Fracture auxiliary reduction external fixation device and manufacturing method

Abstract

The invention discloses a fracture auxiliary reduction external fixing device and a manufacturing method, the device comprises at least two fixing blocks, every two fixing blocks are connected through a telescopic rod, each fixing block is in universal connection with the end of the telescopic rod, and each fixing block is provided with a threaded needle hole; wherein the telescopic length of the telescopic rod and the rotating angle of each fixing block are determined according to image data of the affected limb of the preset threaded needle, so that the external fixing device can provide guidance for restoration and fix the restored affected limb. The device not only provides guidance for manual reduction, but also is used for fixation after reduction, so that unnecessary radiation injury and trauma are avoided, meanwhile, the efficiency and the accuracy of manual reduction of doctors are improved, and the treatment effect of fracture reduction is improved.

Description

Technical Field

[0001] The present invention belongs to the technical field of computer - assisted fracture reduction, and particularly relates to a fracture - assisting reduction external fixation device and a manufacturing method thereof. Background Art

[0002] The statements in this part only provide background technical information related to the present invention and do not necessarily constitute prior art.

[0003] The external fixator technique is a commonly used method for clinical fracture treatment. Its basic principle is to pass threaded pins through the proximal and distal ends of the fracture, and then fix the threaded pins passing through both ends of the fracture to the external fixator outside the skin, thereby achieving the fixation of the fracture. The advantages of the external fixator are that it does not damage the soft tissue morphology at the fracture end and the blood supply of the fracture end, has less trauma, quick recovery, simple operation, and there is no problem of secondary incision to remove the internal fixation. However, for closed fractures, since the fracture ends are not incised, medical staff cannot directly observe the fracture situation, and the accuracy of reduction cannot be guaranteed, which severely limits the clinical application of the external fixation technique.

[0004] To solve this problem, C - arm / X - ray machine fluoroscopy technology is mostly used clinically. Medical staff adjust the position of the fracture ends according to the fluoroscopy images until they are satisfied. Although the fluoroscopy images can roughly restore the alignment of the fracture, it causes cumulative radiation damage to doctors and patients. In addition, navigation real - time tracking technology can also be used for fracture reduction. However, this technology has a high cost, and when performing real - time tracking, it is necessary to first place reflective marker balls and connect them to the bones as a whole, increasing unnecessary trauma. Summary of the Invention

[0005] To overcome the deficiencies of the above - mentioned prior art, the present invention provides a fracture - assisting reduction external fixation device and a manufacturing method thereof. The device provides guidance for manual reduction and is also used for fixation after reduction, improving the efficiency and treatment effect of doctors' manual reduction.

[0006] To achieve the above object, the first aspect of the present invention provides a fracture - assisting reduction external fixation device, including at least two fixing blocks. Each two fixing blocks are connected via a telescopic rod, and each fixing block and the end of the telescopic rod are connected in a universal joint. Each of the fixing blocks is provided with a threaded pin hole; wherein, the telescopic length of the telescopic rod and the rotation angle of each fixing block are determined according to the image data of the affected limb with pre - set threaded pins, so that the external fixation device can provide guidance for reduction and fix the affected limb after reduction.

[0007] In some embodiments, the telescopic length of the telescopic rod of the external fixation device and the rotation angle of each fixing block are adapted to the proximal and distal threaded pins after reduction.

[0008] In some embodiments, the external fixation device is a detachable structure. Both ends of the telescopic rod are universally connected to the connecting piece, and the connecting piece can be detachably connected to the fixing block.

[0009] In some embodiments, the telescopic rod is further provided with a locking mechanism.

