

[0041] Therefore, by strengthening the setting of the screw 230, the initial stability of the joint prosthesis 300 in both axial and rotational directions can be improved, making the joint prosthesis 300 less prone to displacement during long-term use.

[0042] Understandably, in addition to the conventional bone screw 100, the aforementioned femoral head replacement device also includes an auxiliary fixation component 200 and a reinforcing screw 230. The bone screw 100, auxiliary fixation component 200, and reinforcing screw 230 work together to fix the joint prosthesis 300, achieving multi-column integration.

[0043] Please see Figure 2 In some embodiments, the reinforcing stud 230 has a plurality of wings 231. The plurality of wings 231 are arranged around the axis of the reinforcing stud 230 and extend in a direction away from the axis of the reinforcing stud 230.

[0044] Compared with cylindrical or conical reinforcing nails 230, reinforcing nails 230 with multiple wings 231 can maximize the contact area with the femoral head within a limited volume, reduce the damage to the femoral head when nailed into it, and enhance the connection stability between the reinforcing nail 230 and the femoral head.

[0045] For example, there are three wings 231, which are evenly distributed around the axis of the reinforcing nail 230. In addition, each wing 231 has a cutting edge at the end away from the first surface 210 to facilitate nailing into the femoral head after the conical osteotomy.

[0046] Please see Figure 3 In some embodiments, multiple reinforcing nails 230 are provided, and the multiple reinforcing nails 230 are evenly distributed on the first surface 210.

[0047] Understandably, increasing the number of reinforcing screws 230 can significantly improve the connection strength between the reinforcing screws 230 and the femoral head. Furthermore, evenly distributing multiple reinforcing screws 230 on the first surface 210 can disperse the force, which also helps reduce damage to the femoral head.

[0048] For example, the number of reinforcing nails 230 is two.

[0049] Please refer to the following: Figure 4 and Figure 5 Specifically, the bone nail 100 is tapered, extending taperedly from the first end 110 to the second end 120, and the cross-sectional area of ​​the first end 110 is greater than the cross-sectional area of ​​the second end 120.

[0050] Depending on the patient's bone quality, selectively increasing the cone angle design can improve the stability of the aforementioned femoral head replacement device.

[0051] Furthermore, the cone angle of the bone nail 100 is α, which satisfies 0°<α≤45°.

[0052] Specifically, the cone angle of the bone nail 100 refers to the included angle between the two long sides of the longitudinal section of the bone nail 100.

[0053] Optionally, the cone angle of the bone screw 100 can be any value between 1°, 5°, 10°, 15°, 20°, 25°, 30°, 35°, 40°, 45° or 0° to 45°.

[0054] In some embodiments, the bone screw 100 is arranged in a pyramidal shape and is adapted to the osteoporotic femoral head.

[0055] Generally, a patient's bone condition is classified into four grades based on the severity of osteoporosis. Grade 1: If the patient's bone mineral density (BMD) is above -1 and they do not experience lower back pain or general body aches, this is considered normal. Grade 2: If the measured BMD is between -1 and -2.5, it is called osteopenia; patients may experience mild lower back pain and limb pain. Grade 3: If the measured BMD is less than -2.5, it is called osteoporosis. Grade 4: If the measured BMD is less than -2.5 and the patient also has fragility fractures in other areas, it is called severe osteoporosis. The more severe the osteoporosis, the less bone is preserved, and the worse the fixation effect between the femoral head replacement device and the bone, making the device more prone to fixation failure.

[0056] Therefore, for patients with severe osteoporosis (corresponding to grades 3 and 4), the multi-faceted design can increase the stability of the bone screw by 100% through the sharp edges.

[0057] For example, the bone nail 100 can be configured as a triangular pyramid.

[0058] Please refer to the following: Figure 6 and Figure 7 Alternatively, the bone nail 100 can also be set as a square pyramid shape.

[0059] Please refer to the following: Figure 8 and Figure 9 Alternatively, the bone nail 100 can also be set as an irregular pyramid shape, which is not limited in this embodiment.

[0060] Please see Figure 10 In other embodiments, the surface of the bone screw 100 is provided with a plurality of stepped portions 130 to enhance pull-out resistance, which is also suitable for patients with severe osteoporosis.

[0061] Among them, multiple stepped sections 130 are arranged along the length direction of the bone nail 100.

[0062] Please refer to the following: Figure 11 and Figure 12 In some other embodiments, the bone screw 100 is conical in shape and is adapted to a femoral head that is not osteoporotic (corresponding to grade 1 and grade 2).

[0063] For patients with relatively good osteoporosis, the conical fixation can effectively fix the joint prosthesis 300 while increasing bone preservation, resulting in better long-term stability and facilitating future revision.

