A surgical guide plate for pelvic fracture surgery and a manufacturing method and system thereof

Abstract

The present application discloses a surgical guide for pelvic fracture surgery and a manufacturing method and system thereof. Among them, the surgical guide for pelvic fracture surgery includes: a positioning portion, the positioning portion includes a positioning surface, the positioning surface is used to fit with the patient's pelvis; a fixing portion, the fixing portion includes a fixing surface, the fixing surface is used to adhere to the patient's skin surface; a connecting member, the connecting member extends from the side of the positioning portion facing away from the positioning surface to the side of the fixing portion facing away from the fixing surface to connect the positioning portion and the fixing portion; at least one guide rod, the guide rod is located on the positioning portion or the fixing portion, the guide rod has a guide hole, and the guide hole is used for the fracture screw to be implanted into the patient's body. In the above manner, the present application can accurately execute preoperative simulation surgery plans and reduce surgical risks.

Description

Technical Field

[0001] The present application relates to the field of medical technology, and in particular to a surgical guide plate for pelvic fracture surgery and a manufacturing method and system thereof. Background Art

[0002] Due to the different individual characteristics of the human body and the individual characteristics of the disease, each operation has its own unique particularities. The use of virtual surgical planning can simulate the operation before the operation, assess the surgical risks, and plan the surgical steps, which can reduce the surgical risks and shorten the operation time.

[0003] Taking pelvic fracture surgery as an example, when surgeons perform simulated surgery on a model, they have no reference standards or fixed objective reference objects, making it impossible to accurately grasp the position, direction, depth, etc. of the screws during the operation, and unable to accurately execute the preoperative simulation plan, so there is still a certain surgical risk. Summary of the invention

[0004] The main technical problem solved by the present application is to provide a surgical guide for pelvic fracture surgery and a manufacturing method and system thereof, which can accurately execute preoperative simulation surgery plans and reduce surgical risks.

[0005] In order to solve the above technical problems, a technical solution adopted by the present invention is to provide a surgical guide for pelvic fracture surgery, wherein the surgical guide comprises: a positioning portion, wherein the positioning portion comprises a positioning surface, and the positioning surface is used to fit with the patient's pelvis; a fixing portion, wherein the fixing portion comprises a fixing surface, and the fixing surface is used to be attached to the skin surface of the patient; a connecting member, wherein the connecting member extends from the side of the positioning portion facing away from the positioning surface to the side of the fixing portion facing away from the fixing surface to connect the positioning portion and the fixing portion; and at least one guide rod, wherein the guide rod is located on the positioning portion or the fixing portion, and the guide rod has a guide hole, and the guide hole is used for implanting a fracture screw into the patient's body.

[0006] According to a specific embodiment of the present invention, the number of the guide rods is 3, wherein the positioning portion includes one guide rod, and the fixing portion includes two guide rods; the guide rod located at the positioning portion extends from the positioning portion to the side opposite to the positioning surface, and the guide hole of the guide rod located at the positioning portion passes through the positioning surface; the two guide rods located at the fixing portion respectively extend from the fixing portion to the side opposite to the fixing surface, and the guide holes of the two guide rods located at the fixing portion respectively pass through the fixing surface.

[0007] According to a specific embodiment of the present invention, the surgical guide is a surgical guide model obtained according to the patient's pelvis and the implantation direction of the fracture screw, and is obtained by 3D printing.

[0008] According to a specific embodiment of the present invention, the surgical guide is integrally formed.

[0009] According to a specific embodiment of the present invention, the positioning surface is used to fit with the anterior superior iliac spine or the posterior superior iliac spine of the patient.

[0010] In order to solve the above technical problems, another technical solution adopted by the present invention is to provide a method for making a surgical guide for pelvic fracture surgery, the making method comprising the following steps: establishing a preoperative model including the patient's pelvic information; determining the implantation information of the fracture screw according to the preoperative model, the implantation information of the fracture screw including the implantation direction of the fracture screw; selecting a guide surface on the pelvis of the preoperative model according to the implantation information of the fracture screw, selecting a fitting surface on the skin surface around the guide surface of the preoperative model, and generating a surgical guide model based on the selected guide surface and the fitting surface; wherein the implantation direction of the fracture screw The surgical guide is obtained by 3D printing, wherein the surgical guide comprises a positioning portion, a fixing portion, a connecting piece connecting the positioning portion and the fixing portion, and at least one guide rod located on the positioning portion or the fixing portion, the positioning portion comprises a positioning surface, the positioning surface is used to fit with the leading-out surface, the fixing portion comprises a fixing surface, the fixing surface is used to be attached to the fitting surface, the connecting piece extends from the side of the positioning portion facing away from the positioning surface to the side of the fixing portion facing away from the fixing surface, the guide rod has a guide hole, and the extending direction of the guide hole is the same as the implantation direction of the fracture screw.

