A visible developing positioning osteotomy guide and its design method and application

Abstract

The application relates to a design method of a visible developing positioning osteotomy guide plate, which comprises the following steps: establishing a bone dissection three-dimensional model according to preoperative CT or / and nuclear magnetic data of a patient, and simulating osteotomy in the bone dissection three-dimensional model to determine the osteotomy position and direction; after the osteotomy position and direction are determined, individual design of the osteotomy guide plate is carried out according to the bone surface features, a characteristic position relationship is established between the osteotomy guide plate three-dimensional model and the characteristic dissection structure which can be positioned under the intraoperative perspective, a developing structure which can be positioned through the perspective equipment is designed on the osteotomy guide plate three-dimensional model according to the characteristic position relationship, and the individualized osteotomy guide plate after the design confirmation is processed and prepared. The application can be calibrated according to the developing structure and the characteristic dissection position, the accurate osteotomy guide plate placing position is realized, the accurate confirmation of the relationship between the osteotomy position and the characteristic dissection position is realized, support and guarantee are provided for the subsequent high-precision osteotomy, and finally the precise osteotomy is implemented.

Description

Technical Field

[0001] This invention relates to an osteotomy guide plate, and more particularly to a radiopaque positioning osteotomy guide plate, its design method, and its application, belonging to the field of medical device technology. Background Technology

[0002] In orthopedic surgical procedures, osteotomy is a fundamental and crucial operation. Traditional osteotomy methods rely on orthopedic surgeons to roughly determine the position and direction using anatomical references, employing tools such as wire saws, oscillating saws, and osteotomy blades. However, with the increasing precision requirements of surgical procedures, traditional methods are insufficient, typically exhibiting an error margin of around 1 cm. Current navigation technologies in orthopedic surgery significantly improve pre-operative positioning accuracy (up to 4-5 mm), enabling more precise intraoperative localization. However, the high cost of equipment and the additional expenses and time required for preoperative imaging and intraoperative registration incur additional costs. With the advent of 3D printing technology, personalized osteotomy guides can be customized using preoperative patient CT data to create 3D models. Current research consistently suggests that the accuracy of 3D-printed individualized osteotomy guides can be stably controlled at around 2 mm. For complex deformities and tumor resections, this level of precision allows for more accurate osteotomy correction and bone tumor removal.

[0003] However, the precise placement of osteotomy guides during surgery has remained a challenge. While anatomical features are often referenced when placing the guides on the bone surface, the degree of soft tissue dissection and the specific characteristics of the bone surface significantly affect placement accuracy. To improve guide placement accuracy, some surgeons utilize navigation techniques in orthopedic surgery. However, the high cost of the equipment and the complexity of the procedure limit its application and widespread use, making it difficult to meet the practical clinical requirements of most orthopedic surgeons in terms of ease of use and usability. Summary of the Invention

[0004] To address the aforementioned problems, one objective of this invention is to provide a design method for a radiopaque osteotomy guide plate; a second objective of this invention is to provide a radiopaque osteotomy guide plate prepared using this design method; and a third objective of this invention is to provide an application of this radiopaque osteotomy guide plate in osteotomy correction and bone tumor resection.

[0005] To achieve the above objectives, the present invention adopts the following technical solution:

[0006] In a first aspect, the present invention provides a method for designing a radiopaque osteotomy guide plate, comprising the following steps:

[0007] A three-dimensional model of skeletal anatomy is established based on the patient's preoperative CT and / or MRI data, and simulated osteotomy is performed in the three-dimensional model of skeletal anatomy to determine the location and direction of osteotomy.

[0008] After determining the osteotomy location and direction, an individualized osteotomy guide plate is designed based on the bone surface characteristics, resulting in a three-dimensional model of the osteotomy guide plate.

[0009] Establish a characteristic positional relationship between the anatomical structures that can be located under intraoperative fluoroscopy and the osteotomy location;

[0010] Based on the characteristic positional relationship, a radiopaque structure that can be positioned by fluoroscopy is designed on the three-dimensional model of the osteotomy guide plate;

[0011] The individualized osteotomy guide plate was fabricated and prepared after the design was confirmed.

