Solid structure, manufacturing method thereof and distal femur tumor type unicompartmental prosthesis

Abstract

The invention relates to the technical field of medical instruments, in particular to a solid structure, a manufacturing method of the solid structure and a distal femur tumor type unicondylar prosthesis, and the distal femur tumor type unicondylar prosthesis comprises the solid structure which comprises a modeling side and a connecting side. The modeling side has a solid form which is the same as the original skeleton form of the affected part of the patient; the bionic structure is arranged on the connecting side, the bionic structure is provided with a regular bone trabecula structure, the porosity of the bionic structure is 65%-75%, the bionic structure is provided with a thighbone fusion face used for making contact with an affected part of a patient, and the thighbone fusion face is a plane. The artificial bone prosthesis has the advantages that the artificial bone prosthesis fits the original bone form of a patient to the maximum extent, operative wounds are reduced, and the adaptability and postoperative comfort of the prosthesis are improved.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a solid structure and a manufacturing method thereof, and a distal femoral tumor-type unicompartmental prosthesis. Background Art

[0002] The knee joint is one of the largest joints in the human body, and it bears important functions such as supporting body weight, transmitting movement force, protecting the lower limbs, maintaining flexibility and buffering pressure. However, due to fractures, infections, bone tumors, genetic factors, metabolic diseases and other reasons, bone defects may occur in the knee joint, seriously affecting the patient's daily quality of life and mobility. Especially when the tumor involves one side of the condyle, the treatment methods of related technologies often cannot take into account both the treatment effect and postoperative functional recovery.

[0003] At present, there are two main conventional methods for the treatment of distal femoral bone defects: one is the traditional total knee replacement. Although this method can completely remove the lesion, due to the wide range of resection, it will not only destroy the normal bone joint surface, but also damage the normal anterior and posterior cruciate ligaments and collateral ligaments, resulting in severe limitation of joint function after surgery; the second is the application of 3D printed unicompartmental prosthesis, but the 3D printed unicompartmental universal prosthesis in the related technology is not flexible enough in intraoperative installation and application. Once the osteotomy is slightly deviated, the prosthesis cannot be flexibly adjusted and installed, which increases the difficulty and risk of the operation. Moreover, the unicompartmental universal prosthesis only wraps the condylar surface of the distal femur, and cannot cope with larger bone defects, especially complex defects caused by bone tumors. Secondly, the traditional unicompartmental prosthesis lacks an effective biological fixation structure, and the bone ingrowth effect is poor, which makes the prosthesis easy to loosen in the long term. In addition, the unicompartmental prosthesis in the related technology generally lacks the structure to connect and fix the tendon ligament, and cannot fully restore the stability and function of the knee joint, thus affecting the patient's postoperative quality of life. Summary of the invention

[0004] In order to fit the patient's original bone morphology to the greatest extent, reduce surgical trauma, and improve the adaptability and postoperative comfort of the prosthesis, the present application provides a solid structure and a manufacturing method thereof, and a distal femoral tumor-type unicompartmental prosthesis.

[0005] In the first aspect, the present application provides a physical structure, which adopts the following technical solution: A solid structure includes a shaping side, wherein the shaping side has a solid shape that is the same as the original bone shape of the patient's affected part.

[0006] By adopting the above technical solution, the physical structure can accurately simulate the original bone morphology of the distal femur of patients with distal femoral tumors, ensuring that the prosthesis can reproduce the original shape of the distal femur after cooperating with the patient's affected part, thereby improving the success rate of the operation and the patient's rehabilitation effect.

[0007] In a second aspect, the present application provides a distal femoral tumor-type unicompartmental prosthesis, which adopts the following technical solution: A distal femoral tumor-type unicompartmental prosthesis comprises the above-mentioned solid structure, wherein the solid structure further comprises a connection side; a bionic structure, wherein the bionic structure is arranged on the connection side, the bionic structure has a regular trabecular structure, and a porosity of 65%-75%, and the bionic structure has a femoral fusion surface for contacting the patient's affected part, wherein the femoral fusion surface is a plane.

