CN115091776A - Personalized silica gel valve and manufacturing method of calcified silica gel valve physical model - Google Patents

Personalized silica gel valve and manufacturing method of calcified silica gel valve physical model Download PDF

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CN115091776A
CN115091776A CN202210749599.3A CN202210749599A CN115091776A CN 115091776 A CN115091776 A CN 115091776A CN 202210749599 A CN202210749599 A CN 202210749599A CN 115091776 A CN115091776 A CN 115091776A
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valve
model
calcified
silica gel
manufacturing
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CN115091776B (en
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迟青卓
王文君
尹凯
刘巍
颜文涛
母立众
庄熙晶
贺缨
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Dalian University of Technology
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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C69/00Combinations of shaping techniques not provided for in a single one of main groups B29C39/00 - B29C67/00, e.g. associations of moulding and joining techniques; Apparatus therefore
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C33/00Moulds or cores; Details thereof or accessories therefor
    • B29C33/38Moulds or cores; Details thereof or accessories therefor characterised by the material or the manufacturing process
    • B29C33/3842Manufacturing moulds, e.g. shaping the mould surface by machining
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C33/00Moulds or cores; Details thereof or accessories therefor
    • B29C33/44Moulds or cores; Details thereof or accessories therefor with means for, or specially constructed to facilitate, the removal of articles, e.g. of undercut articles
    • B29C33/52Moulds or cores; Details thereof or accessories therefor with means for, or specially constructed to facilitate, the removal of articles, e.g. of undercut articles soluble or fusible
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C41/00Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor
    • B29C41/02Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor for making articles of definite length, i.e. discrete articles
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C41/00Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor
    • B29C41/02Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor for making articles of definite length, i.e. discrete articles
    • B29C41/14Dipping a core
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/48Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor using adhesives, i.e. using supplementary joining material; solvent bonding
    • GPHYSICS
    • G09EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
    • G09BEDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
    • G09B23/00Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes
    • G09B23/28Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes for medicine
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29LINDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00Other particular articles
    • B29L2031/40Test specimens ; Models, e.g. model cars ; Probes

Abstract

The invention belongs to the technical field of surgical medical training equipment, and provides a method for manufacturing a personalized silica gel valve and a calcified silica gel valve physical model. The modeling method of the invention improves the technical problem that the valve can be opened and closed difficultly because the model is manufactured by the early spin coating method. Meanwhile, the technical defects of air bubbles and cavities produced by the valve are avoided. The method can well manufacture the aortic model containing the valve or the calcified valve in real size, and obviously improves the clinical application and experimental research value of the model. The model making method can be applied to the fields of clinical training, medical teaching, aortic stenosis and the like to realize multiple new applications with more practical values.

Description

Method for manufacturing personalized silica gel valve and calcified silica gel valve physical model
Technical Field
The invention belongs to the technical field of surgical medical training equipment, and relates to a method for manufacturing a personalized silica gel valve and a calcified silica gel valve physical model.
Background
AS the average life span of human beings increases, the number and proportion of elderly people increase, and the incidence of Aortic Valve Disorders (AVD) represented by Aortic Valve Stenosis (AS) and Aortic Valve regurgitant (AR) also gradually increases, becoming a major Disease threatening to human health. Prevalence of over moderate AS is 2-4% in developed countries >65 years old. According to research and prediction, the population over 65 years old in China is around 2050 years old or reaches about 4.98 hundred million people, the detection rate of more moderate AS is 0.6-1.4% and the detection rate of more moderate AR is about 2.1-2.8% in the population over 65 years old in China. Is the most common cardiovascular disease that occurs after coronary heart disease and hypertension.
Aortic valve calcification is a significant cause of the development of such aortic valve disorders. Turbulence may occur in the form of flushing flow of blood in the ascending aorta due to calcification. Under normal conditions, there is some physiological swirl in the flow field from the ascending aorta to the interior of the aortic arch. The spiral blood flow is probably formed along with the development of the heart pulsation blood ejection process, and the spiral flow which is induced spontaneously or artificially has potential prevention effect on the occurrence of arteriosclerosis, thereby providing a specific improvement direction for the structural optimization of a plurality of medical devices.
