A fracture-assisted reduction and external fixation device and its manufacturing method

Abstract

This invention discloses an external fixation device for fracture reduction and its manufacturing method. The device includes at least two fixation blocks, each pair connected by a telescopic rod. Each fixation block and the end of the telescopic rod are universally connected, and each fixation block has a threaded pin hole. The telescopic length of the telescopic rod and the rotation angle of each fixation block are determined based on the image data of the affected limb from the pre-placed threaded pin, enabling the external fixation device to guide the reduction and fix the reduced limb. This device provides guidance for manual reduction and fixation after reduction, avoiding unnecessary radiation damage and trauma, while improving the efficiency and accuracy of manual reduction by doctors and enhancing the therapeutic effect of fracture reduction.

Description

Technical Field

[0001] This invention belongs to the field of computer-aided fracture reduction technology, and particularly relates to an external fixation device for fracture reduction and its manufacturing method. Background Technology

[0002] The statements in this section are merely background information related to the present invention and do not necessarily constitute prior art.

[0003] External fixation is a common clinical method for fracture treatment. Its basic principle involves threaded pins passing through the proximal and distal ends of the fracture, and then fixing these pins to an external fixator outside the skin, thus achieving fracture fixation. The advantages of external fixation are that it does not damage the soft tissue morphology or blood supply to the fracture ends, resulting in minimal trauma, rapid recovery, and simple operation, without the need for a secondary incision to remove internal fixation devices. However, for closed fractures, because the fracture ends are not incised, medical personnel cannot directly observe the fracture, compromising the accuracy of reduction and severely limiting the clinical application of external fixation techniques.

[0004] To address this issue, C-arm / X-ray fluoroscopy is commonly used clinically. Medical staff adjust the position of the fracture ends based on the fluoroscopic images until satisfactory results are achieved. While fluoroscopic imaging can roughly restore the alignment of the fracture, it results in cumulative radiation damage to both doctors and patients. Alternatively, real-time navigation tracking technology can be used for fracture reduction; however, this technology is costly, and real-time tracking requires placing reflective marker balls to integrate them with the bone, increasing unnecessary trauma. Summary of the Invention

[0005] To overcome the shortcomings of the prior art, this invention provides a fracture-assisted reduction and external fixation device and its manufacturing method. The device provides guidance for manual reduction and also serves for fixation after reduction, improving the efficiency and therapeutic effect of manual reduction by the surgeon.

[0006] To achieve the above objectives, a first aspect of the present invention provides an external fixation device for fracture reduction, comprising at least two fixation blocks, each pair of fixation blocks being connected by a telescopic rod, and each fixation block being universally connected to the end of the telescopic rod, and each fixation block being provided with a threaded pin hole; wherein the telescopic length of the telescopic rod and the rotation angle of each fixation block are determined based on the image data of the affected limb with the pre-set threaded pin, 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 external fixing device telescopic rod and the rotation angle of each fixing block are adapted to the proximal and distal threaded pins after resetting.

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

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

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

[0011] Acquire the image data of the affected limb with the pre-positioned threaded needle, and determine the positional relationship between the proximal and distal threaded needles after virtual reduction based on virtual reduction;

[0012] A robotic arm is used to hold threaded needles of the same type and spacing, and the near-end and far-end threaded needles after resetting are simulated according to the positional relationship described above.

[0013] For the proximal and distal threaded pins after resetting, adjust the external fixing device so that the proximal and distal threaded pins can pass through the corresponding fixing blocks simultaneously.

[0014] After locking and adjusting the external fixation device, remove the proximal and distal threaded pins to obtain the external fixation device in its reset state.

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

[0016] Unify the image coordinate system and the robotic arm spatial coordinate system;

[0017] Acquire the image data of the affected limb with the pre-placed threaded needle, and perform modeling and artifact processing on the proximal fracture end, distal fracture end, and the threaded needle thereon;

[0018] The proximal combined model of the proximal fracture model and the proximal threaded needle model, as well as the distal combined model of the distal fracture model and the distal threaded needle model, are obtained through the binding operation.

[0019] The distal combined model is matched 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 reset.

[0021] In some embodiments, the simulated reset proximal and distal threaded pins include: operation based on at least two robotic arms, one robotic arm corresponding to one fixed block, at least two robotic arms clamping threaded pins of the same type and spacing as the preset threaded pins, and the at least two robotic arms being connected to a controller, the controller acquiring the positional relationship and adjusting the proximal and distal threaded pins according to the positional relationship.

