A personalized surgical device for femoral head replacement and a manufacturing system thereof

Abstract

The present invention provides a personalized surgical device for femoral head replacement and a manufacturing system thereof, which relates to the technical field of femoral head replacement surgery. The device mainly includes a contoured rotary file, a prosthesis positioning guide plate, a prosthesis trial mold, a bracket, a guide rod and an arc drill; the contoured rotary file is used to file and remove cartilage on the diseased bone tissue; the prosthesis positioning guide plate is an annular structure, and its bottom surface is used to be positioned at the periphery of the necrotic bone, and its top surface is used to position the bottom edge of the prosthesis trial mold; the prosthesis trial mold is a bowl-shaped structure, and its bottom is provided with a customized bone interface for fitting the dividing surface between the necrotic bone and the healthy bone; the bottom of the prosthesis trial mold is provided with a first positioning hole and a second positioning hole. This solution can manufacture personalized femoral head replacement surgical tools according to the femoral head shapes of different patients, can effectively complete the feasibility verification of the repair prosthesis, and can greatly improve the efficiency, effect and accuracy of the operation.

Description

Technical Field

[0001] The invention relates to the technical field of femoral head replacement surgery, and in particular to a personalized surgical device for femoral head replacement and a manufacturing system thereof. Background Art

[0002] In some femoral head replacement surgeries, precise surgical operations are crucial to improving the accuracy of prosthesis implantation, reducing surgical trauma, and improving the recovery of hip joint function in patients after surgery. Traditional surgical devices often adopt standardized designs, which are difficult to fully adapt to the unique anatomical differences of different patients, resulting in problems such as prosthesis positioning deviation and excessive cutting of bone tissue during surgery. With the rapid development of digital technology and medical imaging technology, the research and development of personalized surgical devices has become an important trend in the field of orthopedic surgery. However, personalized surgical devices specifically for some femoral head replacement surgeries still need further innovation and improvement to further improve surgical efficiency and accuracy. Summary of the invention

[0003] The object of the present invention is to provide a personalized surgical device for femoral head replacement and a manufacturing system thereof, so as to solve at least one of the above-mentioned technical problems existing in the prior art.

[0004] In the first aspect, in order to solve the above technical problems, the present invention provides a personalized surgical device for femoral head replacement, which mainly includes a contoured rotary file, a prosthesis positioning guide plate, a prosthesis trial mold, a bracket, a guide rod and an arc drill;

[0005] The profiling rotary file is used for filing and removing cartilage on the diseased bone tissue so as to form a surgical base area; the profiling rotary file is provided with a central through hole for radial positioning in cooperation with a guide rod; the cutter head of the profiling rotary file is a disc-shaped structure, and a profiling filing surface is provided on the top surface of the disc-shaped structure for fitting the surface of the necrotic bone; thus, it is helpful to achieve the technical purpose of filing the diseased bone tissue of the femoral head by a single tool under the condition of one feeding, thereby significantly improving the filing efficiency and effect, quickly processing the surgical base area, and retaining healthy bone tissue to the maximum extent, which is beneficial to improve the matching degree of the prosthesis positioning guide plate, the prosthesis trial mold and the femoral head in the subsequent processing, and saves time and improves the success rate for the final repair prosthesis implantation operation;

[0006] The prosthesis positioning guide is an annular structure, and a first handle is provided at a side wall of one end of the prosthesis positioning guide for the surgical operator to grasp; the bottom surface of the prosthesis positioning guide is used to locate the periphery of the necrotic bone; the top surface of the prosthesis positioning guide is used to locate the bottom edge of the prosthesis trial mold;

[0007] The bracket is in an L-shaped structure. Its short arm end is fixed to the side wall of the prosthesis positioning guide plate away from the first handle. Its long arm end is provided with a through hole for radial positioning in cooperation with the guide rod. The through hole is parallel and concentric with the prosthesis positioning guide plate.

[0008] The prosthesis trial mold is in a bowl-shaped structure. Its bottom is provided with a customized bone interface for fitting the segmentation surface between the necrotic bone and the healthy bone. The bottom of the prosthesis trial mold is provided with a first positioning hole and a second positioning hole. The first positioning hole is set at the center of the prosthesis trial mold for radial positioning in cooperation with the guide rod. A through slot is provided from the first positioning hole to the edge of the prosthesis trial mold for the guide rod to enter or move away from the first positioning hole radially. The second positioning hole is set around the first positioning hole for radial positioning of the bone marrow drill for punching the femoral head. One end of the prosthesis trial mold is also provided with a second handle for the surgical operator to grasp.

