A minimally invasive surgical stent, its manufacturing device and manufacturing method

Abstract

This invention discloses a minimally invasive surgical stent, its manufacturing apparatus, and manufacturing method. The minimally invasive surgical stent manufacturing apparatus includes: a stent production module, a stent reprocessing module, a stent casting module, a control module, and a stent transport module. The control module controls the operation of the stent production module, stent reprocessing module, stent casting module, and stent transport module, with seamless connections between the modules. The stent production module is the first process; the stent reprocessing module is the second process, located after the stent production module; the stent casting module is the third process, located after the stent reprocessing module; the stent transport module transports the stent adjacent to the stent production module, stent reprocessing module, and stent casting module in sequence according to the process steps. This invention semi-automates the manufacturing of minimally invasive surgical stents, solving the problem of the inability to mass-produce minimally invasive surgical stents. It not only enables a streamlined stent manufacturing process but also ensures the quality of stent production.

Description

Technical Field

[0001] This invention relates to the field of bone scaffold manufacturing, and more particularly to a minimally invasive surgical scaffold, its manufacturing apparatus, and manufacturing method. Background Technology

[0002] With the continuous development of medical and scientific technologies, the concept of "minimally invasive" has penetrated into all areas of surgery. Minimally invasive surgery makes up for the shortcomings of traditional surgical methods, meaning that minimally invasive surgery can treat diseases while causing less damage to patients.

[0003] Current minimally invasive surgical methods for repairing bone defects typically involve adding bone cement to the defect site. However, bone cement has poor mechanical properties, low and uncontrollable porosity, and poor biocompatibility, which clearly fails to meet patient needs. With advancements in 3D printing technology, bone repair scaffolds are gradually becoming one of the best methods for repairing bone defects. Bone repair scaffolds possess high mechanical properties, controllable porosity, and controllable pore size. However, most existing bone repair scaffolds are manufactured through one-piece printing, resulting in large sizes that cannot meet the requirements of minimally invasive surgery. Furthermore, the current manufacturing process for bone repair scaffolds is complex and requires highly skilled technicians. On the other hand, there is currently no manufacturing equipment capable of mass-producing bone repair scaffolds for minimally invasive surgery with high efficiency, causing significant inconvenience for both doctors and patients. There is an urgent need for a bone repair scaffold suitable for minimally invasive surgery and a manufacturing device capable of mass-producing minimally invasive surgical scaffolds with high efficiency.

[0004] Therefore, there is a need for a minimally invasive surgical stent, its manufacturing apparatus and manufacturing method, which can be used to repair bone defects in minimally invasive surgery. The manufacturing apparatus can not only realize the manufacturing of the minimally invasive surgical stent, but also minimize the use of manpower while ensuring the quality of the stent, and can be applied to mass production. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to overcome the shortcomings of the prior art and provide a minimally invasive surgical stent manufacturing device, comprising: a stent production module 1, a stent reprocessing module 3, a stent casting module 4, a control module 2 and a stent transport module 5; the control module 2 is used to control the operation of the stent production module 1, the stent reprocessing module 3, the stent casting module 4 and the stent transport module 5.

[0006] The bracket production module 1 includes a photopolymer printer 11 and a material loading area 12;

[0007] The feeding area 12 is used to add bio-ink. The bio-ink enters the photopolymerization printer 11 through the feeding area 12 for printing to obtain product one. The stent transfer module 5 is used to transport product one to the stent reprocessing module 3 for processing to obtain product two. Product two is transported through the stent transfer module 5 to the stent casting module 4 for processing to obtain minimally invasive surgical stent 6.

[0008] The bio-ink is composed of biomaterials and photosensitive resin, wherein the biomaterials comprise 60% to 70% by mass; the biomaterials include bioactive materials and bioinert materials.

[0009] Furthermore, the bioactive material may be calcium magnesium phosphate, calcium silicate, tricalcium phosphate, or hydroxyapatite, etc.; the bio-inert material may be alumina, zirconium oxide, or silicon nitride, etc.

[0010] Preferably, the photopolymer printer 11 includes a frame 111, a material trough 112 is provided on the frame 111, an ultraviolet light machine 118 is provided below the material trough 112, a scraper 117 is provided on the frame 111, the position of the scraper 117 corresponds to the position of the material trough 112, a vertical slide bar 113 is provided on the frame 111, a connecting rod 114 is provided on the vertical slide bar 113, a flipping mechanism 115 is provided on the connecting rod 114, and a forming platform 116 is provided below the flipping mechanism 115.

[0011] During operation, workers pour bio-ink into the material tank in the feeding area. Then, one or more 3D models of the support structure can be imported into the control module. After starting the UV curing printer, the forming platform automatically descends to a position 0.2mm from the bottom of the material tank. Subsequently, the control module causes the UV light machine to project slice images of the model in a controlled manner based on the support structure slices. After the first layer of slices is printed, the forming platform rises to the height of one slice thickness, and the squeegee descends to a position 0.1mm from the bottom of the material tank. Then, the material tank rotates one full turn, and the squeegee rises, thus completing the first layer printing of this batch of support structures. Afterward, the above operation is repeated. With each cured layer, the connecting rod will drive the forming platform and the printed parts to rise to the height of one slice thickness, and so on, layer by layer until printing is complete. After all the support structures in this batch are printed, the forming platform automatically rises to the highest position. Then, the flipping mechanism drives the forming platform to rotate 180 degrees so that the side with the support structure is facing up. After all the support structures are transferred to the support structure transfer module, the flipping mechanism drives the forming platform to rotate 180 degrees back to the initial position, and the above operation is repeated to start printing the next batch of support structures.