[0008] By adopting the above technical solution, the regular trabecular structure of the bionic structure is conducive to the fusion and growth of bone cells, achieving a long-term stable fixation effect. In addition, the flat femoral fusion surface ensures a good contact area and improves the initial stability of the prosthesis.

[0009] Optionally, the distal femoral tumor-type unicompartmental prosthesis further includes a fixing assembly, which includes a steel plate, the steel plate is provided with a plurality of fixing holes, and the shaping side is provided with at least two first screw holes for cooperating with the fixing holes.

[0010] By adopting the above technical solution, at least two first screw holes for matching with the fixing holes are provided on the molding side, and a number of fixing holes are provided on the steel plate in the fixing assembly, part of which is used to match with the first screw hole, and the other part is used to match with the patient's femur, thereby achieving a stable connection between the distal femoral tumor-type unicompartmental prosthesis and the patient's remaining bone. This design not only provides flexibility in intraoperative installation, and can be flexibly adjusted in the event of a slight deviation in osteotomy, increasing the fault tolerance of the operation, but also ensures the stable fixation of the prosthesis in the early postoperative period, which is helpful for the patient's recovery. In addition, the cooperation between the steel plate and the first screw hole enhances the overall structural strength of the prosthesis, providing a reliable structural foundation for long-term stable fixation.

[0011] Optionally, the fixation assembly further includes a fixation pin, the solid structure is provided with a plurality of first fixation pin holes, the bionic structure is provided with a second fixation pin hole matching the first fixation pin holes, the fixation pin simultaneously passes through the first fixation pin hole and the second fixation pin hole and is connected to the remaining bone of the patient.

[0012] By adopting the above technical solution, the fixing pin makes the connection between the prosthesis and the remaining bone of the patient more secure. Specifically, the multiple first fixing pin holes on the physical structure match the second fixing pin holes on the bionic structure, and the fixing pins penetrate the two holes at the same time and connect with the remaining bone of the patient, which effectively improves the initial stability of the prosthesis, reduces installation problems caused by osteotomy errors, and improves the success rate of the operation. In addition, the friction between the fixing pin and the remaining bone of the patient also helps to promote the growth and fusion of bone cells, enhance the long-term stability of the prosthesis, and thus better restore the patient's knee joint function.

[0013] Optionally, the shaping side is provided with a suture hole group, and the suture hole group is used to pass sutures, and the sutures are used to provide attachment points for tendons and ligaments.

[0014] By adopting the above technical solution, the prosthesis can better restore the patient's joint mobility after surgery, ensure the normal function of muscles and ligaments, and improve the patient's rehabilitation effect.

[0015] Optionally, the suture hole group includes two front suture holes connected to each other and two rear suture holes connected to each other, the line connecting the two front suture holes is perpendicular to the extension direction of the femur, the line connecting the two rear suture holes is perpendicular to the extension direction of the femur, and the two rear suture holes are arranged at the distal ends of the two front suture holes.

[0016] By adopting the above technical solution, the sutures passed through the front suture holes can better fix the anterior cruciate ligament, and the sutures passed through the rear suture holes can better fix the posterior cruciate ligament, thereby enhancing the fixation effect of the prosthesis and the surrounding soft tissues, effectively restoring the patient's joint mobility, and improving postoperative function.

[0017] Optionally, the suture hole group includes two suture holes that are interconnected, and a connecting line of the two suture holes is parallel to the surface contour of the affected half of the femoral condyle of the patient.

[0018] By adopting the above technical solution, the sutures passed through the side suture holes can better fix the collateral ligaments, thereby enhancing the fixation effect of the prosthesis and the surrounding soft tissues, effectively restoring the patient's joint range of motion, and improving postoperative function.

