Positioning guide and additive manufacturing method thereof

Abstract

The application discloses a positioning guide and an additive manufacturing method thereof. The positioning guide is used for hip arthroplasty and comprises a positioning base, a main guide structure and first and second guide piles arranged on both sides of the main guide structure. The positioning base comprises first and second fitting parts respectively fitted with local bony surfaces on both sides of a patient's acetabular notch and a connecting part connecting the first and second fitting parts. The main guide structure is arranged on the connecting part and has a guide channel for accommodating a handle of a surgical tool to exert geometric constraint on a placement direction of an acetabular reamer tool. The guide channel is determined according to an acetabular cup designed to a target anatomical position and a simulation handle arranged in association with the acetabular cup. The first and second guide piles are used for guiding the arrangement of Kirschner wires to fix the positioning guide to the acetabular region of the patient, thereby improving the accuracy and stability of acetabular polishing and acetabular cup implantation.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and in particular to a positioning guide and its additive manufacturing method. Background Technology

[0002] Total hip arthroplasty (THA) is a common surgical procedure for treating end-stage hip joint diseases and femoral neck fractures. The placement and angle of the acetabular prosthesis have a significant impact on postoperative joint stability, prosthesis lifespan, and patient functional recovery. Therefore, accurate control of the acetabular grinding direction and the acetabular cup prosthesis implantation direction during surgery is of great clinical significance.

[0003] Currently, clinical acetabular reaming and acetabular cup implantation largely rely on the surgeon's experience, which introduces a degree of subjectivity. To improve surgical consistency, existing technologies have proposed some guide plates or guides to assist in acetabular positioning. These are typically designed based on preoperative imaging data and engage with the patient's bony structures during surgery to help determine the direction of acetabular reaming or prosthesis implantation.

[0004] For example, existing technology discloses an acetabular positioning device that establishes a guiding relationship through a fitting base that matches the acetabular fossa and a guide structure set in the coaxial direction of the acetabular fossa, and combines it with a positioning pin to achieve positioning and assist in operation. This type of solution can provide guidance to a certain extent, but its positioning relationship mainly depends on the overall fitting of the acetabular fossa and the establishment of the additional positioning pin. The chain for establishing the guiding relationship is relatively long, and the operation steps in actual surgery are relatively complex, which is not conducive to completing the acetabular grinding operation quickly and stably in the deep surgical field.

[0005] For example, existing technologies also disclose some individualized customized acetabular guide plate solutions. These solutions typically achieve guide plate positioning by contacting the acetabular edge or adjacent surface and using guide holes or guide components to guide the instrument's direction. However, these solutions still have the following shortcomings in practical applications: First, the guide plate positioning point is far from the actual grinding area of ​​the acetabulum, or there is interference between the positioning structure and the acetabular edge, which can easily affect the entry path of the acetabular grinding tool; Second, some solutions still require the surgeon to continuously manually press the guide plate during the operation, resulting in insufficient guide plate stability and difficulty in maintaining a reliable position in deep surgical fields; Third, although some solutions can provide general guide holes or guide axes, they fail to establish a direct and stable geometric correspondence between the preoperatively planned target acetabular cup position and the actual acetabular grinding tool handle, so the preoperative planning results may still deviate when reproduced intraoperatively.

[0006] In addition, the approach of establishing a guiding relationship by fixing the fixation point to a position far away from the actual functional area of ​​the acetabulum, such as the iliac wing, can form a certain reference positioning. However, due to the long spatial transmission chain between the fixation point and the acetabular grinding area, it is easy to cause the accumulation of guiding errors. Furthermore, it still has shortcomings in terms of intraoperative exposure, angle control, and ease of operation.

