A spinal anesthesia puncture auxiliary positioning device

Abstract

This invention discloses an auxiliary positioning device for lumbar puncture, including a puncture positioning device comprising a positioning module and an adjustable positioning bracket. The positioning module is mounted on a fixing part of the adjustable positioning bracket, which is fixed on the operating table and allows for adjustment and positional tightening of the positioning module in the X / Y / Z axes. The positioning module is provided with a main calibration hole adapted to the patient's lumbar spine marker points, and at least two sets of the main calibration holes are provided along the lumbar spine axis. The positioning module is also provided with a puncture channel slot adapted to the puncture trajectory. This invention uses an auxiliary device to allow the guide plate to be set in a non-direct contact manner with the patient. Therefore, by resetting the guide plate setting during the modeling process using this auxiliary device, a puncture path adapted to the patient's actual lumbar spine physiological characteristics is formed, improving the puncture success rate and reducing puncture risks.

Description

Technical Field

[0001] This invention relates to the field of medical anesthesia, specifically to a spinal puncture auxiliary positioning device. Background Technology

[0002] Spinal anesthesia, also known as spinal anesthesia, involves injecting local anesthetic into the subarachnoid space to act on the spinal nerve roots and produce anesthesia in the corresponding area. This is called subarachnoid block. The low, middle, and high positions of spinal anesthesia can be distinguished according to their distance from the navel. Generally, the L3 / 4, L2 / 3, and L4 / 5 intervertebral spaces are selected as puncture sites for spinal anesthesia. This can avoid damage to the spinal nerves and spinal cord, while achieving anesthesia for surgeries in the lower abdomen, lower limbs, and pelvis.

[0003] Spinal cord injury caused during lumbar puncture can lead to paraplegia in severe cases, and is the most serious complication of lumbar anesthesia. Symptoms of spinal cord injury include significant pain or transient loss of consciousness when the lumbar puncture breaks through the dura mater and touches the spinal cord. Subsequent clinical manifestations often include sensory / motor dissociation, unilateral sensory impairment, contralateral motor impairment, and sensory (superficial) / sensory (deep) dissociation. Alternatively, injury to the conus medullaris can lead to single neurological dysfunction, including biceps femoris paralysis, sensory loss in the posterior thigh and saddle area, and impaired urination and defecation.

[0004] Currently, in general practice, the localization of spinal anesthesia mainly relies on the anesthesiologist's experience. However, due to differences in obesity, lumbar spine morphology, and physiological structure among different patients, this rough localization based on experience can lead to inaccurate localization, requiring repeated localization attempts. This can affect the operation time and surgical risks. In some cases, the anesthesiologist needs to perform puncture localization based on the patient's lumbar spine and experience. Since there are differences in the patient's morphology on CT scans and during surgery, the lumbar spine morphology during surgery also differs from that on CT scans, which further increases the uncertainty in actual localization.

[0005] Meanwhile, in the current localization puncture process, the puncture location point is determined by CT and experience. However, due to the physiological characteristics such as the elasticity of the skin and fat layer, displacement is easily caused during the puncture process, making it impossible to guarantee the determined puncture point, puncture path and angle. This also increases the difficulty and risk of puncture. Summary of the Invention

[0006] The purpose of this invention is to overcome the above-mentioned shortcomings in the prior art and to provide a spinal anesthesia puncture auxiliary positioning device with a reasonable structural design that can provide precise positioning of guide plates obtained by reverse engineering 3D printing, thereby reducing the risk of spinal anesthesia.

[0007] The technical solution adopted by the present invention to solve the above problems is: a lumbar anesthesia puncture auxiliary positioning device, including a puncture positioning device, wherein the puncture positioning device includes a positioning module and an adjustable positioning bracket, the positioning module is set on a fixing part on the adjustable positioning bracket, the adjustable positioning bracket is fixed on the operating table and realizes the adjustment and position fastening of the positioning module in the X / Y / Z axes, the positioning module is provided with a main calibration hole adapted to the patient's lumbar spine marking point, and at least two sets of the main calibration holes are provided front and back along the lumbar spine axis, and the positioning module is provided with a puncture channel slot adapted to the puncture trajectory.