[0019] In a third aspect, the present application provides a method for manufacturing a physical structure, using the following technical solution: A method for manufacturing a solid structure comprises the following steps: S1. Collecting model image data of the condylar distal femur of the patient on the healthy side and the affected side, and importing the obtained image data into three-dimensional reconstruction software for image processing operations, to establish models of the condylar distal femur of the patient on the healthy side and the affected side, as well as a patient tumor model; S2, importing the model of the affected side of the patient's distal femur and the patient's tumor model obtained in step S1 into the simulation module of the three-dimensional modeling software for superposition and comparison observation, determining the tumor boundary and osteotomy range, and performing a simulated osteotomy operation on the affected side of the model of the distal femur in the simulation module; S3, importing the models of the unicondylar distal femur of the patient on the healthy side and the affected side obtained in step S1 into the simulation module of the three-dimensional modeling software for superposition and comparison, and reversely fusing to establish a 3D customized unicondylar prosthesis model that matches the original bone morphology of the unicondylar distal femur of the patient on the affected side; S4, matching the 3D customized unicompartmental prosthesis model obtained in step S3 with the model of the distal unicompartmental femur on the affected side that has completed the simulated osteotomy operation obtained in step S2, and simulating the range of motion of the joint. If the expected design goal is achieved, proceed to step S7; if the analysis result does not achieve the expected design goal, return to step S2; S5. Import the 3D customized unicompartmental prosthesis model obtained in step S3 into a 3D printing terminal to complete the printing of the physical structure.

[0020] By adopting the above technical solution, it is possible to accurately match the bone morphology of the healthy side and the affected side of the patient according to the patient's CT and MRI imaging data, and generate a 3D customized unicompartmental prosthesis model. This method can ensure that the prosthesis fits the patient's original bone morphology to the greatest extent, thereby improving the success rate of the operation and the patient's rehabilitation effect. Specifically, through the image processing and three-dimensional modeling of steps S1-S3, the accurate matching of the prosthesis and the patient's affected part is ensured, and the installation problems caused by osteotomy deviation are avoided. The simulated joint range of motion test in step S4 ensures the functionality of the prosthesis in actual application, thereby improving the safety and effectiveness of the operation. Finally, through the 3D printing of step S5, the rapid manufacturing of personalized customized prostheses is achieved, which shortens the surgical preparation time and reduces medical costs.

[0021] In summary, the present application includes at least one of the following beneficial technical effects: 1. The physical structure of the distal femoral tumor-type unicompartmental prosthesis is customized by 3D printing based on the patient's CT and MRI imaging data, which can fit the patient's original bone morphology to the greatest extent, reduce surgical trauma, and improve the adaptability of the prosthesis and postoperative comfort; 2. The fixed component is designed so that the prosthesis can be flexibly adjusted in position even if there is a slight osteotomy deviation during the operation, which increases the surgical tolerance and improves the success rate of the operation; 3. The contact surface between the prosthesis and the bone adopts a regular trabecular structure, which is conducive to the fusion and growth of bone cells, enhances the long-term fixation effect of the prosthesis, and reduces the risk of prosthesis loosening; 4. A suture hole group is designed on the surface as the attachment point of tendons and ligaments to maximize the restoration of the patient's joint mobility and improve the stability and function of the joint after surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 It is a schematic diagram of the structure of the distal femoral tumor-type unicompartmental prosthesis provided in an embodiment of the present application matching with the patient's femur.

[0023] Figure 2 It is a schematic diagram of the structure of the distal femoral tumor-type unicompartmental prosthesis provided in an embodiment of the present application.

[0024] Explanation of the reference numerals: 1-physical structure; 101-first fixing pin hole; 102-front suture hole; 103-rear suture hole; 104-side suture hole; 2-bionic structure; 3-steel plate; 301-fixing hole; 4-fixing pin. DETAILED DESCRIPTION

[0025] The following is combined with Figure 1-2 This application is described in further detail.