[0012] Preferably, the support transfer module 5 includes a transfer unit 51 and two picking robots 52, named Robot One and Robot Two, respectively; the transfer unit 51 includes a chain conveyor belt 513, which is driven by a motor 514, and a support tray 511 is placed on the chain conveyor belt 513. The chain conveyor belt 513 is supported by a conveyor belt bracket, and three positioning units 512 are fixedly installed on the conveyor belt bracket, named Positioning Unit One, Positioning Unit Two, and Positioning Unit Three, respectively; Robot One is installed at the corresponding position in the support production module 1, and Robot Two is installed at the corresponding position in the support reprocessing module 3;

[0013] The positions of positioning unit one and positioning unit two correspond to the positions of robot arm one and robot arm two, respectively; the position of positioning unit three corresponds to the position of the support casting module 4.

[0014] During operation, when the previous process is completed, the nearest picking robot transfers the bracket to the bracket tray on the chain conveyor belt. Then, the positioning unit releases its positioning, the motor starts, and the chain conveyor belt begins to work. When the bracket moves to the next process with the chain conveyor belt, the positioning unit next to the nearest picking robot for that process automatically positions the bracket tray, the motor stops working, and then the picking robot picks up the bracket and moves it to the next process.

[0015] Preferably, the upper part of the support tray 511 has several grooves, and the rear part of the support tray 511 has a collision protection block 5111.

[0016] During operation, the anti-collision blocks are used to prevent two adjacent support trays from colliding.

[0017] Preferably, the positioning unit 512 includes a positioning cylinder 5122 fixedly installed on the conveyor belt support, and a stop block 5121 that can move with the piston is installed on the positioning cylinder 5122.

[0018] During operation, when the support tray moves above the positioning unit, the positioning cylinder on the conveyor belt support drives the stop block to rise through the guide rod, positioning the support tray next to the picking robot.

[0019] Preferably, the support reprocessing module 3 includes an anhydrous ethanol cleaning unit 31, a drying unit 32, a high-temperature calcination unit 33, and a cooling unit 34. The drying temperature of the drying unit 32 is 50℃~60℃, and the drying time is 1~2 hours. The high-temperature calcination temperature of the high-temperature calcination unit 33 is 1050℃~1140℃, and the high-temperature calcination time is 5~8 hours.

[0020] During operation, the control module controls the robotic arm next to the bracket reprocessing module to put the bracket into anhydrous ethanol for cleaning. After the bracket has been cleaned for 3 minutes, it is placed in a drying oven to dry. After drying, the bracket is placed in a calcining furnace for high-temperature calcination. After high-temperature calcination, the bracket is taken out and cooled.

[0021] Preferably, the support casting module 4 includes a material dispensing unit 41, a connecting unit 42, and a casting unit 43;

[0022] The batching unit 41 includes a mixing chamber 414, a mixing device 415 is provided at the bottom of the mixing chamber 414, a ceramic slurry tank 411 and a magnetic slurry tank 412 are provided above the mixing chamber 414, and liquid outlets 413 are provided at the bottom of both the ceramic slurry tank 411 and the magnetic slurry tank 412. The ceramic slurry tank 411 and the magnetic slurry tank 412 are respectively connected to the mixing chamber 414 through their respective liquid outlets 413.

[0023] The ceramic slurry is composed of salts and polyvinyl alcohol, wherein the salts account for 50% to 60% by mass; the salts are calcium silicate salts or calcium magnesium phosphates.

[0024] The magnetic slurry is composed of ferric oxide powder and polyvinyl alcohol, wherein the ferric oxide powder has a mass percentage content of 50% to 60% and a particle size of 20 nm to 100 nm.

[0025] The casting unit 43 includes a guide rail 431, on which a guide rail slider 434 is mounted. A connecting block 433 is provided on the guide rail slider 434, and a casting device 432 is provided on the connecting block 433, the position of which corresponds to the groove on the support tray 511. The connecting unit 42 connects the mixing chamber 414 and the casting device 432.

[0026] During operation, workers pour ceramic slurry and magnetic slurry into the ceramic slurry tank and magnetic slurry tank respectively. Then, the control module sets the desired total amount of slurry and the proportion of magnetic slurry. After setting, the control module controls the opening time of the two outlets at the bottom of the ceramic and magnetic slurry tanks according to the set parameters. After both outlets are closed, the control module activates the stirring device at the bottom of the mixing chamber. After stirring for 1-3 hours, the slurry is transported to the casting device through the connecting unit. When the support tray is transported to the front of the casting unit and positioned by the positioning unit, the guide rail slider moves the casting device on the connecting block forward, allowing the casting device to insert into the casting channel of the support. At this time, the control module controls the casting device to perform casting. After casting is completed, the guide rail slider moves the casting device on the connecting block backward, returning to the initial position. Then, the positioning unit releases the positioning, awaiting the next casting operation.

