Transparent 3d printed surgical guide and material

Abstract

The present application relates to surgical instrument material field, more particularly to a kind of transparent 3D printing surgical director and material.The director includes matrix, matrix is made of transparent 3D printing material, for being attached to the outer surface of target skeleton;Matrix contains multiple anatomical attachment parts, and the attachment surface of each anatomical attachment part corresponds different anatomical sites respectively;Multiple sensors are used to monitor the fitting condition of anatomical attachment part and target skeleton in real time;Signal conversion module is embedded in the inside of matrix, for converting the signal of sensor into visual signal;Multiple micro light bulbs are embedded in the inside of matrix, micro light bulb is connected with signal conversion module, and the brightness of micro light bulb changes according to the signal change of sensor;Power module is used to provide power for sensor, signal conversion module and micro light bulb.The present application provides a new type of surgical director with global visualization, anatomical universality and real-time force feedback.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of surgical instrument materials, more particularly to a transparent 3D printed surgical guide and material. BACKGROUND

[0002] In the field of orthopedic surgery, individualized surgical guides have become a key tool to improve surgical precision, and are widely used in joint replacement, trauma repair, spinal orthopedic surgery, etc. Based on 3D printing technology of medical image three-dimensional reconstruction, a guide device highly adapted to the patient's anatomical structure can be prepared, which shows significant advantages in improving bone cutting positioning accuracy and shortening operation time.

[0003] However, the existing technology generally uses opaque polymer materials (such as PA12 nylon, PEEK, etc.) to manufacture surgical guides, resulting in multidimensional technical defects:

[0004] Intraoperative evaluation of the guide-bone surface adhesion depends entirely on preoperative planning data, and real-time visual verification is not possible during surgery. In complex procedures such as spinal pedicle navigation and pelvic osteotomy, this defect results in an average positioning error of 1.5-3.2 mm.

[0005] The opaque material forces the designer to avoid important anatomical landmarks, resulting in a decrease in the stability of the guide. Biomechanical studies have shown that the micro-displacement of traditional guides in weight-bearing bone surgery can reach 0.8-1.6 mm.

[0006] Real-time feedback is missing: existing guides lack intraoperative dynamic monitoring capabilities and cannot alert to the attachment failure caused by soft tissue traction or bone surface deformation. Clinical statistics show that about 12.7% of revision surgeries are due to uncontrollable intraoperative attachment state.

[0007] Some existing improvement schemes attempt to create an observation window on the guide, but there are new defects: the window design weakens the structural integrity, with a 40% decrease in Young's modulus, and the external sensor increases the volume, which interferes with the micro-invasive approach operation space. The signal acquisition and visual display system are separated, increasing the complexity of intraoperative operation, therefore, there is an urgent need to develop a new type of surgical guide that combines global visualization, anatomical adaptability, and real-time force feedback. SUMMARY

[0008] The purpose of the present application is to provide a transparent 3D printed surgical guide and material to solve the problems raised in the background art.

[0009] To achieve the above purpose, the following technical solutions are adopted.

[0010] A transparent 3D printed surgical guide, comprising:

[0011] a substrate made of transparent 3D printing material for attaching to the outer surface of the target bone;

[0012] the substrate comprises a plurality of anatomical attachment parts, and the attachment surface of each of the anatomical attachment parts corresponds to a different anatomical part;

[0013] a plurality of sensors, each of which corresponds to one of the anatomical attachment parts, for real-time monitoring of the fit of the anatomical attachment parts with the target bone;

[0014] a signal conversion module embedded in the substrate, the signal conversion module being connected to the sensors for converting the signals of the sensors into visual signals;

[0015] a plurality of micro light bulbs, each of which corresponds to one of the sensors, the micro light bulbs being embedded in the substrate, the micro light bulbs being connected to the signal conversion module, the brightness of the micro light bulbs changing according to the signals of the sensors, for directly displaying the fit of the anatomical attachment parts with the target bone;

[0016] a power module embedded in the substrate, the power module being connected to the sensors, the signal conversion module and the micro light bulbs through micro wires, for providing power for the sensors, the signal conversion module and the micro light bulbs.

[0017] Optionally, the substrate comprises at least one additional attachment part, the attachment surface of the additional attachment part being used to attach to a position invisible to a traditional non-transparent guide plate, and at least one sensor being arranged on the additional attachment part for monitoring the fit of the additional attachment part with the position invisible to the traditional non-transparent guide plate.

[0018] Optionally, the position invisible to the traditional non-transparent guide plate includes a bony depression, a joint space or a region where a blood vessel and nerve bundle passes through.

[0019] Optionally, the substrate further comprises a protective layer covering the anatomical attachment parts, the sensors and the micro light bulbs, the protective layer being made of a transparent biocompatible material for protecting the anatomical attachment parts, the sensors and the micro light bulbs while not affecting the brightness display of the micro light bulbs.

[0020] Optionally, the substrate is provided with an osteotomy groove and a plurality of fixation pin holes.

[0021] Optionally, the substrate further comprises auxiliary positioning markers, the auxiliary positioning markers including anterior-posterior axis reference markers or transcondylar line reference markers, for use in cooperation with a surgical navigation system to improve positioning accuracy during surgery.

