Transparent 3D printing operation guider and material

Abstract

The invention relates to the field of surgical instrument materials, in particular to a transparent 3D printing operation guider and a material. The guider comprises a base body, and the base body is made of a transparent 3D printing material and used for being attached to the outer surface of a target skeleton. The base body comprises a plurality of anatomical attachment parts, and the attachment surfaces of the anatomical attachment parts correspond to different anatomical parts respectively; the plurality of sensors are used for monitoring the fitting condition of the anatomical attachment part and the target skeleton in real time; the signal conversion module is embedded in the base body and used for converting signals of the sensor into visual signals; the plurality of miniature bulbs are embedded in the base body and are connected with the signal conversion module, and the brightness of the miniature bulbs is changed according to the signal change of the sensor; and the power supply module is used for providing power for the sensor, the signal conversion module and the miniature bulb. The novel operation guider provided by the invention has the advantages of global visualization, anatomy universality and real-time force feedback.

Description

Technical Field

[0001] The present invention relates to the field of surgical instrument materials, and more specifically to a transparent 3D printed surgical guide and material. Background Art

[0002] In the field of orthopedic surgery, individualized surgical guides have become a key tool for improving surgical precision and are widely used in joint replacement, trauma repair, spinal correction and other procedures. 3D printing technology based on three-dimensional reconstruction of medical images can produce guide devices that are highly compatible with the patient's anatomical structure, showing significant advantages in improving osteotomy positioning accuracy and shortening operation time.

[0003] However, in the prior art, opaque polymer materials (such as PA12 nylon, PEEK, etc.) are commonly used to manufacture surgical guides, resulting in multi-dimensional technical defects: The intraoperative assessment of the guide-bone fit is completely dependent on preoperative planning data and cannot be visually verified in real time during surgery. This defect leads to an average positioning error of 1.5-3.2 mm in complex procedures such as spinal pedicle navigation and pelvic osteotomy.

[0004] Opaque materials force designers to avoid important anatomical landmarks, resulting in reduced stability of guide fixation. Biomechanical studies have shown that the micro-displacement of traditional guides in load-bearing bone surgery can reach 0.8-1.6mm.

[0005] Lack of real-time feedback: Existing guides lack the ability to monitor dynamic changes during surgery and cannot warn of adhesion failure caused by soft tissue traction or bone deformation. Clinical statistics show that about 12.7% of revision surgeries are caused by uncontrollable adhesion status during surgery.

[0006] Some existing improvement schemes attempt to open observation windows on the guide plate, but there are new defects: the window design weakens the structural integrity, the Young's modulus decreases by 40%, and the external sensor increases the volume, hindering the minimally invasive operation space. The separation of signal acquisition and visual display system increases the complexity of intraoperative operation. Therefore, it is urgent to develop a new surgical guide with full-domain visualization, anatomical universality and real-time force feedback. Summary of the invention

[0007] The purpose of the present invention is to provide a transparent 3D printed surgical guide and material to solve the problems raised in the above background technology.

[0008] To achieve the above purpose, the following technical solution is adopted.

[0009] A transparent 3D printed surgical guide, comprising: A substrate, which is made of a transparent 3D printing material and is used to be attached to the outer surface of a target bone; The base 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 the sensors, each of which corresponds to one of the anatomical attachment parts, for real-time monitoring of the fit between the anatomical attachment part and the target bone; The signal conversion module is embedded in the substrate, and is connected to the sensor to convert the sensor signal into a visual signal; A plurality of micro bulbs, each of which corresponds to one sensor, the micro bulbs are embedded in the matrix, the micro bulbs are connected to the signal conversion module, and the brightness of the micro bulbs changes according to the signal change of the sensor, so as to intuitively display the fitting state of the anatomical attachment part and the target bone; A power module is embedded in the matrix, and is connected to the sensor, the signal conversion module and the micro bulb through micro wires, so as to provide power to the sensor, the signal conversion module and the micro bulb.

[0010] Optionally, the base includes at least one additional attachment part, the attachment surface of the additional attachment part is used to attach to a position that is invisible to a traditional non-transparent guide plate, and at least one sensor is provided on the additional attachment part for monitoring the fit between the additional attachment part and the position that is invisible to the traditional non-transparent guide plate.

[0011] Optionally, locations that are not visible with the conventional non-transparent guide plate include bony depressions, joint spaces, or areas where blood vessels and nerve bundles run.

[0012] Optionally, the substrate also includes a protective layer, which covers the anatomical attachment portion, the sensor and the microbulb, and the protective layer is made of a transparent biocompatible material and is used to protect the anatomical attachment portion, the sensor and the microbulb without affecting the brightness display of the microbulb.

[0013] Optionally, the base is provided with an osteotomy groove and a plurality of fixing nail holes.

[0014] Optionally, the substrate further includes auxiliary positioning marks, which include an anterior-posterior axis reference mark or a condylar line reference mark, and are used in conjunction with a surgical navigation system to improve positioning accuracy during surgery.

