An in-vitro guide plate for assisting intravertebral anesthesia based on 3D printing and a manufacturing method thereof

Abstract

The application provides a 3D printing-based auxiliary intraspinal anesthesia in-vitro guide plate and a manufacturing method thereof. The in-vitro guide plate comprises a skin fitting plate, a guide column is arranged on the upper side of the skin fitting plate, a needle channel is arranged on the upper end of the guide column, and the needle channel penetrates through the guide column and the skin fitting plate. In the manufacturing process, firstly, medical digital imaging data of a patient is collected, and a human three-dimensional digital model a is established by using the medical digital imaging data; then, an in-vitro guide plate three-dimensional digital model is established by using the human three-dimensional digital model a, and a needle channel of an intraspinal anesthesia puncture point is left on the in-vitro guide plate three-dimensional digital model; finally, the in-vitro guide plate is manufactured by using the in-vitro guide plate three-dimensional digital model. The manufacturing method can customize corresponding in-vitro guide plates for different patients, the customized in-vitro guide plates can accurately guide the puncture needle during intraspinal anesthesia, have high reliability, and have low requirements on the experience of doctors.

Description

Technical Field

[0001] This invention belongs to the field of spinal anesthesia technology, specifically relating to an external guide plate for spinal anesthesia based on 3D printing and its manufacturing method. Background Technology

[0002] Injecting anesthetic drugs into the subarachnoid or epidural space of the spinal canal blocks the spinal nerve roots, producing anesthesia in the corresponding area innervated by those nerve roots. This is collectively known as spinal anesthesia. Depending on the injection site, it can be divided into subarachnoid anesthesia (also known as spinal or lumbar anesthesia), epidural block, combined spinal-epidural anesthesia, and sacral block anesthesia.

[0003] Accurate puncture localization is crucial for spinal anesthesia. However, since spinal anesthesia has always been a blind puncture and catheter placement technique, it relies mainly on the operator's subjective intuition. Pre-puncture localization depends heavily on the operator's subjective intuition and requires a high level of experience from the physician. If the direction of needle insertion changes from the pre-puncture localization direction, it can easily cause injury to the patient. Inexperienced physicians find it difficult to perform this procedure successfully. Summary of the Invention

[0004] The purpose of this invention is to provide a 3D-printed external guide plate for spinal anesthesia and its manufacturing method, in order to solve the problems mentioned in the background art.

[0005] To achieve the above objectives, in a first aspect, the present invention provides an external guide plate for spinal anesthesia based on 3D printing, including a skin-adhesive plate, a guide post provided on the upper side of the skin-adhesive plate, a needle channel opened at the upper end of the guide post, and the needle channel penetrating the guide post and the skin-adhesive plate.

[0006] Furthermore, the skin-adhesive plate is a flexible adhesive plate, with an adhesive layer on the lower side and a plurality of positioning vertebrae corresponding to the human spine on the upper side, and the guide column is fixedly connected to the positioning vertebrae.

[0007] Furthermore, the skin-adhesive plate is a rigid adhesive plate, and the lower end of the guide post is fixedly connected to the rigid adhesive plate.

[0008] Furthermore, several positioning vertebrae corresponding to the human spine are fixedly connected to the upper side of the rigid bonding plate.

[0009] Secondly, the present invention also provides a method for fabricating an external guide plate for spinal anesthesia based on 3D printing, the method comprising the following steps:

[0010] S1: Collect patient's medical digital imaging data;

[0011] S2: Using medical digital imaging data to create a three-dimensional digital model of the human body;

[0012] S3: Compare and confirm the three-dimensional digital model of the human body with medical digital imaging data;

[0013] S4: After confirming that there are no errors, use the three-dimensional digital model of the human body (a) to establish a three-dimensional digital model of the external guide plate, and leave the needle path of the spinal anesthesia puncture point on the three-dimensional digital model of the external guide plate.

[0014] S5: Use a three-dimensional digital model of the external guide plate to create the external guide plate.

[0015] Furthermore, the medical digital imaging data is acquired via thin-slice CT or MRI.