[0022] A kind of transparent 3D printing material, it is made of the following mass percentage components:

[0023] Acrylate and / or methacrylate monomer: 50% - 70%;

[0024] Multifunctional acrylate crosslinking monomer: 10% - 25%;

[0025] Benzoyl formate photoinitiator: 2% - 5%;

[0026] Functional additives: 5% - 15%, including: antioxidant and ultraviolet absorber are compounded at a mass ratio of 1:1 to 1:3, the total amount is 0.2% - 2%; Plasticizer and inorganic filler are compounded at a mass ratio of 1:1 to 1:2, the total amount is 3% - 10%.

[0027] Optionally, the plasticizer is acetyl tributyl citrate;

[0028] The inorganic filler is surface-modified nano-silica, with a particle size of 10-50 nm, and the modifier is γ-methacryloxypropyl trimethoxysilane.

[0029] Optionally, the antioxidant is tetra [beta- (3, 5-di-tert-butyl-4-hydroxyphenyl) propionic acid] pentaerythritol ester;

[0030] The ultraviolet absorber is 2- (2H-benzotriazole-2-yl) -4, 6-di-tert-pentyl phenol;

[0031] The compounded mass ratio of the antioxidant and the ultraviolet absorber is 1:2.

[0032] Optionally, the benzoyl formate photoinitiator is 2, 4, 6-trimethylbenzoyl-diphenyl phosphine oxide (TPO);

[0033] The addition amount of the TPO is 2.5% - 3.5%.

[0034] Compared with the prior art, the present application has the following beneficial effects:

[0035] The present application is made of a material with high transparency, allowing doctors to visually observe the fit of the guide and the target bone. This transparent design significantly improves the accuracy during the operation, as doctors can clearly see every contact point between the guide and the bone, ensuring the accuracy of osteotomy and prosthesis installation.

[0036] The sensors built into the guide can monitor the fit of the anatomical attachment to the target bone in real time. The signal conversion module converts the sensor signals into visual signals and displays the fit status through the brightness changes of the micro light bulb. This real-time monitoring function provides immediate feedback for the doctor, further improving the accuracy and safety of the operation.

[0037] The base includes multiple anatomical attachments, each with an attachment surface corresponding to a different anatomical site. This design allows the guide to achieve precise fit at multiple key sites, enhancing the overall stability of the guide.

[0038] The additional attachment surface is used to attach to locations that are not visible on traditional non-transparent guides, such as bony depressions, joint spaces, or areas where blood vessels and nerves run. This design not only improves the applicability of the guide, but also further enhances its stability in complex anatomical structures.

[0039] Each sensor corresponds to an anatomical attachment for real-time monitoring of the fit. The brightness of the micro light bulb changes according to the sensor signal, directly displaying the fit status. Not only does it provide real-time feedback, but it also warns of attachment failure caused by soft tissue traction or bone surface deformation, significantly improving the safety of the operation.

[0040] The protective layer covers the anatomical attachment, sensor, and micro light bulb and is made of transparent biocompatible material. The protective layer not only protects the internal components from possible damage during the operation, but also ensures that the brightness display of the micro light bulb is not affected, thereby improving the durability and reliability of the guide.

[0041] The auxiliary positioning markers include anterior-posterior axis reference markers or transcondylar line reference markers, which are used in conjunction with surgical navigation systems to further improve positioning accuracy during surgery. This auxiliary positioning function helps doctors place the guide more accurately, ensuring the smooth progress of the operation.

[0042] The transparent 3D printing material is composed of specific components, including acrylate and / or methacrylate monomers, multifunctional acrylate crosslinking monomers, benzoyl formate photoinitiators, and functional additives. This material not only has high transparency, but also has excellent mechanical properties, good dimensional stability, and biocompatibility.

[0043] Functional additives include antioxidants, ultraviolet absorbers, plasticizers, and inorganic fillers. These additives not only improve the stability and durability of the material, but also extend the service life of the material. For example, the combination of antioxidants and ultraviolet absorbers significantly improves the anti-aging performance of the material.

[0044] Compared with the prior art of opening an observation window or integrating an external sensor, the transparent 3D printed surgical guide of the present application maintains the integrity of the structure and avoids the decrease in Young's modulus caused by the window design.

[0045] The design of transparent material and built-in sensor reduces the interference of external equipment on the operation space of minimally invasive surgery, and improves the minimally invasive nature of the surgery.

[0046] Through real-time monitoring and early warning function, the doctor can find and correct the fitting problem between the guide and the bone in time, which significantly reduces the surgical risk caused by inaccurate fitting.

[0047] Clinical statistics show that about 12.7% of revision surgeries are caused by uncontrollable intraoperative attachment state. The transparent 3D printed surgical guide of the present application significantly reduces the revision rate and improves the success rate of surgery through real-time monitoring and early warning function.

[0048] The design of additional attachment part allows the guide to fit in places where traditional non-transparent guides cannot be seen, such as bone concave, joint space or vascular nerve bundle area, further expanding the application range of the guide.

[0049] The transparent 3D printed surgical guide is not only suitable for knee replacement surgery, but also can be widely used in spinal orthopedic surgery, trauma repair and other orthopedic surgeries, and has wide applicability.

