CN107157580B - 3D printing guide plate for digital positioning spinal minimally invasive surgery and preparation method - Google Patents

3D printing guide plate for digital positioning spinal minimally invasive surgery and preparation method Download PDF

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Publication number
CN107157580B
CN107157580B CN201710511326.4A CN201710511326A CN107157580B CN 107157580 B CN107157580 B CN 107157580B CN 201710511326 A CN201710511326 A CN 201710511326A CN 107157580 B CN107157580 B CN 107157580B
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guide plate
positioning block
positioning
skin
spine
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CN107157580A (en
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刘大鹏
付立柱
杨红菊
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Fu Lizhu
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Fu Lizhu
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10Computer-aided planning, simulation or modelling of surgical operations
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/10Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis
    • A61B90/11Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis with guides for needles or instruments, e.g. arcuate slides or ball joints
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37Surgical systems with images on a monitor during operation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B33ADDITIVE MANUFACTURING TECHNOLOGY
    • B33YADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y10/00Processes of additive manufacturing
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B33ADDITIVE MANUFACTURING TECHNOLOGY
    • B33YADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y50/00Data acquisition or data processing for additive manufacturing
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B33ADDITIVE MANUFACTURING TECHNOLOGY
    • B33YADDITIVE MANUFACTURING, i.e. MANUFACTURING OF THREE-DIMENSIONAL [3-D] OBJECTS BY ADDITIVE DEPOSITION, ADDITIVE AGGLOMERATION OR ADDITIVE LAYERING, e.g. BY 3-D PRINTING, STEREOLITHOGRAPHY OR SELECTIVE LASER SINTERING
    • B33Y80/00Products made by additive manufacturing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/101Computer-aided simulation of surgical operations
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/101Computer-aided simulation of surgical operations
    • A61B2034/105Modelling of the patient, e.g. for ligaments or bones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/108Computer aided selection or customisation of medical implants or cutting guides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37Surgical systems with images on a monitor during operation
    • A61B2090/376Surgical systems with images on a monitor during operation using X-rays, e.g. fluoroscopy
    • A61B2090/3762Surgical systems with images on a monitor during operation using X-rays, e.g. fluoroscopy using computed tomography systems [CT]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3904Markers, e.g. radio-opaque or breast lesions markers specially adapted for marking specified tissue
    • A61B2090/3916Bone tissue

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Abstract

The invention discloses a digital positioning 3D printing guide plate for minimally invasive spine surgery, which is characterized in that a positioning block cavity and a spinous process positioning line are arranged in the middle of the guide plate, guide holes are formed in two sides of the guide plate, a positioning block is arranged in the positioning block cavity, a T-shaped groove is formed in the bottom of one side of the central axis of the positioning block, a T-shaped fixing groove is formed in the bottom surface of the guide plate, a positioning scale is arranged in the T-shaped fixing groove, and scales. The guide plate of the invention combines digital measurement to optimize the positioning process, is simple and convenient, can directly perform secondary positioning according to the mark made on the epidermis of the tested object, and avoids inconvenience that the operation area of the tested object cannot be completely disinfected in the operation; the puncture point can be quickly and accurately determined in the operation of a doctor, the puncture direction can be ensured to be accurate in the coronal plane and the sagittal plane simultaneously, compared with the traditional operation mode, the operation time can be shortened, the radiation amount of the doctor and the patient in the operation can be reduced, the safety and the accuracy of the operation can be improved, and the puncture method has wide applicability in the field of minimally invasive spine operations.

Description

3D printing guide plate for digital positioning spinal minimally invasive surgery and preparation method
Technical Field
The invention mainly relates to the technical field of medical instruments, in particular to the technical field of 3D printing guide plates.
Background
With the rapid development of the medical field, modern medicine tends to individualized treatment strategies, and the extensive and deep combination of computer information technology and life science generates new interdisciplinary-digital medicine, thereby greatly promoting the development of modern clinical individualized diagnosis and treatment technology. The 3D printing technology is a technology for directly stacking three-dimensional objects layer by layer or point by point from materials for computer models, and has been successfully applied to many aspects of the medical field in recent years as one of Computer Aided Manufacturing (CAM) technologies. The medical image technology is combined with the 3D printing technology, so that the medical image is developed from a two-dimensional plane image to a three-dimensional stereo image and also to a physical model of the current organ. Further combined with Computer Aided Design (CAD), not only can a human anatomy structure model be manufactured, but also an individualized operation guide plate which is completely matched with the surface of the human anatomy structure can be manufactured.