[0010] In some embodiments, the method for determining the telescopic length of the telescopic rod of the external fixation device and the rotation angle of each fixing block is as follows:

[0011] Obtain the imaging data of the affected limb with the pre - set threaded pins, and based on virtual reduction, determine the positional relationship between the proximal threaded pin and the distal threaded pin after reduction;

[0012] Use a robotic arm to clamp threaded pins of the same model and spacing, and simulate the proximal threaded pin and the distal threaded pin after reduction according to the positional relationship;

[0013] For the proximal threaded pin and the distal threaded pin after reduction, adjust the external fixation device so that the proximal threaded pin and the distal threaded pin can simultaneously pass through the corresponding fixing blocks;

[0014] Lock the adjusted external fixation device, remove the proximal threaded pin and the distal threaded pin, and obtain the external fixation device in the reduced state.

[0015] In some embodiments, determining the positional relationship between the proximal threaded pin and the distal threaded pin after reduction includes:

[0016] Unify the imaging coordinate system and the robotic arm space coordinate system;

[0017] Obtain the imaging data of the affected limb with the pre - set threaded pins, and perform modeling and artifact processing on the proximal fracture, the distal fracture, and the threaded pins thereon;

[0018] Through binding operations, obtain the proximal combined model of the proximal fracture model and the proximal threaded pin model, and the distal combined model of the distal fracture model and the distal threaded pin model;

[0019] Match the distal combined model with the proximal combined model to achieve virtual reduction of the proximal fracture model and the distal fracture model;

[0020] Determine the positional relationship between the proximal threaded pin model and the distal threaded pin model after virtual reduction.

[0021] In some embodiments, the proximal threaded needle and the distal threaded needle after simulated reduction include: operating based on at least two robotic arms, with one robotic arm corresponding to one fixed block. At least two robotic arms each hold a threaded needle of the same model and spacing as the pre-set threaded needle. Moreover, the at least two robotic arms are both connected to a controller, and the controller obtains the positional relationship and adjusts the proximal threaded needle and the distal threaded needle according to the positional relationship.

[0022] In some embodiments, operate based on one robotic arm and one or more temporary fixing devices. The robotic arm is connected to a controller, and the controller obtains the positional relationship and respectively determines the coordinate positions of the proximal threaded needle and the distal threaded needle. First, hold the proximal threaded needle, adjust the position according to the coordinate position, then use the temporary fixing device to hold the proximal threaded needle, and then control the robotic arm to release the proximal threaded needle. Then, hold the distal threaded needle and adjust the position according to the coordinate position.

[0023] The second aspect of the present invention provides a method for manufacturing a fracture-assisted reduction external fixation device, including:

[0024] Obtain the imaging data of the affected limb of the pre-set threaded needle, and based on virtual reduction, determine the positional relationship between the proximal threaded needle and the distal threaded needle after reduction;

[0025] Use a robotic arm to hold threaded needles of the same model, and simulate the proximal threaded needle and the distal threaded needle after reduction according to the positional relationship;

[0026] For the proximal threaded needle and the distal threaded needle after reduction, adjust the external fixation device so that the proximal threaded needle and the distal threaded needle can simultaneously pass through the corresponding fixed blocks;

[0027] Lock the adjusted external fixation device, remove the proximal threaded needle and the distal threaded needle, and obtain the external fixation device in the reduced state.

[0028] In some embodiments, after obtaining the external fixation device, the corresponding relationships between each fixed block and the distal and proximal ends in the external fixation device are also marked.

[0029] In the above one or more technical solutions, the provided external fixation device not only provides guidance for manual reduction but also is used for fixation after reduction, avoiding unnecessary radiation damage and trauma. At the same time, it improves the efficiency and accuracy of the doctor's manual reduction and enhances the treatment effect of fracture reduction. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] The accompanying drawings forming a part of this invention are used to provide a further understanding of the invention. The illustrative embodiments and descriptions of the invention are used to explain the invention and do not constitute an improper limitation of the invention.