In vitro experiments are one of the important methods for studying flow disturbances in the ascending aorta caused by aortic valve calcification. In the in vitro experiment, pulsating fluid is intermittently injected into an experiment chamber, and when the pulsating fluid passes through an aortic valve or an aortic valve with a narrow structure, the valve structure is automatically opened and closed. Researchers and related industries can study the working state of the valve or calcified valve, and the flow condition in the aortic cavity after the artificial valve stent is placed.
However, in vitro experiments show that the preparation of aortic valves and aortic valves containing calcification is one of the difficult problems in the industry. First, it was shown that the change in ascending aortic flow pattern with changes in aortic valve obliquity led to experimental studies in vitro with PIV and that a deviation of only 8 ° of aortic incidence angle might cause an increase of 40% in the flow impact force on the aortic wall, indicating that accurate reconstruction of aortic valve geometry is one of the difficulties of this work. Secondly, the valve should have good compliance to achieve autonomous opening and closing under pulsatile flow. Finally, for in vitro experiments, the aortic valve (or calcified valve) should be in close proximity to the aortic sinus, and should remain in close proximity to the aortic sinus canal even if the vessel wall expands radially under blood pressure.
The aortic valve-sinotubular model meeting the points can be better convenient for relevant practitioners in the academic and industrial fields to carry out a series of research works related to aortic valve flow experiments, valve calcification flow experiments, stent expansion experiments and the like. The method helps to clinically stratify risks of suspected high-risk patients with difficulty in determining treatment strategies in aortic valve calcification patients, and provides experimental basis for making clinical treatment strategies.
The patent application: a method for making a personalized transparent silica gel model based on soluble materials, application No. 201811194119.1. This patent does not give a coating method to achieve a specified thickness of the silica gel layer. The aortic or intracardiac valves obtained from the CT images may be in a closed state, and the patent does not mention a method if two unconnected vessel cavities are modeled. And the patent does not mention modeling methods of calcified valve features including valve features.
The patent application: a method for manufacturing a human bionic blood vessel by combining 3D printing with an overturning mold process, which has application number 201910484639.4. The patent adopts the method of manufacturing the blood vessel model by the female mold male mold, and when the blood vessel containing the valve structure is manufactured, the problem of air bubbles staying at the valve volume part is difficult to solve. And when the soluble consumable material is adopted to manufacture a valve type film structure by a male-female die method, the matching precision of the male-female die is difficult to control because the male-female die needs to be smoothly processed. Also, this method does not mention valve fabrication methods involving calcification features.
The patent application: a heart valve model and a manufacturing method thereof, with the application number of 202210032137. X. The patent adopts a mould casting method to manufacture a silica gel heart model containing the valve, focuses on the reproduction of pathological anatomical structures, does not mention the manufacturing tendency of the opening and closing functions of the heart valve, and does not mention the functional manufacturing tendency facing in-vitro experimental use. No mention is made of valve making methods involving calcification.
Disclosure of Invention
The invention aims to solve the technical problem of providing a method for manufacturing a simulated model containing an aortic valve or a calcified aortic valve, wherein the valve model manufactured by the method can be opened and closed like a physiological valve structure under the environment with pressure pulsation change, and the valve model related to calcification has the same position characteristics and geometric shape characteristics as CT data of a patient.