[0009] The arc drill is used to file and shape the customized bone interface, so as to customize the prosthesis trial mold during the trial mold operation, so as to reach the preset implantation position and provide verification for the implantation feasibility of the subsequent repair prosthesis.

[0010] In this way, through the above personalized surgical device, femoral head replacement surgery can be performed for different patients' femoral head morphologies using special tools.

[0011] In a feasible implementation manner, a plurality of file teeth diverging from the central through hole are evenly distributed on the profiling filing surface to improve the filing efficiency.

[0012] In a feasible implementation manner, the top surface of the prosthesis positioning guide plate is the preset width edge contour of the customized bone interface, obtained by offsetting and magnifying by 0.1 - 0.5 mm, so that the prosthesis trial mold can be installed and positioned on the prosthesis positioning guide plate.

[0013] In a feasible implementation manner, the short arm end of the bracket is fixed to the side wall of the prosthesis positioning guide plate away from the first handle by threaded connection.

[0014] In a feasible implementation manner, the customized bone interface is a grid structure, and the pore diameter of the grid is 0.5 - 1 mm. It can be processed by additive manufacturing methods such as 3D printing, and is beneficial for the surgical operator to quickly and intuitively observe the interference points between the customized bone interface and the surgical base area through the grid holes and then mark them, so as to file and process and shape the interference points and other positions in the subsequent process.

[0015] In a feasible embodiment, the customized bone interface is 0.1-0.3 mm smaller than the bone interface offset of the repair prosthesis. In this way, after the customized bone interface is exactly matched with the femoral head, when the repair prosthesis is formally implanted, a tight fit effect between the repair prosthesis and the femoral head is achieved.

[0016] In a feasible embodiment, the diameter of the second positioning hole is slightly smaller than the diameter of the extended handle of the repair prosthesis to achieve press-fitting, thereby more accurately guiding the repair prosthesis to enter the implantation position at a correct angle.

[0017] In a feasible embodiment, a positioning pin is provided at the center of the top of the blade head of the arc drill to facilitate positioning in the pores of the customized bone interface, thereby facilitating the shaping operation.

[0018] In a feasible implementation manner, a plurality of cutting edges are evenly distributed from the center of the top of the cutter head of the arc drill toward the periphery, thereby facilitating improving the shaping efficiency.

[0019] In a possible implementation, the outer contour of the arc drill includes different sphere diameters to adapt to different pores and interference points.

[0020] In the second aspect, based on the same inventive concept, the present application also provides a manufacturing system for manufacturing the above-mentioned personalized surgical device, which mainly includes: a data acquisition and analysis module, a surgical instrument design module and a surgical instrument manufacturing module;

[0021] The data acquisition and analysis module includes a medical image acquisition unit and a medical image processing unit;

[0022] The medical image acquisition unit is used to acquire image data of the patient's hip joint, including the morphological structure of the femoral head, acetabulum, proximal femur and other parts;

[0023] The medical image processing unit is used to perform image segmentation, registration and three-dimensional reconstruction on the image data to obtain a three-dimensional model of the patient's femoral head, and then measure key parameters through an image recognition method to provide accurate data support for subsequent calculations; the key parameters include the location, range, shape of the necrotic bone and the density and thickness of the healthy bone (bone tissue surrounding the necrotic bone);

[0024] The surgical instrument design module includes a contour rotary file design unit, a prosthesis positioning guide plate design unit and a prosthesis trial mold design unit;

[0025] The profiling rotary file design unit is used to extract a first curved surface as a profiling filing surface of the profiling rotary file according to the three-dimensional model of the femoral head and the key parameters, and generate a profiling rotary file manufacturing model in combination with a preset three-dimensional model of the profiling rotary file body; the first curved surface refers to a curved surface defined on the spherical surface of the femoral head with the maximum arc surface occupied by the necrotic bone as the range; in this way, it is convenient to automatically design an integrated filing tool that can cover the current necrotic bone and fit the surface of the femoral head;