[0011] According to a specific embodiment of the present invention, establishing a preoperative model containing the patient's pelvic information includes: acquiring CT data of the patient's pelvis and its accessory tissues; establishing three-dimensional models of the patient's pelvis, organs, blood vessels, hard tissues and skin based on the CT data, and fusing them into the preoperative model.

[0012] According to a specific embodiment of the present invention, determining the implantation information of the fracture screw based on the preoperative model includes: simulating the implantation of the fracture screw on the preoperative model according to the pelvic repair requirements and the surgical requirements to determine the implantation information of the fracture screw, wherein the implantation information of the fracture screw includes the implantation position, implantation direction and length of the fracture screw.

[0013] According to a specific embodiment of the present invention, the number of surgical guides obtained by 3D printing is at least two; after generating the surgical guide model and obtaining the surgical guide by 3D printing, the manufacturing method further includes: sterilizing at least two of the surgical guides, and calibrating one of the sterilized surgical guides with the patient's pelvic prosthesis before surgical application to confirm whether the sterilized surgical guide is deformed.

[0014] In order to solve the above technical problems, another technical solution adopted by the present invention is to provide a system for making a surgical guide for pelvic fracture surgery, the making system comprising: a processing device, the processing device is used to: establish a preoperative model containing the patient's pelvic information; determine the implantation information of the fracture screw according to the preoperative model, the implantation information of the fracture screw includes the implantation direction of the fracture screw; select a guide surface on the pelvis of the preoperative model according to the implantation information of the fracture screw, select a fitting surface on the skin surface around the guide surface of the preoperative model, and generate a surgical guide model; wherein the implantation direction of the fracture screw passes through the guide surface or the fitting surface; a 3D printer is used The invention is used to obtain data information of the surgical guide model generated by the guide generation module, and obtain the surgical guide through 3D printing; wherein, the surgical guide comprises a positioning portion, a fixing portion, a connecting piece connecting the positioning portion and the fixing portion, and at least one guide rod located on the positioning portion or the fixing portion, the positioning portion comprises a positioning surface, the positioning surface is used to fit with the guide-out surface, the fixing portion comprises a fixing surface, the fixing surface is used to be attached to the fitting surface, the connecting piece extends from the side of the positioning portion facing away from the positioning surface to the side of the fixing portion facing away from the fixing surface, the guide rod has a guide hole, and the extending direction of the guide hole is the same as the implantation direction of the fracture screw.

[0015] The beneficial effects of the present invention are as follows: Different from the prior art, the surgical guide of the present application includes a positioning part, a fixing part, a connecting piece connecting the positioning part and the fixing part, and at least one guide rod located on the positioning part or the fixing part, the positioning part includes a positioning surface, the positioning surface is used to fit with the patient's pelvis, the fixing part includes a fixing surface, the fixing surface is used to attach to the patient's skin surface, the connecting piece extends from the side of the positioning part facing away from the positioning surface to the side of the fixing part facing away from the fixing surface, the connecting piece is used to connect the positioning part and the fixing part, the guide rod is located on the positioning part or the fixing part, the guide rod has a guide hole, and the guide hole is used for implanting the fracture screw into the patient's body. The implantation position of the fracture screw can be accurately positioned by the positioning part and the fixing part, and the fracture screw can be accurately implanted by the guide hole on the guide rod, which can ensure the accuracy of implantation, so that the preoperative simulation surgery plan can be accurately executed during the actual surgery, which greatly reduces the error caused by the human factors of the doctor during the operation and avoids the surgical risk; in addition, only the positioning surface of the positioning part is used to fit with the patient's pelvis, while ensuring the positioning accuracy of the surgical guide, the needs of minimally invasive surgery can be met. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following briefly introduces the drawings required for use in the description of the embodiments. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work. Among them:

[0017] Figure 1 This is a structural schematic diagram of an embodiment of a surgical guide of the present application;

[0018] Figure 2 for Figure 1 A schematic structural diagram of a surgical guide from another perspective;

[0019] Figure 3 A schematic diagram of an interface for generating a surgical guide model from a preoperative model in this application;

[0020] Figure 4 for Figure 3 A schematic diagram of the interface from another perspective;

[0021] Figure 5 This is a schematic diagram of the positional relationship between the surgical guide plate and the patient's pelvis in this application;

[0022] Figure 6 for Figure 5 A schematic diagram of the positional relationship from another perspective;

[0023] Figure 7 A schematic diagram of a process of an embodiment of a method for manufacturing a surgical guide plate for pelvic fracture surgery according to the present application;

[0024] Figure 8 A schematic flow chart of another embodiment of a method for manufacturing a surgical guide plate for pelvic fracture surgery according to the present application;

[0025] Fig. 9 It is a structural schematic diagram of an embodiment of a system for making a surgical guide for pelvic fracture surgery according to the present application. DETAILED DESCRIPTION

[0026] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0027] In the following description, for the purpose of explanation rather than limitation, specific details such as specific system structures, interfaces, and technologies are provided to facilitate a thorough understanding of the present application.

[0028] It should be noted that, in the present application, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, the elements defined by the statement "include..." do not exclude the presence of other identical elements in the process, method, article or device including the elements.