At present, with the help of computer digitization related technology, people form anatomical modeling and three-dimensional reconstruction after processing image data in a plurality of medical subject fields, display and position the anatomical structure of the body bones, and carry out simulation operation in a computer, design the optimal operation path and a reasonable individualized operation scheme, thereby improving the accuracy of the operation, simplifying the operation steps, shortening the learning curve of young doctors, laying a solid foundation for the innovation and the array of digital bone science, and creating an unprecedented space for the application of 3D printing in the biomedical field.
At present, spine minimally invasive surgery is increasingly widely carried out, and comprises Percutaneous Vertebroplasty (PVP) or kyphoplasty (PKP) or percutaneous pedicle fixation, an intervertebral foramen mirror, an intervertebral disc mirror, spine tumor focus biopsy and the like, and has the advantages of small surgical trauma, quick recovery and good patient acceptance. The minimally invasive surgery is a percutaneous surgery, and only the position of a vertebral body can be roughly determined through the skin on the back of the vertebra, so that the exact position of the operated vertebral body is difficult to identify through the skin on the back of the vertebral body, and at the moment, in order to determine the operated vertebral body, ensure the accurate needle inserting angle and depth during nail placement, accurately determine the nail inserting point and the nail inserting direction through the pedicle of vertebral arch, and mostly need to perform a large amount of X-ray irradiation for determination. This not only causes great physical injury and economic burden to the patient, but also often causes adverse reactions such as nausea and vomiting after operation due to the large dose of ray projection. But also unpredictable radiation effects on the physician. And even to initiate tumors. At present, although the more advanced intraoperative CT and navigation pedicle screw implantation technology can achieve higher screw implantation accuracy, equipment is expensive, and hospitals capable of being equipped with the equipment are rare at home.
3D printing spine minimally invasive surgery guide plate technology can provide a good solution for the method. Patent CN 204863422U patent discloses a vertebra deflector of 3D printing, but need set up the polylith spacer when using, confirm that selects that piece of spacer as final positioning use according to CT scanning data, and used spacer need paste always on patient's skin until the operation is ended, this makes the position below the spacer can not disinfect, the operation risk has been increased, it receives the restriction also to make this technique use in the operation, patent CN 104287815A uses metal sleeve, the error has been increased, two preceding patent methods still need the X ray to carry out the repeated scanning when finally confirming that a centrum carries out the operation and the deflector places the position, just can realize the accurate of placing the deflector, cause prior art deflector still can not avoid the reliance to X ray scanning in the art when percutaneous pedicle of vertebral arch operation.
Disclosure of Invention
Aiming at the technical current situations that the precision of a guide plate is poor, the dependence on CT scanning in the operation during minimally invasive spine surgery cannot be avoided due to posture factors before the operation and the positioning process of the guide plate is complicated and the sterile requirement of the operation cannot be met in the prior art, the invention provides a 3D printing guide plate for the minimally invasive spine surgery and a preparation method thereof, wherein a special prone position body position frame (which is patented in another application) is used when the data is extracted by CT before the operation, and a measuring tool is used for measuring the distance from the intersection point of any edge of a positioning block and the central axis of the spine to the central point of the operated vertebral body and recording the distance as a value; then measuring the vertical distance from the center point of the surgical vertebral body to the surface of the skin and recording the vertical distance as a b value; the exact position of the guide plate placement during the operation can be calculated from the a and b values, i.e. the distance on the spine centerline that needs to be translated fine-tuned up and down is recorded as the c value. The position of the guide plate in the operation can be marked again by the positioning block in the spine skin area of the tested object according to the marking lines around the positioning block of the tested object, the value a, the value b and the value c, so that the dependence on CT scanning in the operation is thoroughly solved, the defect that the positioning device cannot be removed from the operation to the operation is overcome, the disinfection of the operation area is not influenced, and the method has wide applicability in the minimally invasive spine operation.
The technical scheme provided by the invention is as follows:
the invention provides a preparation method of a 3D printing guide plate for a digital positioning spine minimally invasive surgery, which comprises the following steps:
(1) placing body positions: the tested object lies prostrate on the 3D printing spinal surgery prone position body position frame, the CT scanning body position is consistent with the body position during surgery, and the positioning block is placed on the skin of the central line of the spine of the patient close to the surgery area and marked.
(2) CT scanning: and scanning the trunk of the tested object by adopting a multi-row CT machine, and storing the related data information of the tested object.