[0007] Therefore, it is still necessary to provide a positioning guide and its additive manufacturing method, so that it can establish a stable positioning benchmark at a position closer to the actual grinding area of ​​the acetabulum, and provide a more stable, accurate and convenient intraoperative guide for the grinding direction of the acetabulum and the implantation direction of the acetabular cup, while ensuring that the grinding tool can enter smoothly. Summary of the Invention

[0008] The technical problem to be solved by this invention is to provide a positioning guide for acetabular surgery and its additive manufacturing method, so as to overcome the following defects in the prior art: the guide plate fixing point is far away from the actual working area of ​​the acetabulum, resulting in a large guiding error; the guide plate is not stable in the deep surgical field and requires continuous manual pressure from the surgeon; the guide plate structure interferes with the entry path of the acetabular reamer; and the guide structure fails to be designed specifically for the acetabular cup and the actual acetabular reamer handle in combination with the target anatomical position, so that the preoperative planning results are difficult to be stably and accurately reproduced in the intraoperative operation.

[0009] To address the aforementioned technical problems, the present invention provides a positioning guide for acetabular surgery, comprising: The positioning base is a solid structure made according to individualized anatomical data of the patient's acetabular region. The positioning base includes a first fitting part and a second fitting part that respectively fits against the local bony surfaces on both sides of the patient's acetabular notch, and a connecting part that connects the first fitting part and the second fitting part. A dominant directional structure is disposed on the connecting portion, the dominant directional structure having a guide channel for accommodating the handle of a surgical tool to apply geometric constraints on the placement direction of the acetabular reamer. The first guide post and the second guide post are respectively disposed on both sides of the main directional structure to guide the insertion of the Kirschner wire, so as to fix the positioning guide in the patient's acetabular region. The guide channel is determined based on the acetabular cup pre-designed to the target anatomical position and the simulated handle associated therewith. The simulated handle is used to characterize the spatial position of the handle of the target acetabular grinding tool.

[0010] Preferably, the first and second fitting portions are respectively fitted to the local anatomical regions located on both sides of the acetabular notch in the lower edge of the patient's acetabulum.

[0011] Preferably, the first fitting portion and the second fitting portion are fitting structures that are asymmetrically arranged, and their fitting contours correspond to different local bone surface morphologies on both sides of the acetabular notch.

[0012] Preferably, the connecting portion is disposed across the acetabular notch to connect the first fitting portion and the second fitting portion into one unit and to support the dominant directional structure.

[0013] Preferably, the main guiding structure is a guide cylinder or an open guide groove connected to the connecting part, and the inner contour of the guide channel is adapted to the outer contour of the handle of the target acetabular grinding tool.

[0014] Preferably, the axis of the simulated handle is determined based on the acetabular cup pre-designed to the target anatomical location and is aligned with the normal of the acetabular cup opening plane.

[0015] Preferably, the first and second guide posts are used to stably fix the positioning guide in place after the Kirschner wire is inserted, so that the surgeon does not need to manually press the positioning guide continuously during acetabular shaving.

[0016] Preferably, the dominant directional structure is used not only to guide the acetabular grinding tool to grind the acetabulum, but also to guide the implantation direction of the acetabular cup prosthesis.

[0017] The present invention also provides an additive manufacturing method for a positioning guide, comprising the following steps: Image reconstruction is used to obtain medical imaging data of the patient's acetabular region, and individualized anatomical data of the patient's acetabular region is obtained through three-dimensional reconstruction. The cup design involves establishing a patient's hip model based on the individualized anatomical data and designing the acetabular cup to the target anatomical position. Handle construction, based on the acetabular cup design of the target anatomical location and its associated simulated handle, to characterize the spatial position of the handle of the target acetabular grinding tool; Guide plate modeling: Based on the patient's hip bone model, the acetabular cup and the simulated stem, a three-dimensional digital model of the positioning guide is constructed. The three-dimensional digital model includes a first fitting part and a second fitting part located on both sides of the acetabular notch, a connecting part connecting the first fitting part and the second fitting part, a main directional structure disposed on the connecting part, and a first guide post and a second guide post located on both sides of the main directional structure. The positioning guide is manufactured by additive manufacturing process based on the three-dimensional digital model.