[0027] The present invention also provides a method for manufacturing a minimally invasive surgical stent, using the aforementioned minimally invasive surgical stent manufacturing apparatus, comprising:

[0028] The bone defect model structure of the patient's bone defect site is obtained through medical imaging equipment, and the specific number, shape and size of the minimally invasive surgical stent 6 are determined according to the bone defect model structure and the size of the patient's minimally invasive incision.

[0029] A three-dimensional model of the scaffold is created, and the three-dimensional model of the scaffold is sliced ​​into layers using layering software.

[0030] After adding bio-ink to the feeding area 12 of the stent production module 1, the control module 2 controls the photopolymerization printer 11 to print the stent. After printing, the stent is transported to the stent reprocessing module 3 through the stent transfer module 5. The stent is then sequentially cleaned with anhydrous ethanol, dried, calcined at high temperature, and cooled. After cooling, the stent is transported to the stent casting module 4 through the stent transfer module 5 for casting. After casting, the minimally invasive surgical stent 6 is obtained.

[0031] The present invention also provides a minimally invasive surgical stent 6 manufactured by a manufacturing method, the minimally invasive surgical stent 6 comprising a porous region 63, a dense region 61, and a casting channel 62, the casting channel 62 being located inside the minimally invasive surgical stent 6; the casting port of the casting channel 62 being opened on the surface of the minimally invasive surgical stent 6, the casting port area of ​​the casting channel 62 occupying 20% ​​to 40% of the area of ​​the surface on which it is located; the dense region 61 enclosing the outside of the casting channel 62, having a thickness of 0.3 mm to 1 mm; the porous region 63 enclosing the outside of the dense region 61, having a porosity of 50% to 70% and a pore diameter of 300 μm to 500 μm; the casting channel 62 being filled with a casting slurry consisting of a mixture of magnetic slurry and ceramic slurry.

[0032] This invention manufactures a minimally invasive surgical stent using a combination of 3D printing and casting technologies. This device perfectly solves the problem of magnetite oxidation in the magnetic slurry caused by high-temperature sintering of stents in traditional manufacturing processes, thus ensuring the magnetic performance of the minimally invasive surgical stent. Through model design, any surface of the minimally invasive surgical stent can have casting channels, which can be located on any one or multiple surfaces. The shape of the casting channels can be set arbitrarily as needed, such as triangles, polygons, circles, etc., and the size of the casting channels can be arbitrarily set according to the required magnetic force. Furthermore, the casting channels can be designed to be continuous or non-continuous, or continuous on some surfaces but non-continuous on others, depending on the degradation performance requirements. Simultaneously, the area of ​​the casting port relative to the surface of the casting channel and the mixing ratio of the casting slurry poured into the channel can be adjusted according to the specific mechanical and magnetic properties required. During minimally invasive surgery, doctors can apply an external magnetic field to manipulate a minimally invasive surgical stent, achieving the effect of assembling the stent inside the body. Furthermore, the structure of the minimally invasive surgical stent can be customized according to the shape and size of the patient's bone defect to ensure accuracy and fit. Its shape can be triangular, polygonal, circular, etc. Simultaneously, the assembled structure of the minimally invasive surgical stent can also be adjusted to suit the shape and size of the patient's bone defect.

[0033] Compared with the prior art, the present invention has the following advantages:

[0034] The device of this invention semi-automates the manufacturing of minimally invasive surgical stents. The entire manufacturing process only requires manual handling of loading and unloading, enabling a streamlined stent production process. Compared to traditional manufacturing methods, this process requires almost no physical labor, thus significantly reducing factory labor costs. Simultaneously, the automated production line ensures the production quality of the minimally invasive surgical stent. Furthermore, the produced minimally invasive surgical stent features adjustable casting channels and casting slurry, allowing for adjustments to the mechanical and magnetic properties of the stent according to patient needs. This device also perfectly solves the problem of iron tetroxide oxidation in the magnetic slurry caused by high-temperature sintering of stents in traditional manufacturing processes, thereby ensuring the magnetic performance of the minimally invasive surgical stent. In addition, this technology also solves the problem of the inability to mass-produce minimally invasive surgical stents. Attached Figure Description

[0035] Figure 1 This is a schematic diagram of a minimally invasive surgical stent manufacturing device according to the present invention;

[0036] Figure 2 This is a schematic diagram of the structure of the photopolymer printer of the present invention;

[0037] Figure 3 This is a schematic diagram of the transfer unit structure of the present invention;

[0038] Figure 4 This is a schematic diagram of the support tray structure of the present invention;

[0039] Figure 5 This is a schematic diagram of the positioning unit structure of the present invention;

[0040] Figure 6 This is a schematic diagram of the ingredient dispensing unit structure of the present invention;

