A magnetic locking 3D printing elastic guide plate for low feature surfaces and a manufacturing method thereof

Abstract

The application relates to a magnetic locking 3D printing elastic guide plate for low feature surfaces and a manufacturing method thereof, and relates to the technical field of surgical guide plates. The magnetic locking 3D printing elastic guide plate comprises a guide channel, rigid connection sections, magnetic attraction bases and elastic connection shafts; the guide channel is arranged through the middle position of the top of the elastic connection shaft, both ends of the elastic connection shaft are connected with the rigid connection sections, both ends of the rigid connection sections are connected with the magnetic attraction bases, the bottom end of the magnetic attraction base is provided with a groove, and a magnet is embedded in the groove. The application can implement accurate positioning of surgery for low feature surfaces of the human body and parts with a certain degree of activity, and completely solves the positioning problem of low feature areas of the human body.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of surgical guide plate, in particular to a magnetic locking 3D printing elastic guide plate for low feature surface and a manufacturing method thereof. BACKGROUND

[0002] For high-risk spinal surgery, due to the central nervous system in the spinal canal, the operation requires sufficient clinical experience and solid anatomical foundation. But now CT data can be used to design a guide template in software and 3D printing technology can be used to make a surgical guide plate. For example, in scoliosis surgery, first, a 3D model is established, and the entry point and direction are determined on the model, then a template is designed to make its surface completely fit the posterior surface of the spine, and an entry channel is established. Since the posterior surface of the spine is characteristic, the guide plate can be well embedded with the posterior surface of the spine without deviation. The guide plate is sterilized and used for the placement of pedicle screws in the operation to achieve accurate screw placement under the guidance of the guide plate.

[0003] However, for low feature areas such as flat skull, thoracic cage, and limb bone surface, due to the lack of characteristic concave and convex morphology, the conventional design of the guide plate cannot be accurately positioned, and when placed, due to the lack of anchor points, it is easy to slide and deviate, thereby losing the positioning value. For some situations that require percutaneous positioning, the skin lacks characteristic structures and changes with body position, and the surface is easily deformed by pressing. The clinical application effect of conventional personalized guide plate design is not ideal. These have seriously affected the application range of the guide plate in medical treatment.

[0004] Therefore, how to provide a magnetic locking 3D printing elastic guide plate for low feature surface and a manufacturing method thereof has become a technical problem urgently to be solved by those skilled in the art. SUMMARY

[0005] To solve at least one of the technical problems in the background art, the present application provides a magnetic locking 3D printing elastic guide plate for low feature surface and a manufacturing method thereof, which can implement accurate positioning for low feature surface of human body and parts with certain activity, and completely solves the positioning problem of low feature area of human body.

[0006] To achieve the above purpose, the present application provides a magnetic locking 3D printing elastic guide plate for low feature surface, comprising: a guide channel, a rigid connection section, a magnetic seat and an elastic connection shaft.

[0007] The guide channel is arranged through the middle position of the top of the elastic connection shaft, both ends of the elastic connection shaft are connected with the rigid connection section, both ends of the rigid connection section are connected with the magnetic seat, the bottom end of the magnetic seat is provided with a groove, and the groove is embedded with a magnet.

[0008] Further, the elastic connecting shaft adopts a directional elastic connecting shaft or a telescopic elastic connecting shaft.

[0009] Further, the connection mode between the magnetic seat and the rigid connecting segment adopts fixed connection or spherical hinge.

[0010] A manufacturing method of a magnetic locking 3D printing elastic guide plate for low feature surfaces, for the lack of characteristic concave-convex regions, more than three magnetic markers are pasted on the surface skin, which are away from the surgical operation area to provide a surgical operation space and a disinfection area, and then CT scanning is performed; the reconstructed three-dimensional image contains the markers, the guide plate is designed by taking the markers as the template position constraint condition, and the skin is taken as the outer contour to outline an outward surface stretching magnetic seat, the magnetic seat is designed with a groove at the marker position for clamping the magnet; a channel is designed to be connected with the base and is Boolean combined; the surface magnetic markers are reserved during the operation, the magnetic locking positioning guide plate is realized by the magnetic attraction between the magnets embedded in the corresponding positions of the magnetic seat of the guide plate and the magnetic markers, and accurate positioning is realized; the elastic connecting shaft is connected to the guide channel at the middle position, and the two ends of the elastic connecting shaft are connected with the rigid connecting segments, the magnetic seat is connected at the two ends of the rigid connecting segment, the point-to-point reliable adsorption is realized by conforming to the curved surface change, and thus the magnetic locking is completed.