[0022] In some embodiments, the operation is based on a robotic arm and one or more temporary fixing devices. The robotic arm is connected to a controller, which acquires the positional relationship and determines the coordinate positions of the proximal threaded needle and the distal threaded needle, respectively. The proximal threaded needle is first clamped, and its position is adjusted according to the coordinate position. Then, the proximal threaded needle is clamped using a temporary fixing device, and the robotic arm is controlled to release the proximal threaded needle. The distal threaded needle is then clamped and its position is adjusted according to the coordinate position.

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

[0024] Acquire the image data of the affected limb with the pre-positioned threaded needle, and determine the positional relationship between the proximal and distal threaded needles after virtual reduction based on virtual reduction;

[0025] Using a robotic arm to hold threaded needles of the same model, the near-end and far-end threaded needles after resetting are simulated according to the positional relationship described above.

[0026] For the proximal and distal threaded pins after resetting, adjust the external fixing device so that the proximal and distal threaded pins can pass through the corresponding fixing blocks simultaneously.

[0027] After locking and adjusting the external fixation device, remove the proximal and distal threaded pins to obtain the external fixation device in its reset state.

[0028] In some embodiments, after obtaining the external fixation device, the correspondence between each fixing block in the external fixation device and the distal and proximal ends is also marked.

[0029] The external fixation device provided in one or more of the above technical solutions not only provides guidance for manual reduction but also serves as fixation after reduction, avoiding unnecessary radiation damage and trauma. At the same time, it improves the efficiency and accuracy of manual reduction by doctors and enhances the treatment effect of fracture reduction. Attached Figure Description

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

[0031] Figure 1This is a schematic diagram of the external fixation device for fracture reduction in an embodiment of the present invention;

[0032] Figure 2 This is a flowchart illustrating the manufacturing method of the fracture-assisted reduction and external fixation device in this embodiment of the invention.

[0033] Figure 3 This is a schematic diagram of virtual reset in an embodiment of the present invention. Detailed Implementation

[0034] Embodiments of this application will now be described in more detail with reference to the accompanying drawings. While some embodiments of this application are shown in the drawings, it should be understood that this application can be implemented in various forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided to provide a more thorough and complete understanding of this application. It should be understood that the drawings and embodiments of this application are for illustrative purposes only and are not intended to limit the scope of protection of this application.

[0035] In the description of the embodiments of this application, the term "comprising" and similar terms should be understood as open-ended inclusion, i.e., "including but not limited to". The term "based on" should be understood as "at least partially based on".

[0036] As described in the background section, fracture reduction using fluoroscopic imaging can cause cumulative radiation damage to both medical staff and patients, while tracking based on reflective marker balls is costly and increases unnecessary trauma. To address these issues, one or more embodiments of the present invention provide a fracture-assisted reduction external fixation device, such as... Figure 1 As shown, it includes at least two fixing blocks 1, each pair of fixing blocks 1 is connected by a telescopic rod 2, and the ends of each fixing block 1 and the telescopic rod 2 are universally connected. Each fixing block 1 is provided with a threaded pin hole. 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 the pre-set threaded pin, so that the external fixation device can provide guidance for repositioning and fix the affected limb after repositioning.

[0037] Understandably, the number of fixation blocks is related to the fracture condition; one fixation block corresponds to one segment of broken bone. Each fixation block has one or more threaded pin holes, and each threaded pin hole allows one threaded pin to be inserted. As an example, at least two threaded pins must be inserted into the distal fracture site to prevent rotation and maintain stability of the distal fracture.

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

[0039] The external fixation device is a detachable structure. Both ends of the telescopic rod are universally connected to the connecting piece, which can be detachably connected to the fixation block (e.g., threaded connection). Therefore, in cases of multi-segment fractures, such as three-segment fractures, the fixation can be adjusted as needed. Figure 1 Based on this, add a telescopic rod and a fixed block at the free end of one of the fixed blocks.

[0040] To avoid confusion between the proximal and distal ends later, after obtaining the external fixation device, the correspondence between each fixing block in the external fixation device and the distal and proximal ends is marked.

[0041] Before reduction, threaded pins are inserted into each segment of the fractured bone. The aforementioned external fixation device can provide guidance for manual reduction. Specifically, using this external fixation device, the threaded pins on the proximal fractured bone are first inserted into the threaded pin holes on the proximal fixation block. Then, manual reduction is performed on the distal fractured bone so that the threaded pins on the distal fractured bone are inserted into the threaded pin holes on the distal fixation block, thus completing the reduction. The distance between the external fixator and the affected limb can then be adjusted.