[0029] Pelvic fracture is a more serious type of fracture in the whole body. It may be caused by a more obvious direct violent impact, or compression of the pelvis, or collision caused by falling from a height. The pelvis is a stable structure formed by the ilium as a support and the low thighbone at the back. It is an important part to support the body weight and protect the pelvic viscera. When subjected to severe external force, the bone structure is damaged, which may affect the stability of the pelvic ring. The morphological classification after pelvic fracture is complex and diverse. When the pelvis is fractured, some internal organs surrounded by the pelvic ring may also be damaged, such as the rectum, urethra, and bladder. Of course, there may also be damage to the nervous system. Patients may have a lot of bleeding when they see a doctor. Various situations make pelvic fracture surgery difficult. Traditional surgery basically uses X-ray fluoroscopy to confirm and adjust the direction and depth of the guide needle to complete the implantation of the fracture screw; however, minimally invasive surgery takes a long time, and repeated fluoroscopic positioning is required during the operation. Radiation has a great impact on the body of patients and medical staff, and the positioning accuracy of the guide needle is not high, which is prone to some complications after surgery. Therefore, there is a need for a treatment method that can accurately execute preoperative simulation surgery plans during pelvic fracture surgery, reduce surgical risks, shorten operation time, and achieve minimally invasive surgery.

[0030] This application provides a surgical guide for pelvic fracture surgery, please refer to Figure 1 and Figure 2 ,in, Figure 1 This is a schematic diagram of the structure of an embodiment of a surgical guide of the present application. Figure 2 for Figure 1 A schematic structural diagram of a surgical guide from another perspective. The surgical guide comprises: a positioning portion 10, the positioning portion 10 comprises a positioning surface 100, the positioning surface 100 is used to fit with the patient's pelvis; a fixing portion 12, the fixing portion 12 comprises a fixing surface 120, the fixing surface 120 is used to be attached to the patient's skin surface; a connecting member 14, the connecting member 14 extends from the side of the positioning portion 10 facing away from the positioning surface 100 to the side of the fixing portion 12 facing away from the fixing surface 120, so as to connect the positioning portion 10 and the fixing portion 12; at least one guide rod 16, the guide rod 16 is located on the positioning portion 10 or the fixing portion 12, the guide rod 16 has a guide hole 160, and the guide hole 160 is used for implanting a fracture screw into the patient's body.

[0031] In this embodiment, the positioning surface 100 of the positioning portion 10 of the surgical guide is fitted with the patient's pelvis, so that the relative position of the surgical guide and the patient's pelvis is unique; and the surgical guide also includes a fixing portion 12 and a connecting portion extending from the side of the positioning portion 10 opposite to the positioning surface 100 to the side of the fixing portion 12 opposite to the fixing surface 120, and the fixing surface 120 of the fixing portion 12 is attached to the patient's skin surface, so that the fixing portion 12 cooperates with the positioning portion 10 to further ensure that the surgical guide is relatively fitted and stable with the patient's pelvis during use; and the surgical guide also includes a fixing portion 12 located at the positioning portion 10. 0 or at least one guide rod 16 on the fixing part 12, the guide rod 16 has a guide hole 160, and the fracture screw can be accurately implanted through the guide hole 160 on the guide rod 16 to ensure the accuracy of the implantation, so that the preoperative simulation surgery plan can be accurately executed during the actual surgery, which greatly reduces the error caused by the human factors of the doctor during the operation, shortens the operation time, and avoids various risks during and after the operation; in addition, only the positioning surface 100 of the positioning part 10 is used to fit with the patient's pelvis, which can meet the needs of minimally invasive surgery while ensuring the positioning accuracy of the surgical guide.

[0032] Further, the number of guide rods 16 is 3, wherein the positioning portion 10 includes one guide rod 16, and the fixing portion 12 includes two guide rods 16; the guide rod 16 located in the positioning portion 10 extends from the positioning portion 10 to the side opposite to the positioning surface 100, and the guide hole 160 of the guide rod 16 located in the positioning portion 10 passes through the positioning surface 100; the two guide rods 16 located in the fixing portion 12 extend from the fixing portion 12 to the side opposite to the fixing surface 120, respectively, and the guide holes 160 of the two guide rods 16 located in the fixing portion 12 pass through the fixing surface 120, respectively. It can be understood that in actual application, the number of guide rods 16 of the surgical guide of the present application needs to be determined according to the patient's pelvic fracture condition and the number of fracture screws expected to be used, and the corresponding extension direction of the guide rod 16 and the guide hole 160 needs to be designed according to the implantation direction of each fracture screw. When using a surgical guide for surgery, part of the pelvis is exposed according to the patient's pelvic fracture condition, and then the positioning part 10 is inserted, the positioning surface 100 of the positioning part 10 is attached to the surface of the bone, and at the same time, the fixing surface 120 of the fixing part 12 is attached to the patient's skin surface, so that the surgical guide is fixed to the patient's pelvic position; then, guide needles are respectively inserted through the guide holes 160 of each guide rod 16, and then the fracture screws are implanted into the patient's body through the guide needles.