[0011] Further, the markers adopt a ring layout, when the body surface is pasted with ferromagnetic materials instead of magnets, only one marker needs to be marked at the body surface end and the guide plate end, and accurate magnetic locking can be realized; when the body surface is pasted with magnets, only one magnet needs to be used with the magnetic pole reversed, and the corresponding guide plate end also has one magnet with the magnetic pole reversed, so that all the bit points are in the adsorption state after rotation, and accurate magnetic locking is realized.

[0012] Further, the width of the elastic connecting shaft is more than 10 times the thickness, and the thickness is controlled to be 1-3.5 mm.

[0013] Further, when only small bending performance is required, the elastic connecting shaft adopts a directional elastic connecting shaft, and the connection mode between the magnetic seat and the rigid connecting segment adopts fixed connection; when large bending performance and telescopic performance are required, the elastic connecting shaft adopts a telescopic elastic connecting shaft, and the connection mode between the magnetic seat and the rigid connecting segment adopts spherical hinge.

[0014] Further, when the elastic connecting shaft changes elastically, a certain positioning deviation will occur, the guide channel adopts a honeycomb-shaped guide channel for deviation correction, and the honeycomb-shaped guide channel comprises a central guide channel and a plurality of parallel channels arranged in a concentric circular array around the central guide channel.

[0015] The beneficial effects of the present application are as follows:

[0016] The present application is aimed at human low feature surfaces and parts with certain activity, can implement surgical accurate positioning, and completely solves the human low feature area positioning problem; can realize most human anatomical structure positioning, especially the current more tricky percutaneous positioning of parts with certain activity, thereby widening the application scenario of 3D printing guide plate, and providing a new perspective for digital medicine. BRIEF DESCRIPTION OF DRAWINGS

[0017] Figure 1 The structure schematic diagram of the elastic connecting shaft of the present application adopts a directional elastic connecting shaft;

[0018] Figure 2 The structure schematic diagram of the elastic connecting shaft of the present application adopts a telescopic elastic connecting shaft;

[0019] Figure 3 The bottom view of the telescopic elastic connecting shaft of the present application;

[0020] Figure 4 The structure schematic diagram of the magnetic attraction seat of the present application;

[0021] Figure 5 The distribution of the body surface end and the guide plate end magnet of the present application Figure 1 ;

[0022] Figure 6 The distribution of the body surface end and the guide plate end magnet of the present application Figure 2 ;

[0023] Figure 7 The structure schematic diagram of another embodiment of the present application.

[0024] In the figure: 1, guide channel; 2, rigid connecting section; 3, magnetic attraction seat; 4, elastic connecting shaft; 5, magnet; 11, central guide channel; 12, parallel channel. DETAILED DESCRIPTION

[0025] The technical solutions in the embodiments of the present application will be described clearly and completely below. Obviously, the described embodiments are only part of the embodiments of the present application, not all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the protection scope of the present application.

[0026] It should be noted that the terms "first", "second", and the like in the description and claims of the application and the above drawings are used to distinguish similar objects, and do not necessarily indicate a specific order or sequence. It should be understood that the data thus used can be interchanged under appropriate circumstances, so that the embodiments of the application described herein can be implemented. In addition, the terms "include" and "have" and any variations thereof are intended to cover non-exclusive inclusion, for example, a process, method, system, product or device including a series of steps or units does not necessarily limit to those steps or units clearly listed, but can include other steps or units not clearly listed or inherent to these processes, methods, products or devices.

[0027] In the present application, the terms "upper", "lower", "left", "right", "front", "back", "top", "bottom", "inner", "outer", "middle", "vertical", "horizontal", "lateral", "longitudinal" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings. These terms are mainly used to better describe the present application and its embodiments, and are not intended to limit the indicated devices, elements or components to have a specific orientation, or to be constructed and operated in a specific orientation.

[0028] In addition, in addition to indicating the orientation or positional relationship, the above-mentioned partial terms can also be used to indicate other meanings, for example, the term "upper" can also be used to indicate a certain dependent relationship or connection relationship in some cases. For those skilled in the art, the specific meaning of these terms in the present application can be understood according to the specific circumstances.