[0008] A further preferred embodiment: the spinal anesthesia puncture auxiliary device also includes a body positioning device, which uses positioning components of adapted shape to define the position of the patient's head, arms, torso, knee joint and feet respectively. The body positioning device includes a head locator, a torso locator, a double arm locator, a knee locator and a foot positioning device. The head locator, torso locator, double arm locator, knee locator and foot positioning device are adapted and fixed on the support base plate by a detachable structure.

[0009] In a further preferred embodiment, the head locator, torso locator, arm locator, knee locator, and foot locator are mounted on the support base plate via a Velcro structure.

[0010] A further preferred embodiment: the body locator is provided with an arc-shaped concave surface and the upper end face is provided with an inverted V-shaped bevel. The body locator consists of a first positioning part and a second positioning part. The first positioning part is constructed with a rigid support and a soft structure, and the second positioning part is constructed with an airbag of an adapted shape.

[0011] A further preferred embodiment: The adjustable positioning bracket includes a fixed base for fixing to both sides of the bed, a Z-axis adjustment bracket, and a Y-axis fixing bracket. The two sets of adjustment brackets are respectively used to fix to both sides of the bed. The Z-axis adjustment bracket is slidably mounted on the fixed base along the X-axis and fixed with bolts. The Y-axis fixing bracket uses a telescopic rod and is fixed with bolts. One end of the Y-axis fixing bracket is rotatably connected to the top of the Z-axis adjustment bracket and is positioned and fastened with bolts. The other end of the Y-axis fixing bracket is provided with a strip-shaped groove. An adjustment block is provided on the strip-shaped groove. The adjustment block is slidably mounted on the secondary sliding groove at the bottom of the strip-shaped groove and is positioned and fastened with bolts. Sliding blocks are provided on both sides of the positioning bracket to fit the strip-shaped groove and are fixed by L-shaped limiting heads at the front end of the adjustment blocks.

[0012] A further preferred embodiment: the Y-axis fixing frame is provided with a secondary support component, which includes a secondary support rod, a sliding sleeve, and a support rod. The sliding sleeve is slidably fitted onto the secondary support rod and is secured in position by bolts. The support rod is fixed to the sliding sleeve. The other end of the secondary support rod is provided with a plug-in sleeve adapter connection on the side of the positioning module.

[0013] Further preferred embodiment: The positioning module includes a mounting plate and a guide plate. The mounting plate is composed of a horizontal plate and a vertical plate connected in an L-shape. The mounting plate is provided with a groove for mounting the guide plate. The guide plate is fitted into the groove, and the lower end face of the guide plate is flush with the lower end face of the horizontal plate. The center symmetry line of the main calibration hole coincides with the center symmetry of the guide plate.

[0014] Further preferred embodiment: the main calibration holes on the mounting guide plate are arranged in two sets, one in front of the other, and auxiliary calibration holes are respectively provided on the front side of the mounting guide plate and the end of the secondary support rod. Both the main calibration holes and the auxiliary calibration holes are adapted to be equipped with laser pens that provide point light source markings.

[0015] A further preferred embodiment is that the puncture channel slot is equipped with a needle insert liner, and the needle insert liner is available in various models, so that the needle insert liner is compatible with the needle diameter of various models of epidural puncture needles.

[0016] A further preferred embodiment: the needle insert includes a connecting part and a buffer part. The connecting part is connected to the channel slot through a threaded fit. The buffer part is provided with a sliding cavity and is slidably disposed at the other end of the connecting part. A buffer spring is provided in the sliding cavity. The buffer spring is connected to the connecting part and the buffer part respectively. The buffer part is provided with a needle insertion channel adapted to the epidural puncture needle.

[0017] A further preferred embodiment is that the puncture channel slot is equipped with a needle insert liner, and the needle insert liner is available in various models, so that the needle insert liner is compatible with the needle diameter of various models of epidural puncture needles.

[0018] A further preferred embodiment: the needle insert liner includes a threaded connection portion and a puncture channel portion, the threaded connection portion is threadedly connected to the outer wall of the puncture channel slot, the puncture channel portion is slidably disposed within the puncture channel portion, and the head end of the needle insert liner is provided with a groove adapted to the needle tip limiting portion.