[0031] Figure 1Schematic diagram of the fracture-assisted reduction external fixation device in the embodiments of the present invention;

[0032] Figure 2 Flowchart of the manufacturing method of the fracture-assisted reduction external fixation device in the embodiments of the present invention;

[0033] Figure 3 Schematic diagram of virtual reduction in the embodiments of the present invention. Detailed implementation manners

[0034] Embodiments of the present application will be described in more detail below with reference to the accompanying drawings. Although some embodiments of the present application are shown in the drawings, it should be understood that the present application can be implemented in various forms and should not be construed as limited to the embodiments set forth herein. On the contrary, these embodiments are provided to more thoroughly and completely understand the present application. It should be understood that the drawings and embodiments of the present application are only for exemplary purposes and are not used to limit the protection scope of the present application.

[0035] In the description of the embodiments of the present application, the term "including" and its similar terms should be understood as open inclusion, that is, "including but not limited to". The term "based on" should be understood as "at least partially based on".

[0036] As described in the background art, combining fluoroscopic images for fracture reduction will cause cumulative radiation damage to doctors and patients, while tracking based on reflective marker balls is costly and will increase unnecessary trauma. To solve the above problems, one or more embodiments of the present invention provide a fracture-assisted reduction external fixation device, as Figure 1 shown, including at least two fixing blocks 1, each two fixing blocks 1 are connected via a telescopic rod 2, and the end of each fixing block 1 and the telescopic rod 2 are universally connected. Each of the fixing blocks 1 is provided with a threaded pin hole; wherein, the telescopic length of the telescopic rod and the rotation angle of each fixing block are determined according to the image data of the affected limb of the preset threaded pin, so that the external fixation device can provide guidance for reduction and fix the affected limb after reduction.

[0037] It can be understood that the number of the fixing blocks is related to the fracture fracture condition. One fixing block corresponds to one segment of the broken bone. Each of the fixing blocks is provided with one or more threaded pin holes, and each threaded pin hole is for a threaded pin 3 to penetrate. As an example, at least 2 threaded pins need to be inserted into the distal end of the fracture to play an anti-rotation role and maintain the stability of the distal end of the fracture.

[0038] The telescopic rod is further provided with a locking mechanism (not shown in the figure) for locking when the telescopic rod extends to a suitable length.

[0039] The external fixation device is a detachable structure. Both ends of the telescopic rod are connected to the connecting piece in a universal joint manner, and the connecting piece can be detachably connected to the fixing block (such as threaded connection). Based on this, when facing a scenario of multiple fractures, such as three fractures, on the basis of Figure 1 , another telescopic rod and a fixing block can be added to the free end of one of the fixing blocks as needed.

[0040] To avoid subsequent confusion between the far end and the near end, after obtaining the external fixation device, the corresponding relationship between each fixing block in the external fixation device and the distal end and the proximal end is also marked.

[0041] Before reduction, threaded pins are inserted into each segment of the fractured bone. Using the above external fixation device can provide guidance for manual reduction. Specifically, using this external fixation device, first insert the threaded pin on the proximal fractured bone into the threaded pin hole on the proximal fixing block, and then perform manual reduction on the distal fractured bone so that the threaded pin on the distal fractured bone penetrates into the threaded pin hole on the distal fixing block, that is, the reduction is completed, and then the distance between the external fixation frame and the affected limb can be adjusted.

[0042] Based on this, the external fixation device not only provides guidance for manual reduction but also is used for fixation after reduction, avoiding unnecessary radiation damage and trauma, while improving the efficiency and accuracy of the doctor's manual reduction and the treatment effect of fracture reduction.

[0043] It can be understood that when there are more than two fixing blocks, the external fixation device is used for multiple fractures. After inserting the threaded pin on the proximal fractured bone into the threaded pin hole on the proximal fixing block, perform manual reduction on other fractured bones in sequence from near to far. After the threaded pin on each fractured bone penetrates into the threaded pin hole on the corresponding fixing block, perform reduction on the next fractured bone.