[0012] The design method, preferably, includes bone surface features at the location of osteotomy on the patient and bone surface features of a three-dimensional anatomical model of the skeleton.

[0013] Preferably, the locatable anatomical features in the design method include, but are not limited to, articular surfaces, femoral condyles, or acetabulum.

[0014] The design method, preferably, establishes feature positional relationships including but not limited to the distance and angle between the osteotomy location and a certain feature anatomical structure.

[0015] In the aforementioned design method, preferably, the developing structure is a metal wire or a metal rod.

[0016] In the aforementioned design method, preferably, the fluoroscopic device is a C-arm or a G-arm.

[0017] In the preferred embodiment of the design method, when designing a radiopaque structure that can be positioned by fluoroscopy on the three-dimensional model of the osteotomy guide plate, it is necessary to fully consider the angular error characteristics of C-arm or G-arm fluoroscopy. If necessary, radiopaque structures should be designed in both anteroposterior and lateral fluoroscopy directions to increase the accuracy of the projection angle.

[0018] Secondly, the present invention provides a radiopaque osteotomy guide plate, which is prepared using the design method described above.

[0019] Preferably, the radiopaque osteotomy guide is a distal femoral osteotomy guide, which has a distal femoral condyle positioning portion, an intercondylar fossa positioning portion, and an anterior femoral condyle positioning portion that respectively conform to the distal femoral condyle, the intercondylar fossa, and the anterior femoral condyle. Each of these portions has a fixation hole for temporary fixation of the osteotomy guide by passing a fixation pin. The distal femoral condyle positioning portion and the anterior femoral condyle positioning portion also have transverse osteotomy grooves for passing osteotomy tools. The intercondylar fossa positioning part is provided with a longitudinal osteotomy groove suitable for the osteotomy tool to pass through; the imaging structure includes a fluoroscopic angle correction component that protrudes vertically from the femoral anterior condyle positioning part and a characteristic position relationship positioning component arranged at 90° orthogonal to the fluoroscopic angle correction component. The fluoroscopic angle correction component is used for angle correction and positioning under anteroposterior fluoroscopic fluoroscopy to ensure that the fluoroscopic device and the distal femoral osteotomy guide plate are at an absolute 90°; the characteristic position relationship positioning component is used to identify the characteristic position relationship between the locatable characteristic anatomical structure and the osteotomy position.

[0020] Thirdly, the present invention also provides the application of the above-mentioned radiopaque positioning osteotomy guide plate in osteotomy correction and bone tumor resection.

[0021] The present invention has the following advantages due to the adoption of the above technical solutions:

[0022] This invention addresses the issue of accurate placement of individualized osteotomy guides by incorporating a radiopaque structure that can be positioned using C-arm or G-arm fluoroscopy in the design of the individualized osteotomy guide. Calibration is performed based on the radiopaque structure and the characteristic anatomical position to achieve precise placement of the osteotomy guide. This, in turn, enables accurate confirmation of the relationship between the osteotomy position and the characteristic anatomical position, providing support and assurance for subsequent high-precision osteotomy, and ultimately enabling precise osteotomy. Attached Figure Description

[0023] Figure 1 This is a flowchart illustrating a design method provided according to an embodiment of the present invention;

[0024] Figure 2 This is a schematic diagram of the structure of an osteotomy guide plate prepared according to the design method of the present invention from a first-view perspective.

[0025] Figure 3 This is a schematic diagram of the structure of an osteotomy guide plate prepared according to the design method of the present invention from a second perspective.

[0026] Figure 4 This is a diagram showing the state of an osteotomy guide plate prepared according to the design method of the present invention under intraoperative fluoroscopy. Detailed Implementation

[0027] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this invention. All other embodiments obtained by those skilled in the art based on the embodiments of this invention without creative effort are within the scope of protection of this invention.

[0028] In the description of this invention, it should be noted that the terms "upper" and "lower" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the system or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limiting this invention.

