A method for manufacturing a 3D printed guide plate for spinal anesthesia puncture and a spinal anesthesia puncture guide plate assembly

Abstract

The present invention discloses a manufacturing method of a 3D printed guide plate for spinal anesthesia puncture. The method mainly uses a marker as the basis of a three-dimensional reference system in a fixed body position, and applies a model of a medical image to the three-dimensional reference system to establish and obtain a guide plate. Compared with the traditional method of setting positioning points or locators on the skin, the elasticity of the skin will not cause displacement of the positioning points during the force application process, thereby ensuring accurate positioning and effectively avoiding the risk area of ​​puncture, thereby making the positioning more accurate and effectively reducing the occurrence of spinal anesthesia risks. The method is particularly suitable for spinal anesthesia operations in patients with obesity, spinal deformity, etc.

Description

Technical Field

[0001] The present invention relates to the field of medical anesthesia, and in particular to a method for manufacturing a 3D printed guide plate for spinal anesthesia puncture and a spinal anesthesia puncture guide plate assembly. Background Art

[0002] Spinal anesthesia is a method of injecting local anesthetic into the subarachnoid space, which acts on the spinal nerve roots to produce anesthesia in the corresponding parts. It is called subarachnoid block. The low, middle and high positions of spinal anesthesia can be distinguished by the distance from the navel. That is, when choosing the location, the L3 / 4, L2 / 3 and L4 / 5 interspaces are generally selected as the spinal anesthesia puncture sites. This can avoid damaging the spinal nerves and spinal cord, while achieving anesthesia for lower abdomen, lower limbs and pelvic surgery.

[0003] During the spinal anesthesia puncture, spinal cord injury may cause paraplegia in severe cases, which is the most serious complication of spinal anesthesia. The manifestation of spinal cord injury is that when the spinal anesthesia puncture breaks through the dura mater, it touches the spinal cord, causing obvious pain or transient loss of consciousness. The subsequent clinical manifestations are mostly sensory / motor separation, unilateral sensory impairment, contralateral motor impairment, and sensory (superficial) / sensory (deep) separation. Or when the conus medullaris is injured, it may lead to single nerve dysfunction, with manifestations including biceps femoris paralysis, loss of sensation in the posterior thigh and saddle area, and impaired urination and defecation functions.

[0004] Although spinal cord injury after lumbar anesthesia is uncommon, the damage caused is difficult to recover. Therefore, lumbar positioning is of great clinical significance, especially in some special patient groups. Patients with difficult or incorrect lumbar positioning, severe spinal stenosis, spina bifida, bone metastasis of malignant tumors, tethered spinal cord and other problems may suffer spinal cord injury due to the combined operation of lumbar anesthesia.

[0005] At present, in general operations, the positioning of spinal anesthesia mainly relies on the experience of the anesthesiologist. Due to the differences in obesity, lumbar spine morphology and physiological structure among different patients, this rough positioning method based on experience also causes inaccurate positioning, and repeated positioning is needed, which has a certain impact on the operation time and surgical risk. In some cases, the anesthesiologist needs to perform puncture positioning based on the patient's lumbar spine and experience. Due to the differences in the patient's morphology between CT and surgery, the lumbar spine morphology during surgery is also different from that under CT, which also increases the uncertainty in actual positioning.

[0006] At the same time, during the current positioning puncture process, the puncture positioning point is determined using CT and combined with experience. However, due to physiological characteristics such as the elasticity of the skin and fat layer, displacement is easily caused during the puncture process, and the determined puncture point, puncture path and angle cannot be guaranteed, which also increases the risk and difficulty of puncture. Summary of the Invention

[0007] The purpose of the present invention is to overcome the above-mentioned shortcomings in the prior art and provide a method for manufacturing a 3D printed guide plate for spinal anesthesia puncture and a spinal anesthesia puncture guide plate component that can accurately position and reduce the hidden dangers of spinal anesthesia.