[0041] Figure 7 This is a schematic diagram of the casting unit structure of the present invention;

[0042] Figure 8 This is a schematic diagram of the manufacturing process of a minimally invasive surgical stent according to the present invention;

[0043] Figure 9 This is a schematic diagram of the minimally invasive surgical stent structure of the present invention;

[0044] Figure 10 This is a frontal view of the minimally invasive surgical stent of the present invention;

[0045] Figure 11 This is a schematic cross-sectional view of the minimally invasive surgical stent of the present invention;

[0046] Figure 12 This is a schematic diagram of the circular minimally invasive surgical stent structure of the present invention;

[0047] Figure 13 This is a schematic diagram of the triangular minimally invasive surgical stent structure of the present invention;

[0048] Figure 14 This is a schematic diagram of the square minimally invasive surgical stent structure of the present invention.

[0049] In the diagram: 1 is the stent production module, 2 is the control module, 3 is the stent reprocessing module, 4 is the stent casting module, 5 is the stent transfer module, 6 is the minimally invasive surgical stent, 11 is the photopolymerization printer, 12 is the feeding area, 111 is the frame, 112 is the material trough, 113 is the vertical slide bar, 114 is the connecting rod, 115 is the flipping mechanism, 116 is the forming platform, 117 is the scraper, 118 is the ultraviolet light machine, 31 is the anhydrous ethanol cleaning unit, 32 is the drying unit, 33 is the high-temperature calcination unit, 34 is the cooling unit, 41 is the batching unit, and 42 is the connection unit. Units: 43 is the casting unit, 411 is the ceramic slurry tank, 412 is the magnetic slurry tank, 413 is the outlet, 414 is the mixing chamber, 415 is the mixing device, 431 is the guide rail, 432 is the casting device, 433 is the connecting block, 434 is the guide rail slider, 51 is the transfer unit, 52 is the picking robot, 511 is the support tray, 512 is the positioning unit, 513 is the chain conveyor belt, 514 is the motor, 5111 is the anti-collision block, 5121 is the stop block, 5122 is the positioning cylinder, 61 is the dense area, 62 is the casting channel, and 63 is the porous area. Detailed Implementation

[0050] The embodiments of the present invention are described in detail below. These embodiments are implemented based on the technical solution of the present invention and provide detailed implementation methods and specific operation processes. However, the scope of protection of the present invention is not limited to the following embodiments.

[0051] like Figure 1 As shown, a minimally invasive surgical stent manufacturing device includes: a stent production module 1, a stent reprocessing module 3, a stent casting module 4, a control module 2, and a stent transport module 5; the control module 2 controls the operation of the stent production module 1, the stent reprocessing module 3, the stent casting module 4, and the stent transport module 5, and the modules are seamlessly connected; the stent production module 1 is the first process; the stent reprocessing module 3 is located after the stent production module 1 and is the second process; the stent casting module 4 is located after the stent reprocessing module 3 and is the third process; the stent transport module 5 is adjacent to the stent production module 1, the stent reprocessing module 3, and the stent casting module 4 and transports the stents in the order of the processes.

[0052] like Figure 2As shown, the bracket production module 1 includes a photocurable printer 11 and a feeding area 12; the photocurable printer 11 includes a frame 111, an ultraviolet light machine 118 fixed at the lower part of the frame 111, a material trough 112 mounted on the frame 111 and located above the ultraviolet light machine 118, a scraper 117 mounted on the frame 111 and located outside the material trough 112, a vertical slide bar 113 mounted on the frame 111, a connecting rod 114 fixedly mounted on the vertical slide bar 113, a flipping mechanism 115 movably mounted on the connecting rod 114, and a forming platform 116 fixedly mounted below the flipping mechanism 115; the feeding area 12 is located on the outer side of the photocurable printer 11.

[0053] During operation, the worker pours bio-ink into the ink tank 112 in the feeding area 12. Then, one or more 3D models of the support structure can be imported into the control module 2. At this point, the photopolymer printer 11 is started, and the forming platform 116 automatically descends to a position 0.2mm from the bottom of the ink tank 112. Subsequently, the control module 2 causes the UV light machine 118 to project slice images of the model in a controlled manner based on the support model slices. After the first slice is printed, the forming platform 116 rises to the height of one slice thickness, and the scraper 117 descends to a position 0.1mm from the bottom of the ink tank 112. Then, the ink tank 112 rotates one revolution, and the scraper 117 rises to... After the first layer of this batch of brackets is printed, the above operation is repeated. For each layer that is cured, the connecting rod 114 will drive the forming platform 116 and the printed part to rise to the height of one slice of layer thickness. This process is repeated in a cycle until the printing is completed. After all the brackets in this batch are printed, the forming platform 116 automatically rises to the highest position. Then, the flipping mechanism 115 drives the forming platform 116 to flip 180 degrees so that the side with the brackets is facing up. After all the brackets are transferred to the bracket transfer module 5, the flipping mechanism 115 drives the forming platform 116 to flip 180 degrees back to the initial position. The above operation is repeated to start printing the next batch of brackets.