[0018] Preferably, the guide plate modeling step further includes the following sub-steps: Region selection: Select the lower edge of the acetabulum. The base is formed by cutting and shelling to create a positioning base; Guide construction, creating a guide section connected to the positioning base; Channel formation involves performing Boolean operations on the guide portion based on the simulated handle to form the guide channel of the dominant directional structure; and Guide piles are provided on both sides of the main directional structure to guide the insertion of Kirschner wires.

[0019] Compared with the prior art, the present invention has at least the following beneficial effects.

[0020] First, the present invention constructs a positioning base into a first fitting part and a second fitting part that respectively fit with the local bony surfaces on both sides of the patient's acetabular notch, and connects the two parts into one by a connecting part, so that the guide plate can establish a positioning reference at a position closer to the actual grinding area of ​​the acetabulum, thereby shortening the geometric transmission chain between the fixing point and the guiding direction, which is beneficial to improving the positioning accuracy.

[0021] Secondly, by setting a dominant directional structure on the connecting part and determining its guide channel according to the acetabular cup pre-designed to the target anatomical position and the associated simulation handle, the present invention establishes a direct and stable geometric correspondence between the preoperatively planned target position of the acetabular cup and the actual operation path of the intraoperative acetabular grinding tool, which is beneficial to improving the accuracy of the acetabular grinding direction and the acetabular cup implantation direction.

[0022] Furthermore, by setting a first guide post and a second guide post on both sides of the main directional structure and fixing the positioning guide with Kirschner wires, the present invention enables the positioning guide to be stably fixed in the deep surgical field, thereby reducing the need for the surgeon to continuously manually press the guide plate and improving the convenience and stability of intraoperative operation.

[0023] Furthermore, the dominant directional structure of this invention adopts a combination of guide channel, guide cylinder and open guide groove, which helps to ensure the smooth introduction of the acetabular grinding tool, while reducing the interference of the guide plate structure on the instrument entry path, thereby improving the feasibility of clinical implementation.

[0024] Finally, this invention uses patient-specific anatomical data for modeling and additive manufacturing, which allows for the design and verification of the hip bone model, acetabular cup, and simulation stem before surgery. Furthermore, it enables the stable transformation of planning results into intraoperative procedures through preoperative simulation, thereby improving the consistency between preoperative planning and intraoperative implementation. Attached Figure Description

[0025] Figure 1 This is a schematic diagram of the overall structure of the positioning guide of the present invention.

[0026] Figure 2 yes Figure 1 The diagram shows the back structure of the positioning guide.

[0027] Figure 3 This is a schematic diagram of the positioning guide of the present invention installed in the patient's acetabular region.

[0028] Figure 4 This is a schematic diagram of the structure of the positioning guide of the present invention installed in the patient's acetabular region and correspondingly engaged with the acetabular cup and the simulated handle.

[0029] Figure 5 This is a schematic diagram of the positioning guide of the present invention installed in the patient's acetabular region from another perspective.

[0030] Figure 6 This is a schematic diagram of the preoperative simulation grinding of the positioning guide of the present invention.

[0031] Figure 7 This is a schematic diagram of the structure in which the acetabular cup is fitted with the femoral prosthesis after implantation.

[0032] Figure 8 This is a schematic diagram of the positioning guide of the present invention guiding the acetabular grinding tool to grind the acetabulum during surgery.

[0033] In the diagram: 100, positioning guide; 11, first fitting part; 12, second fitting part; 13, connecting part; 21, guide channel; 22, guide cylinder; 23, open guide groove; 31, first guide post; 32, second guide post; 5, acetabular cup; 6, simulated handle; 7, patient's acetabular region; 71, acetabular notch; 72, lower edge of the acetabulum; 8, Kirschner wire; 9, femoral prosthesis; 200, acetabular grinding tool. Detailed Implementation

[0034] To enable those skilled in the art to better understand the present invention, specific embodiments of the present invention will be further described in detail below with reference to the accompanying drawings. It should be understood that the following embodiments are for illustrative purposes only and are not intended to limit the scope of protection of the present invention.