[0019] Compared with the prior art, the present invention has the following advantages and effects: The present invention, through its auxiliary device and compatible guide plate, uses a non-contact setting method with the patient. Therefore, by resetting the guide plate setting during the modeling process using this auxiliary device, a puncture path adapted to the patient's actual lumbar spine physiological characteristics is formed, improving the puncture success rate and reducing puncture risks. Because this auxiliary method uses non-contact positioning and resetting, and is not directly fixed to the patient's skin, the marking point will not shift due to applied force after positioning puncture, nor will the puncture needle shift due to unstable operation during the operation, greatly improving the puncture success rate. Furthermore, to adapt to the restoration of the coordinate system formed by the guide plate, the auxiliary device provides a static positioning device, ensuring that the patient's position during the establishment of the guide plate remains basically consistent with the patient's position during the spinal anesthesia procedure, further improving the accuracy of the puncture. Attached Figure Description

[0020] Figure 1 This is a schematic diagram of the structure of the spinal anesthesia puncture auxiliary device according to an embodiment of the present invention.

[0021] Figure 2 This is a schematic diagram of the adjustable positioning bracket according to an embodiment of the present invention.

[0022] Figure 3 This is a schematic diagram of the adjustable positioning bracket according to an embodiment of the present invention.

[0023] Figure 4 This is a schematic diagram of the needle insert liner in an embodiment of the present invention.

[0024] Figure 5 This is a schematic diagram illustrating the use of the positioning module in an embodiment of the present invention.

[0025] Figure 6 This is a schematic diagram illustrating the use of the positioning module in an embodiment of the present invention.

[0026] Figure Numbers: Positioning Module 101, Adjustable Positioning Bracket 102, Main Calibration Hole 103, Puncture Channel Slot 104, Head Positioner 105, Torso Positioner 106, Double Arm Positioner 107, Knee Positioner 108, Foot Positioning Device 109, Support Base 110, Arc-shaped Concave Surface 111, First Positioning Part 112, Second Positioning Part 113, Fixed Base 114, Z-axis Adjustment Frame 115, Y-axis Fixing Frame 116, Strip-shaped Groove 117, Adjustment Block 118, Limiting Head 119, Sliding Block 131, Secondary Support Rod 120, Sliding Sleeve 121, Support Rod 122, Insertion Sleeve 123, Mounting Plate 124, Guide Plate 125, Auxiliary Calibration Hole 126, Needle Insert Liner 127, Threaded Connection Part 128, Puncture Channel Part 129, Groove 130. Detailed Implementation

[0027] The present invention will be further described in detail below with reference to the accompanying drawings and embodiments. The following embodiments are explanations of the present invention, but the present invention is not limited to the following embodiments.

[0028] See Figure 1-6 This embodiment provides a lumbar puncture auxiliary positioning device, including a puncture positioning device. The puncture positioning device includes a positioning module 101 and an adjustable positioning bracket 102. The positioning module 101 is set on a fixing part on the adjustable positioning bracket. The adjustable positioning bracket is fixed on the operating table and realizes the adjustment and position fixation of the positioning module 101 in the X / Y / Z axes. The positioning module 101 is provided with a main calibration hole 103 adapted to the patient's lumbar spine marking point. At least two sets of the main calibration holes are provided front and back along the lumbar spine axis. The positioning module 101 is provided with a puncture channel slot 104 adapted to the puncture trajectory.

[0029] This embodiment relates to a lumbar anesthesia puncture auxiliary positioning device, which mainly establishes a positioning point on the lumbar spine and aligns the main calibration hole 103 with the positioning point. This auxiliary method performs non-contact positioning and reset, and is not directly fixed to the patient's skin. After positioning puncture, the marking point will not shift due to the force applied during operation, nor will the puncture needle shift due to unstable operation during operation, which greatly improves the success rate of puncture.