[0008] A method for manufacturing a 3D printed guide plate for spinal anesthesia puncture, comprising the following steps:

[0009] 1.1 Place X-ray imaging markers at the patient's lumbar spine to obtain medical digital imaging data from CT or MRI with the patient in a fixed position.

[0010] 1.2 Use engineering reconstruction software to import DICOM files of medical digital imaging data and obtain a data model with three-dimensional spatial parameters of the vertebral skeleton, skin, blood vessels, and annotations. Then, simulate the puncture channel within the data model based on the distribution characteristics of the vertebral skeleton, skin, and blood vessels to obtain a three-dimensional data model with design parameters. Import the three-dimensional data model into the reverse engineering software in STI format.

[0011] 1.3 In the reverse engineering software, establish a 3D reference system for the guide plate design using the marker's location as the origin. Build the guide plate based on the 3D data model based on the established 3D reference system. Use the horizontal plane at the highest point of contact between the guide plate and the skin as the reference plane for the guide plate's bottom end face design. Create the guide plate's puncture channel hole on the extension line of the simulated puncture channel and generate the guide plate model.

[0012] 1.4 Import the three-dimensional data of the guide plate model from the reverse engineering software into the 3D printer to produce the guide plate.

[0013] Preferably, the engineering reconstruction software is any one of MIMICS, E3D, 3Dslicer, and 3Ddoctor, and the reverse engineering software is any one of 3MATIC, designX, and E3D.

[0014] Preferably, the patient is adapted to maintain a fixed position by an arm fixator, a head fixator, a torso positioner, a knee positioner and a foot positioner; the arm fixator, the head fixator, the torso positioner, the knee positioner and the foot positioner are adapted and fixed on a base plate by a Velcro structure; and a calibration grid and scale for calibrating positions are provided on the base plate.

[0015] Preferably, at least two groups of markers for the lumbar vertebrae are provided, and in establishing a three-dimensional reference system, the markers on the front side of the torso are used as the origin.

[0016] As a preferred embodiment: the body positioner is divided into a front positioning part and a rear positioning part, the end face of the body positioner is provided with a concave arc surface, the cross section of the concave arc surface presents a V-shaped inclined surface transition, the front positioning part adopts a hard soft bag material, and the rear positioning part adopts an airbag of an adaptive shape.

[0017] As a preferred embodiment, the marker is a ring-shaped hollow metal sheet attached to the corresponding position of the patient's waist.

[0018] A lumbar anesthesia puncture guide assembly includes a surgical guide prepared by the above method and a mounting piece, the mounting piece is L-shaped and consists of a horizontal plate and a vertical plate, the horizontal plate is horizontally arranged and provided with a main calibration hole adapted to the distance position of the marker, the horizontal plate is provided with a mounting slot for the guide plate, the bottom end face of the guide plate is flush with the bottom end face of the horizontal plate, the central axis of the mounting slot coincides with the central axis of the calibration hole, the mounting piece is adapted to be arranged on an adjustment bracket, the adjustment bracket includes a fixed base for fixing on both sides of a bed, a Z-axis adjustment bracket, and a Y-axis fixing bracket, two groups of adjustment brackets are respectively arranged on both sides of the bed, the Z-axis adjustment bracket is slidably arranged on the fixed base in an X-axial direction and is fixed by a bolt, the Y-axis fixing bracket adopts a telescopic rod and is fixed by a bolt The Y-axis fixing frame is fixed with the parts, one end of the Y-axis fixing frame is rotatably connected to the top of the Z-axis adjusting frame and is fastened in position by bolt fasteners, the other end of the Y-axis fixing frame is provided with a strip trough body, the strip trough body is provided with an adjusting block, the adjusting block is arranged on the auxiliary slide groove at the bottom of the strip trough body for transverse sliding, and is fastened in position by bolt parts, sliding blocks are provided on both sides of the mounting member to adapt to the strip trough body and are fixed by the L-shaped limit head at the front end of the adjusting block, the Y-axis fixing frame is provided with a secondary support member, and the secondary support member includes a connecting rod, a sliding sleeve and a support rod, the sliding sleeve is provided on the connecting rod and is fastened in position by bolt fasteners, the support rod is fixed to the sliding sleeve, and the other end of the support rod is provided with a plug-in sleeve on the side of the locator for adaptive connection.