[0054] Furthermore, the bio-ink contains 60% to 70% bioactive or bioinert materials by mass percentage, with the remainder being photosensitive resin.

[0055] Furthermore, the bioactive material may be calcium magnesium phosphate, calcium silicate, tricalcium phosphate, or hydroxyapatite, etc.; the bio-inert material may be alumina, zirconium oxide, or silicon nitride, etc.

[0056] like Figure 1 and Figure 3As shown, the support transfer module 5 includes a transfer unit 51 and two picking robots 52; the transfer unit 51 includes a chain conveyor belt 513, a motor 514 fixedly installed below the chain conveyor belt 513, a support tray 511 placed on the chain conveyor belt 513, and three positioning units 512 fixedly installed below the chain conveyor belt 513; the two picking robots 52 are respectively fixedly installed between the support production module 1, the support reprocessing module 3 and the transfer unit 51, and the three positioning units 512 are respectively fixedly installed on the conveyor belt support near the two picking robots 52 and the support casting module 4.

[0057] During operation, when the previous process is completed, the nearest picking robot 52 transfers the bracket to the bracket tray 511 on the chain conveyor 513. Then, the positioning unit 512 releases the positioning, the motor 514 starts, and the chain conveyor 513 begins to work. When the bracket moves to the next process with the chain conveyor 513, the positioning unit 512 next to the nearest picking robot 52 automatically positions the bracket tray 511, the motor 514 stops working, and then the picking robot 52 picks up the bracket and moves it to the next process.

[0058] like Figure 4 As shown, the upper part of the support tray 511 has a groove, the shape of which is consistent with the support; its tail has a bumper block 5111.

[0059] During operation, the anti-collision block 5111 is used to prevent two adjacent support trays 511 from colliding.

[0060] like Figure 3 and Figure 5 As shown, the positioning unit 512 includes a positioning cylinder 5122 fixedly mounted on the conveyor belt support and a stop block 5121 mounted on the positioning cylinder 5122.

[0061] During operation, when the support tray 511 moves above the positioning unit 512, the positioning cylinder 5122 on the conveyor belt support drives the stop block 5121 to rise through the guide rod, so that the support tray 511 is positioned next to the picking robot 52.

[0062] Furthermore, the upper groove of the support tray 511 may have 3 grooves, or it may have 2 grooves, or even 1 groove.

[0063] like Figure 1 As shown, the stent reprocessing module 3 includes an anhydrous ethanol cleaning unit 31, a drying unit 32, a high-temperature calcination unit 33, and a cooling unit 34.

[0064] During operation, the control module 2 controls the picking robot 52 next to the bracket reprocessing module 3 to put the bracket into anhydrous ethanol for cleaning. After the bracket has been cleaned for 3 minutes, it is placed in a drying oven for drying. After drying, the bracket is placed in a calcining furnace for high-temperature calcination. After the high-temperature calcination is completed, the bracket is taken out and cooled.

[0065] Furthermore, the drying temperature is 50℃~60℃, the drying time is 1~2 hours, the high-temperature calcination temperature is 1050℃~1140℃, and the high-temperature calcination time is 5~8 hours.

[0066] like Figure 1 , Figure 6 and Figure 7 As shown, the support casting module 4 includes a batching unit 41, a connecting unit 42, and a casting unit 43. The batching unit 41 includes a bottom mixing chamber 414, a stirring device 415 installed at the bottom of the mixing chamber 414, a ceramic slurry tank 411 and a magnetic slurry tank 412 installed at the top of the mixing chamber 414, and two liquid outlets 413 respectively installed at the bottom of the ceramic slurry tank 411 and the magnetic slurry tank 412. The casting unit 43 includes a fixedly installed guide rail 431, a guide rail slider 434 installed on the guide rail 431, a connecting block 433 installed on the guide rail slider 434, and a casting device 432 installed on the connecting block 433, the positions of which correspond one-to-one with the grooves on the support tray 511. The connecting unit 42 connects the mixing chamber 414 of the batching unit 41 with the casting device 432 of the casting unit 43.

[0067] During operation, workers pour ceramic slurry and magnetic slurry into ceramic slurry tank 411 and magnetic slurry tank 412 respectively. Then, control module 2 sets the desired total volume of slurry and the proportion of magnetic slurry. After setting, control module 2 controls the opening time of the two outlets 413 at the bottom of ceramic slurry tank 411 and magnetic slurry tank 412 according to the set parameters. After both outlets 413 are closed, control module 2 activates the stirring device 415 at the bottom of the mixing chamber 414. After stirring for 1-3 hours, the slurry is poured. The material is conveyed to the pouring device 432 through the connecting unit 42. When the support tray 511 is transported to the front of the pouring unit 43 and positioned by the positioning unit 512, the guide rail slider 434 drives the pouring device 432 on the connecting block 433 to move forward, so that the pouring device 432 is inserted into the pouring channel 62 of the support. At this time, the control module 2 controls the pouring device 432 to pour. After the pouring is completed, the guide rail slider 434 drives the pouring device 432 on the connecting block 433 to move backward and return to the initial position. Then the positioning unit 512 releases the positioning and waits for the next pouring operation.