[0030] Specifically, in this embodiment, the positioning module 101 includes a 3D-printed guide plate 125 as an auxiliary positioning device. This device is primarily used to determine the puncture point and puncture path. The 3D-printed guide plate 125 is installed and positioned at the patient's lumbar puncture site for spinal anesthesia. In this embodiment, the spinal anesthesia puncture is performed in a prone position for ease of operation. The guide plate 125 is modeled using a marked 3D medical image of the patient's lumbar spine, forming a reference system within the 3D medical image. During modeling, the guide plate 125 is set in a non-direct contact manner with the patient. Therefore, this auxiliary device resets the guide plate 125's setting during modeling, thereby creating a puncture path that matches the patient's actual lumbar spine physiological characteristics, improving the puncture success rate and reducing puncture risks. The specific method for 3D printing the guide plate 125 in this embodiment is as follows:

[0031] (1) Place X-ray imaging markers at the patient's lumbar spine position (the markers are made of a ring-shaped hollow metal sheet attached to the corresponding position of the patient's waist. During CT scanning, the metal sheet will cause artifacts at the marked position, which will be reflected in the image. After the CT scan is completed, in order to prevent the metal sheet from shifting and causing a difference from the initial marked position, use a marker pen or other non-erasable marker to fill the mark in the central hole of the metal sheet, so as to facilitate finding the initial marked position in the subsequent operation and facilitate the implementation of the guide plate positioning during the operation), and obtain the patient's CT or MRI medical digital imaging data in a fixed position;

[0032] (2) Import the DICOM file of medical digital imaging data into the engineering reconstruction software and obtain a data model with three-dimensional spatial parameters of vertebral bones, skin, blood vessels and markers; simulate the puncture channel in the data model according to the distribution characteristics of vertebral bones, skin and blood vessels and obtain a three-dimensional data model with design parameters, and import the three-dimensional data model into the reverse engineering software in STI form;

[0033] (3) In the reverse engineering software, a three-dimensional reference system for the design of the guide plate 125 is established with the location of the marker as the origin. The guide plate 125 is established on the three-dimensional data model based on the established three-dimensional reference system. The horizontal plane of the highest contact point of the guide plate 125 with the skin is used as the reference plane for the design of the bottom end face of the guide plate 125. The puncture channel hole of the guide plate 125 is established on the extension line of the simulated puncture channel and the model of the guide plate 125 is generated.

[0034] (4) Import the 3D data of the guide plate 125 model from the reverse engineering software into the 3D printer to produce the guide plate 125.

[0035] The lumbar spine position markers are set in at least two sets. In the establishment of the three-dimensional reference system, the markers on the front of the body are used as the origin. The markers are attached to the corresponding positions of the patient's waist using a ring-shaped hollow metal sheet. The engineering reconstruction software is any one of MIMICS, E3D, 3Dslicer, or 3Ddoctor. The reverse engineering software is any one of 3MATIC, designX, or E3D.

[0036] To ensure that the patient's position remains largely consistent during the establishment of the guide plate 125 and during the spinal anesthesia procedure, thereby avoiding significant discrepancies between the lumbar spine morphology and position in CT scans and during the puncture procedure, which could affect the restoration of the reference system during modeling, the spinal anesthesia puncture auxiliary device in this embodiment also includes a body positioning device. This body positioning device uses adaptable positioning components to define the positions of the patient's head, arms, torso, knees, and feet. The body positioning device includes a head locator 105, a torso locator 106, a bi-arm locator 107, and a knee locator 108. The foot positioning device 109 (the above-mentioned positioning device can be equipped with straps according to the fixation needs) and the head positioning device 105, torso positioning device 106, arm positioning device 107, knee positioning device 108 and foot positioning device 109 are adapted and fixed to the support base plate 110 through a detachable structure. Specifically, the head positioning device 105, torso positioning device 106, arm positioning device 107, knee positioning device 108 and foot positioning device 109 are set on the support base plate 110 through a Velcro structure. The fixed base plate is provided with a calibration grid and scale for calibrating the position. In order to facilitate the restoration and positioning, the Velcro detachable structure makes it convenient to remove the above-mentioned positioning devices from the operating table after the spinal anesthesia is completed, so that the corresponding surgical operation can continue without transfer.

