Device for accurately drilling individualized steel needle into bone tissue and operation method thereof

Abstract

The invention discloses a device for accurately drilling an individualized steel needle into bone tissue and an operation method of the device, and relates to the technical field of orthopedic surgical instruments. The inner side of the guide plate is attached to the tibia, and a positioning part is arranged at the bottom of the guide plate; a guide sleeve; the auxiliary positioning frame is in a horseshoe shape and comprises a first positioning frame and a second positioning frame, a guide block is arranged at one end of the first positioning frame, the other end of the first positioning frame is connected with one end of the second positioning frame, a positioning hole is formed in the other end of the second positioning frame, the guide block is used for being inserted into the guide sleeve, and a first needle hole is formed in the guide block; the auxiliary rod is used for being inserted into the positioning hole, and a second needle hole is formed in the auxiliary rod; provided is a kirschner wire. The device can accurately drill a steel needle at a predetermined part of bone tissue at one time, so that the operation time is saved, tissue wounds are reduced, the risk of operative complications is reduced, and the operation efficiency is improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of orthopedic surgical instruments, more particularly to an individualized steel needle precise drilling into bone tissue device. In addition, it also relates to an operation method applied to the individualized steel needle precise drilling into bone tissue device. BACKGROUND

[0002] Kirschner wire drilling into bone tissue is a routine operation technique in orthopedic clinical practice, especially in the following applications:

[0003] 1. In the treatment of severe deformity of limbs, after the Kirschner wire is drilled into the bone tissue, the ring-shaped external fixation frame is installed to gradually stretch the limb to correct the deformity.

[0004] 2. In the treatment of special fractures, after the fracture is reduced, the Kirschner wire is used for temporary fixation, and then the Kirschner wire is removed when the callus grows satisfactorily.

[0005] In clinical treatment, precise drilling of Kirschner wire (i.e. medical steel needle with a diameter less than 3 mm) into bone tissue is the basic premise for correct installation of external fixation frame. According to the traditional technique, the surgeon drills the Kirschner wire first based on surgical experience and patient's surface anatomy, and then confirms whether the position is satisfactory by X-ray C-arm fluoroscopy. If not, it needs to be drilled again, which will prolong the operation time and increase the risk of damaging blood vessels and nerves. In addition, repeated X-ray fluoroscopy during the operation will expose the doctor and patient to unnecessary multiple radiation, which will cause potential harm to health.

[0006] In summary, how to drill once and accurately, save operation time, reduce tissue trauma, maximize the avoidance of blood vessels and nerves, and reduce the risk of surgical complications is a problem that needs to be solved by technical personnel in this field. SUMMARY

[0007] Therefore, the purpose of the present application is to provide an individualized steel needle precise drilling into bone tissue device, which can drill the steel needle into the bone tissue at the predetermined position once, save the operation time, reduce the tissue trauma, and maximize the avoidance of blood vessels and nerves according to the predetermined surgical plan, so as to reduce the risk of surgical complications, improve the surgical efficiency, and reduce the radiation hazard.

[0008] Another purpose of the present application is to provide an operation method applied to the individualized steel needle precise drilling into bone tissue device.

[0009] In order to achieve the above purpose, the present application provides the following technical scheme:

[0010] An individualized steel needle precise drilling into bone tissue device, comprising:

[0011] A fixing support for traction and fixation of the tibia of a patient;

[0012] a guide plate, an inner side of which is used to fit the tibia, a bottom of the guide plate is provided with a positioning part, which is used to fit the patient's medial malleolus to realize positioning;

[0013] a guide sleeve, which is provided on the outer side of the guide plate, a position of the guide sleeve is used to determine the drilling path of the planned Kirschner wire;

[0014] an auxiliary positioning frame, which is in the shape of a horseshoe, the auxiliary positioning frame comprises a first positioning frame and a second positioning frame, one end of the first positioning frame is provided with a guide block, the other end of the first positioning frame and one end of the second positioning frame are connected, the other end of the second positioning frame is provided with a positioning hole, the guide block is used to be inserted into the guide sleeve, a first needle hole is provided on the guide block;

[0015] an auxiliary rod, which is used to be inserted into the positioning hole, a second needle hole is provided on the auxiliary rod;

[0016] a Kirschner wire, which is inserted from the first needle hole, penetrates into the medial side of the patient's lower leg, penetrates out from the lateral side of the lower leg, and is inserted into the second needle hole.

[0017] In an embodiment, the fixing support comprises:

[0018] a first mounting ring, which is horizontally arranged;

[0019] a second mounting ring, which is arranged in parallel below the first mounting ring, at least two supporting rods are vertically arranged between the first mounting ring and the second mounting ring, the top end of the supporting rod is fixedly connected with the first mounting ring through a fastening nut, the bottom end of the supporting rod is fixedly connected with the second mounting ring through the fastening nut, the fastening nut is provided with a mounting groove for the Kirschner wire to pass through;

[0020] a first U-shaped ring, which is arranged in parallel below the second mounting ring, at least two assembly rods are vertically arranged between the second mounting ring and the first U-shaped ring, the top end of the assembly rod is fixedly connected with the second mounting ring through the fastening nut, the bottom end of the assembly rod is hingedly connected with the first U-shaped ring through a connecting piece;

[0021] a second U-shaped ring, which is vertically arranged at the opening end of the first U-shaped ring, one side of the first mounting ring or the second mounting ring is horizontally provided with a first adapter, the arc-shaped top of the second U-shaped ring is provided with a second adapter, the lower part of the adjusting rod is hingedly connected with the first adapter and the second adapter through the first adapter and the second adapter, the upper part of the adjusting rod is sleeved with a spring, one end of the spring abuts against the first adapter, the other end of the spring abuts against a bolt.