The technical scheme of the invention is as follows:
a method for manufacturing a personalized silica gel valve and a calcified silica gel valve physical model comprises the following steps:
(1) extracting an aortic sinus intracavity structure in the CT image, and manufacturing an aortic sinus vessel model for manufacturing blood vessels and a model of ventricular outflow tract-valve inflow tract for manufacturing valves; manufacturing an extra-extended valve leaflet extension part on one valve leaflet of the valve inflow passage for manufacturing the valve leaflet with the fixed thickness;
(2) designing a positioning mark between the two models obtained in the step (1), wherein the positioning mark of the sinotubular model is a convex structure, the positioning structure of the valve is a concave structure, and the positioning mark is arranged at the root of the proximal end of the outflow tract of the valve;
designing a calcified valve auxiliary positioning mould according to the calcified position and the calcified structure of the valve, and positioning the valve structure and the calcified structure in the bonding process;
the geometric structure of the calcified valve auxiliary positioning mould is the same as the valve structure, and the calcified valve auxiliary positioning mould does not contain positions where calcifications are involved; the number of the calcified valve auxiliary positioning moulds is the same as that of valve leaflets of the valve, the edges of the calcified valve auxiliary positioning moulds are consistent with the outlines of the corresponding valve leaflets, and holes on the calcified valve auxiliary positioning moulds are consistent with positions on the valve leaflets where calcifications are accumulated; the edge of the calcified valve auxiliary positioning mould is used for aligning and positioning with valve leaflets of the valve, and the edge of a hole in the calcified valve auxiliary positioning mould is used for marking a cutting area of the valve and assisting the positioning of a calcified structure on the valve;
(3) manufacturing a calcification model of the valve, and manufacturing a pouring cavity mold according to the calcification model;
(4) manufacturing the sinotubular model and the ventricular outflow tract-valve inflow tract model in the step (1) by a 3D printing method by using soluble materials; scaling the depth and width of the positioning mark in the step (2) by 5% to ensure the size positioning between the valve manufactured by the model of ventricular outflow tract-valve inflow tract and the blood vessel manufactured by the sinotubular model; manufacturing a pouring calcification model by using a soluble material; manufacturing a calcified valve auxiliary positioning mould by using a flexible material or a hard 3D printing material;
(5) manufacturing a thickness measurement calibration point on the outer side of the aortic sinus duct by using a marking pen, and realizing the thickness-fixed manufacturing of the aortic sinus duct model by using a brushing-silica gel removal and thickness measurement method; for the model of 'ventricular outflow tract-valve inflow tract', because the thickness measurement of the 'ventricular outflow tract-valve inflow tract' is difficult, a constant pressure blowing method is adopted, after silica gel is coated on the surface of the model of 'ventricular outflow tract-valve inflow tract', high-pressure airflow of more than 2MPa is blown out of the inner wall surface of the model of 'ventricular outflow tract-valve inflow tract' by an air compressor and a spray gun, and the thickness of the valve is measured by the valve leaflet extension part prepared in the step (1); for the calcified structure, punching a hole at the top of a cavity die, and then immersing the calcified structure into silica gel liquid for vacuum foam pumping to promote the silica gel liquid to be fully filled in the cavity die;
(6) when the thickness of the silica gel prepared in the step (4) reaches the design requirement, ultrasonic cleaning is adopted to accelerate the dissolution of the aortic sinotubular model, the valve model and the calcification model; cutting the valve obtained in the step (4) according to the calcified valve auxiliary positioning mould, assembling the calcified model obtained by casting in the step (4) with the valve with the help of the calcified valve auxiliary positioning mould, and bonding the calcified model and the valve by adopting silica gel;
(7) and (3) assembling the aortic sinotubular model and the valve obtained in the step (6) by using the positioning mark manufactured in the step (2) and bonding the aortic sinotubular model and the valve by using silica gel to prepare the calcified valve sinotubular model.
After the step (6) is finished, according to the use requirements of the test bed, the inner cavities of the calcified valve sinotubular model on the ventricular outflow tract side and the ascending aorta side are subjected to functional inner wall silica gel coating manufacture; and (5) after the step (6) is finished, additionally trimming the opening and closing size and area of the valve according to the use requirement of the test bed.
When the valve is used in an in vitro experiment environment, the valve can be automatically opened, closed and closed due to the induction of the trans-valve pressure difference.
The invention has the beneficial effects that:
(1) the design of the leaflet extensions makes it possible to make a valve in the inner region thick.
(2) The valve and the aortic sinus canal are manufactured in a split mode, the advantages of a spin coating method in manufacturing membrane structures can be respectively exerted, the valve opening and closing model for in-vitro experiment purposes is manufactured, and the problem of air bubble holes easily occurring at the valve when only the aortic sinus canal containing valve-shaped gaps is used for manufacturing is avoided.