[0015] A transparent 3D printing material, composed of the following components in percentage by mass: Acrylate and / or methacrylate monomers: 50% - 70%; Multifunctional acrylate cross-linking monomer: 10% - 25%; Benzoyl formate photoinitiator: 2% - 5%; Functional additives: 5% - 15%, including: antioxidants and UV absorbers are compounded in a mass ratio of 1:1 to 1:3, with a total amount of 0.2% - 2%; plasticizers and inorganic fillers are compounded in a mass ratio of 1:1 to 1:2, with a total amount of 3% - 10%.

[0016] Optionally, the plasticizer is acetyl tributyl citrate; The inorganic filler is surface-modified nano-silicon dioxide with a particle size of 10-50 nm, and the modifier is gamma-methacryloxypropyltrimethoxysilane.

[0017] Optionally, the antioxidant is pentaerythritol tetrakis[β-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate; The ultraviolet absorber is 2-(2H-benzotriazole-2-yl)-4,6-di-tert-amylphenol; The compounding mass ratio of the antioxidant to the ultraviolet absorber is 1:2.

[0018] Optionally, the benzoylformate photoinitiator is 2,4,6-trimethylbenzoyl-diphenylphosphine oxide (TPO); The added amount of TPO is 2.5% - 3.5%.

[0019] Compared with the prior art, the present invention has the following beneficial effects: The invention is made of highly transparent materials, so that doctors can visually observe the fit between the guide and the target bone. This transparent design significantly improves the accuracy during surgery, because doctors can clearly see every contact point between the guide and the bone, thereby ensuring the accuracy of osteotomy and prosthesis installation.

[0020] The built-in sensor of the guide can monitor the fit of the anatomical attachment part and the target bone in real time. The signal conversion module converts the sensor signal into a visual signal and visually displays the fit status through the brightness change of the micro-light bulb. This real-time monitoring function provides doctors with instant feedback, further improving the accuracy and safety of the operation.

[0021] The base includes multiple anatomical attachment parts, each of which has an attachment surface corresponding to a different anatomical part. This design allows the guide to be precisely fitted at multiple key locations, enhancing the overall stability of the guide.

[0022] The additional attachment surface is used to attach to locations that are not visible with traditional non-transparent guides, such as bony depressions, joint spaces, or areas where blood vessels and nerve bundles run. This design not only improves the applicability of the guide, but also further enhances its stability in complex anatomical structures.

[0023] Each sensor corresponds to an anatomical attachment part, which is used to monitor the fit in real time. The brightness of the micro-bulb changes according to the sensor signal, intuitively displaying the fit status. It not only provides real-time feedback, but also warns of attachment failure caused by soft tissue traction or bone surface deformation, significantly improving the safety of surgery.

[0024] The protective layer covers the anatomical attachment, sensor and micro-bulb and is made of transparent biocompatible material. The protective layer not only protects the internal components from possible damage during surgery, but also ensures that the brightness display of the micro-bulb is not affected, thereby improving the durability and reliability of the guide.

[0025] Auxiliary positioning markers include the anteroposterior axis reference marker or the condylar line reference marker, which, when used in conjunction with the surgical navigation system, further improve the positioning accuracy during surgery. This auxiliary positioning function helps doctors place the guide more accurately and ensure the smooth progress of the surgery.

[0026] The transparent 3D printing material is composed of specific components, including acrylate and / or methacrylate monomers, multifunctional acrylate cross-linking monomers, benzoylformate photoinitiators and functional additives. This material not only has high transparency, but also has excellent mechanical properties, good dimensional stability and biocompatibility.

[0027] Functional additives include antioxidants, UV 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 UV absorbers significantly improves the anti-aging performance of the material.

[0028] Compared with the design of opening an observation window or integrating an external sensor in the prior art, the transparent 3D printed surgical guide of the present invention maintains the integrity of the structure and avoids the decrease of Young's modulus caused by the window design.

[0029] The design of transparent materials and built-in sensors reduces the interference of external devices on the minimally invasive surgical operating space and improves the minimally invasive nature of the surgery.

[0030] Through real-time monitoring and early warning functions, doctors can promptly detect and correct fit problems between the guide and the bone, significantly reducing surgical risks caused by inaccurate fit.

[0031] Clinical statistics show that about 12.7% of revision surgeries are caused by uncontrollable adhesion status during surgery. The transparent 3D printed surgical guide of the present invention significantly reduces the revision rate and improves the success rate of surgery through real-time monitoring and early warning functions.

[0032] The design of the additional attachment part allows the guide to be fitted in locations that are not visible with traditional non-transparent guides (such as bony depressions, joint spaces, or areas where blood vessels and nerve bundles run), further expanding the scope of application of the guide.

[0033] The transparent 3D printed surgical guide is not only suitable for knee replacement surgery, but can also be widely used in orthopedic surgeries such as spinal correction and trauma repair, and has a wide range of applicability.

[0034] The transparent design and real-time monitoring function significantly improve the accuracy and safety of surgery, reduce the time for 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 surgical efficiency.