(2) Data segmentation in medical imaging software: the CT scanning data is imported into medical image software for processing, a cone and skin are displayed on the same mask by utilizing a threshold segmentation method and Boolean operation summation, the skin is the outer layer, the relative position of the cone and the skin can be kept consistent with the actual position, and finally a file is exported.
(3) Establishing the guide plate position using the positioning block: measuring the distance from the intersection point of any edge of the positioning block and the central axis of the spine to the central point of the surgical vertebral body by using a measuring tool in medical image software, and recording the distance as a value a; then measuring the vertical distance from the center point of the surgical vertebral body to the surface of the skin and recording the vertical distance as a b value; the exact position of the guide plate placement during the operation can be calculated from the a and b values, i.e. the distance on the spine centerline that needs to be translated fine-tuned up and down is recorded as the c value. And re-labeling the position of the guide plate in the spine skin area of the tested object by using the positioning block.
(4) Data encapsulation in reverse engineering software: and finally, fitting the curved surface, importing the curved surface into a computer to obtain a qualified file and exporting the qualified file.
(5) Computer aided design: and (4) importing the file in the step (4) into computer-aided software to design a spine guide plate model, completing the design of a main body part and a guide hole part of the guide plate, reserving a hole for placing a positioning block in the design, chamfering the guide plate, and designing holes in the middle and two sides of the guide plate.
(6)3D printing of a guide plate model: produce the deflector model through 3D printing technique, there are two pedicle of vertebral arch holes on the deflector surface, and deflector central authorities set up the location cavity, and 3D prints quick shaping and prints out the guider entity.
According to the invention, the body position of the tested object in CT is consistent with the body position of the finally used guide plate, the prone position of the tested object is placed on the body position frame, the shape of the vertebral body and the skin of the tested object is relatively constant, severe errors caused by soft tissue deformation due to body position change on the surface of the fitting guide plate are prevented, the relative position is consistent with the height of the finally used guide plate, when the position of the tested object is determined, the lower edges of the ilium and the rib are taken as body surface standard points, a positioning block is placed on the central line of the spine of the tested object, and the contact edge of the positioning block and the skin is marked on the skin.
In the invention, the waterproof marker pen is preferably adopted for marking in the steps (1) and (4).
According to the invention, the data of the skin binding surface of the main body part of the guide plate is obtained by a tester supported by the body position frame, so that the guide plate prepared according to the skin data of the tester can be ensured to be accurate and reliable; if a tester lies and takes a CT, the skin of the back is always flat, the binding surface of the manufactured guide plate is flat, and the curved surface of the skin after the back is arched is deformed in the prone position during operation; the rest part of the guide plate is obtained by a skin periphery line stretching command and a trimming command, so that the guide plate can be attached to the skin as much as possible, the stretching height is ensured to be parallel to the upper edge and the lower edge of a cone which is driven into a pathological change, and a cavity for placing a positioning block is reserved in the design; the guide hole is designed in such a way that two straight lines which are properly driven into the vertebral pedicle are designed on the section of the vertebral pedicle according to the section of the vertebral pedicle and the upper and lower edges of the vertebral pedicle, the position of the straight line is adjusted, and the straight line is taken as the center of a cylinder to design a pipeline driven into the vertebral pedicle; and finally, carrying out proper chamfering on the guide plate, and designing cavities in the middle and two sides of the guide plate.
In the invention, a positioning block cavity is arranged in the middle of the guide plate, guide holes are arranged on two sides of the positioning block cavity, a spinous process positioning line is arranged in the middle of the guide plate, cavities are arranged on two sides of the guide plate, and a positioning block is arranged in the positioning block cavity.
According to the positioning device, a T-shaped groove is formed in the bottom of one side of the central axis of the positioning block, the T-shaped groove penetrates through the bottom surface of the positioning block, a T-shaped fixing groove is formed in the bottom surface of the guide plate, a positioning scale is arranged in the T-shaped fixing groove and is in a T shape, the positioning scale is arranged in a manner of being matched with the T-shaped fixing groove of the guide plate and the T-shaped groove of the positioning block, scales are arranged on the surface of the positioning scale, and the length from zero scale.
In the invention, the scanning conditions in the step (2) are voltage 120kV, current 166mAs, layer thickness 0.8mm and matrix 512x 512.
According to the invention, the 3D printing spinal surgery prone position frame is provided with a breast placing groove and an abdomen placing groove, a grid is arranged between a pair of breast placing grooves, fixing walls are arranged on two sides of the abdomen placing groove, a chest groove is arranged between the breast placing groove and the abdomen placing groove, a cavity is arranged below the breast placing groove and the chest groove, a cavity is arranged on the back of the position frame, and an opening is formed in the bottom of the abdomen placing groove.