[0019] As a preference, auxiliary calibration holes are provided on the front side of the longitudinal plate and the end of the connecting rod.

[0020] As a preferred embodiment, the main calibration hole and the auxiliary calibration hole are provided with laser pens, and the laser pens are arranged perpendicular to the horizontal plate.

[0021] Compared with the prior art, the present invention has the following advantages and effects: the present method is to first fix the body position, and then obtain a guide plate through reverse engineering in a reference system established with markers as marking points. Therefore, when the guide plate restores the setting scene under the reference system, it can obtain accurate positioning, effectively avoiding the risk areas of puncture (such as venous blood vessel areas). The reference system of the guide plate generated in the present method is non-contact with the patient's body, so during the positioning process, there is no need to fit the patient's skin. Compared with the traditional method of setting positioning points or locators on the skin, the positioning points will not be displaced due to the elasticity of the skin during the force application process. Therefore, even if the positioning is accurate in traditional operations, in actual operations, puncture failure or puncture injury may be caused due to the influence of the operation. Therefore, the guide plate of this method is particularly suitable for use in spinal anesthesia operations on some patients with obesity, spinal deformity, etc. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 4 is a flow chart of a manufacturing method according to an embodiment of the present invention.

[0023] Figure 2 It is a schematic diagram of positioning operation in a fixed position according to an embodiment of the present invention.

[0024] Figure 3 Schematic diagram of a puncture operation using a guide plate according to an embodiment of the present invention.

[0025] Figure 4 It is a schematic diagram of the arrangement of the body position fixing component and the base plate according to an embodiment of the present invention.

[0026] Figure 5 It is a structural schematic diagram of a spinal anesthesia puncture guide assembly according to an embodiment of the present invention.

[0027] Figure 6 It is a structural schematic diagram of a spinal anesthesia puncture guide assembly according to an embodiment of the present invention.

[0028] Figure 7 It is a structural schematic diagram of the needle insertion liner according to an embodiment of the present invention.

[0029] Figure numbers: arm fixer 101, head fixer 102, torso positioner 103, knee positioner 104, foot positioner 105, base plate 106, guide plate 107, puncture channel hole 108, mounting part 109, main calibration hole 110, fixed base 111, Z-axis adjustment frame 112, Y-axis fixing frame 113, strip trough body 114, adjustment block 115, limit head 116, sliding block 117, connecting rod 118, sliding sleeve 119, support rod 120, secondary calibration hole 121, plug-in sleeve 122, front positioning part 123, rear positioning part 124, needle lining 125, threaded connection part 126, puncture channel part 127, groove 128. DETAILED DESCRIPTION

[0030] The present invention will be further described in detail below with reference to the accompanying drawings and through examples. The following examples are intended to explain the present invention but the present invention is not limited to the following examples.

[0031] See also Figure 1-Figure 7 The technical solution adopted by the present invention to solve the above-mentioned problem is: a method for manufacturing a 3D printed guide plate 107 for spinal anesthesia puncture, characterized by comprising the following steps:

[0032] 1.1 Place X-ray imaging markers at the patient's lumbar spine to obtain medical digital imaging data from CT or MRI with the patient in a fixed position.

[0033] 1.2 Use engineering reconstruction software to import DICOM files of medical digital imaging data and obtain a data model with three-dimensional spatial parameters of the vertebral skeleton, skin, blood vessels, and annotations. Then, simulate the puncture channel within the data model based on the distribution characteristics of the vertebral skeleton, skin, and blood vessels to obtain a three-dimensional data model with design parameters. Import the three-dimensional data model into the reverse engineering software in STI format.