[0016] Furthermore, step S2 specifically includes the following steps:

[0017] S201. Using medical digital imaging data, establish a three-dimensional digital model of the human body as a whole (A).

[0018] S202. Select a study area on the overall three-dimensional digital model A of the human body, and generate a three-dimensional digital model a of the human body from the selected study area.

[0019] Furthermore, step S4 specifically includes the following steps:

[0020] S401: Copy the human spine model, move the copied human spine model to the outside of the skin at the puncture site, and use the moved human spine model as the positioning vertebra.

[0021] S402: Establish a skin patch model on the outside of the skin at the puncture site, which is in close contact with the skin at the puncture site. Then, based on the position of the human spine model in the three-dimensional digital model of the human body a, establish a guide column model on the outside of the skin patch model, and leave the needle path for the spinal canal anesthesia puncture point.

[0022] Furthermore, the external guide plate mentioned in step S5 is manufactured using a 3D printer. After the 3D printer finishes manufacturing, the supports on the external guide plate are cleaned.

[0023] Furthermore, after step S5 is completed, an adhesive layer is attached to the inside of the skin-adhesive plate.

[0024] Furthermore, after the adhesive layer is applied, the external guide plate is disinfected and sterilized, and then sealed.

[0025] The advantages of this invention are: This invention provides a 3D-printed external guide plate for spinal anesthesia and its manufacturing method. It can customize external guide plates for different patients. The customized external guide plate can accurately guide the puncture needle during spinal anesthesia, which is highly reliable and requires less experience from the doctor. Moreover, no mold is needed when manufacturing the external guide plate, resulting in low manufacturing cost and strong practicality.

[0026] The present invention will now be described in detail with reference to the accompanying drawings and embodiments. Attached Figure Description

[0027] Figure 1 This is a top view of the external guide plate in Example 1.

[0028] Figure 2 This is a side view of the external guide plate in Example 1.

[0029] Figure 3 This is a partial structural diagram of the external guide plate.

[0030] Figure 4 This is a side view of the external guide plate in Example 2.

[0031] Figure 5 This is a partial cross-sectional view of the extracorporeal guide plate in Example 2.

[0032] Explanation of reference numerals in the attached diagram: 1. Skin bonding plate; 2. Guide post; 3. Needle path; 4. Adhesive layer; 5. Positioning vertebra; 6. Skin at puncture position; 7. Human spine; 8. Bandage. Detailed Implementation

[0033] To further illustrate the technical means and effects of the present invention in achieving its intended purpose, the specific implementation methods, structural features and effects of the present invention are described in detail below with reference to the accompanying drawings and embodiments.

[0034] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0035] In the description of this invention, it should be understood that the terms "center", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "aligned", "overlapping", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0036] The terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature; in the description of this invention, unless otherwise stated, "a plurality of" means two or more.

[0037] Example 1

[0038] This embodiment provides a method such as Figure 1 and Figure 2 The 3D-printed external guide plate for spinal anesthesia shown includes a skin-adhesive plate 1 that fits into the patient's skin 6 during puncture. A guide post 2 is provided on the upper side of the skin-adhesive plate 1, and a needle channel 3 is opened at the upper end of the guide post 2. The needle channel 3 passes through the guide post 2 and the skin-adhesive plate 1. Specifically, the diameter of the needle channel 3 is the same as the outer diameter of the puncture needle, and it is used to guide the puncture needle.

[0039] Furthermore, such as Figure 2 and Figure 3 As shown, the skin patch 1 is a flexible patch. The lower side of the flexible patch has an adhesive layer 4, and the upper side has several positioning vertebrae 5 corresponding to the human spine 7. The guide post 2 is fixedly connected to the positioning vertebrae 5. When the skin patch 1 is a flexible patch, it is suitable for patients who have difficulty acquiring medical digital imaging data of the puncture position. During use, the patient's spine is counted to ensure a one-to-one correspondence between the positioning vertebrae 5 and the patient's spine. After this correspondence, the flexible patch is applied to the skin at the puncture site. Finally, the patient is assisted in assuming the puncture position. During this process, the flexible patch bends along with the skin at the puncture site. Furthermore, the curvature of the patient's spine can be indirectly observed through the positioning vertebrae 5 on the upper side of the skin patch 1, facilitating the determination of whether the patient has reached the appropriate puncture position. Once the patient has reached the puncture position, the puncture needle can be guided through the needle channel 3.