[0022] In an embodiment, the first positioning frame and the second positioning frame are detachably connected.

[0023] In an embodiment, the guide plate is provided with at least two guide sleeves.

[0024] In an embodiment, the guide plate comprises a 3D printed part.

[0025] In an embodiment, the guide plate comprises a plurality of sub-plates connected in sequence or a complete plate.

[0026] An operation method applied to the individualized steel needle precise drilling into bone tissue device of any one of the above-mentioned embodiments, comprising:

[0027] According to the CT data of the patient, the bone tissue lesion information is obtained, and the model of the bone tissue lesion is prepared by 3D printing;

[0028] The drilling path of the Kirschner wire is planned;

[0029] According to the model of the bone tissue lesion and the drilling path, the guide plate and the guide sleeve of the individualized steel needle precise drilling into bone tissue device are printed;

[0030] The inner side of the guide plate is attached to the tibia, the positioning part of the guide plate is attached to the medial malleolus of the patient to realize positioning, the guide block of the auxiliary positioning frame of the individualized steel needle precise drilling into bone tissue device is inserted into the guide sleeve, and the auxiliary rod of the individualized steel needle precise drilling into bone tissue device is inserted into the positioning hole of the auxiliary positioning frame;

[0031] The Kirschner wire is inserted from the first needle hole of the guide block, passes through the tibia, and is inserted from the second needle hole of the auxiliary rod to complete the implantation operation of one Kirschner wire;

[0032] After the implantation operation of each Kirschner wire is completed, the auxiliary positioning frame and the guide plate are detached;

[0033] The fixing support is sleeved outside the patient's limb, each Kirschner wire is fixed by the fixing support, and the tibia and soft tissue are gradually pulled by the fixing support to correct the deformity of the patient.

[0034] In an embodiment, after the implantation operation of one Kirschner wire is completed, the method comprises:

[0035] It is judged whether multiple Kirschner wires need to be implanted, if yes, the auxiliary positioning frame is replaced to the next corresponding guide sleeve, and the step of inserting the guide block into the guide sleeve is returned.

[0036] In an embodiment, the drilling path of the Kirschner wire is planned, comprising:

[0037] Based on the model of the bone tissue lesion, combined with the patient's condition, local anatomy and the type of surgery, the optimal drilling site and angle of the Kirschner wire are planned to obtain the drilling path.

[0038] In one embodiment, the guide plate and guide sleeve of the individualized steel needle precise drilling bone tissue device are printed according to the model of the bone tissue lesion and the drilling path, comprising:

[0039] The pre-operation is performed on the model of the bone tissue lesion according to the drilling path to determine the fitting position of the guide plate and the setting position of the guide sleeve, and the guide plate and the guide sleeve are 3D printed.

[0040] In the use of the individualized steel needle precise drilling bone tissue device provided by the application, first, the detailed three-dimensional information of the bone tissue lesion is obtained according to the CT scan data of the patient, and on this basis, a bone tissue lesion model almost consistent with the real lesion of the patient is prepared by 3D printing technology. The model can clearly show the lesion or deformity of the bone tissue, providing a good three-dimensional physical simulation for subsequent surgical planning and pre-operation. Then, based on the bone tissue lesion model, and considering the patient's deformity condition, local anatomical structure characteristics, type of surgery, and local surgical conditions of the patient and other information, the doctor selects the optimal Kirschner wire drilling site and angle for the patient, i.e. obtains the drilling path of the Kirschner wire. It is particularly emphasized that multiple Kirschner wires are planned and designed as a whole, avoiding the problem that it is difficult to ensure the precise optimal combination effect between multiple Kirschner wires when drilling one by one in the traditional technology.

[0041] Subsequently, according to the above surgical planning, pre-operation is performed on the 3D printed bone tissue lesion model. Through pre-operation, the feasibility of the surgical planning can be verified to further optimize the implantation path and combination mode of the Kirschner wire, and determine the key parameters such as the best fitting position of the guide plate, the precise setting position of the guide sleeve, and the cooperation mode of the auxiliary positioning frame and the guide sleeve. Then, according to the results of the pre-operation planning, 3D printing technology is used to manufacture the components of the device, including the guide plate (including the guide sleeve), the auxiliary positioning frame, and the auxiliary rod, etc.

[0042] During the operation, first, the inner side of the guide plate is fitted on the surface of the target bone tissue (such as the medial tibia), and the positioning part (such as the inner malleolus) at the bottom of the guide plate is used to realize the precise positioning of the guide plate. Then, the guide block of the auxiliary positioning frame is inserted into the pre-set guide sleeve of the guide plate, and the guide block and the guide sleeve are tightly matched. After that, the auxiliary rod is detachably inserted into the positioning hole of the auxiliary positioning frame.