[0035] In summary, the transparent 3D printed surgical guide of the present invention and the transparent 3D printed material used therein 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 THE DRAWINGS

[0036] Figure 1 It is a structural schematic diagram of one direction of an embodiment of a transparent 3D printed surgical guide preferably used for the femoral side provided by the present invention; Figure 2 yes Figure 1 A schematic structural diagram of another direction of an embodiment of a transparent 3D printed surgical guide is shown; Figure 3 It is a structural schematic diagram of one direction of an embodiment of a transparent 3D printed surgical guide preferably used for the tibial side provided by the present invention; Figure 4 yes Figure 3 A schematic structural diagram of another direction of an embodiment of a transparent 3D printed surgical guide is shown; Explanation of the reference numerals in the accompanying drawings: 1. base; 21. first attachment part; 22. second attachment part; 23. third attachment part; 24. first fixing nail hole; 25. second fixing nail hole; 26. third fixing nail hole; 27. front and rear axis reference mark; 28. first oblique fixing nail hole; 31. fifth attachment part; 32. sixth attachment part; 33. seventh attachment part; 34. fourth fixing nail hole; 35. fifth fixing nail hole; 36. sixth fixing nail hole; 37. second oblique fixing nail hole; 4. osteotomy groove; 5. sensor; 6. miniature light bulb. DETAILED DESCRIPTION

[0037] The present invention will be described in detail below with reference to the accompanying drawings and in combination with embodiments. It should be noted that the embodiments and features in the embodiments of the present application can be combined with each other without conflict.

[0038] The following detailed description is an exemplary description, which is intended to provide further detailed description of the present invention. Unless otherwise specified, all technical terms used in the present invention have the same meaning as those generally understood by those skilled in the art to which the present application belongs. The terms used in the present invention are only for describing specific embodiments, and are not intended to limit exemplary embodiments according to the present invention.

[0039] Example 1 The core of the transparent 3D printed surgical guide of the present invention is a base 1, which is made of transparent 3D printed material and is used to attach to the outer surface of the target bone. The design of the base 1 is based on the three-dimensional reconstruction of medical images (such as CT or MRI) before surgery to ensure that its attachment surface is highly adapted to the anatomical structure of the target bone. The base 1 includes multiple anatomical attachment parts, and the attachment surface of each anatomical attachment part corresponds to a different anatomical part, ensuring that it can be stably fixed at a predetermined position during surgery.

[0040] The base 1 includes a plurality of anatomical attachment parts, which may specifically include: a first attachment part 21: the attachment surface is used to fit with the first specific part of the target bone. A second attachment part 22: the attachment surface is used to fit with the second specific part of the target bone. A third attachment part 23: the attachment surface is used to fit with the third specific part of the target bone.

[0041] The attachment surfaces of these attachment parts are designed to be highly compatible with the anatomical structure of the target bone, ensuring that they can be stably fixed in the predetermined position during surgery. In addition, the attachment surface can have a micro-texture structure with a size of 1 μm to 10 μm, which can increase the friction between the guide and the bone surface and enhance the stability and reliability of the fit.

[0042] A plurality of sensors 5 are embedded in the matrix 1, each sensor 5 corresponding to an anatomical attachment part, and used to monitor the fit between the anatomical attachment part and the target bone in real time. The sensor 5 can be a force sensor or an optical fiber sensor. The optical fiber sensor monitors the fit state through the change of the optical signal, and has the characteristics of high precision and fast response. The sensors 5 are evenly distributed on the first attachment part 21, the second attachment part 22 and the third attachment part 23, and can detect the fit between the guide and the bone in real time.

[0043] The signal conversion module is embedded in the base 1 and connected to the optical fiber sensor. The module is responsible for converting the optical signal of the optical fiber sensor into a visual signal so that the doctor can visually 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 signal of the sensor 5, and the signal amplifier is used to enhance the signal to ensure the stability and reliability of the signal.

[0044] A plurality of micro bulbs 6 are also embedded in the base 1, and each micro bulb 6 corresponds to a sensor 5. The brightness of the micro bulb 6 changes according to the signal change of the sensor 5, and is used to intuitively display the fit state of the anatomical attachment part and the target bone. For example, when the guide fits the bone well, the micro bulb 6 displays green; when there is a deviation in the fit, the micro bulb 6 displays red, thereby reminding the doctor to make adjustments.

[0045] The power module is embedded in the base 1 and connected to the sensor 5, the signal conversion module and the micro bulb 6 through micro wires to provide stable power support for these components. The power module can use a rechargeable battery and be equipped with a wireless charging function to reduce wire interference during surgery. The power module can also display the current power status through a power indicator light.

[0046] The base 1 also includes at least one additional attachment portion, whose attachment surface is used to attach to a position that is not visible to a traditional non-transparent guide plate, such as a bony depression, a joint gap, or an area where a vascular nerve bundle runs. For example, it is difficult for a traditional guide plate to fit the horseshoe fossa of the acetabulum of the hip joint, but the present application can fit this area well. At least one sensor 5 is provided on the additional attachment portion to monitor the fit between the additional attachment portion and the target bone. This design not only expands the scope of application of the guide, but also improves its adaptability and stability in complex anatomical structures.