[0026] The embodiment of the present application discloses a physical structure.

[0027] like Figure 1 and Figure 2 As shown, the solid structure 1 includes a shaping side, and the shaping side has a solid shape consistent with the original bone shape of the patient's affected part. The solid structure 1 can accurately simulate the original bone shape of the distal femur of patients with distal femoral tumors, ensuring that the prosthesis can reproduce the original shape of the distal femur after matching with the patient's affected part, thereby improving the success rate of the operation and the patient's rehabilitation effect.

[0028] The embodiment of the present application also discloses a distal femoral tumor-type unicompartmental prosthesis.

[0029] like Figure 1 and Figure 2 As shown, the distal femoral tumor-type unicompartmental prosthesis includes the above-mentioned solid structure 1, which also includes a connection side; a bionic structure 2, which is arranged on the connection side, and has a regular trabecular structure, and a porosity of 65%-75%. The bionic structure has a femoral fusion surface for contacting the patient's affected part, and the femoral fusion surface is a plane. The trabecular structure of the bionic structure 2 is conducive to promoting the fusion and growth of bone cells, thereby achieving a long-term and stable fixation effect. At the same time, the femoral fusion surface in the bionic structure 2 is designed to be a plane, which ensures sufficient contact with the patient's affected part, thereby enhancing the initial stability of the prosthesis.

[0030] like Figure 1 and Figure 2As shown, the distal femoral tumor type unicompartmental prosthesis also includes a fixing assembly, which includes a steel plate 3, on which a plurality of fixing holes 301 are provided, and at least two first screw holes for matching with the fixing holes 301 are provided on the shaping side. The first screw hole on the shaping side is used to match the fixing hole 301 on the steel plate 3 in the fixing assembly, and at least two first screw holes can limit the steel plate 3 and the prosthesis. In addition to the part used to match with the first screw hole, the other part of the fixing hole 301 on the steel plate 3 is used to match with the patient's femur, thereby achieving a stable connection between the distal femoral tumor type unicompartmental prosthesis and the patient's remaining bone. This design not only provides installation flexibility during surgery, so that it can be flexibly adjusted when there is a slight deviation in the osteotomy, thereby improving the fault tolerance of the surgery, but also ensures the stable fixation of the prosthesis in the early postoperative period, which is beneficial to the patient's rehabilitation. In addition, the cooperation between the steel plate 3 and the first screw hole enhances the overall structural strength of the prosthesis, providing a solid structural foundation for long-term stable fixation.

[0031] like Figure 1 and Figure 2 As shown, the fixing assembly also includes a fixing pin 4, a plurality of first fixing pin holes 101 are provided on the physical structure 1, and a second fixing pin hole matching the first fixing pin hole 101 is provided on the bionic structure, and the fixing pin 4 simultaneously penetrates the first fixing pin hole 101 and the second fixing pin hole and is connected to the remaining bone of the patient. The use of the fixing pin 4 can significantly enhance the connection stability between the prosthesis and the residual bone of the patient. Specifically, the plurality of first fixing pin holes 101 configured on the physical structure 1 match the second fixing pin hole on the bionic structure 2, and the fixing pin 4 penetrates the two holes and is tightly combined with the residual bone of the patient, thereby effectively improving the initial stability of the prosthesis. This reduces the installation problems caused by osteotomy errors, thereby improving the success rate of the operation. In addition, the friction between the fixing pin 4 and the residual bone of the patient also helps to promote the growth and fusion of bone cells, thereby enhancing the long-term stability of the prosthesis and further optimizing the patient's knee joint function recovery.