[0064] Please refer to the following: Figure 13 and Figure 14 Taking a conical bone screw 100 as an example, the surface of the bone screw 100 is provided with a groove 140, which extends along the length of the bone screw 100.

[0065] The groove 140 can further increase the amount of bone preserved, while making the bone screw 100 more securely connected to the femoral neck in the circumferential direction.

[0066] For example, there are three grooves 140, which are evenly distributed around the circumference of the bone screw 100.

[0067] In some embodiments, the diameter of the bone screw 100 is D1, which satisfies 6mm≤D1≤18mm, to be suitable for the maximum or minimum diameter of the femoral neck among different individuals, so as to achieve stable fixation.

[0068] In practical application, based on anatomical data of Chinese people, the minimum anteroposterior diameter of the femoral neck in males is (26.11±2.74) mm, and the minimum anteroposterior diameter of the femoral neck in females is (23.33±2.33) mm. By designing bone screws with a diameter of 100 mm to conform to different femoral necks and preserving sufficient cortical and cancellous bone thickness, the aforementioned femoral head replacement device can be stably filled and fixed.

[0069] Optionally, the diameter of the bone screw 100 can be 6mm, 8mm, 10mm, 12mm, 14mm, 16mm, 18mm or any value between 6mm and 18mm.

[0070] Please refer to it again. Figure 4 and Figure 5 In some embodiments, the bone screw 100 extends beyond the auxiliary fixation member 200 by a length L, satisfying 0mm < L ≤ 80mm, to provide stable support to osteoporosis patients.

[0071] Specifically, the length of the bone nail 100 extending beyond the auxiliary fixation member 200 refers to the distance between the end of the second end 120 away from the first end 110 and the first surface 210 along the length direction of the bone nail 100.

[0072] In use, the length of the bone screw 100 exceeding the auxiliary fixation member 200 is designed according to the patient's bone quality. The greater the length of the bone screw 100 exceeding the auxiliary fixation member 200, the more stable the support it can provide, ensuring that the joint prosthesis 300 is stably fixed within the femoral neck.

[0073] Optionally, the length of the bone screw 100 extending beyond the auxiliary fixation member 200 can be any value between 10mm, 20mm, 30mm, 40mm, 50mm, 60mm, 70mm, 80mm or 0mm to 80mm.

[0074] Please refer to it again. Figure 1In some embodiments, the joint prosthesis 300 has a convex articular surface 310. The articular surface 310 is located at one end of the joint prosthesis 300 away from the first end 110 and the auxiliary fixation member 200, and a flange 320 is provided circumferentially at the edge of the articular surface 310.

[0075] On the one hand, the flange 320 can increase the contact area between the articular surface 310 and the bone surface. On the other hand, the flange 320 can effectively support the joint prosthesis 300, preventing it from sinking after implantation and avoiding step formation.

[0076] The width of flange 320 increases with the severity of osteoporosis in the femoral head. That is, for patients with more severe osteoporosis, the size of flange 320 can be increased to more effectively prevent the aforementioned femoral head replacement device from sinking.

[0077] In this embodiment, the width of the flange 320 is no greater than 4 mm.

[0078] Optionally, the width of flange 320 can be 1mm, 1.5mm, 2mm, 2.5mm, 3mm, 3.5mm, 4mm or any value between 0mm and 4mm.

[0079] For example, the articular surface 310 is spherical, and its diameter is D2, satisfying 36mm≤D2≤58mm, to match patients of different heights and body types. In use, articular surfaces 310 with different diameters are set to match patients of different heights and body types. In addition, the angle of the articular surface 310 is 90°-180°, with each 1° increment representing a specification, increasing patient compatibility.

[0080] Optionally, the diameter of the articular surface 310 can be any value between 36 mm, 38 mm, 40 mm, 42 mm, 44 mm, 46 mm, 48 mm, 50 mm, 52 mm, 54 mm, 56 mm, 58 mm, or 36 mm to 58 mm.

[0081] Alternatively, the articular surface 310 can also be aspherical, and it can be modeled based on the patient's imaging data to simulate the defect and necrotic area. In use, a three-dimensional model is first reconstructed based on the patient's imaging data, and then the external dimensions of the articular surface 310 are reconstructed based on the defect and necrotic area of ​​the femoral head to achieve individualized customization. This ensures a smooth connection between the joint prosthesis 300 and the preserved bone surface of the femoral head, avoiding the formation of uneven steps between the articular surface 310 and the preserved bone surface, thereby reducing wear.

[0082] In addition, the surface of the joint surface 310 is polished to form a wear-resistant layer, making it more wear-resistant.

[0083] In some embodiments, the area of ​​the articular surface 310 is less than 60% of the surface area of ​​the femoral head.

[0084] Specifically, the aforementioned femoral head replacement device only replaces the necrotic portion of the femoral head surface, preserving some of the femoral head bone to ensure stable fixation of the joint prosthesis 300 and the remaining bone tissue. During use, a matching articular surface 310 is designed based on the stage and area of ​​femoral head necrosis.