[0035] An exemplary embodiment of the present invention discloses an overall structure of a positioning guide. For example... Figure 1 and Figure 2 As shown, this embodiment provides a positioning guide 100 for acetabular surgery. The positioning guide 100 includes a positioning base, a main directional structure, a first guide post 31, and a second guide post 32.

[0036] The positioning base includes a first fitting portion 11, a second fitting portion 12, and a connecting portion 13 connecting the first fitting portion 11 and the second fitting portion 12. The first fitting portion 11 and the second fitting portion 12 are respectively disposed on both sides of the positioning guide 100 for fitting with the local bony surfaces on both sides of the patient's acetabular notch 71. The connecting portion 13 is located between the first fitting portion 11 and the second fitting portion 12 for connecting the two into one unit, so that the positioning guide 100 forms an integral structure spanning the acetabular notch 71.

[0037] In this embodiment, the first fitting portion 11 and the second fitting portion 12 are preferably fitting structures that are asymmetrically arranged. Since the local bone surfaces on both sides of the patient's acetabular notch 71 usually differ in spatial contour, the first fitting portion 11 and the second fitting portion 12 can be formed according to the anatomical morphology of different local bone surfaces on both sides of the notch, so as to improve the fitting accuracy and placement stability of the guide plate with the patient's local bone surfaces.

[0038] The dominant directional structure is disposed on the connecting part 13 and includes a guide channel 21, a guide cylinder 22, and an open guide groove 23 formed on the guide cylinder 22. The guide channel 21 is used to accommodate the handle of the surgical tool, the guide cylinder 22 is used to provide peripheral support for the guide channel 21, and the open guide groove 23 is used to facilitate the insertion of the handle of the surgical tool into the dominant directional structure under conditions of limited surgical field.

[0039] The first guide post 31 and the second guide post 32 are respectively disposed on both sides of the main directional structure and extend outward from the positioning guide 100. The first guide post 31 and the second guide post 32 are used to guide the insertion of the Kirschner wire 8, so that the positioning guide 100 can be fixed to the patient's acetabular region 7. Preferably, the first guide post 31 and the second guide post 32 are spaced apart from the main directional structure to form a stable fixation relationship after the Kirschner wire 8 is inserted, thereby improving the anti-shaking ability of the positioning guide 100 in the deep surgical field.

[0040] An exemplary embodiment of the present invention also discloses an anatomical positioning method for a positioning guide, such as... Figure 3 As shown, the positioning guide 100 is installed in the patient's acetabular region 7 during use. The first fitting portion 11 and the second fitting portion 12 respectively fit onto the local bony surfaces on both sides of the acetabular notch 71, thus establishing a positioning reference for the positioning guide 100 at a position closer to the actual grinding area of ​​the acetabulum.

[0041] In this embodiment, the positioning base of the positioning guide 100 is not fixed to the iliac wing far from the acetabular functional area, but rather to the anatomical location near the acetabular notch 71, close to the transverse acetabular ligament. Since this location is closer to the actual functional area of ​​the acetabular reamer and acetabular cup implantation, the geometrical transmission chain between the positioning reference established at this location and the actual guiding relationship is shorter, which helps to reduce the cumulative error generated during the transmission from the distal reference to the proximal acetabular region.

[0042] In addition, this location is easier to identify and approach after the acetabulum is exposed during surgery, making it easier to control the angle when placing the guide plate and providing a more direct operating path. By aligning the first fitting portion 11 and the second fitting portion 12 with the patient's individualized local bone surface, and then fixing it with Kirschner wires 8 inserted through the first guide post 31 and the second guide post 32, the positioning guide 100 can be stably maintained in the predetermined position in the deep surgical field.

[0043] Compared to the approach of fixing to the iliac wing, the guide plate fixation point in this embodiment is closer to the actual operating area of ​​the acetabulum, which not only helps to improve the accuracy of the acetabular grinding direction and the prosthesis implantation direction, but also makes it easier to operate during the operation and reproduce the pre-designed guiding relationship.