[0026] The prosthesis positioning guide design unit is used to extract the second curved surface as the bottom surface of the prosthesis positioning guide and the third curved surface as the top surface of the prosthesis positioning guide according to the three-dimensional model of the femoral head and the key parameters, and generate a prosthesis positioning guide manufacturing model in combination with the preset three-dimensional model of the prosthesis positioning guide body; the second curved surface refers to the curved surface encircled on the spherical surface of the femoral head along the periphery of the necrotic bone with a concentric arc band of a preset diameter as the range; the third curved surface refers to the preset width edge contour of the dividing surface between the necrotic bone and the healthy bone; in this way, it is convenient to automatically design a contact positioning surface that can fit the periphery of the current necrotic bone, for the prosthesis positioning guide to provide positioning support, which is conducive to improving the stability of the prosthesis positioning guide during surgery;

[0027] The prosthesis trial mold design unit is used to extract a fourth curved surface as a customized bone interface of the prosthesis trial mold according to the three-dimensional model of the femoral head and the key parameters, and generate a prosthesis trial mold manufacturing model in combination with a preset three-dimensional model of the prosthesis trial mold body; the fourth curved surface refers to a segmentation curved surface between necrotic bone and healthy bone; in this way, it is convenient to automatically design a customized bone interface of the prosthesis trial mold;

[0028] The surgical instrument manufacturing module includes a contouring rotary file manufacturing unit, a prosthesis positioning guide plate manufacturing unit and a prosthesis trial mold manufacturing unit;

[0029] The profiling rotary file manufacturing unit is used to generate a machining program based on the profiling rotary file manufacturing model through a computer-aided manufacturing tool (such as UG) so as to be subsequently input into a machining center to automatically process the profiling rotary file;

[0030] The prosthesis positioning guide manufacturing unit is used to generate an additive manufacturing (e.g. 3D printing) program according to the prosthesis positioning guide manufacturing model (e.g. XT format) through a computer slicing tool (e.g. Cura), so as to automatically manufacture the prosthesis positioning guide through the additive manufacturing equipment later;

[0031] The prosthesis trial mold manufacturing unit is used to generate an additive manufacturing program based on the prosthesis trial mold manufacturing model through a computer slicing tool, so as to automatically manufacture the prosthesis trial mold through additive manufacturing equipment later.

[0032] Through the above system, a personalized surgical device for femoral head replacement can be manufactured conveniently, quickly and accurately.

[0033] In a feasible implementation manner, the image data is CT data or MRI data in a preset format (eg, DICOM).

[0034] In a feasible implementation, the specific method for obtaining the patient's femoral head three-dimensional model includes:

[0035] Step a1: Based on the image data, a bone mask is created by using a medical image processing tool, and the bone density threshold is set in the range of 226-1826 to identify all cancellous bones and cortical bones;

[0036] Step a2, manually identifying necrotic bone in the femoral head;

[0037] Step a3, separating the necrotic bone from the healthy bone layer by layer through the segmentation line;

[0038] Step a4: solidify the necrotic bone and the healthy bone respectively to generate an STL format model.

[0039] In a feasible implementation, the additive manufacturing procedure includes printing layer thickness, printing speed, laser power, etc.

[0040] By adopting the above technical solution, the present invention has the following beneficial effects:

[0041] The present invention provides a personalized surgical device for femoral head replacement and a manufacturing system thereof, which can manufacture personalized femoral head replacement surgical tools according to the femoral head shapes of different patients, can effectively complete the feasibility verification of the repair prosthesis, and can greatly improve the efficiency, effect and accuracy of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings in the following description are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0043] Figure 1 A simplified diagram of an application scenario of a contour rotary file provided in an embodiment of the present invention;

[0044] Figure 2 A three-dimensional diagram of a contoured rotary file provided by an embodiment of the present invention;

[0045] Figure 3 for Figure 2 Bottom view of

[0046] Figure 4 A diagram illustrating the main dimensions of a contoured rotary file provided in an embodiment of the present invention;

[0047] Figure 5 A three-dimensional diagram of the assembly of a prosthesis positioning guide plate, a prosthesis trial mold, a bracket and a guide rod provided in an embodiment of the present invention;

[0048] Figure 6 for Figure 5 A side cross-sectional view of

[0049] Figure 7 for Figure 5 A simplified diagram of the side cross-section application scenario;

[0050] Figure 8 A three-dimensional diagram of a prosthesis positioning guide provided by an embodiment of the present invention;