[0085] In summary, the aforementioned femoral head replacement device is based on the surgical theory of partial femoral head replacement and employs a matched structural design. It replaces only the necrotic area while preserving most of the original femoral head bone, ensuring the stability of the 300mm joint prosthesis. In future revision surgeries, surgeons can still use traditional surface replacement, hemiarthroplasty, or total hip replacement to achieve a stepwise treatment of femoral head necrosis, which is more conducive to maintaining good long-term joint function for patients. Furthermore, the aforementioned femoral head replacement device uses an integrated design, avoiding the risk of connection failure between separate components.

[0086] In all examples shown and described herein, any specific values ​​should be interpreted as merely exemplary and not as limitations; therefore, other examples of exemplary embodiments may have different values.

[0087] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0088] The above-described embodiments are merely illustrative of several implementations of the present invention, and while the descriptions are specific and detailed, they should not be construed as limiting the scope of the invention. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these modifications and improvements all fall within the scope of protection of the present invention.

Claims

1. A multi-column integrated biological fixation partial femoral head replacement device, characterized in that, This includes bone screws, auxiliary fixation devices, and joint prostheses; The bone screw has a first end and a second end that is inserted into the femoral neck medullary canal. The auxiliary fixation member is located on the side of the first end. The joint prosthesis is located at the end of the first end and the auxiliary fixation member opposite to the second end. The first end, the auxiliary fixation member and the joint prosthesis are integrally formed. The auxiliary fixation member has a first surface and a second surface that contact the femoral head after conical osteotomy. The first surface is located at one end of the auxiliary fixation member facing the second end to prevent sinking. The second surfaces are arranged in pairs on both sides of the auxiliary fixation member along the circumference of the first end to prevent lateral rotation. The joint prosthesis is used to replace the resected portion of the necrotic femoral head.

2. The multi-column integrated biological fixation partial femoral head replacement device according to claim 1, characterized in that, The first surface is provided with a reinforcing nail, which is perpendicular to the first surface, and the reinforcing nail is used to drive into the femoral head after a conical osteotomy.

3. The multi-column integrated biological fixation partial femoral head replacement device according to claim 2, characterized in that, The reinforcing stud has a plurality of wings arranged around the axis of the reinforcing stud, and the wings extend in a direction away from the axis of the reinforcing stud; and / or The reinforcing nails are provided in multiple quantities, and the multiple reinforcing nails are evenly distributed on the first surface.

4. The multi-column integrated biological fixation partial femoral head replacement device according to claim 1, characterized in that, The diameter of the bone screw is D1, 6mm≤D1≤18mm, to accommodate the largest or smallest diameter of the femoral neck in different individuals, in order to achieve stable fixation; and / or The bone screw extends beyond the auxiliary fixation member by a length L, where 0mm < L ≤ 80mm, to provide stable support for osteoporosis patients.

5. The multi-column integrated biological fixation partial femoral head replacement device according to claim 4, characterized in that, The bone nail is tapered, and the cross-sectional area of ​​the first end is larger than that of the second end. The cone angle of the bone nail is α, where 0° < α ≤ 45°.

6. The multi-column integrated biological fixation partial femoral head replacement device according to any one of claims 1-5, characterized in that, The bone screw is pyramidal in shape and is suitable for osteoporotic femoral heads; or The bone screw is conical in shape and is suitable for femoral heads without osteoporosis; or The surface of the bone screw is provided with multiple stepped portions to enhance pull-out resistance, and the multiple stepped portions are arranged along the length direction of the bone screw.

7. The multi-column integrated biological fixation partial femoral head replacement device according to claim 6, characterized in that, The surface of the bone screw is provided with a groove, which extends along the length of the bone screw.

8. The multi-column integrated biological fixation partial femoral head replacement device according to any one of claims 1-5, characterized in that, The joint prosthesis has an outwardly convex articular surface located at one end of the joint prosthesis opposite to the first end and the auxiliary fixation member. A flange is provided circumferentially at the edge of the articular surface, and the width of the flange increases with the severity of osteoporosis of the femoral head to prevent subsidence.

9. The multi-column integrated biological fixation partial femoral head replacement device according to claim 8, characterized in that, The articular surface is spherical, and its diameter is D2, 36mm≤D2≤58mm, to match patients of different heights and body types; or The articular surface is a non-spherical surface, and the articular surface is formed by simulating the defect and necrotic area based on the patient's imaging data. The surface of the articular surface is polished to form a wear-resistant layer.

10. The multi-column integrated biological fixation partial femoral head replacement device according to claim 9, characterized in that, The area of ​​the articular surface is less than 60% of the surface area of ​​the femoral head.

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