[0029] In addition, the terms "mount", "set", "provided with", "connected", "connected", "sleeved" should be broadly understood. For example, it can be a fixed connection, a detachable connection, or an integral structure; it can be a mechanical connection, or an electrical connection; it can be directly connected, or indirectly connected through an intermediate medium, or internal communication between two devices, elements or components. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0030] To achieve the above-mentioned purpose, as shown in Figures 1-4 The present application provides a magnetic locking 3D printing elastic guide plate for low feature surfaces, comprising: a guide channel 1, a rigid connection section 2, a magnetic attraction seat 3 and an elastic connection shaft 4;

[0031] The guide channel 1 is arranged through the middle position of the top of the elastic connection shaft 4, both ends of the elastic connection shaft 4 are connected with the rigid connection section 2, both ends of the rigid connection section are connected with the magnetic attraction seat 3, the bottom end of the magnetic attraction seat 3 is provided with a groove, and the groove is embedded with a magnet 5.

[0032] Further optimize the technical scheme, the elastic connecting shaft 4 adopts a directional elastic connecting shaft or a telescopic elastic connecting shaft.

[0033] Further optimize the technical scheme, the magnetic seat 3 and the rigid connecting section 2 are connected in a fixed connection or a spherical hinge.

[0034] The application also provides a manufacturing method of the magnetic locking 3D printing elastic guide plate for low feature surfaces. For the skull which lacks characteristic concave-convex regions, more than three magnetic markers are pasted on the skull surface skin, the markers are far away from the operation area, the operation space and the sterilization area are provided, and then CT scanning is performed; the reconstructed three-dimensional image contains the markers, the guide plate is designed by taking the markers as the template position constraint condition, the scalp is taken as the outer contour, a surface facing the outer surface is stretched to form a magnetic seat, the magnetic seat is designed with a groove at the marker position for clamping the magnet, for the intracranial hematoma, a channel is designed according to the hematoma position, points to the hematoma, and a channel is connected with the base and is Boolean combined; the magnetic markers on the surface of the head are reserved during the operation, the magnets embedded in the corresponding positions of the magnetic seat of the guide plate are adsorbed with the magnetic markers to realize the magnetic locking and positioning of the guide plate, and accurate positioning is realized; the elastic connecting shaft is connected with the guide channel in the middle position, the two ends of the elastic connecting shaft are connected with the rigid connecting section, the magnetic seat is connected at the two ends of the rigid connecting section, the point-to-point reliable adsorption is realized by conforming to the curved surface change, and thus the magnetic locking is completed. In order to accurately realize the magnetic locking, the markers adopt a ring layout, such as an equilateral triangle, a square, a hexagon and the like, and the advantage is that when the body surface is pasted with a ferromagnetic material instead of a magnet, only one marker needs to be marked at the body surface end and the guide plate end, or different sizes and shapes are used for identification, so that accurate magnetic locking is realized; when the body surface is pasted with a magnet, only one magnet 5 is needed, and the magnetic poles are opposite (as shown in Figure 5 , the corresponding guide plate end is also a magnet 5 with opposite magnetic poles, or different sizes and shapes are used for identification, so that all the bit points are in the adsorption state after rotation, or only one characteristic magnet 5 is adsorbed (as shown in Figure 6 , and thus accurate magnetic locking is realized.

[0035] For some areas that change with body position change, such as the spine, it will be very difficult to position the body surface, because the spine can move in 6 degrees of freedom, and sometimes it is difficult to work with the magnetic locking scheme alone, mainly because the CT examination adopts the supine position, and the intraoperative position needs to be prone, which directly leads to the change of its physiological curvature. According to the standard design of the magnetic locking guide plate, due to the change of the magnetic marker after the change of the body position, the rigid structure is difficult to directly lock, at this time the connection between the multiple magnetic suction seats and the guide channel is designed as a directional elastic shaft structure, which can realize point-to-point reliable adsorption by conforming to the curved surface change, so as to complete the magnetic locking. Due to the change of the curved surface, the fixed magnetic suction seat will cause the adsorption to be unreliable, and the magnetic suction seat needs to change direction within a certain range, and the ball head connection structure realizes this function, so that the magnetic suction seat can change with the change of the human body curve. Generally speaking, the difference between the surgical body position and the CT examination is that the human body is placed in a single-axis change, such as the spine, which shows flexion and extension in the sagittal plane, and the chest is positioned, and the breathing mainly shows the movement of the ribs up and down, that is, the change in the longitudinal axis direction of the human body. Therefore, the elastic structure between the positioning channel and the magnetic locking base needs to have a one-way elasticity, such as the spine, which needs to have elasticity in the sagittal plane, and the coronal plane and the horizontal plane cannot have elastic change, that is, the other two dimensions have rigidity. The spiral structure with multi-directional elastic performance, such as a spring, does not meet the requirements. The directional elastic shaft of the present application is a single elastic directional connection structure with this property. The width of the elastic connection shaft is more than 10 times the thickness, and the thickness is controlled to be 1-3.5mm. When the 3D printing material adopts nylon, PEEK, or even metal materials with higher strength, the thickness can be as low as 0.5mm. When only a small bending performance is required, the elastic connection shaft adopts a directional elastic connection shaft, and the connection between the magnetic suction seat and the rigid connection segment adopts fixed connection; when a larger bending performance and expansion performance are required, the elastic connection shaft adopts a telescopic elastic connection shaft, and the connection between the magnetic suction seat and the rigid connection segment adopts a spherical hinge. Accordingly, the positioning problem of the low feature area of the human body is completely solved, and the elastic positioning of the part with a certain range of activity is also solved.