(3) The positioning mark can accurately and reliably position the valve and the sinotubular.
(4) Personalized valve calcification structure manufacturing can be realized, and the hardness of a calcification model can be adjusted by additionally designed silicone oil or other additives.
(5) The accuracy of the position of calcification on the valve structure can be guaranteed through the manufacturing of the calcification valve auxiliary positioning die, and the valve can be matched with the hard calibration die for use if the valve is thin, so that the valve can be conveniently pasted.
(6) Since valve thickness is critical in vitro experimental studies, a just shaped valve is likely to be difficult to actually open and close by itself in an in vitro test rig. The blowing high-pressure air is removed to remove more silica gel, so that the thickness uniformity of valve manufacturing can be ensured, the thickness of each part of the film is increased more uniformly, the configuration that the root part of the valve is thick and the top part of the valve is thin is avoided, and the in vitro experimental research is easier. In addition, the valve of the "leaflet extension" creates a thickness monitoring effect. When the excess glue solution is blown to the valve leaf extension part by the blowing method, the silica gel liquid drops in the extension part can be more easily taken away from the model by high-speed airflow due to the flow field characteristics, so that the thickness control of valve manufacturing is particularly effective.
(7) After the valve model is manufactured according to the method, the size and the area of the opening and closing of the valve can be additionally trimmed according to the use requirement of the test bed. Such model modifications modify the valve opening size, and thus may also enable changes to the model cross-valve pressure differential.
Drawings
Fig. 1 is a schematic cut-away view of the aortic sinus duct inner core (grey) and outer wall attached silicone membrane (white).
Figure 2 is a schematic view of a cutaway (grey) of the valve structure housing.
Detailed Description
The following detailed description of the invention refers to the accompanying drawings.
The valve model inner core of the method can be reconstructed based on a medical image model, and can also be a simplified geometric structure based on clinical data modeling. The 3D printing of the valve model inner core can adopt PVA and other printing consumables which are water-soluble or have solubility. The valve model inner core may be further surface smoothed. The valve model after printing and smoothing is fixed on a rotating device for making a bottom coating.
The valve part and the sinotubular part of the valve model are manufactured respectively. The sinus canal part is manufactured by combining a brushing method for measuring thickness, and the thickness data of the silica gel layer at a specific position is obtained by adopting a mode of measuring the thickness change of each layer of silica gel at a fixed position after the silica gel layer is solidified.
Valve structure is extracted from the CT data, preferably at systolic phase. The geometric features of the ventricular outflow tract-valve inflow tract are reconstructed in imaging reconstruction software such as Mimic or Simpleware. The geometric file is stored as STL or other three-dimensional geometric models and is led into geometric topological software, such as UG, Solidwords, Spaceclaim and the like.
Taking Spaceclaim as an example, geometrically thickening a ventricular outflow tract and a valve inflow tract, wherein the thickened thickness is designed valve thickness, making a thickened geometric file into a solid model by adopting a 3D printing mode, and designing artificial handles and other structures at the periphery or end face of the model for clamping.
And coating a silica gel layer on the inner side of the thickened model of the ventricular outflow tract-valve inflow tract obtained by 3D printing. The silica gel layer is dipped or dripped, and after the silica gel layer is completely attached to the valve area, a high-pressure air gun is used for blowing the inner cavity of the ventricular outflow tract-valve inflow tract, so that redundant silica gel droplets are carried away from the inner cavity of the model by high-pressure air flow.
And drying the model of the ventricular outflow tract-valve inflow tract at 45 ℃ to promote the curing of the silica gel in the inner cavity, and then carrying out the silica gel coating preparation again. And monitoring the thickness increment of the middle part of the valve by adopting a thickness measuring instrument, and dissolving the valve mould when the thickening of the silica gel layer reaches the design thickness.
Bonding the valve structure and the sinotubular structure. In order to ensure that the valve structure and the sinotubular structure are smoothly bonded, concave or convex structures for positioning can be optionally manufactured on the outer surface and the inner surface of the sinotubular and the valve mould. The bonding is still performed using a silica gel solution.