In the invention, the 3D printing spinal surgery prone position posture frame is prepared from a PLA polylactic acid degradable environment-friendly printing material.
In the invention, the 3D printing prone position body position frame for the spinal surgery is formed by 3D printing.
The invention has the beneficial effects that:
the design process of the 3D printing guide plate for the digital positioning spine minimally invasive surgery provided by the invention applies a 3D reconstruction technology of digital medicine, the data of the guide plate completely comes from patients, and the accurate three-dimensional individualized guide plate can be designed according to individual differences of the patients; the design and the use of the guide plate take the influence of the movement of the examined body position and the body position in the operation on soft tissues such as skin and the like on the positioning accuracy into consideration, the matching degree in the design and the application can be obviously improved, the influence of errors on the operation is reduced, and the medical safety is improved.
The positioning block is combined with digital measurement to optimize the positioning process, the positioning process is simple and convenient, secondary positioning can be directly carried out according to the measured values a, b and c and the marks made on the epidermis of the tested object, a positioning mechanism does not need to be fixed on the tested object for a long time, and inconvenience that the operation area of the tested object cannot be completely disinfected in the operation is avoided; the puncture point can be quickly and accurately determined in the operation of a doctor, the puncture direction can be ensured to be accurate in the coronal plane and the sagittal plane simultaneously, compared with the traditional operation mode, the operation time can be shortened, the radiation amount of the doctor and the patient in the operation can be reduced, and the safety and the accuracy of the operation can be improved.
Drawings
FIG. 1 is a diagram showing the processing results of medical imaging software according to the present invention.
FIG. 2 is a diagram showing the processing results of reverse engineering software according to the present invention.
FIG. 3 shows the close contact between the guiding plate and the skin as the result of the CAD of the present invention.
FIG. 4 is a schematic view of a deflector according to the present invention.
Fig. 5 is a side view of the deflector plate of the present invention.
Fig. 6 shows a bottom view of the deflector of the present invention.
Fig. 7 is a first embodiment of the guide plate of the present invention.
Fig. 8 is a second embodiment of the guide plate of the present invention.
FIG. 9 is a schematic view of a positioning block according to the present invention.
FIG. 10 is a schematic view of a positioning scale according to the present invention.
Fig. 11 is a schematic view of the body frame structure of the present invention.
Fig. 12 is a schematic view of the structure of the body position frame supporting plate of the present invention.
Fig. 13 is a schematic view showing a connection structure of 2 support frames of the body position frame of the present invention.
In the drawings 1-13, 1-guide plate, 2-guide hole, 3-positioning block cavity, 4-cavity, 5-spinous process positioning line, 6-T-shaped fixing groove, 7-positioning block, 8-T-shaped groove, 9-positioning scale, 10-scale, 11-breast placing groove, 12-abdomen placing groove, 13-fixing wall, 14-chest groove, 15-block, 16-opening hole, 17-cavity and 20-vertebral body.
Detailed Description
The following is a further detailed description of specific embodiments of the invention, but the process of the invention is not limited to the examples described below.
The first embodiment is as follows: preparation method of 3D printing guide plate for digital positioning spinal minimally invasive surgery
The invention provides a preparation method of a 3D printing guide plate for a digital positioning spine minimally invasive surgery, which comprises the following steps:
(1) placing body positions: the tested object lies prostrate on the 3D printing spinal surgery prone position body position frame, the CT scanning body position is consistent with the body position during surgery, and the positioning block (7) is placed on the skin of the central line of the spine of the patient close to the surgery area and marked.
(2) CT scanning: and scanning the trunk of the tested object by adopting a multi-row CT machine, and storing the related data information of the tested object.
(2) Data segmentation in medical imaging software: the CT scanning data is imported into medical image software for processing, a cone and skin are displayed on the same mask by using a threshold segmentation method and Boolean operation summation, the skin is the outer layer, the relative position of the cone and the skin can be kept consistent with the actual position, and finally a file is exported, as shown in the description attached figure 1.
(3) The guide plate position is established by the positioning block (7): measuring the distance from the intersection point of any edge of the positioning block (7) and the central axis of the spine to the central point of the operation vertebral body (20) by using a measuring tool in medical imaging software and recording the distance as a value a; then measuring the vertical distance from the center point of the operation vertebral body (20) to the skin surface and recording the vertical distance as a b value; the accurate position of the guide plate (1) in the operation can be calculated by the value a and the value b, namely the distance needing fine adjustment of translation up and down on the central line of the vertebral column is recorded as the value c. The position of the guide plate (1) in the spine skin area of the tested object is marked again by using the positioning block.