[0033] Please combine Figure 3 and Figure 4 ,in, Figure 3 This is a schematic diagram of the interface for generating a surgical guide model from a preoperative model in this application. Figure 4 for Figure 3Schematic diagram of the interface from another perspective. Further, the surgical guide is a surgical guide model 22 obtained according to the patient's pelvis and the implantation direction of the fracture screw 24, and is obtained by 3D printing. It is understandable that due to the complex structure of the pelvis and the complex and diverse morphology of the pelvic fracture, surgical simulation is required before surgery. Therefore, it is necessary to first establish a preoperative model 20 of the patient's pelvis. Since the preoperative model 20 displays information such as the location of the patient's pelvic fracture, a personalized surgical plan can be specified according to the preoperative model 20. For example, the implantation position, implantation direction and length of the fracture screw 24 to be implanted can be designed, that is, the implantation channel of the fracture screw 24 to be implanted can be virtualized on the preoperative model 20. The implantation channel includes the position where the fracture screw 24 is finally implanted and the channel through which the fracture screw 24 needs to be implanted, so as to ensure that the fracture position is repaired while avoiding damage to the organs, blood vessels and nerves near the patient's pelvis during the implantation of the fracture screw 24. Then, according to the needs of the operation, an export surface is selected on the preoperative model 20, and the export surface includes the surface of the pelvis that needs to be exposed during the operation, and the export surface has specific bone features to facilitate identification of the specific position, and then the export surface is used as a reference surface to extend toward the side away from the pelvis that needs to be exposed and a positioning portion is virtually formed, and the surface of the positioning portion that is in contact with the export surface is the positioning surface; in addition, a fitting surface is selected on the preoperative model 20, and the fitting surface includes the skin surface located near the export surface, and then the fitting surface is used as a reference surface to extend toward the side away from the skin and a fixing portion is virtually formed, and the surface of the fixing portion that is in contact with the fitting surface is the fixing surface; in addition, it should be noted that at least one of the export surface and the fitting surface must include the implantation direction of all fracture screws 24 that need to be implanted, that is, the implantation direction of all fracture screws 24 that need to be implanted must pass through the export surface or the fitting surface. After forming the positioning part and the fixing part, a guide rod is virtually formed extending from the positioning part and the fixing part to the side facing away from the pelvis, and a guide hole is provided on the guide rod, which penetrates the positioning surface or the fixing surface. The guide hole serves as a passage through which the fracture screw 24 needs to be implanted. Each fracture screw 24 that needs to be implanted is matched with a guide rod. Finally, a connector connecting the positioning part and the fixing part is virtually formed, and the connector extends from the side of the positioning part facing away from the positioning surface to the side of the fixing part facing away from the fixing surface. Thus, the virtually formed positioning part, fixing part, guide rod and connector constitute a surgical guide model 22, and then the surgical guide model 22 can be printed and formed by 3D printing technology, thereby obtaining the surgical guide of the present application; for example, the surgical guide model 22 is imported into an STL format file (a file format used to represent a triangular mesh in a computer graphics application system), and then the STL format file data is imported into a 3D printer to complete the typesetting design and print.

[0034] It is understandable that the surgical guide of the present application can be an integrally formed structure. Therefore, there is no connection between the positioning part, the fixing part, the guide rod and the connecting piece, which avoids unnecessary errors due to manufacturing accuracy problems during the actual manufacturing process, and does not cause deviations in the position of the guide hole due to the assembly of various components; in addition, the integrally formed surgical guide is easy to carry and manage, and avoids the loss of some components.

[0035] It is understandable that the positioning surface of the surgical guide of the present application is used to fit with the anterior superior iliac spine or the posterior superior iliac spine of the patient. Figure 5 and Figure 6 ,in, Figure 5 This is a schematic diagram of the positional relationship between the surgical guide and the patient's pelvis in this application. Figure 6 for Figure 5 It is understandable that the selection of the position of the pelvis 30 that needs to be exposed during the operation needs to be determined according to the surgical position, that is, the position of the lead-out surface that fits with the positioning surface of the surgical guide 32 needs to be determined according to the body position to facilitate the operation; for example, when the operation adopts the prone position, the posterior superior iliac spine of the pelvis 30 is used as the lead-out surface, and the positioning surface of the surgical guide 32 is used to fit with the posterior superior iliac spine of the patient, and when the operation adopts the supine position, the anterior superior iliac spine of the pelvis 30 is used as the lead-out surface, and the positioning surface of the surgical guide 32 is used to fit with the anterior superior iliac spine of the patient.

[0036] The present application also provides a method for manufacturing a surgical guide plate for pelvic fracture surgery, which can be used to manufacture the above-mentioned surgical guide plate. Figure 7 , Figure 7 The flowchart of one embodiment of the method for making a surgical guide for pelvic fracture surgery of the present application is shown in FIG. The method for making a surgical guide for pelvic fracture surgery of the present application includes the following steps:

[0037] S701: Establish a preoperative model including the patient's pelvic information.