[0044] An exemplary embodiment of the present invention also discloses a method for forming a dominant orientation structure, such as... Figure 4 and Figure 5 As shown, the main guide structure in this embodiment is not based on experience to set the direction, but is formed according to the acetabular cup 5 pre-designed to the target anatomical position and the simulated handle 6 associated with it.

[0045] Specifically, before surgery, the acetabular cup 5 is designed in a 3D model to the target anatomical position, ensuring it is within the expected anteversion and abduction angles. Then, a simulated handle 6 is created based on the acetabular cup 5 at this target anatomical position. The simulated handle 6 is used to simulate the spatial position of the actual acetabular grinding tool handle. Preferably, the axis of the simulated handle 6 is aligned with the normal to the opening plane of the acetabular cup 5.

[0046] In some cases, the size of the simulated handle 6 is preferably adapted to the size of the actual acetabular file handle. More preferably, the diameter of the simulated handle 6 is equal to the outer diameter of the actual acetabular file handle, so that the guide channel 21 generated in reverse by the simulated handle 6 forms a more precise guiding fit with the actual file handle.

[0047] In this embodiment, the inner contour of the guide channel 21 is determined according to the simulated handle 6. In other words, the guide channel 21 is not simply set as an arbitrary guide hole, but is formed in reverse according to the outer contour of the simulated handle 6, so that after the actual acetabular reamer handle is placed into the guide channel 21 during the operation, the handle can only extend along the pre-designed spatial direction, thereby directly converting the pre-planned target anatomical position and directional relationship into the actual grinding direction during the operation.

[0048] Therefore, the main guide structure in this embodiment essentially establishes a continuous geometric correspondence between the "target anatomical position acetabular cup 5 - simulated handle 6 - guide channel 21 - actual acetabular grinding tool handle". In this way, the preoperatively designed target position, anteversion angle, and abduction angle of the acetabular cup can be more stably reproduced during the intraoperative operation.

[0049] An exemplary embodiment of the present invention also discloses a method for fixing a guide plate and its function. For example... Figures 3 to 5 As shown, the fixation of the positioning guide 100 depends not only on the shape matching of the first fitting part 11 and the second fitting part 12 with the local bone surface, but also on the guiding effect of the first guide post 31 and the second guide post 32 on the Kirschner wire 8.

[0050] In this embodiment, after the positioning guide 100 is placed on the local bone surfaces on both sides of the acetabular notch 71, Kirschner wires 8 can be inserted through the first guide post 31 and the second guide post 32 respectively. After the Kirschner wires 8 are guided through the guide posts into the corresponding bone tissue, the positioning guide 100 can be stably fixed in place.

[0051] This fixing method has the following functions: Firstly, it can significantly improve the placement stability of the positioning guide 100 in the deep acetabular region, and reduce the shaking, offset or rotation caused by the operating force during acetabular grinding. Secondly, after the Kirschner wire 8 is fixed, the surgeon does not need to continuously manually press the positioning guide 100, and can directly guide the handle of the acetabular grinding tool into the guide channel 21 for grinding operation, thereby reducing the workload of intraoperative operation and improving the convenience of deep operation in the surgical field. Third, the fixed relationship established by the first guide post 31 and the second guide post 32 is coordinated with the main directional structure, so that the guide plate can maintain the correct positional relationship with the patient's anatomical structure after it is fixed, and avoid the guide plate from affecting the guiding accuracy due to unstable hand holding.

[0052] Therefore, in this embodiment, the first guide pile 31 and the second guide pile 32 are not merely auxiliary structures, but together with the first fitting part 11, the second fitting part 12 and the main directional structure, they constitute an overall technical solution for achieving precise guidance and stable fixation.

[0053] An exemplary embodiment of the present invention also discloses a process for constructing a three-dimensional digital model of a positioning guide 100.