[0034] 1.3 In the reverse engineering software, a three-dimensional reference system for the guide plate 107 design is established with the location of the marker as the origin. The guide plate 107 is then constructed based on the three-dimensional data model based on the established three-dimensional reference system. The horizontal plane at the highest point of contact between the guide plate 107 and the skin is used as the reference plane for the design of the bottom end face of the guide plate 107. The puncture channel hole 108 of the guide plate 107 is established on the extension line of the simulated puncture channel, and a model of the guide plate 107 is generated.

[0035] 1.4 Import the three-dimensional data of the guide plate 107 model in the Mimics software into a 3D printer (such as an FDM extrusion fusion printer) to produce the guide plate 107.

[0036] The engineering reconstruction software is any one of MIMICS, E3D, 3Dslicer, and 3Ddoctor, and the reverse engineering software is any one of 3MATIC, designX, and E3D.

[0037] In this method, the patient needs to be kept in a fixed position, and this position needs to be basically maintained during the operation. Therefore, it is necessary to define the position of each part of the body in the position, so as to keep the CT and the position during the operation basically consistent, so as to avoid the morphological position relationship of the lumbar spine in CT being too different from the morphological position relationship during the puncture operation. Therefore, the patient is adapted to maintain a fixed position through the arm fixator 101, the head fixator 102, the body positioner 103, the knee positioner 104 and the foot positioner 105. The arm fixator 101, the head fixator 102, the body positioner 103, the knee positioner 104 and the foot positioner 105 are provided. The torso locator 103, knee locator 104 and foot locator 105 are fixed on the base plate 106 by a Velcro structure (the detachable Velcro structure facilitates the removal of the above-mentioned locators from the operating table after the spinal anesthesia is completed, so that the corresponding surgical operation can be continued without transfer). The base plate 106 is provided with a calibration grid and scale for calibrating the position. In this method of fixing the body position, the main purpose is to keep the body position basically consistent during the CT process and the puncture process, so that the obtained guide plate 107 adapts to the body position requirements during the puncture process, thereby achieving the purpose of precise positioning.

[0038] During the process of acquiring medical digital imaging data by CT, the patient is in a prone position according to the distribution of his limbs. The position fixing components including the arm fixer 101 (with straps), the head fixer 102, the torso positioner 103, the knee positioner 104 (with straps) and the foot positioner 105 are adapted and arranged on the base plate 106. Figure 2 As shown, the prone position is more convenient for controlling the spinal morphology and facilitating clinical operation than the traditional sitting position and lateral position. During the lumbar anesthesia process, a base plate 106 is arranged on the operation window, and the arm fixator 101, the head fixator 102, the torso positioner 103, the knee positioner 104 and the foot positioner 105 are placed according to the arrangement position of the CT process. The patient lies in the prone position according to the arrangement position, thereby ensuring that the body position is basically consistent during the CT process and the puncture process. In this method, the patient's lumbar spine position needs to be positioned before CT, and X-ray imaging is used on the front side of the spine at the approximate position of the lumbar anesthesia puncture. The marker of the image is used as a reference (retained until the operation for the positioning reference of the guide plate 107), wherein the marker points can be set to at least two groups, and the marker is a ring-shaped hollow metal sheet attached to the corresponding position of the patient's waist. During the CT scan, the metal gasket will cause artifacts of the marked part, and the marked point will be reflected in the image. After the CT scan is completed, in order to prevent the metal gasket from shifting and causing a difference from the initial marked position, a marker pen or other non-erasable marker pen is used to fill the mark in the center hole of the metal gasket, so that the initial marked position can be found during the subsequent operation, which is convenient for the implementation of the guide plate positioning during the operation. Figure 2-3The guide plate 107 can be set at the front and rear positions of the mounting member 109, and the mounting member 109 is positioned and matched with the marker point in the vertical direction. On the one hand, it ensures that the posture during CT and puncture is consistent. On the other hand, it is used as a reference point to facilitate positioning of the placement of the guide plate 107 during spinal anesthesia puncture. The guide plate 107 is fixed on the mounting member 109. The mounting member 109 is L-shaped and consists of a horizontal plate and a vertical plate. The horizontal plate is horizontally arranged and provided with a calibration hole for vertical axial adaptation to the origin. The horizontal plate is provided with a mounting slot for the guide plate 107. The bottom end face of the guide plate 107 is flush with the bottom end face of the horizontal plate on the mounting slot, and the central axis of the mounting slot coincides with the central axis of the calibration hole. When the vertical projection of the calibration hole coincides with the positioning point of the marker, it ensures that the body posture is basically the same during the CT process and the puncture process. Consequently, the present method obtains the guide plate 107 by adopting non-direct contact guided puncture. After the subcutaneous anesthesia injection is performed, the cross plate is brought into contact with the highest point of the skin, and then the epidural puncture needle enters the guide along the cylindrical puncture channel hole 108 with a certain length, passes through the skin, subcutaneous fat, supraspinous ligament, interspinous ligament, and yellow ligament, and finally enters the epidural space. Since the puncture channel hole 108 adopts the actual physiological morphology of the patient's spine for puncture, it is not affected by the thickness of the skin. Compared with the traditional method of setting a positioning point or locator on the skin, the elasticity of the skin will not cause the displacement of the positioning point during the force application process, so that the positioning is accurate, and the risk areas of puncture (such as the venous blood vessel area) are effectively avoided, so that the positioning will be more accurate, and the occurrence of spinal anesthesia risks is effectively reduced. It is particularly suitable for spinal anesthesia operations in patients with obesity, spinal deformity, etc.