(4) Data encapsulation in reverse engineering software: through data processing, the final fitting surface is imported into a computer to obtain a qualified file finally, and is exported, as shown in the description attached figure 2.
(5) Computer aided design: and (3) importing the file in the step (4) into computer-aided software to design a spine guide plate model, completing the design of a main body part of the guide plate (1) and the design of a guide hole (2), reserving a hole (3) capable of containing a positioning block in the design, chamfering the guide plate (1), and designing holes in the middle and two sides of the guide plate (1).
(6)3D printing of a guide plate model: produce the deflector model through 3D printing technique, deflector (1) surface has two pediculus arcus vertebrae to beat the hole, and deflector central authorities set up location cavity (4), and 3D prints quick shaping and prints out the guider entity.
In the invention, the scanning conditions in the step (2) are voltage 120kV, current 166mAs, layer thickness 0.8mm and matrix 512x 512.
In the invention, clothes and belts are removed during scanning, so that the skin data processing is prevented from being influenced after the three-dimensional reconstruction of the CT data.
Example two: acquisition and tagging of CT data
According to the invention, the body position of the tested object in the CT is consistent with the body position of the guide plate (1) finally used, the prone position of the tested object is placed on the body position frame, the relative constancy of the shape of the vertebral body (20) and the skin of the tested object is ensured, the serious error of the soft tissue deformation caused by the change of the body position on the surface of the fitting guide plate is prevented, the relative position is consistent with the height of the guide plate (1) finally used, when the position of the tested object is determined, the lower edges of the ilium and the ribs are taken as body surface standard points, a positioning block (7) is placed on the central line of the vertebral column of the tested object, and a waterproof marker pen is used for marking the contact edge of the positioning block (7.
And scanning the trunk of the tested object by adopting a multi-row CT machine, and storing the related information of the tested object.
Example three: computer aided design
According to the invention, the data of the skin binding surface of the main body part of the guide plate (1) is obtained by a tester supported by the body position frame, so that the guide plate (1) prepared according to the skin data of the tester can be ensured to be accurate and reliable; if a tester lies and takes a CT, the skin of the back is always flat, the binding surface of the manufactured guide plate is flat, and the curved surface of the skin after the back is arched is deformed in the prone position during operation; the rest part of the guide plate (1) is obtained by a skin periphery line stretching command and a trimming command, so that the guide plate (1) can be attached to the skin as much as possible, the stretching height is ensured to be parallel to the upper edge and the lower edge of a cone (20) driven into a pathological change, and a cavity (3) for placing a positioning block is reserved in the design; the guide hole (2) is designed in such a way that two straight lines which are properly driven into the vertebral pedicle are designed on the section of the vertebral pedicle according to the section of the vertebral pedicle which is searched and located at the upper and lower edges of the vertebral pedicle, the position of the straight line is adjusted, and a pipeline which is driven into the vertebral pedicle is designed by taking the straight line as the center of a cylinder; then summing the main structure of the pipeline and the guide plate (1) and the guide hole to obtain the guide plate (1), and finally, properly chamfering the guide plate (1) and designing hollow holes in the middle and two sides of the guide plate (1) as shown in the attached drawing 3.
Example four: 3D printing guide plate model
In the invention, as shown in attached figures 4, 5, 6, 7 and 8, a positioning block cavity (3) is arranged in the middle of a guide plate (1), guide holes (2) are arranged at two sides of the positioning block cavity (3), a spinous process positioning line (5) is arranged in the middle of the guide plate (1), cavities (4) are arranged at two sides of the guide plate (1), a positioning block (7) is arranged in the positioning block cavity (3), a T-shaped groove (8) is arranged at the bottom of one side of the central axis of the positioning block (7), the T-shaped groove (8) penetrates through the bottom surface of the positioning block (7), a T-shaped fixing groove (6) is arranged at the bottom surface of the guide plate, a positioning scale (9) is arranged in the T-shaped fixing groove (6), the positioning scale (9) is in a T shape and is matched with the T-shaped fixing groove (6) and the positioning block T-shaped groove, the length from zero scale to the end head is consistent with that of the T-shaped fixing groove (6), the arranging positions of the spinous process positioning line (5) and the four sides of the positioning block cavity (3) are marked with the accurate positioning guide device, and the guide hole (2) is used for accurately puncturing and positioning the pedicle of vertebral arch.