[0050] The transparent design and real-time monitoring function significantly improve the accuracy and safety of the surgery, reduce the time of intraoperative adjustment and verification, and thus shorten the operation time. The integrated design of signal acquisition and visual display system reduces the complexity of intraoperative operation and improves the efficiency of the surgery.

[0051] In summary, the transparent 3D printed surgical guide and the transparent 3D printing material used therein of the present application significantly improve the accuracy, stability and safety of orthopedic surgery through its innovative design and material selection. These improvements not only solve the main defects in the prior art, but also provide a new direction for the development of surgical navigation technology, and have important clinical application value. BRIEF DESCRIPTION OF DRAWINGS

[0052] Figure 1 is a structural schematic diagram of one direction of a preferred transparent 3D printed surgical guide for the femoral side according to the present application;

[0053] Figure 2 is Figure 1 is another structural schematic diagram of one direction of a transparent 3D printed surgical guide according to the present application;

[0054] Figure 3is a structural schematic diagram of one direction of a preferred tibial side transparent 3D printed surgical guide embodiment provided by the present application;

[0055] Figure 4 is Figure 3 is a structural schematic diagram of another direction of a transparent 3D printed surgical guide embodiment shown in the figure;

[0056] Reference signs: 1, base body; 21, first attachment part; 22, second attachment part; 23, third attachment part; 24, first fixed pin hole; 25, second fixed pin hole; 26, third fixed pin hole; 27, front-rear axis reference mark; 28, first inclined fixed pin hole; 31, fifth attachment part; 32, sixth attachment part; 33, seventh attachment part; 34, fourth fixed pin hole; 35, fifth fixed pin hole; 36, sixth fixed pin hole; 37, second inclined fixed pin hole; 4, osteotomy groove; 5, sensor; 6, micro light bulb. DETAILED DESCRIPTION

[0057] The present application will be described in detail below with reference to the accompanying drawings and in conjunction with embodiments. It should be noted that the embodiments in the present application and the features in the embodiments can be combined with each other without conflict.

[0058] The following detailed description is exemplary and is intended to provide further detailed description of the present application. Unless otherwise specified, all technical terms used in the present application have the same meaning as understood by those skilled in the art in the field to which the present application belongs. The terms used in the present application are only for the purpose of describing the specific embodiments and are not intended to limit the exemplary embodiments according to the present application.

[0059] Embodiment 1

[0060] The core of the transparent 3D printed surgical guide of the present application is the base body 1, which is made of transparent 3D printing material and is used for attaching to the outer surface of the target bone. The design of the base body 1 is based on three-dimensional reconstruction through medical imaging (such as CT or MRI) before operation, which ensures that the attachment surface is highly adapted to the anatomical structure of the target bone. The base body 1 contains multiple anatomical attachment parts, and the attachment surface of each anatomical attachment part corresponds to a different anatomical part, respectively, to ensure that it can be stably fixed at the predetermined position during the operation.

[0061] The base body 1 contains multiple anatomical attachment parts, which can specifically include: the first attachment part 21: the attachment surface is used to fit with the first specific part of the target bone. The second attachment part 22: the attachment surface is used to fit with the second specific part of the target bone. The third attachment part 23: the attachment surface is used to fit with the third specific part of the target bone.

[0062] The attachment surfaces of these attachment parts are designed to be highly compatible with the anatomical structure of the target bone, ensuring stable fixation at the predetermined position during the operation. In addition, the attachment surfaces can have a micro-textured structure with a size of 1 μm to 10 μm, which can increase the friction between the guide and the bone surface, enhancing the stability and reliability of the fit.

[0063] The base body 1 has multiple sensors 5 embedded inside, each corresponding to an anatomical attachment part, for real-time monitoring of the fit of the anatomical attachment part with the target bone. The sensors 5 can be force sensors or optical fiber sensors, which monitor the fit state through changes in optical signals, with high precision and fast response characteristics. The sensors 5 are evenly distributed on the first attachment part 21, the second attachment part 22, and the third attachment part 23, allowing real-time detection of the fit between the guide and the bone.

[0064] The signal conversion module is embedded inside the base body 1 and connected with the optical fiber sensor. This module is responsible for converting the optical signals of the optical fiber sensor into visual signals, so that the surgeon can intuitively observe the fit between the guide and the bone during the operation. The signal conversion module includes a microprocessor and a signal amplifier, the microprocessor is used to process and analyze the signals of the sensors 5, and the signal amplifier is used to enhance the signals, ensuring the stability and reliability of the signals.

[0065] The base body 1 also has multiple micro light bulbs 6 embedded inside, each corresponding to a sensor 5. The brightness of the micro light bulbs 6 changes according to the signal changes of the sensors 5, which is used to intuitively display the fit state of the anatomical attachment part with the target bone. For example, when the guide fits well with the bone, the micro light bulbs 6 show green; when the fit deviates, the micro light bulbs 6 show red, prompting the doctor to make adjustments.

[0066] The power module is embedded inside the base body 1 and connected with the sensors 5, the signal conversion module, and the micro light bulbs 6 through micro wires, providing stable power support for these components. The power module can use rechargeable batteries and be equipped with wireless charging function to reduce the interference of wires during the operation. The power module can also display the current power state through a power indicator light.