[0040] Example 2

[0041] like Figure 4 and Figure 5 As shown, the difference between this embodiment and Embodiment 1 is that the skin-adhesive plate 1 is a rigid plate, which matches the patient's skin 6 in the puncture position, and the lower end of the guide post 2 is fixedly connected to the rigid plate. In use, the positioning process is directly completed by the curvature of the rigid plate itself. When the rigid plate is in contact with the skin 6 in the puncture position, the patient reaches the puncture position. Once the patient is in the puncture position, the puncture needle can be guided through the needle channel 3.

[0042] Furthermore, such as Figure 4 and Figure 5As shown, several positioning vertebrae 5 corresponding to the human spine 7 are fixedly connected to the upper side of the rigid bonding plate. By counting the patient's spine, the positioning vertebrae 5 are made to correspond one-to-one with the patient's spine, which can further assist the rigid bonding plate in positioning more accurately.

[0043] Furthermore, such as Figure 3 As shown, the rigid adhesive plate has an adhesive layer 4 on its lower side. During use, the rigid adhesive plate is fixed to the patient's skin 6 at the puncture position through the adhesive layer 4.

[0044] Furthermore, the adhesive layer 4 can be replaced by a bandage 8, which is used to fix the rigid adhesive plate to the patient's waist.

[0045] Example 3

[0046] This embodiment provides a method for fabricating an external guide plate for spinal anesthesia based on 3D printing, the method including the following steps:

[0047] S1: Acquire patient medical digital imaging data using thin-slice CT (computed tomography) or MRI (magnetic resonance imaging).

[0048] When the patient is in the puncture position, collect medical digital imaging data of the patient's puncture position;

[0049] When patients are unable to assume the correct puncture position due to obesity or other reasons, collect medical digital imaging data of the patients in their normal position.

[0050] S2: Using medical digital imaging data to create a three-dimensional digital model of the human body;

[0051] S3: Compare and confirm the three-dimensional digital model of the human body with medical digital imaging data;

[0052] S4: After confirming that there are no errors, use the three-dimensional digital model of the human body a to establish a three-dimensional digital model of the external guide plate, and leave the needle path 3 of the spinal anesthesia puncture point on the three-dimensional digital model of the external guide plate.

[0053] S5: Use a three-dimensional digital model of the external guide plate to create the external guide plate.

[0054] Furthermore, step S2 specifically includes the following steps:

[0055] S201. Using medical digital imaging data, establish a three-dimensional digital model of the human body, A. The three-dimensional digital model of the human body A includes human skeletal models, muscle models, skin models, and other human tissue models.

[0056] S202. Select a study area on the overall three-dimensional digital model A of the human body, and generate a three-dimensional digital model a of the human body from the selected study area.

[0057] Specifically, Mimics software is used to create the 3D digital model, and the operation steps are as follows:

[0058] Medical digital imaging data is entered into Mimics software. Based on the patient's condition or research needs, the required medical digital imaging data is selected, the data input is completed, the three-dimensional orientation of the model is confirmed, and it is converted into a three-dimensional digital model of the human body.

[0059] Furthermore, step S4 specifically includes the following steps:

[0060] S401: Copy the human spine model, move the copied human spine model to the outside of the skin at the puncture site, and use the moved human spine model as the positioning vertebra 5.

[0061] S402: Create a skin patch model that fits the skin at the puncture site on the outside of the skin 6 at the puncture position. Then, based on the position of the human spine model in the three-dimensional digital model a, create a guide column model on the outside of the skin patch model and leave the needle path 3 for the spinal canal anesthesia puncture point. After completion, output the STL file.