[0047] The base 1 also includes a protective layer covering the anatomical attachment portion, the sensor 5 and the micro bulb 6. The protective layer is made of a transparent biocompatible material with a thickness of 10 μm to 50 μm, and is used to protect the internal components from possible damage during surgery without affecting the brightness display of the micro bulb 6. The design of the protective layer further ensures the durability and reliability of the guide.

[0048] The base 1 is provided with an osteotomy groove 4 and multiple fixing nail holes. The design of the osteotomy groove 4 is based on preoperative planning to ensure that the osteotomy operation can be performed accurately during the operation. The fixing nail holes are used to fix the guide on the bone surface to improve the stability and reliability during the operation.

[0049] The transparent guide also includes auxiliary positioning marks, such as the anteroposterior axis reference mark 27 or the condylar line reference mark. These marks are used in conjunction with the surgical navigation system to further improve the positioning accuracy during surgery. The design of the auxiliary positioning marks enables the surgeon to place the guide more accurately during surgery, ensuring the smooth progress of the surgery.

[0050] The present invention can be applied to knee replacement guides, proximal femoral osteotomy orthopedic surgical guides, pelvic tumor resection surgical guides, proximal tibial osteotomy surgical guides, hip replacement surgical guides, shoulder replacement surgical guides, ankle replacement surgical guides, knee ligament reconstruction surgical guides, spinal surgical guides, etc., and has a wide range of applications.

[0051] Example 2

[0052] Taking femoral osteotomy surgery as an example, in the present invention, different methods need to be adopted when determining the attachment surfaces of the first attachment portion 21, the second attachment portion 22, and the third attachment portion 23 according to the source of the femoral original data used in the preoperative planning. When the femoral original data is derived from CT (computer tomography) data, the attachment surfaces of the first attachment portion 21, the second attachment portion 22, and the third attachment portion 23 are consistent with the surface shape of the subchondral bone at the corresponding position; when the femoral original data is derived from MRI (magnetic resonance imaging) data, the attachment surfaces of the first attachment portion 21, the second attachment portion 22, and the third attachment portion 23 are consistent with the surface shape of the cartilage at the corresponding position.

[0053] like Figure 1 and Figure 2 In a preferred embodiment of the present invention, the base 1 includes a first end and a second end, the first end and the second end are arranged in an L shape, the first attachment portion 21 is located on the first end of the base 1, and the second attachment portion 22 and the third attachment portion are located on the second end of the base 1. 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 1 is approximately L-shaped. In this embodiment, by setting the first end and the second end of the base 1 in an L shape, the guide can contact the joint surface of the patient in two nearly vertical spatial directions, thereby improving the attachment stability of the guide and providing a structural basis for increasing the function of the guide.

[0054] In a further preferred embodiment, the attachment surface of the first attachment portion 21 is also attached to the arc surface at the turning continuation of the anterior cortex of the femur and the medial and lateral cortices. In this embodiment, by making the attachment surface of the first attachment portion 21 able to fit the proximal end of the femoral trochlea while also fitting to the arc surface at the turning continuation of the anterior cortex of the femur and the medial and lateral cortices, the rotational stability of the guide can be effectively increased.

[0055] Since errors may occur during the manufacturing and installation of the 3D printed individualized knee replacement surgical guide, such as errors caused by the three-dimensional reconstruction and registration process, especially the errors caused by the registration process of the three-dimensional images of local CT and MRI and the two-dimensional X-ray images of the full-length film of the lower limb, or errors may also be caused by insufficient or excessive scraping of cartilage during the operation. Therefore, in order to further improve the positioning accuracy of the guide, preferably, auxiliary positioning marks are also provided on the base 1, and the auxiliary positioning marks include the anterior-posterior axis reference mark 27 or the condylar line reference mark.

[0056] The anteroposterior axis reference mark 27 is used to compare with the anteroposterior axis of the femur to determine and adjust the positioning accuracy of the locator. The anteroposterior axis, also known as the AP line or Whiteside line, is approximately perpendicular to the condylar line and is the line connecting the lowest point of the femoral trochlear groove to the midpoint of the femoral intercondylar fossa (lateral edge of the PCL).

[0057] The condylar line reference mark is also used to compare with the condylar line of the femur to judge and adjust the positioning accuracy of the locator. The condylar line refers to the line from the lateral epicondyle tip to the medial epicondyle groove. The correct anteroposterior osteotomy plane can be obtained by osteotomizing parallel to this axis.