[0068] Furthermore, the ceramic slurry contains 50% to 60% by mass of calcium silicate or calcium magnesium phosphate, with the remainder being polyvinyl alcohol.

[0069] Furthermore, the magnetic slurry comprises 50% to 60% by mass of iron oxide powder, with the remainder being polyvinyl alcohol.

[0070] Furthermore, the particle size of the iron oxide powder is 20nm to 100nm.

[0071] like Figure 1 , Figure 8 and Figure 9 As shown, a method for manufacturing a minimally invasive surgical stent is characterized by comprising: establishing a three-dimensional model of the stent; performing layered slicing of the three-dimensional model of the stent to be manufactured using layering software; adding slurry to the feeding area 12 of the stent production module 1, and then controlling the photopolymerization printer 11 to print the stent by the control module 2; after printing, transporting the stent to the stent reprocessing module 3 via the stent transfer module 5 for sequential cleaning with anhydrous ethanol, drying, high-temperature calcination, and cooling; and then transporting the stent to the stent casting module 4 via the stent transfer module 5 for casting operation; and obtaining a minimally invasive surgical stent 6 after casting.

[0072] like Figure 9 , Figure 10 and Figure 11 As shown, the minimally invasive surgical stent 6 includes a porous region 63, a dense region 61, and casting channels 62. The casting port of the casting channel 62 is located at the center of any one or several sides of the minimally invasive surgical stent 6. The casting channel 62 can be continuous, non-continuous, or continuous on some sides but not on others. The area of ​​the casting port of the casting channel 62 occupies 20% to 40% of the area of ​​the side it is located on, and its shape can be triangular, polygonal, circular, etc. The dense region 61 surrounds the casting channel 62 and has a thickness of 0.3 mm to 1 mm, forming a dense structure. The porous region 63 is outside the dense region 61 and has a porosity of 50% to 70% and a pore size of 300 μm to 500 μm.

[0073] The specific process for manufacturing the minimally invasive surgical stent using the device of the present invention is as follows:

[0074] The first step involves workers pouring bio-ink into the material tank 112 in the feeding area 12. Then, one or more 3D models of the support structure can be imported into the control module 2. At this point, the photopolymer printer 11 is started, and the forming platform 116 automatically descends to a position 0.2mm from the bottom of the material tank 112. Subsequently, the control module 2 causes the UV light machine 118 to project slice images of the model in a controlled manner based on the support structure model slices. After the first layer of slices is printed, the forming platform 116 rises to the height of one slice thickness, and the scraper 117 descends to a position 0.1mm from the bottom of the material tank 112. Then, the material tank 112 rotates one full turn, and the scraper 117 rises. This completes the first layer printing of this batch of support structures. After printing is complete, the above operation is repeated. For each layer that is cured, the connecting rod 114 will lift the forming platform 116 and the printed part to the height of one slice of layer thickness. This process is repeated in a cycle until the printing is complete. After all the brackets are printed, the forming platform 116 automatically rises to the highest position. Then, the flipping mechanism 115 drives the forming platform 116 to flip 180 degrees so that the side with the bracket is facing up. After all the brackets are transferred to the bracket transfer module 5, the flipping mechanism 115 drives the forming platform 116 to flip 180 degrees back to the initial position. Then, the motor 514 starts, and the chain conveyor belt 513 starts working to move the bracket tray 511 to the second process.

[0075] Then, the second process begins. When the support tray 511, transferred from the first process, moves above the positioning unit 512 before the second process, the positioning cylinder 5122 on the conveyor belt support lifts the stop block 5121 via the guide rod, positioning the support tray 511. The motor 514 stops working, and the control module 2 controls the picking robot 52 next to the support reprocessing module 3 to put the support into anhydrous ethanol for cleaning. After the support has been cleaned for 3 minutes, it is placed in a drying oven for drying. After drying, the support is placed in a calcining furnace for high-temperature calcination. After high-temperature calcination, the support is taken out for cooling. After cooling, the control module 2 controls the picking robot 52 next to the support reprocessing module 3 to move the support back to the original support tray 511. Then, the positioning unit 512 releases the positioning, the motor 514 starts, and the chain conveyor belt 513 starts working, moving the support tray 511 to the third process.

[0076] Then, in the third process, the worker first pours the ceramic slurry and magnetic slurry into the ceramic slurry tank 411 and the magnetic slurry tank 412 respectively. Then, the control module 2 sets the desired total amount of slurry and the proportion of magnetic slurry. After setting, the control module 2 controls the opening time of the two outlets 413 at the bottom of the ceramic slurry tank 411 and the magnetic slurry tank 412 according to the set parameters. After both outlets 413 are closed, the control module 2 activates the stirring device 415 at the bottom of the mixing chamber 414. After stirring for 1-3 hours, the slurry is transported to the casting device 432 through the connecting unit 42, from the second process... When the support tray 511 transferred from the process moves above the positioning unit 512 before the third process, the positioning cylinder 5122 on the conveyor belt support drives the stop block 5121 to rise through the guide rod, positioning the support tray 511. The motor 514 stops working, and then the guide rail slider 434 drives the pouring device 432 on the connecting block 433 to move forward, so that the pouring device 432 is inserted into the pouring channel 62 of the support. At this time, the control module 2 controls the pouring device 432 to pour. After the pouring is completed, the guide rail slider 434 drives the pouring device 432 on the connecting block 433 to move backward and return to the initial position. At this time, the manufactured minimally invasive surgical support 6 can be obtained.