[0051] Fig. 9 for Figure 8 A top view of

[0052] Fig.10 A three-dimensional diagram of a prosthesis trial mold provided by an embodiment of the present invention;

[0053] Fig.11 for Fig.10 A side cross-sectional view of

[0054] Fig.12 A simplified diagram of an application scenario of the arc drill provided by an embodiment of the present invention;

[0055] Fig.13 A side view of a curved drill provided by an embodiment of the present invention;

[0056] Fig.14 A diagram of a manufacturing system for manufacturing the above-mentioned personalized surgical device provided by an embodiment of the present invention;

[0057] Fig.15 An example diagram of the design of the second positioning hole of the prosthesis trial mold provided by an embodiment of the present invention;

[0058] Fig.16 An example diagram of image data provided by an embodiment of the present invention;

[0059] Fig.17 An example diagram of creating a skeleton mask provided by an embodiment of the present invention;

[0060] Fig.18 An example diagram of identifying necrotic bone in the femoral head provided by an embodiment of the present invention;

[0061] Fig.19 An example diagram of a dividing line provided in an embodiment of the present invention;

[0062] Fig. 20 This is an example diagram of an STL format model provided by an embodiment of the present invention.

[0063] Reference numerals:

[0064] 1-contour rotary file; 11-center through hole; 12-file teeth; 2-prosthesis positioning guide; 21-first handle; 22-bottom surface; 23-top surface; 24-threaded hole; 3-prosthesis trial mold; 31-second handle; 32-customized bone interface; 33-first positioning hole; 34-second positioning hole; 35-through slot; 4-bracket; 5-guide rod; 6-arc drill; 61-positioning pin; 62-cutting edge. DETAILED DESCRIPTION

[0065] The technical solution of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only 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.

[0066] In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only, and cannot be understood as indicating or implying relative importance.

[0067] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0068] The present invention is further explained below in conjunction with specific implementation modes.

[0069] It should also be noted that the following specific embodiments or specific implementations are a series of optimized settings listed in the present invention to further explain the specific content of the invention, and these settings can be used in combination or in association with each other.

[0070] Example 1:

[0071] As Figure 1-13 shown, a personalized surgical device for femoral head replacement provided in this embodiment mainly includes a profiling rotary burr 1, a prosthesis positioning guide plate 2, a prosthesis trial mold 3, a bracket 4, a guide rod 5 and an arc drill 6;

[0072] The profiling rotary burr 1, as Figure 1 shown, is used to file and remove the cartilage on the diseased bone tissue so as to machine and form the surgical basic area; as Figure 2 shown, the profiling rotary burr 1 is provided with a central through hole 11 for radial positioning in cooperation with the guide rod 5; the cutter head of the profiling rotary burr 1 is a disc-shaped structure, and a profiling filing surface is arranged on the top surface of the disc-shaped structure for filing in contact with the surface of the necrotic bone; as Figure 3 shown, a plurality of file teeth 12 diverging outward from the central through hole 11 are evenly distributed on the profiling filing surface so as to improve the filing efficiency; in this way, after determining the key dimensions such as the filing angle and the inner ball diameter of the filing, the profiling rotary burr 1 can be customized, as Figure 4 shown, it can help to achieve the technical purpose of filing the diseased bone tissue of the femoral head with one tool under the condition of one feed, thereby significantly improving the filing efficiency and effect, quickly machining the surgical basic area, and can retain the healthy bone tissue to the greatest extent. Furthermore, it is beneficial to improve the matching degree of the prosthesis positioning guide plate, the prosthesis trial mold and the femoral head during the subsequent treatment, and saves time for the final repair prosthesis implantation surgery and improves the success rate;

[0073] As Figure 5-7 shown, the prosthesis positioning guide plate 2 is a ring structure, and a first handle 21 is arranged at one end side wall of the prosthesis positioning guide plate 2 for the surgical operator to grasp; the bottom surface 22 of the prosthesis positioning guide plate 2 is used to be positioned at the periphery of the necrotic bone; the top surface 23 of the prosthesis positioning guide plate is used to position the bottom edge of the prosthesis trial mold 3;

[0074] The bracket 4 is an L-shaped structure, its short arm end is fixed to one end side wall of the prosthesis positioning guide plate 2 far from the first handle 21, and its long arm end is provided with a through hole for radial positioning in cooperation with the guide rod 5; the through hole is parallel and concentric with the prosthesis positioning guide plate 2;