[0067] The base body 1 also includes at least one additional attachment part, whose attachment surface is used to attach to the position that cannot be seen by traditional non-transparent guide plates, such as bone depressions, joint spaces, or areas where blood vessels and nerves run. For example, the traditional guide plate is difficult to fit in the fovea of the hip joint acetabulum, but the present application can fit well in this area. The additional attachment part is provided with at least one sensor 5 for monitoring the fit of the additional attachment part with the target bone. This design not only expands the application range of the guide, but also improves its adaptability and stability in complex anatomical structures.

[0068] The base 1 further comprises a protective layer covering the anatomical attachment, the sensor 5 and the micro-bulb 6. The protective layer is made of transparent biocompatible material with a thickness of 10-50 μm, which is used to protect the internal components from possible damage during the operation, while not affecting the brightness display of the micro-bulb 6. The design of the protective layer further ensures the durability and reliability of the guide.

[0069] The base 1 is provided with an osteotomy slot 4 and multiple fixation pin holes. The design of the osteotomy slot 4 is based on preoperative planning, which ensures accurate osteotomy operation during the operation. The fixation pin holes are used to fix the guide on the bone surface, improving the stability and reliability during the operation.

[0070] The transparent guide plate further comprises auxiliary positioning marks, such as the anterior-posterior axis reference mark 27 or the transcondylar line reference mark. These marks are used in cooperation with the surgical navigation system, further improving the positioning accuracy during the operation. The design of the auxiliary positioning marks enables the surgeon to place the guide more accurately during the operation, ensuring the smooth progress of the operation.

[0071] The present application can be applied to knee replacement guide plates, proximal femur osteotomy orthopedic surgery guide plates, tumor resection in the pelvis surgery guide plates, proximal tibia osteotomy surgery guide plates, hip replacement surgery guide plates, shoulder replacement surgery guide plates, ankle replacement surgery guide plates, knee ligament reconstruction surgery guide plates, spinal surgery guide plates, etc., and has a wide range of applications.

[0072] Example 2

[0073] Taking femur osteotomy surgery as an example, in the present application, according to the source of the femur original data used in preoperative planning, different methods need to be used when determining the attachment surface of the first attachment 21, the second attachment 22 and the third attachment 23. When the source of the femur original data is CT (computed tomography) data, the attachment surface of the first attachment 21, the second attachment 22 and the third attachment 23 is consistent with the surface shape of the subchondral bone at the corresponding position; when the source of the femur original data is MRI (magnetic resonance imaging) data, the attachment surface of the first attachment 21, the second attachment 22 and the third attachment 23 is consistent with the surface shape of the cartilage at the corresponding position.

[0074] As Figure 1 and Figure 2In a preferred embodiment of the present application, the base body 1 comprises a first end and a second end, the first end and the second end are arranged in an L shape, the first attachment part 21 is located on the first end of the base body 1, and the second attachment part 22 and the third attachment part are located on the second end of the base body 1. Wherein the first end and the second end are arranged in an L shape, that is, the first end and the second end are approximately perpendicular, so that the cross section of the base body 1 is approximately L-shaped. In this embodiment, by arranging the first end and the second end of the base body 1 in an L shape, the guide can be in contact with the joint surface of the patient in two approximately vertical spatial directions, thereby improving the adhesion stability of the guide, and also providing a structural basis for increasing the function of the guide.

[0075] In a further preferred embodiment, the attachment surface of the first attachment part 21 also fits the arc-shaped surface at the turning continuation of the anterior cortex and the medial and lateral cortex of the femur. In this embodiment, by making the attachment surface of the first attachment part 21 fit the arc-shaped surface at the turning continuation of the anterior cortex and the medial and lateral cortex of the femur while being able to fit the proximal end of the femoral trochlea, the rotational stability of the guide can be effectively improved.

[0076] Due to the errors that may occur in the manufacturing and installation process of the 3D printed individualized knee replacement surgery guide, such as errors in the three-dimensional reconstruction and registration process, especially errors in the registration process of three-dimensional images of local CT and MRI and two-dimensional X-ray images of full-length film of lower extremity, or errors caused by insufficient or excessive removal of cartilage during intraoperative scraping, therefore, in order to further improve the positioning accuracy of the guide, preferably, an auxiliary positioning mark is also provided on the base body 1, and the auxiliary positioning mark comprises a front-rear axis reference mark 27 or a transcondylar line reference mark.

[0077] Wherein the front-rear axis reference mark 27 is used for comparison with the front-rear axis of the femur to judge and adjust the positioning accuracy of the guide. Wherein the front-rear axis, also known as the AP line or Whiteside line, is approximately perpendicular to the transcondylar line, and is the connecting line from the lowest point of the femoral trochlear groove to the midpoint of the intercondylar fossa (the lateral edge of the PCL).

[0078] The transcondylar line reference mark is also used for comparison with the transcondylar line of the femur to judge and adjust the positioning accuracy of the guide. The transcondylar line refers to the connecting line from the outer upper condyle tip to the inner upper condyle groove, and the bone cutting along this axis can obtain a correct front-rear bone cutting plane.