[0054] First, medical imaging data of the patient's acetabular region is acquired. Thin-slice CT scans are preferred for acquiring data on the patient's pelvis and the affected hip joint, which are then imported into 3D reconstruction software to create a model of the patient's hip.

[0055] Subsequently, based on the patient's hip bone model, the acetabular cup 5 is designed to the target anatomical position, and a simulated stem 6 is constructed according to the acetabular cup 5 at the target anatomical position. Then, based on the lower edge 72 region of the acetabulum in the patient's hip bone model, the basic shape of the positioning base is formed by region selection, trimming, and shelling.

[0056] In this embodiment, the final structure of the positioning base after cutting and shelling is a first fitting part 11 and a second fitting part 12 located on both sides of the acetabular notch 71, and a connecting part 13 connecting the first fitting part 11 and the second fitting part 12.

[0057] Next, a guide portion is created on the connecting portion 13, and a Boolean operation is performed on the guide portion based on the simulated handle 6 to form a guide channel 21 in the guide portion. Preferably, the inner contour of the guide channel 21 is adapted to the outer contour of the simulated handle 6. In this way, the guide channel 21, once formed, can serve as part of the main directional structure for geometrically constraining the handle of the actual surgical tool. Preferably, the guide portion forms a guide cylinder 22, and an open guide groove 23 is formed on the guide cylinder 22 to allow the acetabular reamer tool 200 to be guided into the main directional structure during surgery.

[0058] Furthermore, a first guide post 31 and a second guide post 32 are set on both sides of the main directional structure to form a fixed structure for guiding the insertion of the Kirschner wires 8. This ultimately yields a three-dimensional digital model of the positioning guide 100 used for additive manufacturing.

[0059] An exemplary embodiment of the present invention also discloses an additive manufacturing method for a positioning guide. For example, after completing the construction of a three-dimensional digital model, the model can be imported into an additive manufacturing device for printing to obtain the positioning guide 100.

[0060] Optionally, a patient hip model, an acetabular cup 5, and a corresponding simulated handle 6 can be printed simultaneously for preoperative simulation. In this way, the positioning guide 100 can be installed on the patient hip model before surgery to verify the degree of fit between the first fitting part 11, the second fitting part 12 and the local bone surface, verify the fixation feasibility of the first guide post 31 and the second guide post 32, and verify whether the grinding direction defined by the dominant directional structure is consistent with the target anatomical position.

[0061] The printed positioning guide 100 can also be used for intraoperative procedures after post-processing, cleaning and disinfection.

[0062] As an exemplary embodiment of the present invention, it discloses a preoperative simulation and intraoperative usage method.

[0063] Before the operation, the positioning guide 100 can be installed on the printed patient hip bone model so that the first fitting part 11 and the second fitting part 12 fit with the local bone surfaces on both sides of the acetabular notch 71, and Kirschner wires 8 are inserted through the first guide post 31 and the second guide post 32 to simulate the fixation state during the operation.

[0064] like Figure 6 As shown, during preoperative simulation, the acetabular grinding tool 200 can be guided into the main directional structure via the guide tube 22 and the open guide groove 23, allowing the handle of the acetabular grinding tool 200 to enter the guide channel 21 and simulate grinding the acetabular region along the pre-designed direction. Since the guide channel 21 is formed based on the pre-designed acetabular cup 5 at the target anatomical position and the associated simulated handle 6, and the axis of the simulated handle 6 is aligned with the normal to the opening plane of the acetabular cup 5, the grinding direction of the acetabular grinding tool 200 during preoperative simulation can be consistent with the pre-planned target implantation direction of the acetabular cup 5. Through this preoperative simulation process, the fit between the positioning guide 100 and the patient's local bone surface, the fixation feasibility of the first guide post 31 and the second guide post 32, and the rationality of the entry path and grinding direction of the acetabular grinding tool 200 can be verified in advance, thereby confirming the operational feasibility and guiding accuracy of the positioning guide 100 in actual surgery.