[0037] In specific operation, the consistency of the various components of the body positioning device ensures that the patient's position remains essentially the same during CT and puncture procedures, thus ensuring that the lumbar spine's morphology is essentially consistent anteriorly and posteriorly. Since the guide plate 125 in the positioning module is set based on a three-dimensional reference system established by the position of the markers, the method for restoring the reference system during lumbar puncture is as follows: The body positioning device is used to restore the patient's position. The positioning module 101 is fixed to the adjustable positioning bracket. Because the adjustable positioning bracket can be adjusted in the X / Y / Z axes, first, it is raised to a certain height, aligning the vertical landing point of the main calibration hole 103 with the setting point of the marker. At least two sets of markers are provided, thus adapting to two sets of main calibration holes 103 for axial positioning of the spine. Figure 6 As shown, after calibration, the height of the positioning module 101 is lowered. The lower end face of the positioning module 101 is fixed after contacting the highest point of the skin in the spinal anesthesia area, thus restoring the reference system. Since the simulated puncture channel is based on the patient's actual physiological structure, the epidural puncture needle is inserted along the direction of the puncture channel during the puncture process. It is not affected by skin displacement or operator shaking, so the puncture success rate is higher. In addition, the risk area has been avoided in the 3D simulation process, reducing the puncture risk. It is particularly suitable for use in spinal anesthesia operations for some obese patients, patients with spinal deformities, etc.

[0038] Due to variations in morphology, the lumbar spine exhibits different shapes. To facilitate obtaining a relatively optimal spinal morphology for patient puncture, the body locator 106 is equipped with an arc-shaped concave surface 111, and its upper end face is an inverted V-shaped slope. The body locator 106 consists of a first positioning part 112 and a second positioning part 113. The first positioning part 112 is constructed with a rigid support and a soft structure, while the second positioning part is constructed with an airbag of a suitable shape. The airbag's inflation volume supports the lower body (lumbar region and hip region), as shown in the figure. By adjusting the airbag's inflation volume, the lower body's position can be adjusted. The height is adjusted to adapt to the extension shape of the lumbar spine, making it easier for doctors to find a relatively suitable extension position based on experience for subsequent puncture operations. In the initial operation, the adjustment balloon should be deflated to a vacuum state, and then gas should be injected. Stop after the body is in a suitable position. During the spinal anesthesia operation, all parts of the body should be in the same position proportion as the arm fixator, head fixator, body positioner 106, knee positioner 108, and foot positioner. The amount of air that was inflated during the CT scan is then injected into the adjustment balloon to maintain a relatively consistent body position.

[0039] Specifically, in this embodiment, the adjustable positioning bracket includes a fixed base 114 for fixing to both sides of the bed, a Z-axis adjustment bracket 115, and a Y-axis fixing bracket 116. The two sets of adjustment brackets are respectively fixed to both sides of the bed. The Z-axis adjustment bracket 115 is slidably mounted on the fixed base 114 along the X-axis and fixed with bolts. The Y-axis fixing bracket 116 uses a telescopic rod and is fixed with bolts. One end of the Y-axis fixing bracket 116 is rotatably connected to the top of the Z-axis adjustment bracket 115 and secured with bolts (the rotatable design is mainly used to accommodate lumbar scoliosis or body curvature deviation, allowing the positioning module 101 to shift so that the main calibration hole 103 matches the position of the marker). The other end of the Y-axis fixing bracket 116 is provided with a strip-shaped groove 117. An adjusting block 118 is provided on the strip-shaped groove 117. The adjusting block 118 is laterally slidably disposed on the secondary sliding groove at the bottom of the strip-shaped groove 117 and is fastened in position by bolts. Sliding blocks 131 are provided on both sides of the positioning bracket to adapt to the strip-shaped groove 117 and are limited and fixed by the L-shaped limiting head 119 at the front end of the adjusting block 118. The Y-axis fixing frame 116 is provided with a secondary support component. The secondary support component includes a secondary support rod 120, a sliding sleeve 121 and a support rod 122. The sliding sleeve 121 is disposed on the secondary support rod 120 and is fixed in position by bolts. The support rod 122 is fixed to the sliding sleeve 121. The other end of the secondary support rod 120 is provided with a plug-in sleeve 123 for adaptation and connection on the side of the positioning module 101. The installation stability of the positioning module 101 is improved by the secondary support frame.

[0040] In this embodiment, as Figure 2 As shown, the specific positioning module 101 includes a mounting plate 124 and a guide plate 125. The mounting plate 124 is composed of a horizontal plate and a vertical plate connected in an L-shape. The mounting plate 124 is provided with a groove for mounting the guide plate 125. The guide plate 125 is adapted to the groove, and the lower end face of the guide plate 125 is flush with the lower end face of the horizontal plate. The central symmetry line of the main calibration hole 103 coincides with the central symmetry of the guide plate 125.