[0079] The guide provided by the present application can be provided with a bone cutting groove 4, so that after positioning by the guide, the bone cutting groove 4 of the guide can be used for bone cutting operation. Therefore, in a preferred embodiment, as shown in Figure 1 、 Figure 2As shown, the base body 1 is provided with an osteotomy groove 4. The osteotomy groove 4 is located on the first end of the base body 1. The osteotomy groove 4 can be directly formed by 3D printing, or a part with the osteotomy groove 4 is mounted on the base body 1. The groove width of the osteotomy groove 4 is slightly wider than the thickness of the osteotomy saw blade, or substantially consistent with the thickness of the osteotomy saw blade, so as to improve the accuracy of osteotomy. The specific setting position of the osteotomy groove 4 is different according to different patients, but important structures such as the patellar tendon, the patella, the collateral ligament, etc. should be avoided, and the incision direction and the habit of the surgeon should also be met.

[0080] In the present application, in order to further improve the positioning accuracy of the guide, a fourth attachment part is further provided on the base body 1, and the attachment surface of the fourth attachment part can be attached to the outer surface of the pathological change part, which includes osteophytes or bone defect sites. Meanwhile, a connecting part for mounting a force line rod can also be provided on the base body 1, and the connecting part is a mounting hole for mounting the force line rod.

[0081] In order to prevent the micro-motion caused by the nail placement from affecting the attachment accuracy of the guide, in the present application, preferably, as shown in Figure 1 、 Figure 2 As shown, the first end of the base body 1 is provided with a first fixation nail hole 24, the second attachment part 22 is provided with a second fixation nail hole 25, and the third attachment part 23 is provided with a third fixation nail hole 26. The axis of the first fixation nail hole 24 is perpendicular to the designed force line, and the axis of the first fixation nail hole 24 is perpendicular to the axes of the second fixation nail hole 25 and the third fixation nail hole 26. The designed force line refers to the femoral side force line, which is a line connecting the center point of the femoral head and the center point of the knee joint on the femoral side. The basic principle and method for determining the two center points are as follows: the center of the femoral head is the center of the sphere after the femoral head is fitted as a sphere, and the center of the knee joint on the femoral side is the center point of the distal articular surface of the femur.

[0082] In the present embodiment, by making the axis of the first fixation nail hole 24 perpendicular to the designed force line and the axes of the second fixation nail hole 25 and the third fixation nail hole 26, the over-flexion placement error of the femoral side guide can be effectively prevented.

[0083] On the basis of the above-mentioned embodiments, further preferably, as shown in Figure 1 、 Figure 2As shown, there are two first fixation pin holes 24, and a first oblique fixation pin hole 28 is also provided on the first end of the base 1. The axis of the first oblique fixation pin hole 28 is not parallel to the axis of the first fixation pin hole 24. In this embodiment, by providing two first fixation pin holes 24 and one first oblique fixation pin hole 28 on the first end of the base 1, the fixation screws in the second fixation pin hole 25 and the third fixation pin hole 26 can be removed simultaneously during osteotomy, thereby facilitating osteotomy while ensuring the positioning accuracy of the guide. Those skilled in the art should know that the length and position of the fixation screws installed in the first fixation pin hole 24 and the first oblique fixation pin hole 28 are designed not to affect osteotomy through the osteotomy groove 44.

[0084] For osteotomy procedures of the tibia, refer to Figure 3 , Figure 4 As shown, the 3D-printed individualized knee replacement surgery guide provided by the basic embodiment of the present invention includes a base 1, on which a fifth attachment part 31, a sixth attachment part 32 and a seventh attachment part 33 are provided. The attachment surface of the fifth attachment part 31 can fit with the inner side of the tibial plateau, the attachment surface of the sixth attachment part 32 can fit with the outer side of the tibial plateau, and the attachment surface of the seventh attachment part 33 can fit with the anterior cortical bone of the proximal end of the tibia. The base 1 is also provided with fixation pin holes.

[0085] In this embodiment, the attachment surfaces of the fifth attachment part 31, the sixth attachment part 32, and the seventh attachment part 33 are designed as follows:

[0086] The guide plate is designed to fit into the medial side, lateral side, and anterior cortical bone of the proximal tibia, respectively. This three-sided attachment surface works together to increase the accuracy of the guide plate's attachment and reduce the tendency of the guide plate to tilt forward and inward during attachment due to the downward and backward tilting of the anterior cortical surface of the proximal tibia. This results in a stable attachment position and effectively improves the attachment accuracy of the guide plate.

[0087] In this invention, by selecting the fifth attachment part 31 and the sixth attachment part 32, the attachment surfaces of the fifth attachment part 31 and the sixth attachment part 32 have a large attachment area, but the attachment surfaces should leave a gap from the rear edge and outer edge of the platform, because these areas may be blocked by tissues such as retractors, menisci, and femoral condyles.

[0088] like Figure 4As shown, in the present application, the base body 1 comprises a first end and a second end, the first end and the second end are arranged in an L shape, the fifth attachment part 31 and the sixth attachment part 32 are located on the first end of the base body 1, and the seventh attachment part 33 is located on the second end of the base body 1. Wherein the first end and the second end are arranged in an L shape, which means that the first end and the second end are approximately perpendicular, so that the cross section of the base body 1 is approximately L-shaped. Similarly, in this embodiment, by arranging the first end and the second end of the base body 1 in an L shape, the guide can be in contact with the joint surface of the patient in two approximately vertical spatial directions, thereby improving the adhesion stability of the guide, and providing a structural basis for increasing the function of the guide.