[0043] Subsequently, the Kirschner wire is inserted from the first needle hole on the guide block of the auxiliary positioning frame, and is inserted into the limb (e.g., the medial side of the lower leg) according to the preset path, and is inserted out of the limb (e.g., the lateral side of the lower leg) after passing through the target bone tissue, and is inserted into the second needle hole on the auxiliary rod, so as to complete the accurate implantation of the Kirschner wire. If multiple Kirschner wires need to be implanted during the operation, the auxiliary positioning frame is removed from the current guide sleeve, is matched with another guide sleeve on the guide plate, and the process of installing the auxiliary rod and implanting the Kirschner wire is repeated. After the guide plate and the auxiliary positioning frame are installed in place, the Kirschner wire is inserted from the first needle hole and is inserted into the medial side of the lower leg, and is inserted out of the lateral side of the lower leg and is inserted into the second needle hole. Meanwhile, multiple guide sleeves can be arranged on the guide plate as needed, the auxiliary positioning frame is matched with one guide sleeve, is removed, and is matched with another guide sleeve. Moreover, the auxiliary positioning frame is in the shape of a horseshoe, so that the accurate insertion of the Kirschner wire is ensured, that is, the auxiliary positioning frame in the shape of the horseshoe provides an accurate insertion point and an insertion-out point for the Kirschner wire.

[0044] After the implantation operation of each Kirschner wire 6 is completed, the auxiliary positioning frame 4 and the guide plate 2 and the like are removed, and only the Kirschner wire 6 is left. Finally, the fixing support 1 is sleeved on the limb of the patient, the fixing support can traction and fix the limb (e.g., the tibia), and each Kirschner wire 6 is fixed by the fixing support 1 (for example, the fixing support 1 is provided with a mounting groove for fixing the Kirschner wire 6), and the tibia 7 and the soft tissue are gradually pulled by the fixing support 1, so as to correct the deformity of the patient's limb (e.g., the lower leg).

[0045] In summary, the individualized steel needle accurate drilling into bone tissue device provided by the application can accurately drill a steel needle into a predetermined position of a bone tissue at one time, saves operation time, reduces tissue trauma, and can maximize avoid blood vessels and nerves according to a predetermined operation scheme, so as to reduce the risk of operation complications, improve operation efficiency, and reduce radiation hazards.

[0046] In addition, the application also provides an operation method applied to the individualized steel needle accurate drilling into bone tissue device. BRIEF DESCRIPTION OF DRAWINGS

[0047] In order to more clearly illustrate the technical solutions in the embodiments of the application or the prior art, the following will briefly introduce the drawings needed to be used in the embodiments or the prior art description. Obviously, the drawings in the following description are only embodiments of the application, and other drawings can be obtained by those skilled in the art without any creative effort on the basis of the provided drawings.

[0048] Figure 1 The assembly schematic view of the fixing support, the guide plate, the guide sleeve, the auxiliary positioning frame, the auxiliary rod, the Kirschner wire and the tibia of the individualized steel needle accurate drilling into bone tissue device provided by the application;

[0049] Figure 2 It is the assembly schematic of the fixed support, the guide plate, the guide sleeve, the auxiliary positioning frame, the auxiliary rod and the Kirschner wire;

[0050] Figure 3 It is the structural schematic of the fixed support;

[0051] Figure 4 It is the exploded view of the guide plate and the auxiliary positioning frame;

[0052] Figure 5 It is the assembly schematic of the guide plate, the guide sleeve, the auxiliary positioning frame and the Kirschner wire;

[0053] Figure 6 It is another assembly schematic of the guide plate, the guide sleeve, the auxiliary positioning frame and the Kirschner wire;

[0054] Figure 7 It is the structural schematic diagram that the Kirschner wire is penetrated into the tibia under the action of the guide plate, the guide sleeve and the auxiliary positioning frame;

[0055] Figure 8 It is Figure 7 The structural schematic diagram under another perspective;

[0056] Figure 9 It is the structural schematic diagram that the fixed support sleeve is fixed into the lower leg and the Kirschner wire;

[0057] Figure 10 It is the flow schematic diagram of the operation method provided by the application.

[0058] Figures 1-10 In the middle:

[0059] 1 is a fixed support, 11 is a first mounting ring, 12 is a second mounting ring, 13 is a support rod, 14 is a fastening nut, 15 is a first U-shaped ring, 16 is an assembly rod, 17 is a connecting piece, 18 is a second U-shaped ring, 19 is a first adapter, 110 is a second adapter, 111 is an adjusting rod, 112 is a spring, 113 is a bolt, 2 is a guide plate, 21 is a positioning part, 22 is a groove, 3 is a guide sleeve, 4 is an auxiliary positioning frame, 41 is a first positioning frame, 42 is a second positioning frame, 43 is a guide block, 44 is a positioning hole, 45 is a first needle hole, 5 is an auxiliary rod, 51 is a second needle hole, 6 is a Kirschner wire, and 7 is a tibia. DETAILED DESCRIPTION

[0060] The technical solutions in the embodiments of the application will be clearly and completely described below with reference to the drawings in the embodiments of the application. Obviously, the described embodiments are only part of the embodiments of the application, rather than all the embodiments of the application. Based on the embodiments in the application, all other embodiments obtained by a person of ordinary skill in the art without creative work fall within the protection scope of the application.

[0061] The core of the present application is to provide an individualized steel needle precise drilling into bone tissue device, which can precisely drill a steel needle into a predetermined site of bone tissue at one time, save operation time, reduce tissue trauma, and can maximize avoid blood vessels and nerves according to the predetermined surgical plan, thereby reducing the risk of surgical complications, improving surgical efficiency, and reducing radiation hazards. Another core of the present application is to provide an operation method applied to the individualized steel needle precise drilling into bone tissue device.