[0036] It should be noted that the design of the magnetic locking elastic guide plate needs to be very careful, the guide channel should be designed in the middle of the elastic connection shaft, and the S-shaped elastic connection structure on both sides must be consistent, that is, the bending layer is the same, such as Figure 2As shown, so as to ensure that the bending on both sides is consistent with the ductility, so as to minimize the positioning error. Since the guide channel can be at any angle, theoretically, it is easier to design it at the central position of the elastic connecting shaft, that is, when designing, the line connecting the target point and the expected midpoint of the elastic connecting shaft is taken as the axis of the elastic connecting shaft. There is another case that when the area to be reached is not a target point but a channel, such as a pedicle screw channel, at this time the guide channel is constrained, and the body surface projection thereof can be outside the periphery of the magnetic locking base, at this time the design of the elastic connecting shaft still needs to comply with the design concept, that is, the elastic performance of the elastic connecting shaft on both sides of the guide channel needs to be symmetrical, and the single elastic direction of the elastic guide plate is consistent with the direction of the body bending axis of the magnetic locking area.

[0037] When the guide plate appears elastic change, a certain positioning deviation will occur, and the honeycomb-shaped guide channel is used for deviation correction, which is a detachable guide channel reserving the central guide channel, and the surrounding is a concentric circular array of parallel channels.

[0038] In another embodiment, referring to Figure 7 When the elastic connecting shaft appears elastic change, a certain positioning deviation will occur, and the honeycomb-shaped guide channel is used for deviation correction, the honeycomb-shaped guide channel includes a central guide channel 11 and a plurality of parallel channels 12 arranged in a concentric circular array around the central guide channel 11, and the diameter is 1mm, when the central guide channel appears deviation in a certain direction, the guide needle is penetrated into the corresponding channel according to the deviation direction and interval, so as to realize accurate positioning.

[0039] The present application can implement accurate positioning for human low feature surfaces and parts with certain activity, and completely solves the positioning problem of low feature areas of human body; most of the human anatomical structure positioning can be realized, especially the current more difficult percutaneous positioning of parts with certain activity, thereby widening the application scene of the 3D printing guide plate and providing a new perspective for digital medicine. Embodiment 1

[0040] Single magnetic locking structure: for a patient with intracranial hematoma, after pre-removing the hair, 4 gel stickers with embedded magnets are pasted around the scalp area projected by the hematoma, CT plain scan is performed, the head DICOM data is imported into MIMICS software, and the head three-dimensional image including the magnet is obtained through threshold segmentation and other methods, the guide hole is set according to the hematoma position, the direction points to the hematoma center area, and the guide channel is drawn, 4 magnetic seats with grooves are designed and made in the scalp magnet area for embedding the magnet, such as Figure 1The head does not appear axial shape change, the connecting structure can be rigidly connected. The elastic connecting shaft is connected with the magnetic seat through the rigid connecting section, and the elastic connecting shaft is connected with the guide channel at the middle position. The Boole sum combines each entity, completes the positioning guide plate design and 3D printing. The four magnetic locking areas need to be marked with numbers, which is convenient for correct positioning and adsorption during magnetic locking.