[0038] This embodiment first needs to obtain a preoperative model of the patient's pelvis. Since the preoperative model shows information such as the location of the patient's pelvic fracture, the final appearance of the pelvis after repair can be determined based on the preoperative model according to the principles of repair.

[0039] S702: Determine implantation information of the fracture screw according to the preoperative model, where the implantation information of the fracture screw includes an implantation direction of the fracture screw.

[0040] After obtaining the preoperative model, the implantation information of the fracture screws to be implanted can be obtained according to the actual needs of surgical fixation and repair. The implantation information of the fracture screws includes the implantation direction of the fracture screws. Among them, the implantation of the fracture screws must take into account both the repair and fixation of the fracture position and the avoidance of damage to the patient's organs, blood vessels, nerves and other tissues near the pelvis during the implantation of the fracture screws. Therefore, the process of determining the implantation information of the fracture screws according to the preoperative model is equivalent to completing the design process of the pelvic fracture surgical plan.

[0041] S703: Select an export surface on the pelvis of the preoperative model according to the implantation information of the fracture screw, select a fitting surface on the skin surface around the export surface of the preoperative model, and generate a surgical guide model based on the selected export surface and fitting surface; wherein the implantation direction of the fracture screw passes through the export surface or the fitting surface.

[0042] In order to complete the implantation process according to the implantation direction of the fracture screw during the operation, a surgical guide can be formed. First, a guide surface is selected on the preoperative model, and the guide surface includes the surface of the pelvis that needs to be exposed during the operation, such as the patient's anterior superior iliac spine or posterior superior iliac spine. The guide surface has specific bone features to facilitate identification of the specific position. The selection is mainly based on the surgical position and the implantation information of the fracture screw. In addition, a fitting surface is selected on the preoperative model, and the fitting surface includes the skin surface located near the guide surface. The surgical guide is respectively fitted to the guide surface and the fitting surface, which can ensure that the surgical guide is relatively fitted and stable with the patient's pelvis during use. Then, based on the selected lead-out surface and fitting surface, a surgical guide model can be generated; for example, the lead-out surface is used as a reference surface to extend toward the side of the pelvis that needs to be exposed and virtually form a positioning portion, and the surface of the positioning portion that fits with the lead-out surface is the positioning surface; then, the fitting surface is used as a reference surface to extend toward the side away from the skin and virtually form a fixing portion, and the surface of the fixing portion that fits with the fitting surface is the fixing surface; in addition, at least one of the lead-out surface and the fitting surface must include the implantation direction of all fracture screws that need to be implanted, that is, the implantation direction of all fracture screws that need to be implanted must pass through the lead-out surface. surface or fitting surface; after the positioning portion and the fixing portion are formed, a guide rod is virtually formed extending from the positioning portion and the fixing portion to the side facing away from the pelvis, and the guide rod has a guide hole, which passes through the positioning surface or the fixing surface. The guide hole serves as a channel for implanting fracture screws, and each fracture screw to be implanted is matched with a guide rod. Finally, a connecting piece connecting the positioning portion and the fixing portion is virtually formed, and the connecting piece extends from the side of the positioning portion facing away from the positioning surface to the side of the fixing portion facing away from the fixing surface; thus, the virtually formed positioning portion, fixing portion, guide rod and connecting piece constitute a surgical guide model.

[0043] S704: Obtain a surgical guide through 3D printing; wherein the surgical guide includes a positioning portion, a fixing portion, a connecting piece connecting the positioning portion and the fixing portion, and at least one guide rod located on the positioning portion or the fixing portion, the positioning portion includes a positioning surface, the positioning surface is used to fit with the guide surface, the fixing portion includes a fixing surface, the fixing surface is used to be attached to the fitting surface, the connecting piece extends from a side of the positioning portion facing away from the positioning surface to a side of the fixing portion facing away from the fixing surface, the guide rod has a guide hole, and the extension direction of the guide hole is the same as the implantation direction of the fracture screw.

[0044] After obtaining the surgical guide model, the surgical guide model can be printed and formed by 3D printing technology to obtain the surgical guide of the present application; for example, the surgical guide model is imported into an STL format file, and then the STL format file data is imported into a 3D printer to complete the layout design and print it.