[0039] Due to the different morphologies, the morphologies of the lumbar spine are all different. In order to facilitate the acquisition of the patient's relatively better spinal morphology suitable for puncture, in this method, the body positioner 103 is divided into a front positioning part 123 and a rear positioning part 124. The end face of the body positioner 103 is provided with an inward concave arc surface, and the cross section of the inward concave arc surface is a V-shaped inclined surface transition. The front positioning part 123 adopts a hard soft bag material, and the rear positioning part 124 adopts an airbag of an adaptive shape. The lower part of the body (waist and hip) is supported by the inflation volume of the airbag. Figure 2As shown, by adjusting the filling amount of the airbag, the height of the lower part of the body can be adjusted, thereby adapting the extension shape of the lumbar spine, so that the doctor can find a relatively suitable extension position based on experience to facilitate the subsequent puncture operation. In the initial operation of this operation, the adjustment airbag should be evacuated to a vacuum state, and then the gas should be injected, and the operation should be stopped after the body is in a suitable position. During the spinal anesthesia operation, various parts of the body should be in the same position ratio of the arm fixator 101, the head fixator 102, the body positioner 103, the knee positioner 104 and the foot positioner 105. During the CT process, the inflation amount of the adjustment airbag is filled in it, so that the front and back positions are kept relatively straight.

[0040] Example 2:

[0041] See also Figure 1-Figure 7 , this embodiment provides a lumbar anesthesia puncture guide plate 107 assembly adapted to the method of the present invention for obtaining a surgical guide plate 107 for precise positioning, including a surgical guide plate 107 and a mounting member 109, the mounting member 109 is L-shaped and consists of a horizontal plate and a vertical plate, the horizontal plate is horizontally arranged and provided with a main calibration hole 110 adapted to the distance position of the marker, the horizontal plate is provided with a mounting slot for the guide plate 107, the bottom end surface of the guide plate 107 is flush with the bottom end surface of the horizontal plate, the central axis of the mounting slot coincides with the central axis of the calibration hole, the mounting member 109 is adapted to be arranged on the adjustment bracket, the adjustment bracket includes a fixed base 111 for fixing on both sides of the bed, a Z-axis adjustment bracket 112, and a Y-axis fixing bracket 113, two groups of adjustment brackets are respectively arranged on both sides of the bed, the Z-axis adjustment bracket 112 is slidably arranged on the fixed base 111 in the X-axis direction and is fixed by bolts, and the Y-axis fixing bracket 113 adopts a telescopic rod and is fixed by bolts The Y-axis fixing frame 113 is rotatably connected to the top of the Z-axis adjusting frame 112 at one end and is fastened in position by bolt fasteners. The other end of the Y-axis fixing frame 113 is provided with a strip groove 114. The strip groove 114 is provided with an adjustment block 115. The adjustment block 115 is arranged on the auxiliary slide groove at the bottom of the strip groove 114 in a horizontal sliding manner and is fastened in position by bolts. Sliding blocks 117 are provided on both sides of the mounting member 109 to adapt to and The Y-axis fixing frame 113 is limited and fixed by the L-shaped limit head 116 at the front end of the adjustment block 115. The secondary support member includes a connecting rod 118, a sliding sleeve 119 and a support rod 120. The sliding sleeve 119 is arranged on the connecting rod 118 and is fastened in position by bolt fasteners. The support rod 120 is fixed to the sliding sleeve 119. The other end of the support rod 120 is provided with a plug-in sleeve 122 on the side of the locator for adaptive connection.

[0042] A secondary calibration hole 121 is provided on the front side of the longitudinal plate and the end of the connecting rod 118 . A laser pen is installed in the main calibration hole 110 and the secondary calibration hole 121 . The laser pen is perpendicular to the transverse plate.

[0043] According to Example 1, the guide plate 107 is obtained by the above method. The main effect is that in a fixed position, the model of the medical image is applied to the three-dimensional reference system to establish the guide plate 107 with the marker as the basis of the three-dimensional reference system. Therefore, when using it, it is necessary to ensure that the three-dimensional reference system that needs to be restored during use is restored. Therefore, the guide plate 107 obtained needs to be used in conjunction with the mounting member 109. The mounting member 109 is fixedly set on the adjustment bracket. The adjustment bracket enables the guide plate 107 mounted on the mounting member 109 to have the adjustment function of the X, Y and Z axes. During the CT image acquisition stage, it is necessary to set markers at appropriate positions of the spine (the front and back sides of the estimated spinal anesthesia site), at least two sets of markers, and the setting distance of the markers should be adapted to the position of the main calibration hole 110 set by the mounting member 109. After obtaining the guide plate 107, the guide plate 107 is mounted on the mounting member 109. The mounting member 109 is adapted to the adjustment structure. After adjusting to the appropriate height, the guide plate 107 is positioned in the main calibration hole 110. A laser pointer is placed on the mounting bracket 10, and the vertical point of the laser pointer's light source coincides with the position of the marker (by adjusting the front-to-back distance between the Z-axis adjustment bracket 112 and the fixed base 111 and the relative rotation angle between the Y-axis adjustment bracket and the Z-axis adjustment bracket 112). The patient maintains their position, and the Z-axis adjustment bracket 112 is lowered so that the bottom surface of the guide plate 107 contacts the highest point of the skin around the puncture site. The height of the Z-axis adjustment bracket 112 is then fixed, thereby restoring the position of the guide plate 107 in the three-dimensional reference system during the modeling process. As a result, the path through the puncture channel hole 108 of the guide plate 107 is aligned with the simulated path. In this process, to facilitate medical personnel in visually detecting whether the patient has actively moved their position away from the reference system, auxiliary calibration holes 121 are provided on the rear side of the mounting bracket and at the end of the connecting rod 118. The laser pointer is placed in the auxiliary calibration hole 121, and a marker is used to mark the point of light source where the laser pointer lands on the skin. If any point of light source deviates from the landing point, the operation is stopped and reset according to the marked point.