[0029] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "assembly," "setup," and "connection" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0030] The present invention provides a method for designing a radiopaque osteotomy guide, comprising the following steps: establishing a three-dimensional anatomical model of the skeleton based on the patient's preoperative CT and / or MRI data, and performing simulated osteotomy within the three-dimensional anatomical model to determine the osteotomy position and direction; after determining the osteotomy position and direction, designing an individualized osteotomy guide based on the bone surface characteristics, resulting in a three-dimensional model of the osteotomy guide, and establishing a characteristic positional relationship between the characteristic anatomical structures that can be located under intraoperative fluoroscopy and the osteotomy position; designing a radiopaque structure on the three-dimensional model of the osteotomy guide that can be located under fluoroscopy based on the characteristic positional relationship; and fabricating the individualized osteotomy guide after design confirmation. This invention can be calibrated according to the radiopaque structure and characteristic anatomical position to achieve precise placement of the osteotomy guide, thereby accurately confirming the relationship between the osteotomy position and the characteristic anatomical position, providing support and assurance for subsequent high-precision osteotomy, and ultimately enabling precise osteotomy.

[0031] The design method of the radiopaque positioning osteotomy guide plate provided in the embodiments of the present invention will be described in detail below with reference to the accompanying drawings.

[0032] like Figure 1 As shown, the design method of the radiopaque positioning osteotomy guide plate provided in this embodiment of the invention includes the following steps:

[0033] S100. Based on the patient's preoperative CT and / or MRI data, establish a three-dimensional anatomical model of the skeleton in CAD three-dimensional modeling software, and perform simulated osteotomy in the three-dimensional anatomical model of the skeleton to determine the location and direction of the osteotomy.

[0034] S200. After determining the osteotomy location and direction, an individualized osteotomy guide plate is designed based on the bone surface features, resulting in a three-dimensional model of the osteotomy guide plate. The bone surface features include the bone surface features at the patient's osteotomy location and the bone surface features of the three-dimensional anatomical model of the skeleton.

[0035] S300. Establish a characteristic positional relationship between the locatable characteristic anatomical structures and the osteotomy position under intraoperative fluoroscopy, including the distance and angle between the osteotomy position and a certain characteristic anatomical structure; wherein, the locatable characteristic anatomical structure can be a joint surface, femoral condyle or acetabulum, etc.

[0036] S400. Based on the characteristic positional relationship, design a radiopaque structure that can be positioned by fluoroscopy on the three-dimensional model of the osteotomy guide plate in step 200.

[0037] S500 uses 3D printing technology to fabricate individualized osteotomy guide plates designed and confirmed by orthopedic surgeons.

[0038] In the above embodiments, preferably, the shape and contour of the developing structure can be designed as needed, including but not limited to any shape such as strip or filament. For example, the developing structure can be a metal wire or a metal rod.

[0039] In the above embodiments, preferably, the fluoroscopic device is a C-arm or G-arm, which is most widely used in orthopedic clinical surgery.

[0040] In the above embodiments, preferably, during step S400, the angular error characteristic of C-arm or G-arm perspective needs to be fully considered. If necessary, development structures need to be designed in both front-to-back perspective and side perspective to increase the accuracy of projection angle.

[0041] Figure 2 and Figure 3An example of an osteotomy guide designed for patients with distal femoral tumors is shown. The osteotomy guide has a distal femoral condyle positioning part 1, an intercondylar fossa positioning part 2, and an anterior femoral condyle positioning part 3, which respectively fit the distal femoral condyle, the intercondylar fossa, and the anterior femoral condyle. Fixing holes 6 are provided on the distal femoral condyle positioning part 1, the intercondylar fossa positioning part 2, and the anterior femoral condyle positioning part 3 to facilitate the passage of fixation pins for temporary fixation of the osteotomy guide. Transverse osteotomy grooves 4 are provided on the distal femoral condyle positioning part 1 and the anterior femoral condyle positioning part 3 to facilitate the passage of osteotomy tools (such as the blade of an electric oscillating saw). Longitudinal osteotomy grooves 5 are provided on the intercondylar fossa positioning part 2 to facilitate the passage of osteotomy tools. The imaging structure includes a fluoroscopic angle correction element 7 that protrudes vertically from the positioning part 3 of the anterior femoral condyle, and a characteristic positional relationship positioning element 8 arranged orthogonally to the fluoroscopic angle correction element 7 at 90°. The fluoroscopic angle correction element 7 is used for angle correction and positioning under anteroposterior fluoroscopic views to ensure that the fluoroscopic device and the osteotomy guide plate are at an absolute 90° (at this time, the fluoroscopic angle correction element 7 is a point under anteroposterior fluoroscopic views). The characteristic positional relationship positioning element 8 is used to identify the characteristic positional relationship between the locatable characteristic anatomical structures and the osteotomy position. For example... Figure 4 As shown in the example, the distance between the transverse osteotomy groove and the edge of the distal femoral bone is 23mm. By aligning the distal end of the transverse osteotomy line with the edge of the femoral condyle, the distance from this position can be accurately located at 23mm, thereby improving the placement accuracy of the osteotomy guide plate and providing support and guarantee for subsequent high-precision osteotomy.