Example five: 3D prints backbone operation prone position frame
The invention provides a 3D printing prone position posture frame for spinal surgery, which is provided with breast placing grooves (11) and abdomen placing grooves (12), a block (15) is arranged between a pair of breast placing grooves (11), fixing walls (13) are arranged on two sides of the abdomen placing groove (12), a chest groove (14) is arranged between the posture frame breast placing grooves (11) and the abdomen placing groove (12), and the bottom of the abdomen placing groove (12) is provided with an opening (6)
In the invention, a cavity (17) is arranged on the back of the body position frame.
In the invention, all edges and corners of the upper surface of the position frame are arc angles.
In the invention, the horizontal section of the breast placing groove (11) is trapezoidal.
In the invention, the arc angle radian of both sides of the abdomen placing groove (12) is larger than that of the periphery of the breast placing groove (11).
In the invention, the 3D printing spinal surgery prone position posture frame is prepared from a PLA polylactic acid degradable environment-friendly printing material.
In the invention, the 3D printing prone position body position frame for the spinal surgery is formed by 3D printing.
Adopts 3D printing integrated molding, adopts ergonomic curved surface radian, accords with human body biomechanics, specially designs a breast placing groove for women, so that the test and operation are more comfortable, the PLA polylactic acid degradable environment-friendly printing material is adopted for non-metal structure and non-magnetic integrated 3D printing molding, when the preoperative CT is used for extracting data, the X-ray CT bed can be used on a CT bed, so that the prone position of a patient in the CT is consistent with that in the operation, the operation precision is improved, the X-ray CT bed can be used on an MRI machine, the dependence on CT scanning in the operation is thoroughly solved, the defect that the positioning device cannot be removed from the operation to the operation and the defect that the traditional operation body position frame cannot be used for operation body position scanning under nuclear magnetic resonance are overcome, the disinfection of an operation area is not influenced, the 3D printing speed is accelerated by the cavity design at the bottom, the material waste is reduced, and the spine minimally invasive surgery instrument has wide applicability.
Example six: clinical trial
6.1 test specimens
The following experiments were carried out using the embodiment of the present invention shown in FIGS. 7 and 8.
The patients with 5 thoracolumbar fractures who were seen in the orthopedics department of the fifth affiliated hospital of the Xinjiang medical university from 8 months to 12 months in 2014 were selected, wherein 4 patients were vertebroplasty, 1 patient was percutaneous screw fixation, the age was 31-66 years, the average age was 52.6 years, 0 men and 5 women, 6 groups of punctured vertebral bodies, 2 groups of thoracic vertebrae and 4 groups of lumbar vertebrae, wherein:
patient 1: for women, in 60 years old, the patient has trauma to cause multiple soft tissue injuries on the whole body, and has a half-day chief complaint of admission of low back pain and admission diagnosis: 1. lumbar 1 vertebral compression fracture, 2, multiple soft tissue injuries of the whole body, 3, lumbar intervertebral disc protrusion.
Patient 2: female, age 49, admission to hospital with a high fall to limited activity of low back pain for more than 4 hours, admission diagnosis: 1. thoracic 12 vertebral compression fracture, 2, 10, 12 vertebral spinous process fracture, and 3, 12 rib fracture.
Patient 3: female, age 66, admission to hospital with 5 hours of pain in the low back from the injury, admission diagnosis: 1. lumbar 1 vertebral compression fracture, 2 severe osteoporosis, 3, hypertension 3 grade-high risk.
Patient 4: female, age 57, admission to hospital for 2 hours of low back pain due to traumatic injury, admission diagnosis: 1. lumbar 1 vertebral compression fracture, 2, hypertension 3-level-extreme high risk.
Patient 5: female, 31 years old, admission with 4 hours of pain in the low back caused by trauma as chief complaints, admission diagnosis: 1. chest 12 vertebral compression fracture, 2 head trauma, 3 right scapula fracture, 4 right chest trauma, 5 lumbar degenerative change, 6 th and 10 th rib fracture, 7 th and right clavicle fracture, 8 th and two lung contusion and laceration, 9 th and two side pleural effusion.
No neurological symptoms were observed in all the 5 patients, and the stool and urine were normal, and all the patients were examined by x-ray and CT before surgery. Patients 1, 2, 3 and 4 all adopt percutaneous balloon dilatation, patient 5 adopts a percutaneous screw internal fixation method, and clinical experimental subjects are included in the standard: according to AO typing, all the types are A-type injuries and have no neurological symptoms.