[0041] In this embodiment, the main calibration holes 103 on the mounting plate 124 are arranged in two sets, one in front of the other. The front side of the mounting guide plate and the end of the secondary support rod 120 are respectively provided with auxiliary calibration holes 126. Both the main calibration holes 103 and the auxiliary calibration holes 126 are adapted to provide laser pens for marking point light sources. The purpose of this structure is to facilitate medical staff to intuitively detect whether the patient's body position deviates from the reference frame due to active displacement (because the displacement caused by the positioning module 101 after descent is not easily seen from the main calibration holes 103). Specifically, auxiliary calibration holes are provided on the rear side of the mounting bracket and the end of the connecting rod. A laser pen is placed on the auxiliary calibration holes. A marker is used to mark the point light source on the skin when the laser pen falls. When any point light source falls off, the operation is stopped and the point is reset according to the marked point.

[0042] In this embodiment, the puncture channel slot 104 is adapted to a needle insert liner 127. Various models of the needle insert liner 127 are available to match the diameters of different types of epidural puncture needles. The needle insert liner 127 includes a threaded connection portion 128 and a puncture channel portion 129. The threaded connection portion 128 is threadedly connected to the outer wall of the puncture channel slot 104. The puncture channel portion 129 is slidably disposed within the puncture channel portion 129. The tip of the needle insert liner 127 has a groove 130 adapted to a needle tip limiting portion. This structure is primarily because the puncture distance in the puncture path is basically determined in the established reference frame. Therefore, to adapt to the puncture distance and prevent insufficient puncture distance (not reaching the epidural space) or excessive depth (excessive puncture will perforate the dura mater and cause cerebrospinal fluid leakage), the height of the puncture channel slot 104 is limited based on the puncture distance during 3D printing design. The depth of the puncture needle is limited, therefore an inner liner is provided on the puncture channel slot 104. On the one hand, the inner liner is replaceable to adapt to different models of puncture needles. On the other hand, since there may be differences between actual operation and theory, the threaded connection part 128 in its structure is adapted to the thread on the outer wall of the puncture channel slot 104. It rotates upward at the beginning of puncture to increase the safe puncture margin and avoid excessive puncture force, which may cause puncture to be too deep. After the puncture needle tube limiting part contacts the end of the inner liner and adapts to the groove 130, the needle is then rotated to gradually lower the height of the inner liner, and the puncture needle gradually penetrates 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 slot 104. The height of the inner liner is constant, so the actual needle insertion depth is known. Therefore, when inserting the epidural tube, the insertion operation is completed by entering 3-5cm from its depth. The insertion is accurate and effectively prevents puncture complications during the puncture process.

[0043] The above description is merely illustrative of the invention. Those skilled in the art can make various modifications or additions to the described specific embodiments or use similar methods to replace them, as long as they do not depart from the content of this specification or exceed the scope defined by the claims, all of which should fall within the protection scope of this invention.

Claims

1. A spinal anesthesia puncture auxiliary positioning device, characterized in that: The device includes a puncture positioning device, which comprises a positioning module and an adjustable positioning bracket. The positioning module is fixed on a fixed part of the adjustable positioning bracket. The adjustable positioning bracket is fixed on the operating table and enables the positioning module to be adjusted and secured in position in the X / Y / Z axes. The positioning module is provided with a main calibration hole adapted to the patient's lumbar spine marker point. At least two sets of the main calibration holes are provided along the lumbar spine axis. The positioning module is provided with a puncture channel slot adapted to the puncture trajectory. The positioning module includes a mounting plate and a guide plate. The mounting plate is composed of a horizontal plate and a vertical plate connected in an L-shape. The mounting plate is provided with a groove for mounting the guide plate. The guide plate is fitted into the groove, and the lower end face of the guide plate is flush with the lower end face of the horizontal plate. The center symmetry line of the main calibration hole coincides with the center symmetry of the guide plate. The guide plate is obtained through reverse engineering 3D printing, and the specific steps include: S1: Place X-ray imaging markers at the patient's lumbar spine position to acquire medical digital imaging data of the patient in a fixed position using CT or MRI. S2 uses engineering reconstruction software to import DICOM files of medical digital imaging data and obtains a data model with three-dimensional spatial parameters of vertebral bones, skin, blood vessels, and markers; within the data model, it simulates the puncture channel based on the distribution characteristics of vertebral bones, skin, and blood vessels and obtains a three-dimensional data model containing design parameters; the three-dimensional data model is then imported into reverse engineering software in STI format. In reverse engineering software, S3 establishes a three-dimensional reference system for the guide plate design with the location of the marker as the origin. The guide plate is then built on the three-dimensional data model based on the established three-dimensional reference system. The horizontal plane of the highest contact point of the guide plate with the skin is used as the reference plane for the bottom end face design of the guide plate. The puncture channel hole of the guide plate is built on the extension line of the simulated puncture channel, and the guide plate model is generated. S4 imports the 3D data of the guide plate model from the reverse engineering software into the 3D printer to produce the guide plate.