[0062] Please refer to Figure 1 and Figure 2 , the present embodiment provides an individualized steel needle precise drilling into bone tissue device, comprising:

[0063] A fixing support 1 is used to pull and fix the tibia 7 of a patient;

[0064] A guide plate 2 is used to fit the tibia 7 on the inner side, and the bottom of the guide plate 2 is provided with a positioning part 21 for fitting and positioning with the medial malleolus of the patient;

[0065] A guide sleeve 3 is arranged on the outer side of the guide plate 2, and the position of the guide sleeve 3 is used to determine the drilling path of the planned Kirschner wire 6;

[0066] An auxiliary positioning frame 4 is in the shape of a horseshoe, and the auxiliary positioning frame 4 comprises a first positioning frame 41 and a second positioning frame 42. One end of the first positioning frame 41 is provided with a guide block 43, and the other end of the first positioning frame 41 and one end of the second positioning frame 42 are connected (for example, by riveting or the like). The other end of the second positioning frame 42 is provided with a positioning hole 44, and the guide block 43 is used to be inserted into the guide sleeve 3, and the guide block 43 is provided with a first needle hole 45;

[0067] An auxiliary rod 5 is used to be inserted into the positioning hole 44, and the auxiliary rod 5 is provided with a second needle hole 51;

[0068] A Kirschner wire 6 is inserted from the first needle hole 45, and then is inserted into the second needle hole 51 from the outside of the lower leg.

[0069] It should be noted that the inner side of the guide plate 2 can be designed to be in the shape of the surface of the target bone tissue (such as the inner side of the tibia 7) to ensure the stability and accurate positioning of the guide plate 2. The bottom of the guide plate 2 is provided with a positioning part 21, and the shape of the positioning part 21 matches the medial malleolus of the patient. By fitting with the medial malleolus, the guide plate 2 can be accurately positioned on the bone tissue. The structure of the guide plate 2 can be designed to be in multiple segments for splicing according to actual needs, so as to adapt to complex bone shapes or different parts, or it can be a complete segment.

[0070] For example, a positioning part 21 can be arranged at the bottom of the guide plate 2, which matches the inner malleolus of the patient. In addition, grooves 22 can be arranged on the opposite sides of the guide plate 2, which correspond to the front edge and the rear edge of the tibia. In this way, the guide plate 2 can be prevented from moving up and down and left and right. Of course, the structure of the grooves 22 can be cancelled, and the opposite sides of the guide plate 2 can be aligned, which is equivalent to widening the guide plate 2. After widening, the guide plate 2 can be prevented from being easily deformed. During clinical operation, the positioning part 21 is aligned with the inner malleolus of the patient, and the side surface of the entire guide plate 2 is attached to the bone of the patient. During actual application, the shape, structure, size, etc. of the guide plate 2 can be determined according to actual conditions and actual needs.

[0071] It should be further noted that the guide sleeve 3 is arranged on the outside of the guide plate 2. The specific position of the guide sleeve 3 is determined according to the individual condition of the patient and the pre-surgery result in the preoperative planning stage, which corresponds to the drilling path required by the Kirschner wire 6. The guide sleeve 3 is a key component for connecting the guide plate 2 and the auxiliary positioning frame 4. The auxiliary positioning frame 4 is one of the core components for realizing precise guidance of the Kirschner wire 6. The auxiliary positioning frame 4 has a horseshoe shape. This shape design can better adapt to the physiological curvature of the limb, and facilitate the Kirschner wire 6 to be inserted from one side of the auxiliary positioning frame 4 and to be taken out from the other side of the auxiliary positioning frame 4. The auxiliary rod 5 is detachably inserted into the positioning hole 44 of the auxiliary positioning frame 4. The second needle hole 51 is arranged on the auxiliary rod 5.

[0072] In addition, it should be noted that the shape of the guide block 43 matches the guide sleeve 3, and the guide block 43 can be closely matched with the guide sleeve 3 in the form of insertion, so as to fix the auxiliary positioning frame 4 on the guide plate 2. The first needle hole 45 is arranged on the guide block 43, and the axis of the first needle hole 45 is completely consistent with the drilling path of the Kirschner wire 6 planned in the pre-surgery. During the operation, the Kirschner wire 6 is inserted from the first needle hole 45, sequentially passes through the skin, the subcutaneous tissue, the target bone tissue, and is taken out from the outside of the lower leg (or other limbs), and is finally inserted into the second needle hole 51 on the auxiliary rod 5. Through the common guiding action of the first needle hole 45 and the second needle hole 51, and the horseshoe shape design of the auxiliary positioning frame 4, the Kirschner wire 6 is provided with an accurate insertion point and a taking-out point, so as to ensure that the Kirschner wire 6 can be accurately implanted according to the preset optimal path. In order to adapt to the implantation requirement of multiple Kirschner wires 6, multiple guide sleeves 3 can be arranged on the guide plate 2 according to the pre-surgery planning. After implanting one Kirschner wire 6, the auxiliary positioning frame 4 can be removed from the current guide sleeve 3, and is matched with another guide sleeve 3, so as to realize the precise implantation of multiple Kirschner wires 6.