[0058] The guide provided by the present invention may be provided with an osteotomy groove 4, so that after being positioned by the guide, the osteotomy groove 4 of the guide may be used to perform an osteotomy operation. Figure 1 , Figure 2 As shown, an osteotomy groove 4 is provided on the base 1. The osteotomy groove 4 is located on the first end of the base 1. The osteotomy groove 4 can be directly formed by 3D printing, or a part with the osteotomy groove 4 is installed on the base 1. The groove width of the osteotomy groove 4 is slightly wider than the thickness of the osteotomy saw blade, or is basically the same as the thickness of the osteotomy saw blade, so as to improve the accuracy of osteotomy. The specific setting position of the osteotomy groove 4 varies according to different patients, but it should avoid important structures, such as the patellar tendon, patella, collateral ligament, etc., and it also needs to conform to the incision orientation and the operator's habits.

[0059] In the present invention, in order to further improve the positioning accuracy of the guide, a fourth attachment portion is further provided on the base 1, and the attachment surface of the fourth attachment portion can be fitted with the outer surface of the pathological change portion, and the pathological change portion includes a bone spur or a bone defect. At the same time, a connecting portion for installing a force line rod can also be provided on the base 1, and the connecting portion is a mounting hole for installing the force line rod.

[0060] In order to prevent the micro-movement that may be caused during the nail placement process from affecting the guide attachment accuracy, in the present invention, preferably, Figure 1 , Figure 2As shown, a first fixing nail hole 24 is provided on the first end of the base 1, a second fixing nail hole 25 is provided on the second attachment portion 22, and a third fixing nail hole 26 is provided on the third attachment portion 23. The axis of the first fixing nail hole 24 is perpendicular to the design force line, and the axis of the first fixing nail hole 24 is perpendicular to the axis of the second fixing nail hole 25 and the axis of the third fixing nail hole 26. The design force line refers to the femoral side force line, which is the line connecting the center point of the femoral head and the center point of the femoral knee joint. The basic principle and method for determining these two center points are as follows: the center of the femoral head is the center of the sphere after the femoral head is fitted into a sphere, and the center of the femoral knee joint is the center point of the distal femoral articular surface.

[0061] In this embodiment, by making the axis of the first fixing nail hole 24 perpendicular to the design force line, the axis of the second fixing nail hole 25 and the axis of the third fixing nail hole 26 at the same time, the over-flexion placement error of the femoral side guide can be effectively prevented.

[0062] On the basis of the above embodiments, it is further preferred that Figure 1 , Figure 2 As shown, the number of the first fixing nail holes 24 is 2, and a first oblique fixing nail hole 28 is also provided on the first end of the base 1, and the axis of the first oblique fixing nail hole 28 is not parallel to the axis of the first fixing nail hole 24. In this embodiment, by providing two first fixing nail holes 24 and one first oblique fixing nail hole 28 on the first end of the base 1, when performing an osteotomy operation, the fixing screws in the second fixing nail hole 25 and the third fixing nail hole 26 can be taken out at the same time, thereby facilitating the osteotomy operation while ensuring the positioning accuracy of the guide. Those skilled in the art should know that the length and position of the fixing screws installed in the first fixing nail hole 24 and the first oblique fixing nail hole 28 are based on not affecting the osteotomy operation through the osteotomy groove 44.

[0063] For tibial osteotomy, refer to Figure 3 , Figure 4 As shown, the basic embodiment of the 3D printed individualized knee replacement surgical guide provided by the present invention includes a base 1, on which a fifth attachment portion 31, a sixth attachment portion 32 and a seventh attachment portion 33 are arranged, the attachment surface of the fifth attachment portion 31 can be fitted with the inner side of the tibial plateau, the attachment surface of the sixth attachment portion 32 can be fitted with the outer side of the tibial plateau, the attachment surface of the seventh attachment portion 33 can be fitted with the proximal anterior tibia bone cortex, and the base 1 is also provided with fixing nail holes.

[0064] In this embodiment, by setting the attachment surfaces of the fifth attachment portion 31, the sixth attachment portion 32 and the seventh attachment portion 33 The guide plate is arranged to fit with the inner side of the tibial plateau, the outer side of the tibial plateau and the proximal anterior tibia bone cortex respectively, that is, through the cooperation of the three attachment surfaces, the accuracy of the guide attachment can be increased, and the tendency of the guide plate to tilt forward and inward when attached due to the downward and backward tilting characteristics of the proximal anterior tibia cortical surface can be reduced, forming a stable attachment positioning and effectively improving the attachment accuracy of the guide.

[0065] In the present 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 larger attachment area, but a slight gap should be reserved between the attachment surface and the rear edge and the outer edge of the platform because these areas may be blocked by tissues such as retractors, meniscus, and femoral condyle.

[0066] like Figure 4 As shown, in the present invention, the base 1 includes a first end and a second end, the first end and the second end are arranged in an L shape, the fifth attachment portion 31 and the sixth attachment portion 32 are located on the first end of the base 1, and the seventh attachment portion 33 is located on the second end of the base 1. 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 1 is approximately L-shaped. Similarly, in this embodiment, by setting the first end and the second end of the base 1 to an L shape, the guide can be in contact with the patient's joint surface in two nearly vertical spatial directions, thereby improving the attachment stability of the guide and providing a structural basis for increasing the function of the guide.