[0042] Based on this, the external fixation device not only provides guidance for manual reduction but also serves as fixation after reduction, avoiding unnecessary radiation damage and trauma. At the same time, it improves the efficiency and accuracy of manual reduction by doctors and enhances the treatment effect of fracture reduction.

[0043] Understandably, when there are more than two fixation blocks, the external fixation device is used for multi-segment fractures. After the threaded pin on the proximal fracture bone is inserted into the threaded pin hole on the proximal fixation block, the other fractures are manually reduced from proximal to distal. After the threaded pin on each fracture bone is inserted into the threaded pin hole on the corresponding fixation block, the next fracture bone segment is reduced.

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

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

[0046] Step 2: Using a robotic arm to hold threaded needles of the same model, simulate the repositioned proximal and distal threaded needles according to the aforementioned positional relationship;

[0047] Step 3: Adjust the external fixing device for the repositioned proximal and distal threaded pins so that the proximal and distal threaded pins can pass through the corresponding fixing blocks simultaneously.

[0048] Step 4: Tighten the adjusted external fixation device, remove the proximal and distal threaded pins, and obtain the external fixation device in the reset state.

[0049] Specifically, step 1 includes:

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

[0051] Step 1.2: Obtain the image data of the affected limb with the pre-placed threaded needle, and model the proximal fracture end, distal fracture end, and the threaded needle thereon;

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

[0053] Step 1.4: Match 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 pin model and the distal threaded pin model after virtual reset.

[0055] It should be noted that the term "distal" is relative to "proximal" and does not necessarily mean only one segment. When there are multiple segments of fracture, there will be multiple distal ends.

[0056] In step 1.1, a robotic arm spatial coordinate system and an image coordinate system are established respectively. The image coordinate system is then transformed and unified with the robot coordinate system, so that the image coordinate system and the robot coordinate system are in the same coordinate system. The above coordinate system unification method can be implemented using existing methods, which will not be elaborated here.

[0057] In step 1.2, the image data is obtained from CT scan images using a CT scanner. The modeling can be performed using digital medical modeling software or directly on the CT scanner. In steps 1.3-1.5, the proximal fracture model and the proximal threaded needle are combined to form a new model A, and the distal fracture model and the distal threaded needle model are combined to form a new model B. Virtual reduction is performed on models A and B to obtain the fracture reduction position. The proximal and distal models are then separated, and the spatial coordinates of the proximal and distal threaded needles are obtained.

[0058] The virtual repositioning can be achieved through automatic repositioning, based on the registration of the fracture surfaces of the distal and proximal models; or it can be achieved by using 3D modeling software to drag and rotate the distal bone replica model, thereby splicing the fracture surfaces of the distal bone replica model and the proximal model.

[0059] If the distal bone fracture is shattered and virtual repositioning based on fracture splicing is not possible, a CT image of the patient's healthy side can be obtained and modeled to obtain a healthy limb model. The proximal combined model and the distal combined model are then registered with the healthy limb model to achieve virtual repositioning.

[0060] As a specific implementation method, the centerline is extracted for both the proximal threaded pin model and the distal threaded pin model, 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 proximal threaded pin model and the distal threaded pin model after virtual reset obtained in step 1, and uses threaded pins of the same model to simulate the proximal and distal threaded pins in the reset state.

[0062] As a specific implementation, the operation is based on at least two robotic arms, with one robotic arm corresponding to one fixed block. Both robotic arms hold threaded needles of the same model as the preset threaded needles. Furthermore, both robotic arms are connected to a controller. The controller obtains the positional relationship between the proximal threaded needle model and the distal threaded needle model after virtual reset and adjusts the proximal and distal threaded needles according to the positional relationship.

[0063] As another specific implementation method, to save costs, only one robotic arm is used, assisted by a temporary fixation device for operation. Specifically, the robotic arm is connected to a controller, which obtains the positional relationship between the proximal and distal threaded needle models after virtual reset, determines the coordinate positions of the proximal and distal threaded needles respectively, clamps the proximal threaded needle first, adjusts its position according to the target coordinate position, clamps the proximal threaded needle with the temporary fixation device, and then controls the robotic arm to release the threaded needle; then clamps the distal threaded needle and adjusts its position according to the target coordinate position. Understandably, if there is a multi-segment fracture, the distal threaded needle is also fixed with a temporary fixation device, and then the robotic arm is controlled to release it before clamping the more distal threaded needle for position adjustment.

[0064] Understandably, a gripper can be installed at the end of the robotic arm, the gripper having threaded pin holes for gripping threaded pins, specifically for gripping parallel threaded pins. To ensure the same threaded pin spacing as in parallel pin placement, the hole spacing of the threaded pin holes on the gripper is the same as the hole spacing of the threaded pins on the pin placement steel plate used for auxiliary parallel pin placement.