2. The spinal anesthesia puncture auxiliary positioning device according to claim 1, characterized in that: It also includes a body positioning device, which uses positioning components of adapted shape to define the position of the patient's head, arms, torso, knee joints and feet respectively. The body positioning device includes a head locator, a torso locator, a double arm locator, a knee locator and a foot positioning device. The head locator, torso locator, double arm locator, knee locator and foot positioning device are adapted and fixed on the support base plate through a detachable structure.

3. The spinal anesthesia puncture auxiliary positioning device according to claim 2, characterized in that: The head locator, torso locator, arm locator, knee locator, and foot locator are mounted on the support base plate via a Velcro structure.

4. The spinal anesthesia puncture auxiliary positioning device according to claim 3, characterized in that: The body locator is provided with an arc-shaped concave surface and the upper end face is provided with an inverted V-shaped sloping surface. The body locator is composed of a first positioning part and a second positioning part. The first positioning part is made of a rigid support and a soft structure, and the second positioning part is made of an airbag with an adaptive shape.

5. The spinal anesthesia puncture auxiliary positioning device according to claim 1, characterized in that: The adjustable positioning bracket includes a fixed base for fixing to both sides of the bed, a Z-axis adjustment bracket, and a Y-axis fixing bracket. The two sets of adjustment brackets are respectively used to fix to both sides of the bed. The Z-axis adjustment bracket is slidably mounted on the fixed base along the X-axis and fixed with bolts. The Y-axis fixing bracket uses a telescopic rod and is fixed with bolts. One end of the Y-axis fixing bracket is rotatably connected to the top of the Z-axis adjustment bracket and is positioned and fastened with bolts. The other end of the Y-axis fixing bracket is provided with a strip groove. An adjustment block is provided on the strip groove. The adjustment block is slidably mounted on the secondary sliding groove at the bottom of the strip groove and is positioned and fastened with bolts. Sliding blocks are provided on both sides of the positioning bracket to fit the strip groove and are fixed by L-shaped limiting heads at the front end of the adjustment blocks.

6. The spinal anesthesia puncture auxiliary positioning device according to claim 5, characterized in that: The Y-axis fixing frame is provided with a secondary support component, which includes a secondary support rod, a sliding sleeve, and a support rod. The sliding sleeve is slidably fitted onto the secondary support rod and is fixed in position by bolts. The support rod is fixed to the sliding sleeve. The other end of the secondary support rod is provided with a plug-in sleeve adapter connection on the side of the positioning module.

7. The spinal anesthesia puncture auxiliary positioning device according to claim 1, characterized in that: The main calibration holes on the mounting guide plate are arranged in two sets, one in front of the other. Auxiliary calibration holes are provided on the front side of the mounting guide plate and at the end of the secondary support rod. Both the main calibration holes and the auxiliary calibration holes are adapted to be equipped with laser pens that provide point light source markings.

8. The spinal anesthesia puncture auxiliary positioning device according to claim 1, characterized in that: The puncture channel slot is adapted to be fitted with a needle insert liner, and the needle insert liner is available in various models so that it can be matched with the needle diameter of various models of epidural puncture needles.

9. The spinal anesthesia puncture auxiliary positioning device according to claim 8, characterized in that: The needle insert liner includes a threaded connection part and a puncture channel part. The threaded connection part is threadedly connected to the outer wall of the puncture channel slot. The puncture channel part is slidably disposed within the puncture channel part. The head end of the needle insert liner is provided with a groove adapted to the needle tip limiting part.

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