And after the valve is bonded, the model is subjected to functional coating manufacture for protecting the inner wall, and the number of manufacture layers is determined by the working pressure-bearing environment of the valve.
When the aortic valve relates to a calcified structure, a calcified valve auxiliary positioning mould is manufactured particularly for calcified features, the mould is manufactured into a solid model in a 3D printing mode, and the valve is attached to the mould to carry out calcified affected position marking. And (3) cutting off a calcification mark area on the valve model in a pressing manner by using an annular cutter. Obtaining the valve model hollowed out due to calcification.
And (4) independently extracting calcified structures on the aortic valve, and manufacturing a pouring shell. And immersing the shell into a silica gel liquid pool for bubble extraction to prepare the calcified plaque with silica gel texture. Physical parameters such as color and hardness of calcification can be controlled by silica gel coloring agent, silica gel type, silicone oil content and other additives.
And taking the calcified shell cast with the silica gel out of the solidified silica gel liquid pool, and dissolving the shell to obtain the silica gel calcified structure. And attaching the calcified structure to the hollowed-out valve model through a mold, and bonding the calcified structure and the hollowed-out valve model by adopting silica gel.
The region from the left ventricular inflow tract to the ascending aorta containing the aortic valve was extracted from the medical image and modeled in reverse. And copying and storing the modeled model to obtain an aortic sinotubular model and a model of ventricular outflow tract-valve inflow tract. For the sinotubular aortic model, the valve and possibly the calcified structures are filled and the protruding structures of the positioning markers are made. Copying a positioning structure to a model of ventricular outflow tract-valve inflow tract, extracting the outer contour of a valve structure in geometric modeling software such as Ansys Spaceclaim, thickening the outer contour to the designed thickness of the valve, and manufacturing the outer contour into a solid model. And extracting specific positions of calcification affected valves and manufacturing a calibration mould of the calcification affected valves. And (4) extracting a calcification model, and manufacturing a calcified soluble pouring cavity through the shell of the calcification model.
By a 3D printing technology, a soluble inner core of a model of ventricular outflow tract-valve inflow tract, a soluble outer shell of the model of ventricular outflow tract-valve inflow tract and a calcified valve auxiliary positioning mould are manufactured. And manufacturing a silica gel coating on the surface of the model by adopting a silica gel spin-coating method until the sinus canal and the valve reach the specified thickness. And pouring the calcification model, and placing the calcification model into a water bath environment for dissolving after all models are solidified.
And cutting the valve by using the calcified valve auxiliary positioning mould, and adhering the calcified structure on the calcified model.
The sinotubular aortic model and the ventricular outflow tract-valve inflow tract model are bonded by using the positioning structure between the sinotubular model and the valve model.
According to the requirements of specific experiments, the functional inner wall silica gel coating is made on the ascending aorta part of the sinotubular.
The valve opening size is modified as required by the particular experiment.
Compared with the existing method for manufacturing the personalized transparent silica gel model, the method for manufacturing the aortic sinus duct can manufacture the aortic sinus duct containing the valve, and the valve structure can be automatically opened and closed in an in-vitro experiment table according to the trans-valve pressure.
The calcification position of the manufactured aortic calcification valve is the same as the personalized physiological characteristics on the model structure, the technical realization is easier, the aortic calcification valve is more in line with a solid model, and more important references can be provided for multiple purposes such as operation, scientific research and teaching.
The above embodiments and drawings are not intended to limit the form and style of the product of the present invention, and any suitable changes or modifications thereof by one of ordinary skill in the art should be considered as not departing from the scope of the present invention.