[0041] After the 3D printing magnetic locking guide plate is sterilized at low temperature, the depth is planned in advance during the operation, the depth is limited and accurately drilled through the guide channel, and the operation is directly performed on the hematoma area. Example 2

[0042] The tiltable magnetic locking is combined with the directional elastic connecting shaft: for lung tumor patients, four magnets are adsorbed on the chest wall near the tumor area in advance, two groups of rigid connecting sections of the rigid connecting magnetic seats are parallel to the cross section of the trunk as much as possible, and the purpose is to design the directional elastic connecting shaft structure perpendicular to the rigid connecting section, so that the body position can be changed, because the body position will be stretched and laterally flexed in the longitudinal axis direction, the elastic connecting shaft is designed as a longitudinal S-shaped structure, which can ensure extension and bending in the longitudinal axis, and can maintain a certain rigidity in other dimensions, such as Figure 2 Then, it is spliced with the guide channel and the magnetic seat to form a whole and 3D printed, so that the magnetic locking and elastic fitting can still be realized under the condition of body position change, and accurate positioning can be realized. After the rib is touched to determine the puncture point, the puncture is performed according to the direction of the guide channel and the puncture is confirmed by fluoroscopy.

[0043] The above is only a preferred embodiment of the present application, and does not limit the technical scope of the present application. Any slight modification, equivalent change and modification of the above embodiment according to the technical essence of the present application still belongs to the scope of the technical scheme of the present application.

Claims

1. A magnetic locking 3D printed elastic guide plate for low feature surfaces, characterized in that, The utility model relates to a kind of magnetic locking guide plate, including: Guiding channel (1), rigid connection section (2), magnetic attraction seat (3) and elastic connecting shaft (4); The guiding channel (1) is arranged in the middle position of the top of the elastic connecting shaft (4), both ends of the elastic connecting shaft (4) are connected with rigid connection section (2), both ends of the rigid connection section are connected with magnetic attraction seat (3), the bottom of the magnetic attraction seat (3) is provided with a groove, and the groove is embedded with a magnet (5).

2. A magnetic locking 3D printed elastic guide plate for low feature surfaces as claimed in claim 1, wherein, The elastic connecting shaft (4) is a directional elastic connecting shaft or a telescopic elastic connecting shaft.

3. A magnetic locking 3D printing elastic guide plate for low feature surfaces as claimed in claim 2, wherein, The connection mode of the magnetic attraction seat (3) and the rigid connection section (2) is fixed connection or ball hinge.

4. A method for fabricating a magnetic locking 3D printed elastic guide plate for low feature surfaces, characterized in that, For those lacking characteristic concave-convex regions, more than three magnetic markers are pasted on the surface skin, away from the surgical operation area, to provide a surgical operation space and a sterilization area, and then CT scanning is performed; The reconstructed three-dimensional image contains markers, and the guide plate is designed using the markers as template position constraints, with the skin as the outer contour, and a magnetic attraction seat is outlined on the outward-facing surface. The magnetic attraction seat is designed with a groove at the marker position for clamping the magnet. A channel is designed to connect the base and is Boolean combined. The surface magnetic markers are retained during the operation, and the guide plate is magnetically locked and positioned by the magnets embedded in the corresponding positions of the magnetic attraction seat of the guide plate, to achieve accurate positioning. The elastic connecting shaft is connected to the guiding channel at the middle position, and the elastic connecting shaft is connected to the rigid connection section at both ends. The magnetic attraction seat is connected to the rigid connection section at both ends. By conforming to the curved surface change, point-to-point reliable adsorption is achieved, thereby completing the magnetic locking.

5. The method of claim 4, wherein the method further comprises: The markers are arranged in a ring shape. When ferromagnetic materials instead of magnets are pasted on the body surface, only one marker needs to be marked on the body surface end and the guide plate end, or different sizes and shapes are used for identification, to achieve accurate magnetic locking. When magnets are pasted on the body surface, only one magnet with opposite magnetic poles is needed, and the corresponding guide plate end also has one magnet with opposite magnetic poles, or different sizes and shapes are used for identification. In this way, all bit points are in the adsorbed state after rotation, or only the characteristic magnet is attracted, to achieve accurate magnetic locking.

6. The method of claim 5, wherein the method further comprises: The width of the elastic connecting shaft is more than 10 times the thickness, and the thickness is controlled to be 1-3.5 mm.

7. The method of claim 6, wherein the method further comprises: When only small bending performance is needed, the elastic connecting shaft is a directional elastic connecting shaft, and the connection mode of the magnetic attraction seat and the rigid connection section is fixed connection. When large bending performance and telescopic performance are needed, the elastic connecting shaft is a telescopic elastic connecting shaft, and the connection mode of the magnetic attraction seat and the rigid connection section is ball hinge.

8. The method of claim 4, wherein the method further comprises: When the elastic connecting shaft changes elastically, there will be a certain positioning deviation. The guiding channel (1) is a honeycomb guiding channel for deviation correction. The honeycomb guiding channel includes a central guiding channel (11) and a plurality of parallel channels (12) arranged around it in concentric circular array.

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