[0077] The minimally invasive surgical stent 6 can achieve the effect of being assembled inside the human body by controlling an external magnetic field through the following steps:

[0078] (1) Obtain the bone defect model structure of the patient's bone defect site through medical imaging equipment, and select the specific number, shape and size of the minimally invasive surgical stent 6 according to the bone defect model structure and the size of the patient's minimally invasive incision.

[0079] (2) Select an appropriate external magnetic field size based on the height difference between the upper and lower parts of the bone defect at the specific location in the patient's bone defect model structure, so that the external magnetic field applied outside the patient can attract the minimally invasive surgical stent 6 and move it under this height difference.

[0080] (3) The minimally invasive surgical stent 6 is placed into the bone defect area of ​​the patient through the minimally invasive surgical incision. Then, a suitable external magnetic field is applied outside the patient and the external magnetic field is positioned directly above the minimally invasive surgical stent 6 to control the movement of the minimally invasive surgical stent 6 to a suitable position. When the minimally invasive surgical stent 6 is moved to the suitable position, the external magnetic field is removed, and then the next minimally invasive surgical stent 6 is placed in and the above operation is repeated so that several minimally invasive surgical stents 6 are assembled layer by layer in the order from left to right, from top to bottom, and from low to high.

[0081] (4) Each time the operation of step (3) above is repeated to manipulate the minimally invasive surgical stent 6 through the external magnetic field, the magnitude of the external magnetic field needs to be adjusted according to the height difference between the upper and lower parts of the bone defect in the specific location of the bone defect model structure in the patient, so as to meet the requirements of step (2).

[0082] (5) After the entire minimally invasive surgical stent 6 is assembled, its overall shape and size are consistent with the shape and size of the patient's bone defect.

[0083] Example 1

[0084] The specific process of manufacturing a minimally invasive surgical stent using the device of the present invention is as follows: First, the worker pours bio-ink into the material tank 112 in the feeding area 12 of the stent production module 1. Then, the stent model designed according to the shape and size of the patient's injury is imported into the control module 2, and the photopolymerization printer 11 is started to print the stent. After the stent is printed, it is transported by the stent transfer module 5 to the stent reprocessing module 3 for stent reprocessing. After anhydrous ethanol cleaning, drying, high-temperature calcination, and cooling, the stent is transported by the stent transfer module 5 to the stent casting module 4 for casting. The worker pours ceramic slurry and magnetic slurry into the ceramic slurry tank 411 and magnetic slurry tank 412 of the mixing unit 41, respectively. Then, the total amount of casting slurry to be configured and the proportion of magnetic slurry are set in the control module 2. After the setting is completed, the mixing unit 41 automatically configures the casting slurry. After the casting slurry is configured, it is transported to the casting unit 43 through the connecting unit 42 for casting the stent. After casting, the manufactured minimally invasive surgical stent 6 is obtained. This stent can be manipulated by an external magnetic field during minimally invasive surgery to achieve the effect of assembling a stent inside the body, such as... Figure 12 , Figure 13 and Figure 14 The circles, triangles, and quadrilaterals shown are used to fill and repair bone defects.

[0085] The above description is only a part of the specific embodiments of the present invention, but the protection scope of the present invention is not limited thereto. Any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the protection scope of the present invention.

Claims

1. A minimally invasive surgical stent manufacturing device, characterized in that: The support includes a support production module (1), a support reprocessing module (3), a support casting module (4), a control module (2), and a support transfer module (5); the control module (2) is used to control the operation of the support production module (1), the support reprocessing module (3), the support casting module (4), and the support transfer module (5). The bracket production module (1) includes a photopolymer printer (11) and a material loading area (12); The feeding area (12) is used to add bio-ink. The bio-ink enters the photopolymerization printer (11) through the feeding area (12) for printing to obtain product one. The stent transfer module (5) is used to transport product one to the stent reprocessing module (3) for processing to obtain product two. Product two is transported through the stent transfer module (5) to the stent casting module (4) for processing to obtain a minimally invasive surgical stent (6). The bio-ink is composed of biomaterials and photosensitive resin, wherein the biomaterials comprise 60% to 70% by mass; the biomaterials include bioactive materials and bioinert materials. The bracket transfer module (5) includes a transfer unit (51) and two picking robots (52), named Robot One and Robot Two, respectively. The transfer unit (51) includes a chain conveyor belt (513), which is driven by a motor (514). A bracket tray (511) is placed on the chain conveyor belt (513). The chain conveyor belt (513) is supported by a conveyor belt bracket. Three positioning units (512) are fixedly installed on the conveyor belt bracket, named Positioning Unit One, Positioning Unit Two, and Positioning Unit Three, respectively. Robot One is installed in the corresponding position of the bracket production module (1), and Robot Two is installed in the corresponding position of the bracket reprocessing module (3). The positions of positioning unit one and positioning unit two correspond to the positions of robot arm one and robot arm two, respectively; the position of positioning unit three corresponds to the position of the support casting module (4).