[0075] As Figure 10-11 shown, the prosthesis trial mold 3 is a bowl-shaped structure, and a customized bone interface 32 is arranged at its bottom for fitting the dividing surface between the necrotic bone and the healthy bone; the bottom of the prosthesis trial mold 3 is provided with a first positioning hole 33 and a second positioning hole 34; the first positioning hole 33 is arranged at the center of the prosthesis trial mold 3 for radial positioning in cooperation with the guide rod 5; as Figure 5As shown, a through slot 35 is provided from the first positioning hole 33 to the edge of the prosthesis trial mold 3 (in this embodiment, the diameter of the first positioning hole 33 is consistent with the width of the through slot 35), which is used to make the guide rod 5 radially enter or move away from the first positioning hole 33; the number of the second positioning holes 34 is 2, which are symmetrically arranged on both sides of the first positioning hole 33, and the connecting line between the two second positioning holes 34 is perpendicular to the axis of the through slot 35, which is used for radial positioning of the intramedullary drill (not shown in the figure) for drilling the femoral head; a second handle 31 is also provided at one end of the prosthesis trial mold 3 for the surgical operator to grasp;

[0076] like Fig.12 As shown, the arc drill 6 is used to file and shape the customized bone interface 32, so that during the trial mold operation, the prosthesis trial mold 3 can be customized and shaped to reach the preset implantation position, providing verification for the feasibility of implantation of the subsequent repair prosthesis (not shown in the figure);

[0077] In this way, through the above-mentioned personalized surgical device, femoral head replacement surgery can be performed using special tools according to the femoral head morphology of different patients.

[0078] Furthermore, the top surface 23 of the prosthesis positioning guide 2 is the preset width edge contour of the customized bone interface 32 , which is offset and enlarged by 0.1-0.5 mm, so that the prosthesis trial mold 3 can be installed on the prosthesis positioning guide 2 .

[0079] Furthermore, the short arm end of the bracket 4 is fixed to the threaded hole 24 of the side wall of the prosthesis positioning guide plate 2 away from the first handle 21 through a threaded connection, such as Figure 6-9 shown.

[0080] Furthermore, if Figure 11-12 As shown, the customized bone interface 32 is a dense, light-transmitting grid structure with a mesh aperture of 0.5 to 1 mm, which can be processed by additive manufacturing methods such as 3D printing, and is beneficial for surgical operators to quickly and intuitively observe the interference points between the customized bone interface 32 and the surgical base area through the grid holes and then mark them, so that the interference points and other positions can be filed and reshaped later.

[0081] Furthermore, the customized bone interface 32 is 0.1-0.3 mm smaller than the bone interface offset of the repair prosthesis. In this way, after the customized bone interface 32 is exactly matched with the femoral head, when the repair prosthesis is formally implanted, a tight fit effect between the repair prosthesis and the femoral head is achieved.

[0082] Furthermore, the diameter of the second positioning hole 34 is 0.2-0.5 mm smaller than the diameter of the extended handle of the repair prosthesis, so as to achieve press-fitting during the subsequent implantation of the repair prosthesis and more accurately guide the repair prosthesis to enter the implantation position at a correct angle.

[0083] Furthermore, if Fig.13 As shown, a positioning pin 61 is provided at the center of the top of the blade head of the arc drill 6 to facilitate positioning in the pores of the customized bone interface 32, thereby facilitating the shaping operation.

[0084] Furthermore, a plurality of cutting edges 62 are evenly distributed from the center of the top of the cutter head of the arc drill 6 to the periphery, which is beneficial to improving the shaping efficiency.

[0085] Furthermore, the outer contour of the arc drill 6 includes different spherical diameters, so as to adapt to different pores and interference points.