[0065] During the procedure, after exposing the patient's acetabular region 7, the positioning guide 100 is placed on the local bone surfaces on both sides of the acetabular notch 71, so that the first fitting part 11 and the second fitting part 12 are fitted together. Subsequently, Kirschner wires 8 are inserted through the first guide post 31 and the second guide post 32 to stably fix the positioning guide 100 in place. After the positioning guide 100 is fixed, the surgeon can place the handle of the actual acetabular grinding tool 200 into the guide channel 21 and grind the acetabulum in the direction defined by the dominant directional structure without continuously pressing the guide plate by hand. Since the guide plate fixing point is close to the actual acetabular action area, and the dominant directional structure is formed in the opposite direction of the acetabular cup 5 and the simulated handle 6 at the target anatomical position, the preoperatively planned anteversion angle and abduction angle relationship can be more stably reproduced in the intraoperative operation.

[0066] After the acetabulum is polished, the spatial direction relationship corresponding to the same dominant directional structure can be used to guide the implantation of the acetabular cup 5 along the target direction, thereby improving the accuracy of the implantation position and angle of the acetabular cup 5.

[0067] like Figure 7As shown, after the acetabulum is ground and the acetabular cup 5 is implanted into the target position, the femoral prosthesis 9 can be further assembled or trial-fitted. Since the implantation direction of the acetabular cup 5 is defined by the positioning guide 100 of the present invention, the acetabular cup 5 can be implanted according to the preoperatively planned target anatomical position, thus improving the accuracy of the fit between the acetabular cup 5 and the subsequent femoral prosthesis 9, which is conducive to the stable implementation of subsequent artificial hip joint assembly.

[0068] As an exemplary embodiment, an intraoperative grinding procedure is also disclosed. For example... Figure 8 As shown in the figure, this embodiment further illustrates the usage of the positioning guide 100 of the present invention in an actual surgical procedure.

[0069] After exposing the patient's acetabular region, the positioning guide 100 is placed in the predetermined anatomical position, so that the positioning guide 100 is attached to and stably fixed to the local bone surface of the patient. Subsequently, the acetabular grinding tool 200 is introduced through the main guiding structure, so that its handle is guided and constrained by the positioning guide 100, thereby grinding the acetabulum in a pre-designed direction.

[0070] In this embodiment, the positioning guide 100 is located in the deep region of the surgical field and provides guidance for the acetabular reamer 200 during the operation. Therefore, the positioning guide 100 of the present invention can not only be simulated and verified on a preoperative model, but also provide a stable guiding path for the acetabular reamer 200 in the actual surgical environment, thereby improving the consistency between the intraoperative reaming direction and the preoperative planned direction.

[0071] With the guidance of the positioning guide 100, the surgeon can complete the acetabular reaming operation in a deeper surgical field without relying solely on experience to repeatedly judge the reaming direction. This helps improve the stability and repeatability of the surgical procedure and facilitates the accurate placement and orientation of the subsequent acetabular cup 5 implantation.

[0072] In some cases, the positioning guide 100 can be used in conjunction with the fixation structure during surgery to further improve its stability during the reaming process. Because the positioning guide 100 of this invention can directly guide the acetabular reaming tool 200 during surgery, it is suitable not only for preoperative planning and simulation but also for actual guidance during the intraoperative acetabular reaming process.

[0073] This invention is not limited to the embodiments described above. Without departing from the spirit and principle of this invention, the specific outlines of the first fitting part 11 and the second fitting part 12, the shape of the connecting part 13, the specific form of the main directional structure, and the length and setting angle of the first guide post 31 and the second guide post 32 can all be adjusted according to the individualized anatomical condition of the patient and the form of the surgical instruments.

[0074] For example, the main guiding structure can be in the form of a guide cylinder 22 or a structure with an open guide groove 23; the size of the simulated handle 6 can be adjusted according to the handle of different specifications of acetabular grinding tools; the tilt angle of the first guide post 31 and the second guide post 32 can also be optimized according to the patient's bone surface conditions and the fixation path of the Kirschner wire 8.