[0044] In this embodiment, the puncture channel hole 108 is adapted to be equipped with a needle lining 125, and the needle lining 125 is provided with a variety of models, so that the needle lining 125 is adapted to the needle diameters of various models of epidural puncture needles. The needle lining 125 includes a threaded connection portion 126 and a puncture channel portion 127. The threaded connection portion 126 is threadedly connected to the outer wall surface of the puncture channel hole 108, and the puncture channel portion 127 is slidably arranged in the puncture channel portion 127. The head end of the needle lining 125 is provided with a groove 128 adapted to the needle limit portion. This structure is mainly because in the established reference system, the puncture distance in the puncture path is basically determined. Therefore, in order to adapt the puncture distance and prevent the puncture distance from being insufficient (not reaching the epidural space) or too deep (puncturing too deep will pierce the dura mater and cause cerebrospinal fluid leakage), the height of the puncture channel hole 108 is limited according to the puncture distance during the 3D printing design. The depth of the puncture needle is limited, so the puncture channel hole 108 is provided with a liner. On the one hand, the liner is replaceable to adapt to different types of puncture needles. On the other hand, since there may be differences between actual operations and theory, in its structure, the threaded connection part 126 is threadedly adapted to the outer wall of the puncture channel hole 108. It rotates upward at the beginning of puncture to increase the safe puncture margin and avoid excessive puncture force, which causes the puncture to be too deep. After the puncture needle tube limiter contacts the end of the liner and adapts to the groove 128, the needle is rotated to gradually rotate the liner to lower its height, and the puncture needle gradually goes deeper. Therefore, when the needle tail is connected to the glass tube syringe and the pushing resistance disappears, a mark is provided on the puncture channel hole 108. The height of the liner is certain, and the actual needle insertion depth is known. Therefore, when inserting the epidural tube, based on its depth, the insertion operation is completed when it enters 3-5 cm. The insertion is accurate and effectively prevents puncture complications caused by the puncture process.

[0045] The above contents described in this specification are merely examples of the present invention. Those skilled in the art may make various modifications, additions, or substitutions to the described embodiments, without departing from the contents of this specification or exceeding the scope defined by the claims, and such modifications, additions, or substitutions may be made to the described embodiments. Such modifications, additions, or substitutions may be made by persons skilled in the art. Such modifications, additions, or substitutions may be made to the described embodiments without departing from the contents of this specification or exceeding the scope defined by the claims, and such modifications shall fall within the scope of protection of the present invention.

Claims

1. A method for manufacturing a 3D printed guide plate for spinal anesthesia puncture, comprising the following steps: 1.1 Place X-ray imaging markers at the patient's lumbar spine to obtain medical digital imaging data from CT or MRI with the patient in a fixed position; 1.2 Use engineering reconstruction software to import DICOM files of medical digital imaging data and obtain a data model with three-dimensional spatial parameters of the vertebral skeleton, skin, blood vessels, and annotations. Then, simulate the puncture channel within the data model based on the distribution characteristics of the vertebral skeleton, skin, and blood vessels to obtain a three-dimensional data model with design parameters. Import the three-dimensional data model into the reverse engineering software in STI format. 1.3 In the reverse engineering software, establish a 3D reference system for the guide plate design using the marker's location as the origin. Build the guide plate based on the 3D data model based on the established 3D reference system. Use the horizontal plane at the highest point of contact between the guide plate and the skin as the reference plane for the guide plate's bottom end face design. Create the guide plate's puncture channel hole on the extension line of the simulated puncture channel and generate the guide plate model. 1.4 Import the three-dimensional data of the guide plate model from the reverse engineering software into the 3D printer to produce the guide plate.

2. The method for manufacturing a 3D printed guide plate for spinal anesthesia puncture according to claim 1, characterized in that: The engineering reconstruction software adopts any one of MIMICS, E3D, 3Dslicer and 3Ddoctor, and the reverse engineering software adopts any one of 3MATIC, designX and E3D.

3. The method for manufacturing a 3D printed guide plate for spinal anesthesia puncture according to claim 1, characterized in that: The patient is adapted to maintain a fixed position through an arm fixator, a head fixator, a torso positioner, a knee positioner and a foot positioner. The arm fixator, the head fixator, the torso positioner, the knee positioner and the foot positioner are adapted and fixed on a base plate through a Velcro structure. The base plate is provided with a calibration grid and scale for calibrating the position.