[0045] In this embodiment, a preoperative model including the patient's pelvic information is first established; then, the implantation information of the fracture screw is determined according to the preoperative model, and the implantation information of the fracture screw includes the implantation direction of the fracture screw; according to the implantation information of the fracture screw, an export surface is selected on the pelvis of the preoperative model, and a fitting surface is selected on the skin surface around the export surface of the preoperative model, and a surgical guide model is generated based on the selected export surface and fitting surface; wherein, the implantation direction of the fracture screw passes through the export surface or the fitting surface; finally, a surgical guide is obtained by 3D printing; wherein, the surgical guide includes a positioning portion, a fixing portion, a connecting piece connecting the positioning portion and the fixing portion, and at least one guide rod located on the positioning portion or the fixing portion, the positioning portion includes a positioning surface, the positioning surface is used to fit with the export surface, the fixing portion includes a fixing surface, the fixing surface is used to attach to the fitting surface, the connecting piece extends from the side of the positioning portion facing away from the positioning surface to the side of the fixing portion facing away from the fixing surface, and the guide rod has a guide hole, and the extension direction of the guide hole is the same as the implantation direction of the fracture screw. The positioning part and the fixing part can be used to accurately locate the implantation position of the fracture screw, and the fracture screw can be accurately implanted through the guide hole on the guide rod, thereby ensuring the accuracy of the implantation and accurately executing the preoperative simulation surgery plan during the actual surgery, greatly reducing the errors caused by the doctor's human factors during the operation and avoiding surgical risks. In addition, only the positioning surface of the positioning part is used to fit the patient's pelvis, which can meet the needs of minimally invasive surgical treatment while ensuring the positioning accuracy of the surgical guide.

[0046] See also Figure 8 , Figure 8 This is a flow chart of another embodiment of the method for making a surgical guide for pelvic fracture surgery of the present application. The method for making a surgical guide for pelvic fracture surgery in this embodiment includes the following steps:

[0047] S801: Acquire CT data of the patient's pelvis and its accessory tissues.

[0048] S802: Three-dimensional models of the patient's pelvis, organs, blood vessels, hard tissues and skin are established respectively according to the CT data, and are fused into a preoperative model.

[0049] Due to the complex structure of the pelvis and the complex and diverse morphology of pelvic fractures, before formulating a surgical plan for the patient, it is first necessary to understand the patient's pelvic fracture situation. Therefore, the CT (Computed Tomography) data of the patient's pelvis and its accessory tissues can be collected first. The relevant information of the patient's pelvis, organs, blood vessels, hard tissues and skin can be obtained from the CT data. Then, three-dimensional models of the patient's pelvis, organs, blood vessels, hard tissues and skin can be established respectively through three-dimensional modeling. Then, they are fused to form a preoperative model of the patient's pelvic fracture information. For example, the mutual information of image pixels in the CT data, the local gradient direction of the image, the mutual correlation coefficient, the grayscale, the local entropy of the image, the image gradient, the Laplace neighborhood graph and the self-similarity features, as well as the improvement based on the above information can be analyzed, and the information is spatially transformed to obtain a preoperative model; thus, a personalized surgical plan can be specified according to the preoperative model.

[0050] S803: Perform simulated implantation of fracture screws on the preoperative model according to the pelvic repair requirements and surgical requirements to determine implantation information of the fracture screws, where the implantation information of the fracture screws includes the implantation position, implantation direction, and length of the fracture screws.

[0051] It is understandable that the implanted fracture screws must not only take into account the repair and fixation of the fracture position, but also avoid damaging the organs, blood vessels, nerves and other tissues near the patient's pelvis during the implantation of the fracture screws. Therefore, it is necessary to specify a personalized surgical plan based on the preoperative model. For example, the implantation position, implantation direction and required length of the fracture screw can be designed. That is, the implantation channel of the fracture screw to be implanted can be virtualized on the preoperative model. The implantation channel includes the position where the fracture screw needs to be ultimately implanted and the channel through which the implanted fracture screw needs to pass, so as to ensure that the fracture position is repaired while avoiding damage to the organs, blood vessels, nerves and other tissues near the patient's pelvis during the implantation of the fracture screw.

[0052] S804: Select an export surface on the pelvis of the preoperative model according to the implantation information of the fracture screw, select a fitting surface on the skin surface around the export surface of the preoperative model, and generate a surgical guide model based on the selected export surface and fitting surface; wherein the implantation direction of the fracture screw passes through the export surface or the fitting surface.

[0053] S805: Obtain a surgical guide through 3D printing; wherein the surgical guide includes a positioning portion, a fixing portion, a connecting piece connecting the positioning portion and the fixing portion, and at least one guide rod located on the positioning portion or the fixing portion, the positioning portion includes a positioning surface, the positioning surface is used to fit with the guide surface, the fixing portion includes a fixing surface, the fixing surface is used to be attached to the fitting surface, the connecting piece extends from a side of the positioning portion facing away from the positioning surface to a side of the fixing portion facing away from the fixing surface, the guide rod has a guide hole, and the extension direction of the guide hole is the same as the implantation direction of the fracture screw.

[0054] In this implementation scenario, steps S804-S805 provided in this embodiment are substantially similar to steps S703-S704 in the previous embodiment of a method for making a surgical guide for pelvic fracture surgery provided in this application, and are not described in detail here.

[0055] In this embodiment, the number of surgical guides obtained by 3D printing is at least two. After step S805, the manufacturing method further includes:

[0056] S806: Disinfect at least two surgical guides, and calibrate one of the sterilized surgical guides with the patient's pelvic prosthesis before surgical application to confirm whether the sterilized surgical guide is deformed.