And simultaneously, 15 cases in 6 months to 2016 years of 2 months of medical record systems of a fifth affiliated hospital of Xinjiang medical university are called as simple controls by a spine minimally invasive surgery mode in a medical record system, wherein 13 patients adopt vertebroplasty, 2 patients adopt percutaneous screw fixation, the ages of the patients are 44-91 years, the average age is 66.2 years, 5 men and 10 women, 16 groups of puncture vertebral bodies, 7 groups of thoracic vertebrae and 9 groups of lumbar vertebrae.
5 patients guide the puncture surgery process to be smooth by applying the 3D printed percutaneous pedicle guide plate, bone cement has no leakage, the position of a pedicle screw is good, and the surgery is completed according to a plan. The incisions of all cases are healed for the first time, no incision infection and delayed healing are caused, no complications such as spinal cord nerve injury symptom and the like occur after the operation, the postoperative effect is good, the abnormality found in the operation is consistent with that of the preoperative Mimcs software three-dimensional reconstruction model, and the intraoperative fluoroscopy and the postoperative X-ray reexamination show that the bone cement injection and the pedicle screw position are good. Postoperative patients all achieve first-stage healing, postoperative follow-up is 4-8 weeks, and the average is 6 weeks. The centrum perspective dose measured by the C-arm is 1.13 +/-0.24 mSv, which is less than 1.97 +/-1.20 mSv reported by related documents.
6.2 Collection of data
TABLE 1 data statistics of the experimental groups
6.3 statistical analysis
4 patients of the experimental group with percutaneous balloon vertebroplasty have the fluoroscopy times of 5 +/-0.82 times and the operation time of 40 +/-8.16 min, 13 cases of patients adopting the percutaneous balloon vertebroplasty method, which are called from 6 months in 2013 to 2 months in 2016 (one case of data is lost) by a retrospective analysis medical record system of fifth affiliated hospital of Xinjiang medical university, and have the fluoroscopy times of 9.33 +/-1.37 times and the operation time of 62.5 +/-13.57 min. The average of the two samples is compared by adopting t test, the value t of the number of the perspective times is calculated to be-5.899, and p is found to be less than 0.05. The value of the operation time t is calculated to be-3.091, and p is found to be less than 0.05, which shows that the guide plate group has reduced perspective times and time compared with the comparison group.
Compared with the prior art, the technical scheme provided by the invention has the advantages that the 3D printed spine guide plate is disclosed in the patent CN 204863422U, the position below the positioning sheet cannot be disinfected, the operation risk is increased, the use in the operation is limited, the error is increased by using a metal sleeve in the patent CN 104287815A, when finally determining which vertebral body is operated and the position of the guide plate is placed, the accurate placement of the guide plate can be realized by using the X-ray in the two previous patent methods, the guide plate in the prior art cannot avoid the dependence on the X-ray scanning in the operation when the pedicle of vertebral arch is operated, the design process of the 3D printed guide plate for the digital positioning spine minimally invasive surgery provided by the invention uses the 3D reconstruction technology of digital medicine, and the data completely comes from patients, an accurate three-dimensional individualized guide plate can be designed according to individual differences of patients; the design and the use of the guide plate consider the influence of the examined body position and the body position in the operation on the movement of soft tissues such as skin and the like on the positioning accuracy, the matching degree in the design and the application can be obviously improved, the influence of errors on the operation is reduced, and the medical safety is improved; the puncture point can be quickly and accurately determined in the operation of a doctor, the puncture direction can be ensured to be accurate in the coronal plane and the sagittal plane simultaneously, compared with the traditional operation mode, the operation time can be shortened, the radiation amount of the doctor and the patient in the operation can be reduced, the safety and the accuracy of the operation can be improved, and the remarkable technical effect can be obtained.
The above-mentioned embodiments are merely illustrative of the preferred embodiments of the present invention, and do not limit the scope of the present invention, and various modifications and improvements of the technical solutions of the present invention made by those skilled in the art without departing from the spirit of the present invention should fall within the protection scope defined by the present invention.