[0067] In order to avoid errors that may occur during the manufacturing and installation of the 3D printed individualized knee replacement surgical guide and to further improve the positioning accuracy of the guide, preferably, an auxiliary positioning mark is also provided on the base 1, and the auxiliary positioning mark includes a tibial rotation axis reference mark. The tibial rotation axis, that is, the rotation axis on the tibial side, is the line connecting the posterior cruciate ligament attachment point and the inner 1 / 3 point of the tibial tuberosity. The tibial rotation axis reference mark is used for comparison with the tibial rotation axis to judge and adjust the positioning accuracy of the locator. The tibial rotation axis reference mark can adopt various appropriate marks that can be compared with the tibial rotation axis.

[0068] In a preferred embodiment of the present invention, the tibial rotation axis reference mark is the line connecting the fourth fixing nail hole 34 and the fifth fixing nail hole 35, and the line connecting the fourth fixing nail hole 34 and the fifth fixing nail hole 35 is perpendicular to the tibial rotation axis. The line connecting the fourth fixing nail hole 34 and the fifth fixing nail hole 35 refers to the line connecting the center point of the fourth fixing nail hole 34 and the center point of the fifth fixing nail hole 35 formed on the surface of the guide by a mark, a groove or a protrusion.

[0069] In the present invention, in order to further improve the positioning accuracy of the guide, a fourth attachment portion is further provided on the base 1, and the attachment surface of the fourth attachment portion can be fitted with the outer surface of the pathological change portion, and the pathological change portion includes a bone spur or a bone defect. At the same time, a connecting portion for installing a force line rod can also be provided on the base 1, and the connecting portion is a mounting hole for installing the force line rod.

[0070] In order to prevent the micro-movement that may be caused during the nail placement process from affecting the guide attachment accuracy, in the present invention, preferably, Figure 3 , Figure 4 As shown, the fifth attachment portion 31 is provided with a fourth fixing nail hole 34, the sixth attachment portion 32 is provided with a fifth fixing nail hole 35, and the second end of the base body 1 is provided with a sixth fixing nail hole 36. The axis of the fourth fixing nail hole 34 and / or the fifth fixing nail hole 35 is perpendicular to the tibial osteotomy surface. In this embodiment, by making the axis of the fourth fixing nail hole 34 and / or the fifth fixing nail hole 35 perpendicular to the tibial osteotomy surface, that is, the axis of the fourth fixing nail hole 34 and / or the fifth fixing nail hole 35 is tilted backward relative to the coronal plane, forming a certain angle, such as 5-10 degrees, it is possible to effectively prevent the tibial guide from having anterior tilt errors.

[0071] On the basis of the above embodiments, it is further preferred that Figure 4 As shown, the number of the sixth fixing nail holes 36 is two, and a second oblique fixing nail hole 37 is provided at the second end of the base 1, and the axis of the second oblique fixing nail hole 37 is not parallel to the axis of the sixth fixing nail hole 36. In this embodiment, by providing a sixth fixing nail hole 36 and a second oblique fixing nail hole 37 on the second end of the base 1, when performing an osteotomy operation, the fixing screws in the fourth fixing nail hole 34 and the fifth fixing nail hole 35 can be taken out at the same time, thereby facilitating the osteotomy operation while ensuring the positioning accuracy of the guide. Those skilled in the art should know that the length and position of the fixing screws installed in the sixth fixing nail hole 36 and the second oblique fixing nail hole 37 are based on not affecting the osteotomy operation through the osteotomy groove 4.

[0072] At the same time, the present invention also provides a verification tool for 3D printing an individualized knee replacement surgery guide, the verification tool being a 3D printed femur model after osteotomy, a 3D printed tibia model after osteotomy, a 3D printed three-dimensional model of the femur of the patient's joint part, a 3D printed three-dimensional model of the tibia of the patient's joint part, or a 3D printed cut bone chip model.

[0073] Among them, the 3D printed femoral model after osteotomy and the 3D printed tibia model after osteotomy can be used as a reference for installing the guide before surgery; the 3D printed femoral three-dimensional model of the patient's joint part, the 3D printed tibia three-dimensional model of the patient's joint part and the 3D printed cut bone chip model can assist and verify the accuracy of the guide attachment during surgery.

[0074] Example 3 The transparent 3D printing material of the present invention is particularly suitable for manufacturing a transparent 3D printing surgical guide, and is composed of the following components in percentage by mass: Acrylate and / or methacrylate monomers (50% - 70%): These monomers are the main components of the material, providing high transparency and good mechanical properties. Specific monomers such as methyl methacrylate, ethyl acrylate, etc. can be selected. These monomers form a strong polymer network during the curing process to ensure the strength and transparency of the material.

[0075] Multifunctional acrylate crosslinking monomers (10% - 25%): These crosslinking monomers form a network structure during the curing process, significantly enhancing the strength and toughness of the material. Divinylbenzene, trimethylolpropane triacrylate, etc. can be selected. These crosslinking monomers can improve the mechanical properties and durability of the material.