[0073] A key feature of this device is its detachable and modular structure. This design effectively avoids the drawback of some small hospitals being unable to use it due to the large size of the model and guide plate 2, which limits the capacity of their sterilization equipment. The individual components are smaller and easier to sterilize, thus expanding the applicability of this invention. Figure 1 This is an assembly diagram of the fixed bracket 1, guide plate 2, guide sleeve 3, auxiliary positioning frame 4, auxiliary rod 5, Kirschner wire 6, and tibia 7. However, in actual use, the fixed bracket, guide plate, guide sleeve, auxiliary positioning frame, and auxiliary rod will not all be present simultaneously. Figure 7 , 8 As shown in Figure 9, after the implantation of each Kirschner wire 6 is completed, the auxiliary positioning frame 4 and guide plate 2 are removed, and then the fixing bracket 1 is installed. In actual use, the shape, structure, size, material, position, and type of the fixing bracket 1, guide plate 2, guide sleeve 3, auxiliary positioning frame 4, and auxiliary rod 5 can be determined according to the actual situation and needs.

[0074] In one embodiment, such as Figure 2 and Figure 3 As shown, the fixed bracket 1 includes:

[0075] The first mounting ring 11 is horizontally positioned.

[0076] The second mounting ring 12 is arranged parallel to the bottom of the first mounting ring 11. At least two support rods 13 are vertically arranged between the first mounting ring 11 and the second mounting ring 12. The top end of the support rod 13 is fixedly connected to the first mounting ring 11 by a fastening nut 14, and the bottom end of the support rod 13 is fixedly connected to the second mounting ring 12 by a fastening nut 14. The fastening nut 14 is provided with a mounting groove for passing through the Kirschner wire 6, which can fix the Kirschner wire 6.

[0077] The first U-shaped ring 15 is arranged parallel to the lower part of the second mounting ring 12. At least two mounting rods 16 are vertically arranged between the second mounting ring 12 and the first U-shaped ring 15. The top end of the mounting rod 16 is fixedly connected to the second mounting ring 12 by a fastening nut 14, and the bottom end of the mounting rod 16 is hinged to the first U-shaped ring 15 by a connector 17.

[0078] The second U-shaped ring 18 is vertically disposed at the open end of the first U-shaped ring 15. A first adapter 19 is horizontally disposed on one side of the first mounting ring 11 or the second mounting ring 12. A second adapter 110 is disposed at the arc-shaped top of the second U-shaped ring 18. The lower part of the adjusting rod 111 passes through the first adapter 19 and is hinged to the second adapter 110. A spring 112 is sleeved on the upper part of the adjusting rod 111. One end of the spring 112 abuts against the first adapter 19, and the other end of the spring 112 abuts against the bolt 113.

[0079] The fixation bracket 1, through the cooperation of components such as a circular ring, a U-shaped ring, a spring 112, a support rod 13, and bolts 113, can flexibly achieve functions such as traction and fixation of the limb to maintain the stability of the surgical area and provide a good foundation for subsequent operations. In tibial surgery, the lower leg is placed in the fixation bracket 1, which mainly serves to traction and fix the patient's limb.

[0080] In one embodiment, the first positioning frame 41 and the second positioning frame 42 are detachably connected. For example, the first positioning frame 41 and the second positioning frame 42 are connected by means of riveting or the like.

[0081] In one embodiment, the guide plate 2 is provided with at least two guide sleeves 3. That is, the guide sleeves 3 are located on the outside of the guide plate 2. When manufacturing the guide plate 2, the specific position and number of guide sleeves 3 are determined based on the preliminary diagnostic structure.

[0082] In one embodiment, the guide plate 2 includes a 3D printed part to ensure that the guide plate 2 is fabricated into the desired structure.

[0083] In one embodiment, the guide plate 2 comprises multiple sequentially connected sub-plates or a single complete plate. The type of guide plate 2 can be determined based on actual conditions and requirements during practical application.

[0084] In addition to the aforementioned personalized steel needle precision drilling device for bone tissue, this invention also provides an operating method for the personalized steel needle precision drilling device for bone tissue disclosed in the above embodiments. This operating method, as follows... Figure 7 As shown, it includes:

[0085] Step S1: Obtain bone tissue lesion information based on the patient's CT data, and prepare a model of the bone tissue lesion by 3D printing;

[0086] Step S2: Plan the drilling path of Kirschner wire 6;

[0087] Step S3: Based on the model of the bone tissue lesion and the drilling path, print the guide plate 2 and guide sleeve 3 of the individualized steel needle precision drilling device for bone tissue.

[0088] Step S4, as follows Figure 7 and Figure 8 As shown, the inner side of the guide plate 2 is attached to the tibia 7, and the positioning part 21 of the guide plate 2 is attached to the patient's medial malleolus to achieve positioning. The guide block 43 of the auxiliary positioning frame 4 of the individualized steel needle precision drilling into bone tissue device is inserted into the guide sleeve 3, and the auxiliary rod 5 of the individualized steel needle precision drilling into bone tissue device is inserted into the positioning hole 44 of the auxiliary positioning frame 4.

[0089] Step S5: The Kirschner wire 6 is inserted through the first pin hole 45 of the guide block 43, passes through the tibia 7, and exits through the second pin hole 51 of the auxiliary rod 5 to complete the implantation of one Kirschner wire 6.

[0090] Step S6: After the implantation of each Kirschner wire 6 is completed, remove the auxiliary positioning frame 4 and guide plate 2;

[0091] Step S7, as follows Figure 9 As shown, the fixation bracket 1 is fitted over the patient's limb, and each Kirschner wire 6 is fixed by the fixation bracket 1. The fixation bracket 1 is used to gradually pull the tibia 7 and soft tissue to correct the patient's deformity. In one embodiment, after completing the implantation of one Kirschner wire 6, the procedure includes:

[0092] Determine whether multiple Kirschner wires 6 need to be implanted. If so, replace the auxiliary positioning frame 4 with the next corresponding guide sleeve 3 and return to the step of inserting the guide sleeve 3 into the guide block 43.