[0044] In some embodiments, as Figure 2 shown, the specific method for determining the telescopic length of the telescopic rod and the rotation angle of each fixing block relative to the telescopic rod according to the image data of the affected limb with pre-set threaded pins includes:

[0045] Step 1: Obtain the image data of the affected limb with pre-set threaded pins, and based on virtual reduction, determine the positional relationship between the proximal threaded pin and the distal threaded pin after reduction;

[0046] Step 2: Use a robotic arm to clamp threaded pins of the same model, and simulate the proximal threaded pin and the distal threaded pin after reduction according to the positional relationship;

[0047] Step 3: For the proximal threaded pin and the distal threaded pin after reduction, adjust the external fixation device so that the proximal threaded pin and the distal threaded pin can pass through the corresponding fixing blocks simultaneously;

[0048] Step 4: Lock the adjusted external fixator, remove the proximal threaded pin and the distal threaded pin, and obtain the external fixator in the reduced state.

[0049] Wherein, the step 1 specifically includes:

[0050] Step 1.1: Unify the image coordinate system and the robotic arm space coordinate system;

[0051] Step 1.2: Obtain imaging data of the affected limb with the pre-installed threaded pin, and model the proximal and distal ends of the fracture and the threaded pin thereon;

[0052] Step 1.3: Obtain a proximal combined model of the fracture proximal model and the proximal threaded pin model, and a distal combined model of the fracture distal model and the distal threaded pin model through a binding operation;

[0053] Step 1.4: matching the distal combined model with the proximal combined model to achieve virtual reduction of the proximal fracture model and the distal fracture model;

[0054] Step 1.5: Determine the positional relationship between the proximal threaded needle model and the distal threaded needle model after virtual reduction.

[0055] It should be noted that the above-mentioned "distal end" is relative to the "proximal end" and does not necessarily have only one section. When there are multiple fractures, there are multiple distal ends.

[0056] In step 1.1, the robot space coordinate system and the image coordinate system are established respectively, and the image coordinate system and the robot coordinate system are converted and unified so that the image coordinate system and the robot coordinate system are in the same coordinate system. The above coordinate system conversion method can be implemented using existing methods and will not be described in detail here.

[0057] In step 1.2, the image data is obtained by CT scanning images using a CT scanning device. The modeling can be performed using digital medical modeling software or directly by segmentation modeling on a CT machine. In steps 1.3-1.5, the proximal fracture entity model and the proximal threaded needle are combined into a new model A, and the distal fracture entity model and the distal threaded needle entity model are combined into a new model B. Models A and B are virtually reset to obtain the position of the fracture after reduction, and the proximal and distal models are released to obtain the spatial coordinate positions of the proximal and distal threaded needles.

[0058] Among them, the virtual reduction can adopt automatic reduction, and the fracture sections of the distal model and the proximal model are aligned; or with the help of three-dimensional modeling software, the distal bone replication model can be dragged, rotated and other operations are performed to splice the sections of the distal bone replication model and the proximal model.

[0059] If the fracture surface of the distal bone is comminuted and virtual reduction cannot be performed based on the fracture surface splicing, the healthy-side CT image of the patient can be obtained and modeled to obtain a healthy-side limb model; the proximal combined model and the distal combined model are respectively registered with the healthy-side limb model to achieve virtual reduction.

[0060] As a specific implementation manner, the centerlines of both the proximal threaded pin model and the distal threaded pin model are extracted, and the coordinate positions of the endpoints of the centerlines of the proximal threaded pin model and the distal threaded pin model are calculated.

[0061] In step 2, the robotic arm obtains the positional relationship between the positions of the proximal threaded pin model and the distal threaded pin model obtained after virtual reduction in step 1, and uses threaded pins of the same model to simulate the proximal threaded pin and the distal threaded pin in the reduced state.

[0062] As a specific implementation manner, operations are performed based on at least two robotic arms, one robotic arm corresponds to one fixing block, at least two robotic arms all clamp threaded pins of the same model as the preset threaded pins, and moreover, the at least two robotic arms are all connected to a controller, and the controller obtains the positional relationship between the positions of the proximal threaded pin model and the distal threaded pin model after virtual reduction, and adjusts the proximal threaded pin and the distal threaded pin according to the positional relationship.