[0042] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A radiopaque osteotomy guide plate, characterized in that, The osteotomy guide plate is a distal femoral osteotomy guide plate. The distal femoral osteotomy guide plate has a distal femoral condyle positioning part, an intercondyle positioning part, and an anterior femoral condyle positioning part that respectively fit with the distal femoral condyle, the intercondyle fossa, and the anterior femoral condyle. The distal femoral condyle positioning part, the intercondyle fossa positioning part, and the anterior femoral condyle positioning part are all provided with fixation holes suitable for fixing nails to pass through for temporary fixation of the osteotomy guide plate. The distal femoral condyle positioning part and the anterior femoral condyle positioning part are provided with transverse osteotomy grooves suitable for osteotomy tools to pass through. The intercondyle fossa positioning part is provided with longitudinal osteotomy grooves suitable for osteotomy tools to pass through. The femoral anterior condyle positioning part is designed with a radiopaque structure that can be positioned under fluoroscopy. The radiopaque structure includes a fluoroscopy angle correction component that protrudes vertically from the femoral anterior condyle positioning part and a characteristic position relationship positioning component that is orthogonal to the fluoroscopy angle correction component at 90°. The fluoroscopy angle correction component is used for angle correction and positioning under anteroposterior fluoroscopy to ensure that the fluoroscopy device and the distal femoral osteotomy guide plate are at an absolute 90°. The characteristic position relationship positioning component is used to identify the characteristic position relationship between the locatable characteristic anatomical structure and the osteotomy position.

2. A design method for a radiopaque osteotomy guide plate as described in claim 1, characterized in that, Includes the following steps: A three-dimensional model of skeletal anatomy is established based on the patient's preoperative CT and / or MRI data, and simulated osteotomy is performed in the three-dimensional model of skeletal anatomy to determine the location and direction of osteotomy. After determining the osteotomy location and direction, an individualized osteotomy guide plate is designed based on the bone surface characteristics, resulting in a three-dimensional model of the osteotomy guide plate. Establish a characteristic positional relationship between the anatomical structures that can be located under intraoperative fluoroscopy and the osteotomy location; Based on the characteristic positional relationship, a radiopaque structure that can be positioned by fluoroscopy is designed on the three-dimensional model of the osteotomy guide plate; The individualized osteotomy guide plate was fabricated and prepared after the design was confirmed.

3. The design method according to claim 2, characterized in that, The bone surface features include the bone surface features at the location where osteotomy is to be performed on the patient and the bone surface features of the three-dimensional anatomical model of the skeleton.

4. The design method according to claim 2, characterized in that, The locatable anatomical features include articular surfaces, femoral condyles, or acetabulum.

5. The design method according to claim 2, characterized in that, The established positional relationships include the distance and angle between the osteotomy location and the characteristic anatomical structures.

6. The design method according to claim 2, characterized in that, The developing structure is a metal wire or a metal rod.

7. The design method according to claim 2, characterized in that, The fluoroscopic device is a C-arm or a G-arm.

8. The design method according to claim 7, characterized in that, When designing a radiopaque structure on a 3D model of an osteotomy guide plate that can be positioned via fluoroscopy, it is necessary to fully consider the angular error characteristics of C-arm or G-arm fluoroscopy. Radiopaque structures should be designed in both anteroposterior and lateral fluoroscopy to increase the accuracy of the projection angle.

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