[0086] The specific method of using the personalized surgical device is as follows:

[0087] Step 1: Use a medullary cavity drill to vertically drill a preset installation hole for the guide rod 5 at the preset center position of the necrotic bone, and then install the guide rod 5;

[0088] Step 2, put the contour rotary file 1 on the guide rod 5, file the necrotic bone, remove the cartilage layer, and remove the contour rotary file 1 after obtaining the surgical base area;

[0089] Step 3, after the prosthesis positioning guide plate 2 is sleeved on the guide rod 5 through the through hole on the bracket 4, it is hand-held for positioning so that the bottom surface 22 of the prosthesis positioning guide plate 2 rests on the surface of the femoral head;

[0090] Step 4, move the prosthesis trial mold 3 close to the guide rod 5 through the through slot 35 until the guide rod 5 reaches the first positioning hole 33 of the prosthesis trial mold 3;

[0091] Step 5, the handheld prosthesis trial mold 3 is moved downward along the guide rod 5, and the interference position between the surgical base area and the customized bone interface 32 is observed through the grid holes on the customized bone interface 32, and marking is made on the corresponding grid holes;

[0092] Step 6, remove the prosthesis trial mold 3, file and shape the outside of the grid holes marked on the customized bone interface 32 by using the arc drill 6, and then perform step 4 until the prosthesis trial mold 3 can be positioned on the top surface 23 of the prosthesis guide plate 2; this proves that the prosthesis trial mold 3 can be installed in the preset implantation position, verifies the feasibility of implantation of subsequent repair prostheses (using the same bone interface), and improves the success rate of subsequent operations;

[0093] Step 7: Based on the second positioning hole 34 of the prosthesis trial mold 3, an extension handle mounting hole for the repair prosthesis is processed on the femoral head through a medullary cavity drill to facilitate the subsequent installation of the repair prosthesis.

[0094] Embodiment 2:

[0095] like Fig.14 As shown, this embodiment provides a manufacturing system for manufacturing the above-mentioned personalized surgical device, which mainly includes: a data acquisition and analysis module, a surgical instrument design module and a surgical instrument manufacturing module;

[0096] The data acquisition and analysis module includes a medical image acquisition unit and a medical image processing unit;

[0097] The medical image acquisition unit is used to acquire image data of the patient's hip joint, including the morphological structure of the femoral head, acetabulum, proximal femur and other parts;

[0098] The medical image processing unit is used to perform (conventional) image segmentation, registration and three-dimensional reconstruction on the image data to obtain a three-dimensional model of the patient's femoral head, and then measure key parameters through a (conventional) image recognition method to provide accurate data support for subsequent calculations; the key parameters include the location, range, shape of the necrotic bone and the density and thickness of the healthy bone (bone tissue surrounding the necrotic bone);

[0099] The surgical instrument design module includes a contour rotary file design unit, a prosthesis positioning guide plate design unit and a prosthesis trial mold design unit;

[0100] The profiling rotary file design unit is used to extract a first curved surface as a profiling filing surface of the profiling rotary file (manually or automatically through conventional reverse engineering tools) according to the three-dimensional model of the femoral head and the key parameters, and generate a profiling rotary file manufacturing model in combination with a preset three-dimensional model of the profiling rotary file body; the first curved surface refers to a curved surface defined on the spherical surface of the femoral head with the maximum arc surface occupied by the necrotic bone as the range; in this way, it is convenient to automatically design an integrated filing tool that can cover the current necrotic bone and fit the surface of the femoral head;

[0101] The prosthesis positioning guide design unit is used to extract (manually or automatically through conventional reverse engineering tools) a second curved surface as the bottom surface of the prosthesis positioning guide, extract a third curved surface as the top surface of the prosthesis positioning guide, and generate a prosthesis positioning guide manufacturing model in combination with a preset three-dimensional model of the prosthesis positioning guide body (including physical features such as the first handle and the threaded hole); the second curved surface refers to a curved surface encircled on the spherical surface of the femoral head along the periphery of the necrotic bone with a concentric arc band of a preset diameter as the range; the third curved surface refers to a preset width edge contour of a dividing surface between the necrotic bone and the healthy bone (i.e., the bone interface of the repair prosthesis); in this way, it is convenient to automatically design a contact positioning surface that can fit the periphery of the current necrotic bone for positioning support of the prosthesis positioning guide, which is beneficial to improving the stability of the prosthesis positioning guide during surgery;

[0102] The prosthesis trial mold design unit is used to extract the fourth curved surface as the customized bone interface of the prosthesis trial mold (manually or automatically through conventional reverse engineering tools) according to the femoral head three-dimensional model and the key parameters, and combine the preset three-dimensional model of the prosthesis trial mold body (including the second handle, the first positioning hole, the second positioning hole and the through slot and other physical features, wherein the axis of the second positioning hole is consistent with the axis of the extended handle of the repair prosthesis, such as Fig.15 As shown), a prosthesis trial mold manufacturing model is generated; the fourth curved surface refers to the segmentation curved surface between the necrotic bone and the healthy bone (i.e., the bone interface of the repair prosthesis); in this way, it is convenient to automatically design a customized bone interface of the prosthesis trial mold;