[0089] In order to avoid errors that may occur in the manufacturing and installation process of the 3D printed individualized knee replacement surgery guide, and further improve the positioning accuracy of the guide, preferably, an auxiliary positioning mark is further arranged on the base body 1, and the auxiliary positioning mark comprises a tibial rotation axis reference mark. The tibial rotation axis, that is, the rotation axis of the tibia, is the connecting line between the posterior cruciate ligament stop point and the inner 1 / 3 point of the tibial tuberosity. Wherein the tibial rotation axis reference mark is used for comparison with the tibial rotation axis to judge and adjust the positioning accuracy of the positioner. The tibial rotation axis reference mark can adopt various appropriate marks that can be compared with the tibial rotation axis.

[0090] In a preferred embodiment of the present application, the tibial rotation axis reference mark is the connecting line of the fourth fixation nail hole 34 and the fifth fixation nail hole 35, and the connecting line of the fourth fixation nail hole 34 and the fifth fixation nail hole 35 is perpendicular to the tibial rotation axis. Wherein the connecting line of the fourth fixation nail hole 34 and the fifth fixation nail hole 35 refers to the connecting line connecting the center point of the fourth fixation nail hole 34 and the center point of the fifth fixation nail hole 35 formed on the surface of the guide by marking or groove or protrusion.

[0091] In the present application, in order to further improve the positioning accuracy of the guide, a fourth attachment part is further arranged on the base body 1, and the attachment surface of the fourth attachment part can be attached to the outer surface of the pathological change part, and the pathological change part comprises osteophyte or bone defect site. At the same time, a connecting part for installing a force line rod can also be arranged on the base body 1, and the connecting part is a mounting hole for installing the force line rod.

[0092] In order to prevent the micro-motion that may be caused during the nail installation from affecting the adhesion accuracy of the guide, in the present application, preferably, as shown in Figure 3 、 Figure 4As shown, the fifth attachment part 31 is provided with a fourth fixation pin hole 34, the sixth attachment part 32 is provided with a fifth fixation pin hole 35, and the second end of the base body 1 is provided with a sixth fixation pin hole 36. The axis of the fourth fixation pin hole 34 and / or the fifth fixation pin hole 35 is perpendicular to the tibial bone cutting surface. In the embodiment, by making the axis of the fourth fixation pin hole 34 and / or the fifth fixation pin hole 35 perpendicular to the tibial bone cutting surface, i.e. the axis of the fourth fixation pin hole 34 and / or the fifth fixation pin hole 35 is inclined backward relative to the coronal plane, at an angle, for example, 5-10 degrees, the error caused by the possible forward inclination of the tibial bone guide can be effectively prevented.

[0093] Further preferably, as shown in the above embodiment, Figure 4 As shown, the number of the sixth fixation pin holes 36 is two, and the second end of the base body 1 is provided with a second inclined fixation pin hole 37, and the axis of the second inclined fixation pin hole 37 is not parallel to the axis of the sixth fixation pin hole 36. In the embodiment, by providing the sixth fixation pin hole 36 and the second inclined fixation pin hole 37 on the second end of the base body 1, when the cutting operation is performed, the fixation screws in the fourth fixation pin hole 34 and the fifth fixation pin hole 35 can be taken out at the same time, so as to facilitate the cutting operation and ensure the positioning accuracy of the guide. It should be known by those skilled in the art that the length and position of the fixation screws installed in the sixth fixation pin hole 36 and the second inclined fixation pin hole 37 are subject to the condition that they do not affect the cutting operation through the cutting groove 4.

[0094] Meanwhile, the application also provides a verification tool for the 3D printed individualized knee replacement surgery guide, which is a 3D printed post-cutting femur model, a 3D printed post-cutting tibia model, a 3D printed patient joint part femur three-dimensional model, a 3D printed patient joint part tibia three-dimensional model or a 3D printed cut bone piece model.

[0095] Among them, the 3D printed post-cutting femur model and the 3D printed post-cutting tibia model can be used as a reference for installing the guide before the operation; the 3D printed patient joint part femur three-dimensional model, the 3D printed patient joint part tibia three-dimensional model and the 3D printed cut bone piece model can assist and verify the accuracy of the guide attachment during the operation.

[0096] Embodiment 3

[0097] The transparent 3D printing material of the application is particularly suitable for manufacturing a transparent 3D printing surgery guide, which is composed of the following components in mass percentage:

[0098] Acrylate and / or methacrylate monomers (50% - 70%): These monomers are the main components of the material, providing high transparency and good mechanical properties. Specific options such as methyl methacrylate, ethyl acrylate, etc. These monomers form a strong polymer network during the curing process, ensuring the strength and transparency of the material.

[0099] Multi-functional acrylate cross-linking monomers (10% - 25%): These cross-linking monomers form a network structure during the curing process, significantly enhancing the strength and toughness of the material. Options such as divinylbenzene, trimethylolpropane triacrylate, etc. These cross-linking monomers can improve the mechanical properties and durability of the material.

[0100] Benzoyl formate photoinitiator (2% - 5%): Photoinitiator is an indispensable component in the photocuring process, which can initiate the polymerization reaction of monomers and cross-linking monomers. The invention selects benzoyl formate photoinitiator, such as 2,4,6-trimethylbenzoyl-diphenyl phosphine oxide (TPO), the amount of which is 2.5% - 3.5%, ensuring that the material is quickly cured under ultraviolet light irradiation.