[0063] As another specific implementation manner, to save costs, only one robotic arm is used to assist the temporary fixing device for operation. Specifically, the robotic arm is connected to a controller, the controller obtains the positional relationship between the positions of the proximal threaded pin model and the distal threaded pin model after virtual reduction, respectively determines the coordinate positions of the proximal threaded pin and the distal threaded pin, first clamps the proximal threaded pin, adjusts its position according to the target coordinate position, then uses the temporary fixing device to clamp the proximal threaded pin, and then controls the robotic arm to release the threaded pin; then clamps the distal threaded pin and adjusts its position according to the target coordinate position. It can be understood that for multiple fractures, the distal threaded pin is also fixed with a temporary fixing device, and then after controlling the robotic arm to release, the more distal threaded pin is clamped for position adjustment.

[0064] It can be understood that a gripper can be provided at the end of the robotic arm, and threaded pin holes are provided on the gripper for clamping threaded pins, specifically, for clamping parallel threaded pins. To ensure the same threaded pin spacing as when placing the pins in parallel, the hole pitch of the threaded pin holes on the gripper is the same as the hole pitch of the threaded pins on the pinning plate for assisting parallel pinning.

[0065] When the robotic arm makes position adjustments, a positioning device can be provided on the gripper at the end of the robotic arm, so that when the threaded pin is clamped at the end of the robotic arm, the initial position is fixed, and then the position of the threaded pin is adjusted based on the fixed known position.

[0066] In addition, one or more embodiments of the present invention also provide a method for manufacturing an external fixation device for fracture assisted reduction, as Figure 2 shown, including:

[0067] Step 1: Obtain the imaging data of the affected limb of the pre - set threaded pin, and based on virtual reduction, determine the positional relationship between the proximal threaded pin and the distal threaded pin after reduction;

[0068] Step 2: Use a robotic arm to clamp threaded pins of the same model, and according to the positional relationship, simulate the proximal threaded pin and the distal threaded pin after reduction;

[0069] Step 3: For the proximal threaded pin and the distal threaded pin after reduction, adjust the external fixation device so that the proximal threaded pin and the distal threaded pin can pass through the corresponding fixing blocks simultaneously;

[0070] Step 4: Lock the adjusted external fixation device, remove the proximal threaded pin and the distal threaded pin, and obtain the external fixation device in the reduced state.

[0071] For the specific implementation of the above steps, reference can be made to the specific method in the above text for determining the telescopic length of the telescopic rod and the rotation angle of each fixing block relative to the telescopic rod according to the imaging data of the affected limb of the pre - set threaded pin, which will not be elaborated here.

[0072] Although the operations are depicted in a particular order, this should be understood to require that the operations be performed in the particular order shown or in a sequential order, or that all of the illustrated operations be performed to achieve the desired result. In certain environments, multitasking and parallel processing may be advantageous. Similarly, although a number of specific implementation details are included in the above discussion, these should not be construed as limiting the scope of the present application. Certain features described in the context of separate embodiments can also be implemented combinatorially in a single implementation. Conversely, the various features described in the context of a single implementation can also be implemented separately or in any suitable sub - combination in multiple implementations.

[0073] Although the subject matter has been described in language specific to structural features and / or methodological logical acts, it should be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or acts described above. Rather, the specific features and acts described above are merely example forms of implementing the claims.

Claims

1. A fracture-assisted reduction external fixation device, characterized in that, It includes at least two fixed blocks, which are connected via telescopic rods between every two of them, and each fixed block is universally connected to the end of the telescopic rod. Each of the fixed blocks is provided with a threaded pin hole. Wherein, the telescopic length of the telescopic rod and the rotation angle of each fixed block are determined according to the image data of the affected limb with pre-set threaded pins, so that the external fixation device can provide guidance for reduction and fix the affected limb after reduction.

2. The fracture-assisted reduction and external fixation device according to claim 1, wherein The telescopic length of the telescopic rod of the external fixation device and the rotation angle of each fixed block are adapted to the proximal and distal threaded pins after reduction.