[0103] The surgical instrument manufacturing module includes a contouring rotary file manufacturing unit, a prosthesis positioning guide plate manufacturing unit and a prosthesis trial mold manufacturing unit;

[0104] The profiling rotary file manufacturing unit is used to generate a machining program based on the profiling rotary file manufacturing model through a computer-aided manufacturing tool (such as UG) so as to be subsequently input into a machining center to automatically process the profiling rotary file;

[0105] The prosthesis positioning guide manufacturing unit is used to generate an additive manufacturing (e.g. 3D printing) program according to the prosthesis positioning guide manufacturing model (e.g. XT format) through a computer slicing tool (e.g. Cura), so as to automatically manufacture the prosthesis positioning guide through the additive manufacturing equipment later;

[0106] The prosthesis trial mold manufacturing unit is used to generate an additive manufacturing program based on the prosthesis trial mold manufacturing model through a computer slicing tool, so as to automatically manufacture the prosthesis trial mold through additive manufacturing equipment later.

[0107] Through the above system, a personalized surgical device for femoral head replacement can be manufactured conveniently, quickly and accurately.

[0108] Furthermore, the image data is CT data or MRI data in a preset format (such as DICOM).

[0109] Furthermore, the specific method for obtaining the patient's femoral head three-dimensional model includes:

[0110] Step a1: Based on the image data, a bone mask (Predefinedthresholds sets) is created by using a medical image processing tool. The bone density threshold setting range is 226-1826 (HU) so as to identify all cancellous bones and cortical bones. Figure 16-17 As shown;

[0111] Step a2: Manually identify necrotic bone in the femoral head, such as Fig.18 As shown;

[0112] Step a3: Separate the necrotic bone from the healthy bone layer by layer through the segmentation line. Fig.19 As shown;

[0113] Step a4: Solidify the necrotic bone and the healthy bone respectively to generate STL format models, such as Fig. 20 shown.

[0114] Furthermore, the additive manufacturing procedure includes printing layer thickness, printing speed, laser power, etc.

[0115] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A personalized surgical device for femoral head replacement, characterized in that: It includes a profiling rotary file, a prosthesis positioning guide plate, a prosthesis trial mold, a bracket, a guide rod and an arc drill; The profiling rotary file is used to file and remove the cartilage on the diseased bone tissue; the profiling rotary file is provided with a central through hole for radial positioning in cooperation with the guide rod; the cutter head of the profiling rotary file is a disc structure, and a profiling filing surface is arranged on the top surface of the disc structure for fitting the surface of the necrotic bone; The prosthesis positioning guide plate is an annular structure, and a first handle is arranged on the side wall at one end of the prosthesis positioning guide plate; the bottom surface of the prosthesis positioning guide plate is used for positioning around the necrotic bone; the top surface of the prosthesis positioning guide plate is used for positioning the bottom edge of the prosthesis trial mold; The bracket is an L-shaped structure, the short arm end of which is fixed to the side wall of the prosthesis positioning guide plate away from the first handle, and a through hole is arranged at the long arm end for radial positioning in cooperation with the guide rod; the through hole is parallel and concentric with the prosthesis positioning guide plate; The prosthesis trial mold is a bowl-shaped structure, and a customized bone interface is arranged at the bottom thereof for fitting the segmentation surface between the necrotic bone and the healthy bone; a first positioning hole and a second positioning hole are arranged at the bottom of the prosthesis trial mold; the first positioning hole is arranged at the center of the prosthesis trial mold for radial positioning in cooperation with the guide rod; a through slot is arranged from the first positioning hole to the edge of the prosthesis trial mold for the guide rod to enter or leave the first positioning hole radially; the second positioning hole is arranged outside the first positioning hole for radially positioning a medullary cavity drill for drilling the femoral head; a second handle is further arranged at one end of the prosthesis trial mold; the customized bone interface is a grid structure; The arc drill is used for filing and shaping the customized bone interface; the specific method includes: observing the interference position between the surgical basic area and the customized bone interface through the grid holes on the customized bone interface, and making marks on the corresponding grid holes. After removing the prosthesis trial mold, filing and shaping the outside of the grid holes marked on the customized bone interface through the arc drill.