[0032] like Figure 1 and Figure 2 As shown, a suture hole group is provided on the shaping side, and the suture hole group is used to pass sutures, and the sutures are used to provide attachment points for tendons and ligaments. Specifically, the suture hole group includes two front suture holes 102 that are interconnected, two rear suture holes 103 that are interconnected, and two side suture holes 104 that are interconnected. The line connecting the two front suture holes 102 is perpendicular to the extension direction of the femur, and the line connecting the two rear suture holes 103 is perpendicular to the extension direction of the femur, and the two rear suture holes 103 are arranged at the distal ends of the two front suture holes 102. The line connecting the two side suture holes 104 is parallel to the surface contour of the patient's affected half femoral condyle.

[0033] The sutures passing through the front suture hole 102 are used to provide attachment points for the anterior cruciate ligament, and the sutures passing through the rear suture hole 103 at the distal end (the distal end here refers to the one that is farther away from the heart) are used to provide attachment points for the posterior cruciate ligament, thereby improving the bonding strength between the prosthesis and the adjacent soft tissues, effectively promoting the recovery of the patient's joint mobility, and improving postoperative functional performance. Similarly, the sutures passing through the side suture holes 104 are used to provide attachment points for the collateral ligaments, further strengthening the bonding between the prosthesis and the surrounding soft tissues, helping to restore the patient's joint mobility, and improving postoperative functional performance.

[0034] The implementation principle of a distal femoral tumor-type unicompartmental prosthesis of the present application embodiment is as follows: the distal femoral tumor-type unicompartmental prosthesis includes a solid structure 1 and a bionic structure 2. The solid structure 1 can accurately simulate the original bone morphology of the distal femur of patients with distal femoral tumors, ensuring that the prosthesis can reproduce the original shape of the distal femur after cooperating with the patient's affected part, thereby improving the patient's rehabilitation effect. The bionic structure 2 has a regular trabecular structure that is conducive to the fusion and growth of bone cells and achieves long-term stable fixation. At the same time, the femoral fusion surface of the bionic structure 2 is a plane to ensure full contact with the patient's affected part and enhance initial stability. The fixing component ensures the stable fixation of the prosthesis in the early postoperative period, which is helpful for the patient's rehabilitation. At the same time, it can stimulate the patient's remaining bone, which helps promote the growth and fusion of bone cells and enhance the long-term stability of the prosthesis. A suture hole group is provided on the modeling side for threading sutures, providing attachment points for tendons and ligaments, improving the bonding strength between the prosthesis and adjacent soft tissues, promoting the recovery of joint mobility, and improving postoperative functional performance.

[0035] The present application also discloses a method for manufacturing a physical structure 1, comprising the following steps: S1. Collecting model image data of the condylar distal femur of the patient on the healthy side and the affected side, and importing the obtained image data into three-dimensional reconstruction software for image processing operations, to establish models of the condylar distal femur of the patient on the healthy side and the affected side, as well as a patient tumor model; S2, importing the model of the affected side of the patient's distal femur and the patient's tumor model obtained in step S1 into the simulation module of the three-dimensional modeling software for superposition and comparison observation, determining the tumor boundary and osteotomy range, and performing a simulated osteotomy operation on the affected side of the model of the distal femur in the simulation module; S3, importing the models of the unicondylar distal femur of the patient on the healthy side and the affected side obtained in step S1 into the simulation module of the three-dimensional modeling software for superposition and comparison, and reversely fusing to establish a 3D customized unicondylar prosthesis model that matches the original bone morphology of the unicondylar distal femur of the patient on the affected side; S4, matching the 3D customized unicompartmental prosthesis model obtained in step S3 with the model of the distal unicompartmental femur on the affected side that has completed the simulated osteotomy operation obtained in step S2, and simulating the range of motion of the joint. If the expected design goal is achieved, proceed to step S7; if the analysis result does not achieve the expected design goal, return to step S2; S5. Import the 3D customized unicompartmental prosthesis model obtained in step S3 into the 3D printing terminal to complete the printing of the entity structure 1.

[0036] The above are all preferred embodiments of the present application, and the protection scope of the present application is not limited thereto. Therefore, any equivalent changes made according to the structure, shape, and principle of the present application should be included in the protection scope of the present application.