[0062] Furthermore, the external guide plate mentioned in step S5 is manufactured using a 3D printer, and the specific operation is as follows:

[0063] Import the STL file into the 3D printer's operating software, analyze and process the model. After confirming there are no errors, select the appropriate printing mode and material for pre-processing. Before starting the printing task, start the printer and clear it two to three times. After completion, perform a print pattern test and check the results. Repeat the clearing process two to three times and perform another print pattern test. Compare the results of the two tests. If the results are good or the missing stripes are in different positions, printing can proceed. After the 3D printer finishes printing, clean the supports on the external guide plate. The specific steps are as follows: First, manually remove the supports from the surface and grooves. Then, use a scraper to remove the supports from the gaps and small holes inside the external guide plate. Be careful of the internal structure of the external guide plate during removal to prevent damage. Next, clean the external guide plate with clean water. Finally, set the working temperature of the electric heating drying oven to 50 degrees Celsius and the working time to 60 minutes. After setting, place the cleaned external guide plate into the electric heating drying oven for drying.

[0064] When fabricating an external guide plate using medical digital imaging data acquired in a normal body position, the skin-adhesive plate is a flexible plate made of transparent soft adhesive, while the remaining materials of the external guide plate are all transparent hard adhesive; specifically, the transparent soft adhesive is Agilus30, the preferred printing temperature is 70 degrees Celsius, and the transparent hard adhesive is VeroClear.TM The preferred printing temperature is 70 degrees Celsius.

[0065] When using medical digital imaging data acquired in the puncture position to fabricate an external guide plate, the external guide plate is made of transparent hard plastic.

[0066] Furthermore, after step S5 is completed, an adhesive layer is attached to the inner side of the skin-adhesive plate. After the adhesive layer is attached, the external guide plate is sterilized using a hydrogen peroxide low-temperature plasma sterilizer. After sterilization, the external guide plate is sealed.

[0067] The specific steps for packaging are as follows:

[0068] 1. Confirm that the self-sealing bag is sealed properly; check that the printed text on the product nameplate is clear and verify that the content on the product nameplate matches the production plan.

[0069] 2. Place the product nameplate in the center of the resealable bag, ensuring it is not crooked.

[0070] 3. Place the qualified products into a self-sealing bag with the product nameplate affixed, and pinch the seal closed.

[0071] 4. Check that the printed content on the packaging box is clear and that the exterior is intact and undamaged;

[0072] 5. Adjust the inkjet printer and print the product number, production date, and expiration date according to the requirements of the production plan;

[0073] 6. Place the sealed bag containing the product into the packaging box, and add the certificate of conformity;

[0074] 7. Place the packaged product box into the heat-sealing bag, turn on the red power switch of the foot-operated sealing machine, and adjust the time knob to the 1.5s position; place the package box into the plastic sealing bag to the bottom, keeping the open end of the plastic sealing bag flat, and place the entire box horizontally into the heating and sealing part of the foot-operated sealing machine (the heat-cutting length is about 3-4cm). Press down the foot pedal, and when the heating indicator light goes out, remove the product while releasing the foot pedal. The seal should be straight, tight, and without wrinkles. Then, perform the same operation to cut off the remaining four protruding corners of the plastic sealing bag.

[0075] 8. Equipment power-on preheating: ① Turn on the main power and turn on the red switches for "fan" and "conveyor". ② Adjust the white indicator line of the "temperature controller" knob on the heat sealing equipment control panel to 160℃, adjust the pointer of the "upper and lower temperature adjustment" knob to position 5, and adjust the "speed adjustment" knob to position 3-4. Wait for the equipment to preheat to the set temperature. Take the qualified products from the previous process and check that the seals of all cut ends of the heat sealing bag are intact.

[0076] 9. Once the equipment indicates that the temperature has reached the set temperature (red light on), place 10 sealed products sequentially at intervals in the middle of the conveyor belt from the left entrance of the equipment for heat sealing;

[0077] 10. Observe the heat sealing effect of the product at the product outlet on the right side of the equipment. When the effect meets the requirements of heat sealing operation (flat without wrinkles, cracks, holes and other defects), continuous batch heat sealing can begin.