3. The fracture-assisted reduction and external fixation device according to claim 1, characterized in that, The external fixation device is of a detachable structure. Both ends of the telescopic rod are universally connected to connecting pieces, and the connecting pieces can be detachably connected to the fixed blocks.

4. The fracture-assisted reduction and external fixation device according to claim 1, wherein The telescopic rod is also provided with a locking mechanism.

5. The fracture-assisted reduction external fixation device according to claim 1, characterized in that, The method for determining the telescopic length of the telescopic rod of the external fixation device and the rotation angle of each fixed block is as follows: Obtain the image data of the affected limb with pre-set threaded pins, and based on virtual reduction, determine the positional relationship between the proximal threaded pin and the distal threaded pin after reduction; Use a robotic arm to clamp threaded pins of the same model and spacing, and simulate the proximal and distal threaded pins after reduction according to the positional relationship; For the proximal and distal threaded pins after reduction, adjust the external fixation device so that the proximal and distal threaded pins can simultaneously pass through the corresponding fixed blocks; Lock the adjusted external fixation device, remove the proximal and distal threaded pins, and obtain the external fixation device in the reduced state.

6. The fracture-assisted reduction and external fixation device according to claim 5, characterized in that, Determining the positional relationship between the proximal threaded pin and the distal threaded pin after reduction includes: Unify the image coordinate system and the robotic arm space coordinate system; Obtain the image data of the affected limb with pre-set threaded pins, and perform modeling and artifact processing on the proximal fracture segment, the distal fracture segment and the threaded pins thereon; Obtain the proximal combined model of the proximal fracture segment model and the proximal threaded pin model, and the distal combined model of the distal fracture segment model and the distal threaded pin model through binding operations; Match the distal combined model with the proximal combined model to achieve virtual reduction of the proximal fracture segment model and the distal fracture segment model; Determine the positional relationship between the proximal threaded pin model and the distal threaded pin model positions after virtual reduction.

7. The fracture-assisted reduction and external fixation device according to claim 5, characterized in that, Simulating the proximal and distal threaded pins after reduction includes: operating based on at least two robotic arms, one robotic arm corresponding to one fixed block. At least two robotic arms all clamp threaded pins of the same model and spacing as the pre-set threaded pins, and moreover, the at least two robotic arms are all connected to a controller, and the controller obtains the positional relationship and adjusts the proximal and distal threaded pins according to the positional relationship.

8. The fracture-assisted reduction and external fixation device according to claim 5, characterized in that, Operate based on one robotic arm and one or more temporary fixation devices. The robotic arm is connected to a controller, and the controller obtains the positional relationship and respectively determines the coordinate positions of the proximal and distal threaded pins; first clamp the proximal threaded pin, adjust the position according to the coordinate position, then use the temporary fixation device to clamp the proximal threaded pin, and then control the robotic arm to release the proximal threaded pin; then clamp the distal threaded pin and adjust the position according to the coordinate position.

9. A method for manufacturing an external fixation device for fracture-assisted reduction, including: Obtain the image data of the affected limb with the pre-set threaded pins, and based on virtual reduction, determine the positional relationship between the proximal threaded pin and the distal threaded pin after reduction; Use a robotic arm to clamp threaded pins of the same model, and according to the positional relationship, simulate the proximal threaded pin and the distal threaded pin after reduction; For the proximal threaded pin and the distal threaded pin after reduction, adjust the external fixation device so that the proximal threaded pin and the distal threaded pin can simultaneously pass through the corresponding fixing blocks; Lock the adjusted external fixation device, remove the proximal threaded pin and the distal threaded pin, and obtain the external fixation device in the reduced state.

10. The method for manufacturing the fracture-assisted reduction external fixation device according to claim 9, wherein, After obtaining the external fixation device, also mark the corresponding relationship between each fixing block in the external fixation device and the distal and proximal ends.

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