[0093] In one embodiment, planning the drilling path of the Kirschner wire 6 includes:

[0094] Based on a model of bone tissue lesions, combined with the patient's condition, local anatomy, and surgical type, the optimal drilling location and angle of the Kirschner wire 6 are planned to obtain the drilling path.

[0095] In one embodiment, based on a model of the bone tissue lesion and the drilling path, a guide plate 2 and a guide sleeve 3 of a personalized steel needle precision drilling device for bone tissue are printed, including:

[0096] Pre-operative procedures were performed on a model of bone lesions according to the drilling path to determine the fitting position of guide plate 2 and the setting position of guide sleeve 3, and guide plate 2 and guide sleeve 3 were 3D printed.

[0097] To further illustrate the operation method of the personalized steel needle precision drilling device for bone tissue provided by the present invention, the following examples will be provided.

[0098] The operation method includes the following steps:

[0099] 1) Data Acquisition and Model Preparation: First, detailed three-dimensional information of the bone lesions was obtained based on the patient's CT scan data. Then, a bone lesion model almost identical to the patient's actual lesion was prepared using 3D printing technology. This bone lesion model clearly displays the lesions or deformities in the bone tissue, providing a good three-dimensional physical simulation for subsequent surgical planning and pre-operative procedures.

[0100] 2) Surgical Planning: Based on the bone lesion model obtained in Step 1, and taking into account the patient's deformity, local anatomical features, surgical type, and local surgical conditions, the surgeon selects the optimal insertion site and angle for the Kirschner wire 6. It is particularly important to emphasize that multiple Kirschner wires 6 are planned and designed as a whole, avoiding the problem of difficulty in ensuring a precise and optimal combination effect when drilling individual Kirschner wires 6 in traditional techniques.

[0101] 3) Pre-operative rehearsal: Based on the above surgical plan, a pre-operative operation is performed on a 3D-printed bone tissue lesion model. Through the pre-operative operation, the feasibility of the surgical plan can be verified, the implantation path and combination of the Kirschner wire 6 can be further optimized, and key parameters such as the optimal fitting position of the guide plate 2, the precise setting position of the guide sleeve 3, and the cooperation method between the auxiliary positioning frame 4 and the guide sleeve 3 can be determined.

[0102] 4) Fabrication of positioning device: Based on the results of the pre-operative planning, the various components of the modular positioning device of the present invention are fabricated using 3D printing technology, including guide plate 2 (including guide sleeve 3), auxiliary positioning frame 4 and auxiliary rod 5, etc.

[0103] 5) Intraoperative Positioning and Device Assembly: During the surgery, firstly, the inner side of the guide plate 2 is placed against the surface of the target bone tissue (such as the inner side of the tibia 7), and the guide plate 2 is precisely positioned using the positioning part 21 at the bottom of the guide plate 2 (such as fitting against the medial malleolus). Next, the guide block 43 of the auxiliary positioning frame 4 is inserted into the pre-set guide sleeve 3 on the guide plate 2, ensuring a tight fit between the guide block 43 and the guide sleeve 3. Finally, the auxiliary rod 5 is detachably inserted into the positioning hole 44 of the auxiliary positioning frame 4.

[0104] 6) Kirschner wire 6 implantation: Insert the Kirschner wire 6 through the first pin hole 45 on the guide block 43 of the auxiliary positioning frame 4, pass through the limb (such as the inner side of the lower leg) according to the preset path, pass through the target bone tissue, and then exit from the outer side of the limb (such as the outer side of the lower leg) and insert it into the second pin hole 51 on the auxiliary rod 5, completing the precise implantation of one Kirschner wire 6. If the surgery requires the implantation of multiple Kirschner wires 6, remove the auxiliary positioning frame 4 from the current guide sleeve 3, and then cooperate with another guide sleeve 3 on the guide plate 2 to repeat the auxiliary rod 5 installation process in step 5 and the Kirschner wire 6 implantation process in step 6.

[0105] 7) After the implantation of each Kirschner wire 6 is completed, remove the auxiliary positioning frame 4 and the guide plate 2. For example, first, the auxiliary rod 5 can be removed, then the first positioning frame 41 and the second positioning frame 42 can be removed, then the auxiliary positioning frame 4 can be removed from the current guide sleeve 3, then the guide plate 2 can be removed, and finally, only the Kirschner wire 6 that has passed through the target bone tissue remains.

[0106] 8) Install the fixation bracket 1: The fixation bracket 1 is placed on the outside of the patient's limb, and each Kirschner wire 6 is fixed by the fixation bracket 1. The fixation bracket 1 is used to gradually pull the tibia 7 and soft tissue (such as the cooperation of the spring 112, support rod 13 and bolt 113 of the fixation bracket 1 to achieve traction and fixation of the limb) in order to correct the patient's deformity.

[0107] It should be noted that the 3D printing technology itself and the method of performing pre-surgery on the model are existing technologies. The specific operation process and parameters are not the core design points of this invention. The core of this invention is to use these existing technologies and combine them with the innovatively designed modular positioning device structure to achieve precise and efficient implantation of Kirschner wires 6.