[0078] After the operation is completed, first turn the "temperature controller" knob to 0℃ to stop the equipment from heating, and let the conveyor belt and fan continue to run. When the red temperature pointer on the "temperature controller" panel approaches room temperature, then turn off the red switches for "fan" and "conveyor" and the main power supply in sequence.

[0079] The above description, in conjunction with specific preferred embodiments, provides a further detailed explanation of the present invention. It should not be construed that the specific implementation of the present invention is limited to these descriptions. For those skilled in the art, various simple deductions or substitutions can be made without departing from the concept of the present invention, and all such modifications and substitutions should be considered within the scope of protection of the present invention.

Claims

1. A 3D printing based extradural anaesthesia in-vitro guide, characterized in that: The application relates to a skin-adaptable plate (1) provided with a guide column (2) on the upper side, wherein a needle channel (3) is formed in the upper end of the guide column (2) and penetrates the guide column (2) and the skin-adaptable plate (1); the skin-adaptable plate (1) is a flexible plate, the lower side of the flexible plate is provided with a glue layer (4), and the upper side of the flexible plate is provided with a plurality of positioning vertebrae (5) corresponding to human vertebrae (7); the positioning vertebrae (5) are made according to a human vertebrae model, and the guide column (2) is fixedly connected with the positioning vertebrae (5).

2. A 3D printing based external guide for performing an epidural block, according to claim 1, wherein: The skin-adaptable plate (1) is a rigid plate, and the lower end of the guide column (2) is fixedly connected with the rigid plate.

3. A 3D printing based external guide for performing an epidural block, according to claim 2, wherein: The upper side of the rigid plate is fixedly connected with a plurality of positioning vertebrae (5) corresponding to human vertebrae (7).

4. A method for manufacturing the 3D printing-based auxiliary intravertebral anesthesia body external guide plate according to any one of claims 1-3, characterized in that: The method comprises the following steps: S1: collecting medical digital imaging data of a patient; S2: establishing a three-dimensional digital model a of a human body by using the medical digital imaging data; S3: comparing and confirming the three-dimensional digital model a of the human body with the medical digital imaging data; S4: after confirmation, establishing a three-dimensional digital model of an external guide plate by using the three-dimensional digital model a of the human body, and leaving a needle channel (3) of an intraspinal anesthesia puncture point on the three-dimensional digital model of the external guide plate; S5: manufacturing the external guide plate by using the three-dimensional digital model of the external guide plate.

5. The method of claim 4, wherein the 3D printing-based production of an extracorporeal guide for an epidural anesthesia is characterized by: The medical digital imaging data is obtained by thin-layer CT or MRI.

6. The method of claim 4, wherein the 3D printing-based fabrication of an extracorporeal guide for an epidural anesthesia is characterized by: The step S2 specifically comprises the following steps: S201: establishing a three-dimensional digital model whole A of a human body by using the medical digital imaging data; S202: selecting a research region on the three-dimensional digital model whole A of the human body, and generating a three-dimensional digital model a of the human body from the selected research region.

7. The method of claim 4, wherein the 3D printing-based fabrication of an in vitro guide for an epidural anesthesia is characterized by: The step S4 specifically comprises the following steps: S401: copying a human vertebrae model, moving the copied human vertebrae model to the outside of skin at a puncture position, and taking the moved human vertebrae model as a positioning vertebra (5); S402: establishing a skin-adaptable plate model on the outside of skin (6) at a puncture position, then establishing a guide column (2) model on the outside of the skin-adaptable plate model according to the position of the human vertebrae model in the three-dimensional digital model a of the human body, and leaving a needle channel (3) of an intraspinal anesthesia puncture point.

8. The method of claim 4, wherein the 3D printing-based fabrication of an extracorporeal guide for an epidural anesthesia is characterized by: The external guide plate in the step S5 is manufactured by using a 3D printer, and the support on the external guide plate is cleaned after the 3D printer is finished with the manufacturing.

9. The method of claim 4, wherein the 3D printing-based fabrication of an extraprocedural intravertebral anesthesia guide is characterized by: After the step S5 is completed, the glue layer (4) is attached to the inside of the skin-adaptable plate (1).

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