4. The method for manufacturing a 3D printed guide plate for spinal anesthesia puncture according to claim 3, characterized in that: At least two groups of markers are provided for the lumbar vertebrae. In establishing a three-dimensional reference system, the markers on the front side of the body are used as the origin.

5. The method for manufacturing a 3D printed guide plate for spinal anesthesia puncture according to claim 3, characterized in that: The body positioner is divided into a front positioning part and a rear positioning part. The end face of the body positioner is provided with a concave arc surface, and the cross section of the concave arc surface presents a V-shaped inclined surface transition. The front positioning part adopts a hard soft bag material, and the rear positioning part adopts an airbag of an adaptive shape.

6. The method for manufacturing a 3D printed guide plate for spinal anesthesia puncture according to claim 1, characterized in that: The marker is a ring-shaped hollow metal sheet attached to the corresponding position of the patient's waist.

7. A spinal anesthesia puncture guide assembly, characterized by: It includes a surgical guide and a mounting piece prepared by the method described in any one of claims 1 to 6, wherein the mounting piece is L-shaped and consists of a horizontal plate and a vertical plate, the horizontal plate is horizontally arranged and provided with a main calibration hole adapted to the distance position of the marker, the horizontal plate is provided with a mounting slot for the guide plate, the bottom end face of the guide plate is flush with the bottom end face of the horizontal plate, the central axis of the mounting slot coincides with the central axis of the calibration hole, the mounting piece is adapted to be arranged on an adjustment bracket, the adjustment bracket includes a fixed base for fixing on both sides of the bed, a Z-axis adjustment bracket, and a Y-axis fixing bracket, two groups of adjustment brackets are respectively arranged on both sides of the bed, the Z-axis adjustment bracket is arranged on the fixed base in an X-axial sliding manner and is fixed by bolts, the Y-axis fixing bracket adopts a telescopic rod and is fixed by bolts The Y-axis fixing frame is fixed with the parts, one end of the Y-axis fixing frame is rotatably connected to the top of the Z-axis adjusting frame and is fastened in position by bolt fasteners, the other end of the Y-axis fixing frame is provided with a strip trough body, the strip trough body is provided with an adjusting block, the adjusting block is arranged on the auxiliary slide groove at the bottom of the strip trough body for transverse sliding, and is fastened in position by bolt parts, sliding blocks are provided on both sides of the mounting member to adapt to the strip trough body and are fixed by the L-shaped limit head at the front end of the adjusting block, the Y-axis fixing frame is provided with a secondary support member, and the secondary support member includes a connecting rod, a sliding sleeve and a support rod, the sliding sleeve is provided on the connecting rod and is fastened in position by bolt fasteners, the support rod is fixed to the sliding sleeve, and the other end of the support rod is provided with a plug-in sleeve on the side of the locator for adaptive connection.

8. The spinal anesthesia puncture guide plate assembly according to claim 7, characterized in that: Auxiliary calibration holes are provided on the front side of the longitudinal plate and the end of the connecting rod.

9. The spinal anesthesia puncture guide plate assembly according to claim 7, characterized in that: The main calibration hole and the auxiliary calibration hole are provided with laser pens, and the laser pens are arranged perpendicular to the horizontal plate.

10. The spinal anesthesia puncture guide plate assembly according to claim 7, characterized in that: The puncture channel hole is adapted to be equipped with a needle insertion lining, and the needle insertion lining is provided with a variety of models, so that the needle insertion lining is adapted to the needle diameters of various models of epidural puncture needles. The needle insertion lining includes a threaded connection portion and a puncture channel portion. The threaded connection portion is threadedly connected to the outer wall surface of the puncture channel hole. The puncture channel portion is slidably arranged in the puncture channel portion, and the head end of the needle insertion lining is provided with a groove adapted to the needle limit portion.

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