[0057] Since the surgical guide needs to act directly on the surgical site of the patient, the surgical guide after printing is required to be sterile to prevent infection. Therefore, before the operation, the surgical guide needs to be disinfected, and the sterilized surgical guide is checked with the patient's pelvic prosthesis before the operation to confirm whether the surgical guide is deformed after disinfection. Therefore, in this embodiment, at least two surgical guides are printed at one time, so as to play a role in comparison and verification. It is understandable that plasma disinfection and other methods can be used to avoid large deformation of the surgical guide during the disinfection process. After confirming that the deformation of the sterilized surgical guide does not exceed the preset threshold, for example, the deformation does not exceed 5%, 6% or 10%, it means that the surgical guide can be matched with the patient. Generally speaking, when the matching degree of the sterilized surgical guide exceeds 90%, it can meet the surgical requirements. Then the surgeon can position the posterior superior iliac spine (or anterior superior iliac spine) of the pelvis and the surrounding skin according to the actual situation, fix the positioning surface and the fixing surface on the posterior superior iliac spine of the pelvis and the surrounding skin respectively, and then insert the guide needle through the guide hole in the guide rod. After evaluating the insertion accuracy through pelvic imaging positioning technology, the remaining operations are completed one by one.

[0058] The present application also provides a system for making a surgical guide plate for pelvic fracture surgery, and the system is used to make any of the above surgical guide plates. Fig. 9 , Fig. 9It is a structural schematic diagram of an embodiment of a system for making a surgical guide for pelvic fracture surgery according to the present application. The manufacturing system in this embodiment includes: a processing device 91, the processing device 91 is used to: establish a preoperative model including the patient's pelvic information; determine the implantation information of the fracture screw according to the preoperative model, the implantation information of the fracture screw includes the implantation direction of the fracture screw; select a lead-out surface on the pelvis of the preoperative model according to the implantation information of the fracture screw, select a fitting surface on the skin surface around the lead-out surface of the preoperative model, and generate a surgical guide model; wherein the implantation direction of the fracture screw passes through the lead-out surface or the fitting surface; a 3D printer 92 connected to the processing device 91 is used to obtain data information of the surgical guide model generated by the guide generation module, and obtain the surgical guide by 3D printing; wherein the surgical guide includes a positioning part, a fixing part, a connecting member connecting the positioning part and the fixing part, and at least one guide rod located on the positioning part or the fixing part, the positioning part includes a positioning surface, the positioning surface is used to fit with the lead-out surface, the fixing part includes a fixing surface, the fixing surface is used to attach to the fitting surface, the connecting member extends from the side of the positioning part facing away from the positioning surface to the side of the fixing part facing away from the fixing surface, and the guide rod has a guide hole, and the extension direction of the guide hole is the same as the implantation direction of the fracture screw.

[0059] The manufacturing system in this embodiment can be used to implement the manufacturing method described above to manufacture the surgical guide for pelvic fracture surgery described above. The processing device 91 can be a computer device with corresponding data processing and modeling functions. The specific functions of the processing device 91 and the 3D printer 92 in the manufacturing system of this embodiment can be referred to the above method embodiment.

[0060] In the several embodiments provided in the present application, it should be understood that the disclosed surgical guide and its manufacturing method and system can be implemented in other ways. For example, the surgical guide and its manufacturing method and system implementation described above are only schematic. For example, the division of modules or units is only a logical function division. There may be other division methods in actual implementation, such as multiple units or components can be combined or integrated into another system, or some features can be ignored or not executed. Another point is that the mutual coupling or direct coupling or communication connection shown or discussed can be an indirect coupling or communication connection through some interfaces, devices or units, which can be electrical, mechanical or other forms.

[0061] The units described as separate components may or may not be physically separated, and the components shown as units may or may not be physical units, that is, they may be located in one place or distributed on multiple network units. Some or all of the units may be selected according to actual needs to achieve the purpose of the present embodiment.

[0062] In addition, each functional unit in each embodiment of the present application may be integrated into one processing unit, or each unit may exist physically separately, or two or more units may be integrated into one unit. The above-mentioned integrated unit may be implemented in the form of hardware or in the form of software functional units.

[0063] If the integrated unit is implemented in the form of a software functional unit and sold or used as an independent product, it can be stored in a computer-readable storage medium. Based on this understanding, the technical solution of the present application, or the part that contributes to the prior art, or all or part of the technical solution can be embodied in the form of a software product, which is stored in a storage medium and includes several instructions for a computer device (which can be a personal computer, a server, or a network device, etc.) or a processor to execute all or part of the steps of the various implementation methods of the present application.