2. The personalized surgical device according to claim 1, characterized in that: A plurality of file teeth diverging outward from the central through hole are evenly distributed on the profiling filing surface.

3. The personalized surgical device according to claim 1, characterized in that: The aperture of the grid is 0.5 - 1 mm.

4. The personalized surgical device according to claim 1, characterized in that: A positioning pin is arranged at the center of the top of the cutter head of the arc drill.

5. The personalized surgical device according to claim 4, characterized in that: A plurality of cutting edges are evenly distributed from the center of the top of the cutter head of the arc drill to the periphery.

6. A manufacturing system for manufacturing a personalized surgical device as claimed in any one of claims 1 to 5, characterized in that: It includes: A data acquisition and analysis module, a surgical instrument design module and a surgical instrument manufacturing module; The data acquisition and analysis module includes a medical image acquisition unit and a medical image processing unit; The medical image acquisition unit is used to acquire the image data of the patient's hip joint, including the morphological structures of the femoral head, acetabulum and proximal femur; The medical image processing unit is used to perform image segmentation, registration and three-dimensional reconstruction on the image data to obtain the three-dimensional model of the patient's femoral head, and then measure the key parameters through an image recognition method; the key parameters include the position, range, shape of the necrotic bone and the density and thickness of the healthy bone; The surgical instrument design module includes a profiling rotary file design unit, a prosthesis positioning guide plate design unit and a prosthesis trial mold design unit; The profiling rotary file design unit is used to extract a first curved surface as a profiling filing surface of the profiling rotary file according to the three-dimensional model of the femoral head and the key parameters, and generate a profiling rotary file manufacturing model in combination with a preset three-dimensional model of the profiling rotary file body; the first curved surface refers to a curved surface defined on the spherical surface of the femoral head with the maximum arc surface occupied by the necrotic bone as the range; The prosthesis positioning guide design unit is used to extract the second curved surface as the bottom surface of the prosthesis positioning guide, extract the third curved surface as the top surface of the prosthesis positioning guide according to the three-dimensional model of the femoral head and the key parameters, and generate a prosthesis positioning guide manufacturing model in combination with a preset three-dimensional model of the prosthesis positioning guide body; the second curved surface refers to a curved surface encircled on the spherical surface of the femoral head along the periphery of the necrotic bone with a concentric arc band of a preset diameter as a range; the third curved surface refers to a preset width edge contour of a dividing surface between the necrotic bone and the healthy bone; The prosthesis trial mold design unit is used to extract a fourth curved surface as a customized bone interface of the prosthesis trial mold according to the three-dimensional model of the femoral head and the key parameters, and generate a prosthesis trial mold manufacturing model in combination with a preset three-dimensional model of the prosthesis trial mold body; the fourth curved surface refers to a segmentation curved surface between the necrotic bone and the healthy bone; The surgical instrument manufacturing module includes a contouring rotary file manufacturing unit, a prosthesis positioning guide plate manufacturing unit and a prosthesis trial mold manufacturing unit; The profiling rotary file manufacturing unit is used to generate a machining program through a computer-aided manufacturing tool according to the profiling rotary file manufacturing model; The prosthesis positioning guide manufacturing unit is used to generate an additive manufacturing program based on the prosthesis positioning guide manufacturing model through a computer slicing tool; The prosthesis trial mold manufacturing unit is used to generate an additive manufacturing program based on the prosthesis trial mold manufacturing model through a computer slicing tool.

7. The manufacturing system according to claim 6, characterized in that: The image data is CT data or MRI data in a preset format.

8. The manufacturing system according to claim 7, characterized in that: The specific method of obtaining the three-dimensional model of the femoral head of the patient includes: Step a1: Based on the image data, a bone mask is created by using a medical image processing tool, and the bone density threshold is set in the range of 226-1826 to identify all cancellous bones and cortical bones; Step a2, manually identifying necrotic bone in the femoral head; Step a3, separating the necrotic bone from the healthy bone layer by layer through the segmentation line; Step a4: solidify the necrotic bone and the healthy bone respectively to generate an STL format model.

9. The manufacturing system according to claim 6, characterized in that: The additive manufacturing process includes printing layer thickness, printing speed and laser power.

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