Claims (7)

1. A preparation method of a 3D printing guide plate for a digital positioning spine minimally invasive surgery is characterized by comprising the following steps:
(1) placing body positions: the tested object lies prostrate on the 3D printing spinal surgery prone position body position frame, the CT scanning body position is consistent with the body position during surgery, the positioning block is placed on the skin of the patient in the spinal central line near the surgery area and marked;
(2) CT scanning: scanning the trunk of the tested object by adopting a multi-row CT machine, and storing related data information of the tested object;
(3) data segmentation in medical imaging software: importing CT scanning data into medical image software for processing, utilizing a threshold segmentation method and Boolean operation summation to display a cone and skin on the same mask, wherein the skin is the outer layer, the relative position of the cone and the skin can be kept consistent with the actual position, and finally exporting a file;
(4) establishing the guide plate position using the positioning block: measuring the distance from the intersection point of any edge of the positioning block and the central axis of the spine to the central point of the surgical vertebral body by using a measuring tool in medical image software, and recording the distance as a value a; then measuring the vertical distance from the center point of the surgical vertebral body to the surface of the skin and recording the vertical distance as a b value; the accurate position of the guide plate in the operation can be calculated according to the value a and the value b, namely the distance needing to be translated and finely adjusted up and down on the central line of the spine is recorded as a value c, and the position of the guide plate in the operation is marked again in the spine skin area of the tested object by utilizing the positioning block;
(5) data encapsulation in reverse engineering software: through data processing, finally fitting a curved surface, importing the curved surface into a computer to obtain a qualified file and exporting the qualified file;
(6) computer aided design: importing the file in the step (4) into computer-aided software to design a spine guide plate model, completing the design of a main body part and the design of a guide hole part of a guide plate, reserving a hole for placing a positioning block in the design, chamfering the guide plate, and designing holes in the middle and two sides of the guide plate;
(7) 3D printing of a guide plate model: produce the deflector model through 3D printing technique, there are two pedicle of vertebral arch holes on the deflector surface, and deflector central authorities set up the location cavity, and 3D prints quick shaping and prints out the guider entity.
2. The method for preparing a 3D printing guide plate for minimally invasive surgery on digital positioning spine according to claim 1, wherein the body position of the tested subject CT in the step (1) is consistent with the body position of the guide plate finally used, the relative position of the tested subject is consistent with the height of the guide plate finally used, when the position of the tested subject is determined, the lower edges of ilium and rib are taken as body surface standard points, a positioning block is placed on the central line of the spine of the tested subject, and the skin at the contact edge of the positioning block and the skin is marked.
3. The method for preparing the 3D printing guide plate for the minimally invasive spine surgery based on the digital positioning as claimed in any one of claim 1 or claim 2, wherein the waterproof marker pen is used for marking in the step (1) and the step (4).
4. The method for preparing the digitally-positioned 3D printed guide plate for minimally invasive spine surgery according to claim 1, wherein the scanning conditions in the step (2) are a voltage of 120kV, a current of 166mAs, a layer thickness of 0.8mm, and a matrix of 512x 512.
5. The method for preparing the digitally-positioned spine minimally invasive surgery 3D-printed guide plate according to claim 1, wherein the step (5) is that the data of the skin adhesion surface of the main body part of the guide plate is obtained by a body position frame holding tester; the rest part of the guide plate is obtained by a skin peripheral line stretching command and a trimming command, and a cavity for placing a positioning block is reserved in the design; the guide hole is designed in such a way that two straight lines which are properly driven into the vertebral pedicle are designed on the section of the vertebral pedicle according to the section of the vertebral pedicle and the upper and lower edges of the vertebral pedicle, the position of the straight line is adjusted, and the straight line is taken as the center of a cylinder to design a pipeline driven into the vertebral pedicle; and summing the pipeline with the main structure of the guide plate and the guide hole to obtain the guide plate, chamfering the guide plate, and designing cavities in the middle and two sides of the guide plate.
6. The method for preparing the digitally-positioned 3D-printed guide plate for minimally invasive spine surgery according to claim 1, wherein a positioning block cavity is disposed in the middle of the guide plate, guide holes are disposed on two sides of the positioning block cavity, a spinous process positioning line is disposed in the middle of the guide plate, cavities are disposed on two sides of the guide plate, and a positioning block is disposed in the positioning block cavity.
7. The method for preparing a 3D printed guide plate for minimally invasive digital positioning spine surgery according to claim 6, wherein a T-shaped groove is formed in the bottom of one side of the central axis of the positioning block, the T-shaped groove penetrates through the bottom surface of the positioning block, a T-shaped fixing groove is formed in the bottom surface of the guide plate, a positioning scale is arranged in the T-shaped fixing groove, the positioning scale is T-shaped and is arranged to be matched with the T-shaped fixing groove of the guide plate and the T-shaped groove of the positioning block, scales are arranged on the surface of the positioning scale, and the length from zero scale to the end is consistent with the length of the T-shaped.
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