Claims

1. A physical structure for simulating the original bone morphology of the distal femur of a patient with a distal femur tumor, characterized in that: include: The modeling side has a physical shape that is the same as the original bone shape of the patient's affected part.

2. A distal femoral tumor-type unicompartmental prosthesis, characterized in that: include: The entity structure (1) according to claim 1, further comprising a connection side; A bionic structure (2), wherein the bionic structure (2) is arranged on the connection side, the bionic structure (2) has a regular trabecular structure and a porosity of 65%-75%, and the bionic structure has a femoral fusion surface for contacting the patient's affected part, and the femoral fusion surface is a plane.

3. The distal femoral tumor-type unicompartmental prosthesis according to claim 2, characterized in that: The distal femoral tumor-type unicompartmental prosthesis also includes a fixing assembly, which includes a steel plate (3), on which a plurality of fixing holes (301) are provided, and the shaping side is provided with at least two first screw holes for matching with the fixing holes (301).

4. The distal femoral tumor-type unicompartmental prosthesis according to claim 3, characterized in that: The fixing assembly also includes a fixing pin (4), the solid structure (1) is provided with a plurality of first fixing pin holes (101), the release structure is provided with a second fixing pin hole matching the first fixing pin hole (101), and the fixing pin (4) simultaneously passes through the first fixing pin hole (101) and the second fixing pin hole and is connected to the remaining bone of the patient.

5. The distal femoral tumor-type unicompartmental prosthesis according to claim 2, characterized in that: The shaping side is provided with a suture hole group, and the suture hole group is used for passing sutures, and the sutures are used to provide attachment points for tendons and ligaments.

6. The distal femoral tumor-type unicompartmental prosthesis according to claim 5, characterized in that: The suture hole group comprises two front suture holes (102) connected to each other and two rear suture holes (103) connected to each other, the line connecting the two front suture holes (102) is perpendicular to the extension direction of the femur, the line connecting the two rear suture holes (103) is perpendicular to the extension direction of the femur, and the two rear suture holes (103) are arranged at the distal ends of the two front suture holes (102).

7. The distal femoral tumor-type unicompartmental prosthesis according to claim 5, characterized in that: The suture hole group comprises two suture holes (104) that are interconnected, and the connecting line of the two suture holes (104) is parallel to the surface contour of the affected half of the femoral condyle of the patient.

8. A method for manufacturing a physical structure (1), characterized in that: Used to manufacture the entity structure (1) as claimed in claim 1, the manufacturing method comprising: S1. Collecting model image data of the condylar distal femur of the patient on the healthy side and the affected side, and importing the obtained image data into three-dimensional reconstruction software for image processing operations, to establish models of the condylar distal femur of the patient on the healthy side and the affected side, as well as a patient tumor model; S2, importing the model of the affected side of the patient's distal femur and the patient's tumor model obtained in step S1 into the simulation module of the three-dimensional modeling software for superposition and comparison observation, determining the tumor boundary and osteotomy range, and performing a simulated osteotomy operation on the affected side of the model of the distal femur in the simulation module; S3, importing the models of the unicondylar distal femur of the patient on the healthy side and the affected side obtained in step S1 into the simulation module of the three-dimensional modeling software for superposition and comparison, and reversely fusing to establish a 3D customized unicondylar prosthesis model that matches the original bone morphology of the unicondylar distal femur of the patient on the affected side; S4, matching the 3D customized unicompartmental prosthesis model obtained in step S3 with the model of the distal unicompartmental femur on the affected side that has completed the simulated osteotomy operation obtained in step S2, and simulating the range of motion of the joint. If the expected design goal is achieved, proceed to step S7; if the analysis result does not achieve the expected design goal, return to step S2; S5. Import the 3D customized unicompartmental prosthesis model obtained in step S3 into a 3D printing terminal to complete the printing of the physical structure (1).

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