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

[0066] Furthermore, one or more embodiments of the present invention also provide a method for manufacturing a fracture-assisted reduction and external fixation device, such as... Figure 2 As shown, it includes:

[0067] Step 1: Obtain the image data of the affected limb with the pre-placed threaded needle, and determine the positional relationship between the proximal and distal threaded needles after virtual reduction based on virtual reduction;

[0068] Step 2: Using a robotic arm to hold threaded needles of the same model, simulate the repositioned proximal and distal threaded needles according to the aforementioned positional relationship;

[0069] Step 3: Adjust the external fixing device for the repositioned proximal and distal threaded pins so that the proximal and distal threaded pins can pass through the corresponding fixing blocks simultaneously.

[0070] Step 4: Tighten the adjusted external fixation device, remove the proximal and distal threaded pins, and obtain the external fixation device in the reset state.

[0071] The specific implementation of the above steps can be found in the above text, which describes how to determine the telescopic length of the telescopic rod based on the image data of the affected limb with the pre-set threaded needle, as well as the specific method for the rotation angle of each fixed block relative to the telescopic rod. These details will not be repeated here.

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

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

Claims

1. A fracture-assisted reduction and external fixation device, characterized in that, It includes at least two fixing blocks, each pair of fixing blocks is connected by a telescopic rod, and the end of each fixing block and the telescopic rod is universally connected. Each fixing block is provided with a threaded pin hole. The telescopic length of the telescopic rod and the rotation angle of each fixing block are determined based on the image data of the affected limb with the pre-set threaded pin, so that the external fixation device can provide guidance for repositioning and fix the affected limb after repositioning. The method for determining the telescopic length of the external fixing device's telescopic rod and the rotation angle of each fixing block is as follows: Image data of the affected limb with pre-placed threaded needles are acquired. Based on virtual repositioning, the positional relationship between the proximal and distal threaded needles after repositioning is determined. A robotic arm is used to clamp threaded needles of the same type and spacing. Based on the stated positional relationship, the repositioned proximal and distal threaded needles are simulated. The external fixation device is adjusted for the repositioned proximal and distal threaded needles so that they can simultaneously pass through their respective fixation blocks. The adjusted external fixation device is then locked, and the proximal and distal threaded needles are removed, resulting in the external fixation device in its repositioned state. Determining the positional relationship between the proximal and distal threaded pins after reset includes: A unified image coordinate system and a robotic arm spatial coordinate system are established. Image data of the affected limb with pre-set threaded needles are acquired, and modeling and artifact processing are performed on the proximal fracture end, the distal fracture end, and the threaded needles thereon. A proximal combined model of the proximal fracture model and the proximal threaded needle model, and a distal combined model of the distal fracture model and the distal threaded needle model are obtained through binding operations. The distal combined model is matched with the proximal combined model to achieve virtual reduction of the proximal and distal fracture models. The positional relationship between the proximal and distal threaded needle models after virtual reduction is determined.

2. The fracture-assisted reduction and external fixation device as described in claim 1, characterized in that, The telescopic length of the external fixing device telescopic rod and the rotation angle of each fixing block are adapted to the proximal and distal threaded pins after resetting.

3. The fracture-assisted reduction and external fixation device as described in claim 1, characterized in that, The external fixing 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.

4. The fracture-assisted reduction and external fixation device as described in claim 1, characterized in that, The telescopic rod is also equipped with a locking mechanism.

5. The fracture-assisted reduction and external fixation device as described in claim 1, characterized in that, The simulated reset proximal and distal threaded pins include: operation based on at least two robotic arms, one robotic arm corresponding to one fixed block, at least two robotic arms clamping threaded pins of the same type and spacing as the preset threaded pins, and the at least two robotic arms being connected to a controller, the controller acquiring the positional relationship and adjusting the proximal and distal threaded pins according to the positional relationship.

6. The fracture-assisted reduction and external fixation device as described in claim 1, characterized in that, The operation is based on a robotic arm and one or more temporary fixing devices. The robotic arm is connected to a controller, which obtains the positional relationship and determines the coordinate positions of the proximal threaded needle and the distal threaded needle respectively. First, the proximal threaded needle is clamped and its position is adjusted according to the coordinate position. Then, the proximal threaded needle is clamped by the temporary fixing device and the robotic arm is controlled to release the proximal threaded needle. Then, the distal threaded needle is clamped and its position is adjusted according to the coordinate position.

Images