Claims

1. A surgical guide for pelvic fracture surgery, characterized in that: The surgical guide comprises: A positioning portion, the positioning portion comprising a positioning surface, the positioning surface being used to fit with the patient's pelvis; A fixing part, the fixing part comprising a fixing surface, the fixing surface being used to be attached to the skin surface of the patient; A connecting member, the connecting member extending from a side of the positioning portion facing away from the positioning surface to a side of the fixing portion facing away from the fixing surface, so as to connect the positioning portion and the fixing portion; At least one guide rod, the guide rod is located on the positioning portion or the fixing portion, the guide rod has a guide hole, and the guide hole is used for implanting a fracture screw into a patient's body; The number of the guide rods is determined according to the pelvic fracture condition of the patient, and the extension direction of the guide holes in the guide rods is determined according to the implantation direction of the fracture screws corresponding to the guide rods; The number of the guide rods is 3, wherein the positioning portion includes one guide rod, and the fixing portion includes two guide rods; The guide rod located at the positioning portion extends from the positioning portion to a side facing away from the positioning surface, and the guide hole of the guide rod located at the positioning portion passes through the positioning surface; The two guide rods located at the fixing portion extend from the fixing portion to a side opposite to the fixing surface, and the guide holes of the two guide rods located at the fixing portion penetrate the fixing surface respectively; The positioning surface is used to fit with the anterior superior iliac spine or the posterior superior iliac spine of the patient.

2. The surgical guide according to claim 1, characterized in that: The surgical guide is a surgical guide model obtained according to the patient's pelvis and the implantation direction of the fracture screw, and is obtained through 3D printing.

3. The surgical guide according to claim 1, characterized in that: The surgical guide is integrally formed.

4. A method for manufacturing a surgical guide for pelvic fracture surgery according to any one of claims 1 to 3, characterized in that: The production method comprises the following steps: Create a preoperative model that includes the patient's pelvic information; Determining implantation information of the fracture screw according to the preoperative model, wherein the implantation information of the fracture screw includes an implantation direction of the fracture screw; A guide surface is selected on the pelvis of the preoperative model according to the implantation information of the fracture screw, a fitting surface is selected on the skin surface around the guide surface of the preoperative model, and a surgical guide model is generated based on the selected guide surface and the fitting surface; wherein the implantation direction of the fracture screw passes through the guide surface or the fitting surface; A surgical guide is obtained by 3D printing; wherein, the surgical guide includes a positioning portion, a fixing portion, a connecting piece connecting the positioning portion and the fixing portion, and at least one guide rod located on the positioning portion or the fixing portion, the positioning portion includes a positioning surface, the positioning surface is used to fit with the guide surface, the fixing portion includes a fixing surface, the fixing surface is used to be attached to the fitting surface, the connecting piece extends from the side of the positioning portion facing away from the positioning surface to the side of the fixing portion facing away from the fixing surface, the guide rod has a guide hole, and the extension direction of the guide hole is the same as the implantation direction of the fracture screw.

5. The method according to claim 4, characterized in that: The step of establishing a preoperative model including the patient's pelvic information comprises: Collect CT data of the patient's pelvis and its accessory tissues; Three-dimensional models of the patient's pelvis, organs, blood vessels, hard tissues and skin are respectively established based on the CT data and fused into the preoperative model.

6. The method according to claim 4, characterized in that: Determining the implantation information of the fracture screw according to the preoperative model includes: The fracture screw is simulatedly implanted on the preoperative model according to the pelvic repair requirements and the surgical requirements to determine the implantation information of the fracture screw, which includes the implantation position, implantation direction and length of the fracture screw.

7. The method according to claim 4, characterized in that: The number of the surgical guides obtained by 3D printing is at least two; After generating the surgical guide model and obtaining the surgical guide by 3D printing, the manufacturing method further includes: At least two surgical guides are sterilized, and one of the sterilized surgical guides is checked against the patient's pelvic prosthesis before surgical application to confirm whether the sterilized surgical guide is deformed.

8. A system for making a surgical guide for pelvic fracture surgery according to any one of claims 1 to 3, characterized in that: The production system comprises: A processing device, the processing device is used to: establish a preoperative model including pelvic information of a patient; determine implantation information of a fracture screw according to the preoperative model, wherein the implantation information of the fracture screw includes an implantation direction of the fracture screw; select a lead-out surface on the pelvis of the preoperative model according to the implantation information of the fracture screw, select a fitting surface on the skin surface around the lead-out surface of the preoperative model, and generate a surgical guide model; wherein the implantation direction of the fracture screw passes through the lead-out surface or the fitting surface; A 3D printer is used to obtain data information of the surgical guide model generated by the guide generation module, and obtain the surgical guide through 3D printing; wherein the surgical guide includes a positioning portion, a fixing portion, a connecting piece connecting the positioning portion and the fixing portion, and at least one guide rod located on the positioning portion or the fixing portion, the positioning portion includes a positioning surface, the positioning surface is used to fit with the guide surface, the fixing portion includes a fixing surface, the fixing surface is used to be attached to the fitting surface, the connecting piece extends from the side of the positioning portion facing away from the positioning surface to the side of the fixing portion facing away from the fixing surface, the guide rod has a guide hole, and the extension direction of the guide hole is the same as the implantation direction of the fracture screw.

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