[0101] Functional additives (5% - 15%):

[0102] Antioxidants and ultraviolet absorbers: Antioxidants and ultraviolet absorbers are compounded in a mass ratio of 1:1 to 1:3, with a total amount of 0.2% - 2%. The antioxidant is selected as tetra[β-(3,5-di-tert-butyl-4-hydroxyphenyl) propionic acid] pentaerythritol ester, and the ultraviolet absorber is selected as 2-(2H-benzotriazole-2-yl)-4,6-di-tert-pentyl phenol. This compound can effectively prevent the material from degrading due to oxidation and ultraviolet light irradiation during long-term use, prolonging the service life of the material.

[0103] Plasticizer and inorganic filler: Plasticizer and inorganic filler are compounded in a mass ratio of 1:1 to 1:2, with a total amount of 3%- 10%. The plasticizer is selected as acetyl tri-butyl citrate, and the inorganic filler is selected as surface modified nano-silica with a particle size of 10-50nm and a modifier of γ-methacryloyl propyl trimethoxysilane. This compound can improve the flexibility and processing performance of the material, while maintaining the strength and transparency of the material.

[0104] The plasticizer is selected as acetyl tri-butyl citrate, which has good plasticizing effect and can improve the flexibility and processing performance of the material, while not affecting the transparency of the material. The inorganic filler is selected as surface modified nano-silica with a particle size of 10-50nm and a modifier of γ-methacryloyl propyl trimethoxysilane. This modified nano-silica can improve the mechanical properties and heat resistance of the material, while maintaining the transparency of the material.

[0105] The antioxidant is selected as tetra[β-(3,5-di-tert-butyl-4-hydroxyphenyl) propionic acid] pentaerythritol ester, which has excellent antioxidant performance and can effectively prevent the material from degrading due to oxidation during long-term use. The ultraviolet absorber is selected as 2-(2H-benzotriazole-2-yl)-4,6-di-tert-pentyl phenol, which can absorb ultraviolet light and prevent the material from degrading due to ultraviolet light irradiation. The mass ratio of the antioxidant to the ultraviolet absorber is 1:2, which can provide the best protection effect.

[0106] The photoinitiator is selected as 2,4,6-trimethylbenzoyl-diphenyl phosphine oxide (TPO), and the addition amount is 2.5%-3.5%. TPO is a high-efficiency photoinitiator that can quickly initiate the polymerization reaction of monomers and crosslinking monomers under ultraviolet light irradiation, ensuring that the material is cured in a short time. This photoinitiator not only can improve the curing speed, but also can ensure the transparency and mechanical properties of the material.

[0107] The following is a specific example showing how to prepare and use the transparent 3D printing material of the present application:

[0108] Material preparation:

[0109] Acrylate and / or methacrylate monomer: 60%

[0110] Multi-functional acrylate crosslinking monomer: 15%

[0111] 2,4,6-trimethylbenzoyl-diphenyl phosphine oxide (TPO): 3%

[0112] Antioxidant (tetra[β-(3,5-di-tert-butyl-4-hydroxyphenyl) propionic acid] pentaerythritol ester): 0.5%

[0113] Ultraviolet absorber (2-(2H-benzotriazole-2-yl)-4,6-di-tert-pentyl phenol): 1%

[0114] Plasticizer (acetyl citric acid tributyl ester): 3%

[0115] Inorganic filler (surface-modified nano-silicon dioxide, particle size 10-50 nm, modifier γ-methacryloxypropyl trimethoxysilane): 8%

[0116] Mixing and pretreatment:

[0117] Mix the above components in proportion to form a uniform premix.

[0118] Pretreat the premix at a temperature of 25°C and a pressure of 0.1 MPa to remove bubbles and uniformly disperse the ingredients.

[0119] Curing:

[0120] Pour the pretreated premix into the 3D printing mold, irradiate with ultraviolet light of 365 nm wavelength for 10 minutes to achieve complete curing of the photosensitive resin.

[0121] Post-processing:

[0122] The cured material is subjected to a 2-hour heat treatment at a temperature of 60°C to further improve the strength and dimensional stability of the material.

[0123] The cured material is subjected to a polishing process to improve its surface smoothness.

[0124] A layer of transparent protective film with a thickness of 30 μm is coated on the surface of the cured material, the protective film is made of transparent biocompatible material, which can further reduce the water absorption of the material, improve its surface smoothness and transparency.

[0125] The following is the preparation method of the guide of the present application based on the material:

[0126] The plurality of sensors 5 are evenly distributed in the first attachment part 21, the second attachment part 22 and the third attachment part 23.

[0127] The signal conversion module is embedded inside the base body 1 and connected with the sensor 5.

[0128] The plurality of micro light bulbs 6 are embedded inside the base body 1 and connected with the signal conversion module.

[0129] The power module is embedded inside the base body 1 and connected with the sensor 5, the signal conversion module and the micro light bulb 6 through micro wires.