[0076] Benzoyl formate photoinitiator (2% - 5%): The photoinitiator is an indispensable component in the photocuring process, which can initiate the polymerization reaction of monomers and cross-linking monomers. The present invention uses a benzoyl formate photoinitiator, such as 2,4,6-trimethylbenzoyl-diphenylphosphine oxide (TPO), and the addition amount is 2.5% - 3.5% to ensure that the material is quickly cured under ultraviolet light.

[0077] Functional additives (5% - 15%): Antioxidant and UV absorber: Antioxidant and UV absorber are compounded in a mass ratio of 1:1 to 1:3, with a total amount of 0.2% - 2%. The antioxidant is pentaerythritol tetrakis[β-(3,5-di-tert-butyl-4-hydroxyphenyl) propionate, and the UV absorber is 2-(2H-benzotriazole-2-yl)-4,6-di-tert-amylphenol. This compounding can effectively prevent the material from being degraded due to oxidation and UV irradiation during long-term use, thereby extending the service life of the material.

[0078] 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 tributyl acetyl citrate, the inorganic filler is surface-modified nano-silica with a particle size of 10-50nm, and the modifier is γ-methacryloxypropyltrimethoxysilane. This compounding can improve the flexibility and processing properties of the material while maintaining the strength and transparency of the material.

[0079] The plasticizer is acetyl tributyl citrate, which has a good plasticizing effect and can improve the flexibility and processing performance of the material without affecting the transparency of the material. The inorganic filler is surface-modified nano-silica with a particle size of 10-50nm, and the modifier is γ-methacryloxypropyltrimethoxysilane. This modified nano-silica can improve the mechanical properties and heat resistance of the material while maintaining the transparency of the material.

[0080] The antioxidant is pentaerythritol tetra[β-(3,5-di-tert-butyl-4-hydroxyphenyl) propionate, which has excellent antioxidant properties and can effectively prevent the material from being degraded due to oxidation during long-term use. The ultraviolet absorber is 2-(2H-benzotriazole-2-yl)-4,6-di-tert-amylphenol, which can absorb ultraviolet light and prevent the material from being degraded due to ultraviolet light. The compounding mass ratio of the antioxidant to the ultraviolet absorber is 1:2, which can provide the best protection effect.

[0081] The photoinitiator is 2,4,6-trimethylbenzoyl-diphenylphosphine oxide (TPO), and its addition amount is 2.5% -3.5%. TPO is a highly efficient photoinitiator that can quickly initiate the polymerization reaction of monomers and cross-linking monomers under ultraviolet light to ensure that the material cures in a short time. This photoinitiator can not only increase the curing speed, but also ensure the transparency and mechanical properties of the material.

[0082] The following is a specific example showing how to prepare and use the transparent 3D printing material of the present invention: Materials preparation: Acrylate and / or methacrylate monomers: 60% Multifunctional acrylate crosslinking monomer: 15% 2,4,6-Trimethylbenzoyl-diphenylphosphine oxide (TPO): 3% Antioxidant (pentaerythritol tetrakis[β-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate): 0.5% UV absorber (2-(2H-benzotriazole-2-yl)-4,6-di-tert-amylphenol): 1% Plasticizer (acetyl tributyl citrate): 3% Inorganic filler (surface modified nano-silica, particle size 10-50nm, modifier is γ-methacryloxypropyltrimethoxysilane): 8% Mixing and pretreatment: Mix the above components in proportion to form a uniform premix.

[0083] The premix was pretreated at 25°C and 0.1 MPa to remove air bubbles and evenly disperse the components.

[0084] Curing: The pre-treated premixed liquid was poured into the 3D printing mold and irradiated with ultraviolet light of 365 nm wavelength for 10 minutes to achieve complete curing of the photosensitive resin.

[0085] Post-processing: The cured material was heat treated at 60°C for 2 hours to further improve the strength and dimensional stability of the material.

[0086] The solidified material is polished to improve its surface smoothness.

[0087] A transparent protective film with a thickness of 30 μm is coated on the surface of the cured material. The protective film is made of a transparent biocompatible material, which can further reduce the water absorption rate of the material and improve its surface smoothness and transparency.

[0088] The following is a preparation method of the guide of the present invention based on materials: The plurality of sensors 5 are evenly distributed on the first attachment portion 21 , the second attachment portion 22 and the third attachment portion 23 .

[0089] The signal conversion module is embedded in the base body 1 and connected to the sensor 5 .

[0090] A plurality of micro bulbs 6 are embedded in the base 1 and connected to the signal conversion module.

[0091] The power module is embedded in the base body 1 and connected with the sensor 5, the signal conversion module and the micro bulb 6 through micro wires.

[0092] Before the operation, a transparent 3D printed surgical guide is placed on the patient's femur to ensure that the first attachment portion 21, the second attachment portion 22 and the third attachment portion 23 are respectively in contact with the anterior bone surface of the distal femur, the distal end of the medial femoral condyle and the distal end of the lateral femoral condyle.