[0075] All equivalent substitutions, improvements, and modifications made within the spirit and principles of this invention shall fall within the protection scope of this invention.

Claims

1. A positioning guide for hip replacement surgery, characterized in that, include: The positioning base is a solid structure made according to individualized anatomical data of the patient's acetabular region. The positioning base includes a first fitting part and a second fitting part that respectively fits against the local bony surfaces on both sides of the patient's acetabular notch, and a connecting part that connects the first fitting part and the second fitting part. A dominant directional structure is disposed on the connecting portion, the dominant directional structure having a guide channel for accommodating the handle of a surgical tool to apply geometric constraints on the placement direction of the acetabular reamer. The first guide post and the second guide post are respectively disposed on both sides of the main directional structure to guide the insertion of the Kirschner wire, so as to fix the positioning guide in the patient's acetabular region. The guide channel is determined based on the acetabular cup pre-designed to the target anatomical position and the simulated handle associated therewith. The simulated handle is used to characterize the spatial position of the handle of the target acetabular grinding tool.

2. The positioning guide according to claim 1, characterized in that: The first and second fitting parts are respectively fitted to the local anatomical regions located on both sides of the acetabular notch in the lower edge of the patient's acetabulum.

3. A positioning guide according to claim 1 or 2, characterized in that: The first and second fitting parts are fitting structures that are asymmetrically arranged, and their fitting contours correspond to different local bone surface morphologies on both sides of the acetabular notch.

4. A positioning guide according to claim 1, characterized in that: The connecting portion extends across the acetabular notch to connect the first fitting portion and the second fitting portion into one unit and to support the dominant directional structure.

5. A positioning guide according to claim 1, characterized in that: The main guiding structure is a guide cylinder connected to the connecting part, and the inner contour of the guide channel is adapted to the outer contour of the handle of the target acetabular grinding tool.

6. The positioning guide according to claim 1, characterized in that, The axis of the simulated handle is determined based on the acetabular cup pre-designed to the target anatomical location and is aligned with the normal of the acetabular cup opening plane.

7. The positioning guide according to claim 1, wherein the first guide post and the second guide post are used to stably fix the positioning guide in place after the Kirschner wire is inserted, so that the surgeon does not need to manually press the positioning guide continuously during acetabular grinding.

8. The positioning guide according to claim 1, characterized in that: The dominant directional structure is used not only to guide the acetabular grinding tool to grind the acetabulum, but also to guide the implantation direction of the acetabular cup prosthesis.

9. An additive manufacturing method for a positioning guide, characterized in that, Includes the following steps: Image reconstruction is used to obtain medical imaging data of the patient's acetabular region, and individualized anatomical data of the patient's acetabular region is obtained through three-dimensional reconstruction. The cup design involves establishing a patient's hip model based on the individualized anatomical data and designing the acetabular cup to the target anatomical position. Handle construction, based on the acetabular cup design of the target anatomical location and its associated simulated handle, to characterize the spatial position of the handle of the target acetabular grinding tool; Guide plate modeling: Based on the patient's hip bone model, the acetabular cup and the simulated stem, a three-dimensional digital model of the positioning guide is constructed. The three-dimensional digital model includes a first fitting part and a second fitting part located on both sides of the acetabular notch, a connecting part connecting the first fitting part and the second fitting part, a main directional structure disposed on the connecting part, and a first guide post and a second guide post located on both sides of the main directional structure. The positioning guide is manufactured by additive manufacturing process based on the three-dimensional digital model.

10. The additive manufacturing method according to claim 9, characterized in that, The guide plate modeling step also includes the following sub-steps: Region selection: Select the lower edge of the acetabulum. The base is formed by cutting and shelling to create a positioning base; Guide construction, creating a guide section connected to the positioning base; Channel formation is achieved by performing Boolean operations on the guide portion based on the analog handle to form the guide channel of the dominant directional structure; as well as Guide piles are provided on both sides of the main directional structure to guide the insertion of Kirschner wires.

Images