[0130] Before the operation, the transparent 3D printed surgical guide is placed on the patient's femur to ensure that the first attachment part 21, the second attachment part 22 and the third attachment part 23 respectively fit the distal anterior bone surface of the femur, the distal end of the medial condyle of the femur and the distal end of the lateral condyle of the femur.

[0131] The sensor 5 monitors the fitting of the guide with the femur in real time, the signal conversion module converts the signal of the sensor 5 into a visual signal, and the fitting state is intuitively displayed through the brightness change of the micro light bulb 6.

[0132] During the operation, the doctor can adjust the position of the guide according to the brightness change of the micro light bulb 6 to ensure the accurate fitting of the guide with the femur.

[0133] The osteotomy is performed through the osteotomy slot 4 to ensure the accuracy and consistency of the osteotomy.

[0134] After the operation, the signal data of the sensor 5 recorded by the data recording module is used to analyze and evaluate the operation process, improving the traceability and quality control of the operation.

[0135] Through the above examples, the transparent 3D printed surgical guide of the present application not only solves the main defects in the prior art, but also provides more functions and advantages, significantly improving the accuracy and safety of knee replacement surgery. These improvements not only improve the success rate of surgery and the postoperative recovery effect of patients, but also provide a new direction for the development of surgical navigation technology.

[0136] From the technical common sense, the present application can be realized by other embodiments without departing from the spirit or essential characteristics thereof. Therefore, the above disclosed embodiments, in all aspects, are only illustrative, not the only. All changes within the scope of the present application or within the scope equivalent to the present application are included in the present application.

Claims

1. A transparent 3D printed surgical guide, characterized in that, Comprising: a base body (1) made of transparent 3D printing material for attaching to the outer surface of the target bone; the 3D printing material is composed of the following components in mass percentage: acrylate and / or methacrylate monomer: 60%-70%; polyfunctional acrylate crosslinking monomer: 10%-25%; benzoyl formate photoinitiator: 2%-5%; functional additives: 5%-15%, including: antioxidants and ultraviolet absorbers compounded at a mass ratio of 1:1 to 1:3, accounting for 0.2%-2% of the total; plasticizers and inorganic fillers compounded at a mass ratio of 1:1 to 1:2, accounting for 3%-10% of the total; the base body (1) comprises a plurality of anatomical attachment parts, and the attachment surface of each anatomical attachment part corresponds to a different anatomical part; a plurality of sensors (5), each corresponding to an anatomical attachment part, for real-time monitoring of the fit of the anatomical attachment part with the target bone; the sensor (5) is an optical fiber sensor for real-time monitoring of the fit through changes in optical signals; a signal conversion module embedded in the base body (1), connected to the sensor (5), for converting the signal of the sensor (5) into a visual signal; a plurality of micro light bulbs (6), each corresponding to a sensor (5), embedded in the base body (1), connected to the signal conversion module, and the brightness of the micro light bulb (6) changes according to the signal change of the sensor (5), for directly displaying the fit state of the anatomical attachment part with the target bone; a power module embedded in the base body (1), connected to the sensor (5), the signal conversion module and the micro light bulb (6) through micro wires, for providing power to the sensor (5), the signal conversion module and the micro light bulb (6); the base body (1) comprises at least one additional attachment part, and the attachment surface of the additional attachment part is used for attaching to the target bone position invisible to the traditional non-transparent guide plate; the target bone position invisible to the traditional non-transparent guide plate includes bony depressions, joint spaces or vascular nerve bundle running areas, and at least one sensor (5) is arranged on the additional attachment part for monitoring the fit of the additional attachment part with the target bone position invisible to the traditional non-transparent guide plate.

2. The transparent 3D printed surgical guide of claim 1, wherein, The base body (1) further comprises a protective layer covering the anatomical attachment parts, sensors (5) and micro light bulbs (6), which is made of transparent biocompatible material for protecting the anatomical attachment parts, sensors (5) and micro light bulbs (6) without affecting the brightness display of the micro light bulbs (6).

3. The transparent 3D printed surgical guide of claim 1, wherein, The base body (1) is provided with an osteotomy groove (4) and a plurality of fixation pin holes.

4. The transparent 3D printed surgical guide of claim 1, wherein, The base body (1) further comprises an auxiliary positioning mark, which comprises a front-rear axis reference mark (27) or a condylar line reference mark, for use in cooperation with a surgical navigation system to improve positioning accuracy during surgery.

5. The transparent 3D printed surgical guide of claim 1, wherein, The plasticizer is acetyl tri-butyl citrate; The inorganic filler is surface-modified nano-silica with a particle size of 10-50 nm, and the modifier is γ-methacryloxypropyl trimethoxysilane. 6.The transparent 3D-printed surgical guide according to claim 1, wherein, The antioxidant is tetra[β-(3,5-di-tert-butyl-4-hydroxyphenyl)propionic acid]pentaerythritol ester; The ultraviolet absorber is 2-(2H-benzotriazol-2-yl)-4,6-di-tert-pentylphenol; The mass ratio of the antioxidant to the ultraviolet absorber is 1:

2. 7.The transparent 3D-printed surgical guide according to claim 1, wherein, The benzoyl formate photoinitiator is 2,4,6-trimethylbenzoyl-diphenyl phosphine oxide; The addition amount of the 2,4,6-trimethylbenzoyl-diphenyl phosphine oxide is 2.5%-3.5%.

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