[0093] The sensor 5 is used to monitor the fit between the guide and the femur in real time. The signal conversion module converts the signal of the sensor 5 into a visual signal and visually displays the fit status through the brightness change of the micro bulb 6.

[0094] During the operation, the doctor can adjust the position of the guide according to the brightness change of the micro bulb 6 to ensure the precise fit of the guide and the femur.

[0095] The osteotomy operation is performed through the osteotomy groove 4 to ensure the accuracy and consistency of the osteotomy.

[0096] 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, thereby improving the traceability and quality control of the operation.

[0097] Through the above embodiments, the transparent 3D printed surgical guide of the present invention 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.

[0098] It is known from common technical knowledge that the present invention can be implemented by other embodiments that do not deviate from its spirit or essential features. Therefore, the above disclosed embodiments are only illustrative in all respects and are not exclusive. All changes within the scope of the present invention or within the scope equivalent to the present invention are included in the present invention.

Claims

1. A transparent 3D printed surgical guide, characterized in that: include: A substrate (1), the substrate (1) being made of a transparent 3D printing material and being used for being attached to the outer surface of a target bone; The base (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 of the sensors (5) corresponding to one of the anatomical attachment parts, and used for real-time monitoring of the fit between the anatomical attachment part and the target bone; A signal conversion module, embedded in the base (1), connected to the sensor (5) and used for converting the signal of the sensor (5) into a visual signal; A plurality of micro bulbs (6), each of the micro bulbs (6) corresponds to one of the sensors (5), the micro bulbs (6) are embedded in the base (1), the micro bulbs (6) are connected to the signal conversion module, the brightness of the micro bulbs (6) changes according to the signal change of the sensor (5), and is used to intuitively display the fitting state of the anatomical attachment part and the target bone; A power module is embedded in the base (1); the power module is connected to the sensor (5), the signal conversion module and the micro light bulb (6) via micro wires, and is used to provide power to the sensor (5), the signal conversion module and the micro light bulb (6).

2. A transparent 3D printed surgical guide according to claim 1, characterized in that: The base (1) comprises at least one additional attachment part, the attachment surface of the additional attachment part is used to be attached to a position invisible to a traditional non-transparent guide plate, and at least one sensor (5) is provided on the additional attachment part for monitoring the fit between the additional attachment part and the position invisible to the traditional non-transparent guide plate.

3. A transparent 3D printed surgical guide according to claim 2, characterized in that: Locations that are not visible with traditional opaque guides include bony depressions, joint spaces, or areas where vascular and neural bundles run.

4. The transparent 3D printed surgical guide according to claim 1, characterized in that: The substrate (1) further comprises a protective layer, which covers the anatomical attachment portion, the sensor (5) and the micro bulb (6). The protective layer is made of a transparent biocompatible material and is used to protect the anatomical attachment portion, the sensor (5) and the micro bulb (6) without affecting the brightness display of the micro bulb (6).

5. The transparent 3D printed surgical guide according to claim 1, characterized in that: The base (1) is provided with an osteotomy groove (4) and a plurality of fixing nail holes.

6. The transparent 3D printed surgical guide according to claim 1, characterized in that: The base (1) also includes auxiliary positioning marks, which include an anterior-posterior axis reference mark (27) or a condylar line reference mark, and are used in conjunction with a surgical navigation system to improve positioning accuracy during surgery.

7. A transparent 3D printing material, applied to a transparent 3D printing surgical guide according to any one of claims 1 to 6, characterized in that: It is composed of the following components in percentage by mass: Acrylate and / or methacrylate monomers: 50% - 70%; Multifunctional acrylate cross-linking monomer: 10% - 25%; Benzoyl formate photoinitiator: 2% - 5%; Functional additives: 5% - 15%, including: antioxidants and UV absorbers are compounded in a mass ratio of 1:1 to 1:3, with a total amount of 0.2% - 2%; plasticizers and inorganic fillers are compounded in a mass ratio of 1:1 to 1:2, with a total amount of 3% - 10%.

8. The transparent 3D printing material according to claim 7, characterized in that: The plasticizer is acetyl tributyl citrate; The inorganic filler is surface-modified nano-silicon dioxide with a particle size of 10-50 nm, and the modifier is gamma-methacryloxypropyltrimethoxysilane.

9. The transparent 3D printing material according to claim 7, characterized in that: The antioxidant is pentaerythritol tetrakis[β-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate; The ultraviolet absorber is 2-(2H-benzotriazole-2-yl)-4,6-di-tert-amylphenol; The compounding mass ratio of the antioxidant to the ultraviolet absorber is 1:

2.

10. The transparent 3D printing material according to claim 7, characterized in that: The benzoylformate photoinitiator is 2,4,6-trimethylbenzoyl-diphenylphosphine oxide (TPO); The added amount of TPO is 2.5% - 3.5%.

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