[0108] Compared with the prior art, this application has the following significant advantages:

[0109] a. Achieving precise one-time implantation of Kirschner wire 6, significantly saving surgical time and reducing tissue trauma: This application, through precise preoperative planning and pre-operative surgery based on 3D printed models, and the precise guidance provided by the modular positioning device during surgery (especially the cooperation between the horseshoe-shaped auxiliary positioning frame 4 and the guide plate 2 and guide sleeve 3), ensures that Kirschner wire 6 can be precisely drilled and exited in one go along the optimal path, avoiding the drawbacks of traditional techniques that require repeated adjustments and re-drilling due to unsatisfactory positioning. This not only greatly shortens the surgical time and improves surgical efficiency, but also reduces additional trauma to surrounding soft tissues and bone tissues caused by repeated operations.

[0110] b. Minimizing the risk of surgical complications by avoiding blood vessels and nerves: During the preoperative planning stage, surgeons can clearly observe the relative positions of bone structures and surrounding important blood vessels and nerves on a 3D-printed model of the bone lesion. Combined with pre-operative simulations, this allows for precise design of the insertion location and angle of the Kirschner wire 6, thereby minimizing the risk of damage to important structures such as blood vessels and nerves. Precise intraoperative guidance further ensures the realization of this plan, effectively reducing the risk of blood vessel and nerve damage due to Kirschner wire 6 misalignment, thus lowering the incidence of surgical complications.

[0111] c. Avoid repeated intraoperative fluoroscopy and reduce unnecessary multiple radiation exposures to doctors and patients: Since this application can achieve one-time precise implantation of Kirschner wire 6, it is not necessary to perform X-ray C-arm fluoroscopy to confirm the position after each Kirschner wire 6 is drilled or adjusted, as is the case with traditional techniques. Therefore, the number of intraoperative X-ray fluoroscopy sessions can be significantly reduced. In ideal cases, the position of multiple Kirschner wires 6 can even be confirmed with a single fluoroscopy, thereby greatly reducing the unnecessary radiation dose received by doctors and patients and helping to protect the health of both doctors and patients.

[0112] d. The device features an ingenious design, is detachable and assembleable, and has strong applicability: This application adopts a detachable and assembleable structural design. This feature effectively solves the problem that traditional large-scale integrated models and guide plates are too large for small hospitals to use due to limited sterilization equipment capacity. The disassembled components are smaller in size, making them easier to sterilize and facilitating their application in medical institutions at all levels.

[0113] e. Assisting surgeons in intraoperative decision-making and enhancing their confidence: The 3D-printed bone model, created based on the patient's individual condition, can be used for intraoperative reference after sterilization. Combined with the innovative auxiliary positioning frame 4, guide plate 2, guide sleeve 3, and auxiliary rod 5, the surgeon can visually confirm whether the installation of the entire treatment device is scientifically sound and whether the implantation path of the Kirschner wire 6 conforms to the preoperative plan. This visualized operation and confirmation process helps the surgeon make accurate decisions during the operation, enhances their confidence, and improves the success rate of the surgery.

[0114] f. Optimizing the combined effect of Kirschner wires 6: This application emphasizes designing and optimizing multiple sets of Kirschner wires 6 as a whole during preoperative planning, avoiding the problem that it is difficult to guarantee the overall optimal combined effect when implanting Kirschner wires 6 one by one in traditional techniques. Through the setting of multiple guide sleeves 3 on the guide plate 2 and the flexible cooperation of the auxiliary positioning frame 4, multiple Kirschner wires 6 can be accurately implanted according to the preset optimal spatial configuration to obtain better fixation effect or corrective force.

[0115] It should be noted that the first adapter 19 and the second adapter 110, the first U-ring 15 and the second U-ring 18, the first mounting ring 11 and the second mounting ring 12, the first positioning frame 41 and the second positioning frame 42 mentioned in this application are only distinguished by their different positions and do not have any order of precedence.

[0116] In addition, it should be noted that the orientation or positional relationship indicated by "up and down", "horizontal", "vertical", etc. in this application is based on the orientation or positional relationship shown in the accompanying drawings, and is only for the purpose of simplifying the description and making it easier to understand, and is not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the present invention.

[0117] The various embodiments in this specification are described in a progressive manner, with each embodiment focusing on its differences from other embodiments. Similar or identical parts between embodiments can be referred to interchangeably. Any combination of all embodiments provided by this invention is within the scope of protection of this invention and will not be elaborated upon here.

[0118] The above provides a detailed description of the individualized steel needle precision drilling device for bone tissue and its operation method provided by the present invention. Specific examples have been used to illustrate the principles and implementation methods of the present invention. The descriptions of the above embodiments are merely for the purpose of helping to understand the method and core ideas of the present invention. It should be noted that those skilled in the art can make various improvements and modifications to the present invention without departing from its principles, and these improvements and modifications also fall within the protection scope of the claims of the present invention.

Claims

1. An individualized steel needle precision drilling into bone tissue device, characterized in that, The utility model relates to a kind of medical devices and methods for fixing tibia, comprising: Fixed support (1) for traction fixed patient's tibia (7); Guide plate (2) inside for fitting the tibia (7), the bottom of the guide plate (2) is equipped with positioning part (21), and the positioning part (21) is used to fit the positioning of patient's medial malleolus; Guide sleeve (3) is equipped on the outside of the guide plate (2), and the position of the guide sleeve (3) is used to determine according to the planned drilling path of kirschner wire (6); Auxiliary positioning frame (4) is in the shape of horseshoe, and the auxiliary positioning frame (4) includes first positioning frame (41) and second positioning frame (42), one end of the first positioning frame (41) is equipped with guide block (43), the other end of the first positioning frame (41) and one end of the second positioning frame (42) are connected, the other end of the second positioning frame (42) is equipped with positioning hole (44), the guide block (43) is used to be inserted into the guide sleeve (3), and first needle hole (45) is opened in the guide block (43); Auxiliary rod (5) is used to be inserted into the positioning hole (44), and second needle hole (51) is opened in the auxiliary rod (5); Kirschner wire (6) is inserted from the first needle hole (45), and is inserted into the second needle hole (51) from the outside of the lower leg of patient, and is inserted into the second needle hole (51) from the outside of the lower leg of patient.