2. The minimally invasive surgical stent manufacturing device according to claim 1, characterized in that: The light curing printer (11) includes a frame (111), a material trough (112) is provided on the frame (111), an ultraviolet light machine (118) is provided below the material trough (112), a scraper (117) is provided on the frame (111), the position of the scraper (117) corresponds to the position of the material trough (112), a vertical slide bar (113) is provided on the frame (111), a connecting rod (114) is provided on the vertical slide bar (113), a flipping mechanism (115) is provided on the connecting rod (114), and a forming platform (116) is provided below the flipping mechanism (115).

3. The minimally invasive surgical stent manufacturing device according to claim 1, characterized in that: The upper part of the support tray (511) has several grooves, and the rear part of the support tray (511) has a bumper block (5111).

4. The minimally invasive surgical stent manufacturing device according to claim 1, characterized in that: The positioning unit (512) includes a positioning cylinder (5122) fixedly installed on the conveyor belt support, and a stop (5121) that can move with the piston is installed on the positioning cylinder (5122).

5. The minimally invasive surgical stent manufacturing device according to claim 1, characterized in that: The support reprocessing module (3) includes an anhydrous ethanol cleaning unit (31), a drying unit (32), a high-temperature calcination unit (33), and a cooling unit (34).

6. The minimally invasive surgical stent manufacturing device according to claim 5, characterized in that: The drying unit (32) has a drying temperature of 50℃~60℃ and a drying time of 1~2 hours. The high-temperature calcination unit (33) has a high-temperature calcination temperature of 1050℃~1140℃ and a high-temperature calcination time of 5~8 hours.

7. The minimally invasive surgical stent manufacturing device according to claim 1, characterized in that: The support casting module (4) includes a material dispensing unit (41), a connecting unit (42), and a casting unit (43); The batching unit (41) includes a mixing chamber (414), a mixing device (415) is provided at the bottom of the mixing chamber (414), a ceramic slurry tank (411) and a magnetic slurry tank (412) are provided above the mixing chamber (414), and a liquid outlet (413) is provided at the bottom of both the ceramic slurry tank (411) and the magnetic slurry tank (412). The ceramic slurry tank (411) and the magnetic slurry tank (412) are respectively connected to the mixing chamber (414) through their respective liquid outlets (413). The ceramic slurry is composed of salts and polyvinyl alcohol, wherein the salts account for 50% to 60% by mass; the salts are calcium silicate salts or calcium magnesium phosphates. The magnetic slurry is composed of ferric oxide powder and polyvinyl alcohol, wherein the ferric oxide powder has a mass percentage content of 50% to 60% and a particle size of 20 nm to 100 nm. The casting unit (43) includes a guide rail (431), a guide rail slider (434) is mounted on the guide rail (431), a connecting block (433) is provided on the guide rail slider (434), and a casting device (432) is provided on the connecting block (433), the position of which corresponds to the groove on the support tray (511); the connecting unit (42) connects the mixing chamber (414) and the casting device (432).

8. A method for manufacturing a minimally invasive surgical stent, using the minimally invasive surgical stent manufacturing apparatus as described in any one of claims 1 to 7, characterized in that, include: The bone defect model structure of the patient's bone defect site is obtained through medical imaging equipment, and the specific number, shape and size of the minimally invasive surgical stent (6) are determined according to the bone defect model structure and the size of the patient's minimally invasive incision. A three-dimensional model of the scaffold is created, and the three-dimensional model of the scaffold is sliced ​​into layers using layering software. After adding bio-ink to the feeding area (12) of the stent production module (1), the control module (2) controls the photopolymer printer (11) to print the stent. After printing, the stent is transported to the stent reprocessing module (3) through the stent transfer module (5) to be cleaned with anhydrous ethanol, dried, calcined at high temperature, and cooled in sequence. After cooling, the stent is transported to the stent casting module (4) through the stent transfer module (5) to be cast. After casting, a minimally invasive surgical stent (6) is obtained.

9. The minimally invasive surgical stent manufactured by the method of manufacturing a minimally invasive surgical stent according to claim 8, characterized in that: The minimally invasive surgical stent (6) includes a porous region (63), a dense region (61), and a casting channel (62). The casting channel (62) is located inside the minimally invasive surgical stent (6). The casting port of the casting channel (62) is opened on the surface of the minimally invasive surgical stent (6), and the area of ​​the casting port of the casting channel (62) accounts for 20% to 40% of the area of ​​the surface. The dense region (61) is wrapped around the outside of the casting channel (62) and has a thickness of 0.3 mm to 1 mm. The porous region (63) is wrapped around the outside of the dense region (61) and has a porosity of 50% to 70% and a pore size of 300 μm to 500 μm. The casting channel (62) is filled with a casting slurry made by mixing magnetic slurry and ceramic slurry.

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