Claims (3)

1. A method for manufacturing a personalized silica gel valve and a calcified silica gel valve physical model is characterized by comprising the following steps:
(1) extracting an aortic sinus intracavity structure in the CT image, and manufacturing an aortic sinus vessel model for manufacturing blood vessels and a model of ventricular outflow tract-valve inflow tract for manufacturing valves; manufacturing an extra-extended valve leaflet extension part on one valve leaflet of the valve inflow passage for manufacturing the valve leaflet with the fixed thickness;
(2) designing a positioning mark between the two models obtained in the step (1), wherein the positioning mark of the sinotubular model is a convex structure, the positioning structure of the valve is a concave structure, and the positioning mark is arranged at the root of the proximal end of the outflow tract of the valve;
designing a calcified valve auxiliary positioning mould according to the calcified position and the calcified structure of the valve, and positioning the valve structure and the calcified structure in the bonding process;
the geometry of the calcified valve auxiliary positioning mould is the same as the valve structure, and the calcified valve auxiliary positioning mould does not contain calcified positions; the number of the calcified valve auxiliary positioning moulds is the same as that of valve leaflets of the valve, the edges of the calcified valve auxiliary positioning moulds are consistent with the outlines of the corresponding valve leaflets, and holes on the calcified valve auxiliary positioning moulds are consistent with the positions of calcified valve leaflets; the edge of the calcified valve auxiliary positioning mould is used for aligning and positioning valve leaflets of the valve, and the edge of a hole in the calcified valve auxiliary positioning mould is used for marking a cutting area of the valve and assisting the positioning of a calcified structure on the valve;
(3) manufacturing a calcification model of the valve, and manufacturing a pouring cavity mold according to the calcification model;
(4) manufacturing a sinotubular model and a ventricular outflow tract-valve inflow tract model in the step (1) by using a soluble material through a 3D printing method; scaling the depth and width of the positioning mark in the step (2) by 5% to ensure the size positioning between the valve manufactured by the model of ventricular outflow tract-valve inflow tract and the blood vessel manufactured by the sinotubular model; manufacturing a pouring calcification model by using a soluble material; manufacturing a calcified valve auxiliary positioning mould by using a flexible material or a hard 3D printing material;
(5) manufacturing a thickness measurement calibration point on the outer side of the aortic sinus duct by using a marking pen, and realizing the thickness-fixed manufacturing of the aortic sinus duct model by using a brushing-silica gel removal and thickness measurement method; for the model of 'ventricular outflow tract-valve inflow tract', because the thickness measurement of the 'ventricular outflow tract-valve inflow tract' is difficult, a constant pressure blowing method is adopted, after silica gel is coated on the surface of the model of 'ventricular outflow tract-valve inflow tract', high-pressure airflow of more than 2MPa is blown out of the inner wall surface of the model of 'ventricular outflow tract-valve inflow tract' by an air compressor and a spray gun, and the thickness of the valve is measured by the valve leaflet extension part prepared in the step (1); for the calcified structure, punching a hole at the top of a cavity die, and then immersing the calcified structure into silica gel liquid for vacuum foam pumping to promote the silica gel liquid to be fully filled in the cavity die;
(6) when the thickness of the silica gel prepared in the step (4) reaches the design requirement, ultrasonic cleaning is adopted to accelerate the dissolution of the aortic sinus canal model, the valve model and the calcification model; cutting the valve obtained in the step (4) according to the calcified valve auxiliary positioning mould, assembling the calcified model obtained by casting in the step (4) with the valve with the help of the calcified valve auxiliary positioning mould, and bonding the calcified model and the valve by adopting silica gel;
(7) and (3) assembling the aortic sinotubular model and the valve obtained in the step (6) by using the positioning mark manufactured in the step (2) and bonding the aortic sinotubular model and the valve by using silica gel to prepare the calcified valve sinotubular model.
2. The manufacturing method of claim 1, wherein after the step (6) is finished, functional inner wall silica gel coating is manufactured on the inner cavity of the ventricular outflow tract side and the ascending aorta side of the sinus duct of the calcified valve sinus duct model valve according to the use requirement of a test bench; and (5) after the step (6) is finished, additionally trimming the opening and closing size and area of the valve according to the use requirement of the test bed.
3. The silica gel valve model and the calcified silica gel valve model manufactured by the manufacturing method according to claim 1 or 2, wherein the valve can be opened and closed spontaneously due to the induction of the trans-valve pressure difference when the valve is used in an in vitro experiment environment.
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