2. The individualized steel needle precise drilling into bone tissue device according to claim 1, characterized in that, The fixed support (1) includes: First mounting ring (11) is horizontally arranged; Second mounting ring (12) is arranged parallel below the first mounting ring (11), and at least two supporting rods (13) are vertically arranged between the first mounting ring (11) and the second mounting ring (12), the top end of the supporting rod (13) is fixedly connected with the first mounting ring (11) through fastening nut (14), the bottom end of the supporting rod (13) is fixedly connected with the second mounting ring (12) through the fastening nut (14), the fastening nut (14) is equipped with mounting groove for passing through the kirschner wire (6); First U-shaped ring (15) is arranged parallel below the second mounting ring (12), and at least two assembly rods (16) are vertically arranged between the second mounting ring (12) and the first U-shaped ring (15), the top end of the assembly rod (16) is fixedly connected with the second mounting ring (12) through the fastening nut (14), and the bottom end of the assembly rod (16) is hinged with the first U-shaped ring (15) through connecting piece (17); A second U-shaped ring (18) is vertically arranged at the opening end of the first U-shaped ring (15), one side of the first mounting ring (11) or the second mounting ring (12) is horizontally provided with a first adapter (19), the arc-shaped top of the second U-shaped ring (18) is provided with a second adapter (110), the lower part of an adjusting rod (111) is hingedly connected through the first adapter (19) and the second adapter (110), the upper part of the adjusting rod (111) is sleeved with a spring (112), one end of the spring (112) abuts against the first adapter (19), and the other end of the spring (112) abuts against a bolt (113).

3. The individualized steel needle precise drilling into bone tissue device according to claim 1, characterized in that, The first positioning frame (41) and the second positioning frame (42) are detachably connected.

4. The individualized steel needle precise drilling into bone tissue device according to claim 1, characterized in that, The guide plate (2) is provided with at least two guide sleeves (3).

5. The individualized steel needle precise drilling into bone tissue device according to any one of claims 1 to 4, characterized in that, The guide plate (2) comprises a 3D printed part.

6. The individualized steel needle precise drilling into bone tissue device according to claim 5, characterized by, The guide plate (2) comprises a plurality of sub-plates which are sequentially connected or a complete plate.

7. An operating method applied to the individualized steel needle precision drilling into bone tissue device according to any one of claims 1 to 6, characterized in that, Comprise: Obtaining bone tissue lesion information according to CT data of a patient, and preparing a model of the bone tissue lesion through 3D printing; Planning a drilling path of the Kirschner wire (6); Printing a guide plate (2) and a guide sleeve (3) of an individualized steel needle precise drilling into bone tissue device according to the model of the bone tissue lesion and the drilling path; Attaching the inner side of the guide plate (2) to a tibia (7), positioning by attaching the positioning part (21) of the guide plate (2) to the inner malleolus of the patient, inserting a guide block (43) of an auxiliary positioning frame (4) of the individualized steel needle precise drilling into bone tissue device into the guide sleeve (3), and inserting an auxiliary rod (5) of the individualized steel needle precise drilling into bone tissue device into a positioning hole (44) of the auxiliary positioning frame (4); The Kirschner wire (6) is inserted from a first needle hole (45) of the guide block (43), passes through the tibia (7), and is then inserted out of a second needle hole (51) of the auxiliary rod (5), so as to complete the implantation operation of one Kirschner wire (6); After the implantation operation of each Kirschner wire (6) is completed, the auxiliary positioning frame (4) and the guide plate (2) are removed; The fixed support (1) is sleeved on the patient's limb, each Kirschner wire (6) is fixed by the fixed support (1), and the tibia (7) and soft tissue are gradually pulled by the fixed support (1) to correct the deformity of the patient.

8. The method of claim 7, wherein, After the implantation operation of one Kirschner wire (6) is completed, it comprises: Determining whether multiple Kirschner wires (6) need to be implanted, if yes, replacing the auxiliary positioning frame (4) to the next corresponding guide sleeve (3), and returning to the step of inserting the guide block (43) into the guide sleeve (3).

9. The method of claim 7, wherein, The planning of the drilling path of the Kirschner wire (6) comprises: Based on the model of the bone tissue lesion, combining the patient's condition, local anatomy and operation type, the optimal drilling position and drilling angle of the Kirschner wire (6) are planned to obtain the drilling path.

10. The operating method according to claim 7, characterized in that, The printing of the guide plate (2) and the guide sleeve (3) of the individualized steel needle precise drilling into bone tissue device according to the model of the bone tissue lesion and the drilling path comprises: Preoperatively according to the drilling path on the model of the bone tissue lesion, the fitting position of the guide plate (2) and the setting position of the guide sleeve (3) are determined, and the guide plate (2) and the guide sleeve (3) are 3D printed.

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