CN115709153A - Integrated manufacturing method and device for durable artificial heart valve - Google Patents
Integrated manufacturing method and device for durable artificial heart valve Download PDFInfo
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- CN115709153A CN115709153A CN202211356948.1A CN202211356948A CN115709153A CN 115709153 A CN115709153 A CN 115709153A CN 202211356948 A CN202211356948 A CN 202211356948A CN 115709153 A CN115709153 A CN 115709153A
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Abstract
The invention discloses an integrated manufacturing method and device of a durable artificial heart valve, wherein the method comprises the following steps: providing a valve frame and a mandrel; the clamping and rotating unit clamps the mandrel and moves to the position above the dip-coating unit, and the valve leaf end is always upward; the clamping and rotating unit vertically moves downwards at the speed of 1-10mm/s to immerse the valve frame and the mandrel into the polymer solution, and the liquid level of the polymer solution stops when reaching the transverse line part of the mandrel; the clamping and rotating unit moves vertically upwards at the speed of 1-10mm/s to lift the valve frame coated and formed with the valve leaflets out of the polymer solution, and the dip coating process is completed; the negative pressure drying unit dries the valve frame coated and molded with the valve leaves, the drying temperature is 30-120 ℃, and the negative pressure range is 1-50kPa; and after drying, separating the valve frame coated and formed with the valve leaflets from the mandrel to obtain the durable artificial heart valve. The one-step type upright plastic dipping accelerates and simplifies the process, and the prepared valve leaf does not need to be cut at the later stage.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to an integrated manufacturing method and device of a durable artificial heart valve.
Background
With the increasing pace of life, the decreasing environmental quality, the aging population and other problems, the number of patients with valvular heart diseases is increasing year by year. According to the survey results of cardiovascular health and disease reports in China, more than 2500 million heart valve disease patients in China in 2010 are shown, and the number of people is predicted to increase to 4000 million people by 2025. At present, the artificial heart valve replacement is the best means for treating heart valve diseases, however, only 1-2% of patients in our country receive surgical intervention due to low cognition rate and high treatment price.
To date, the heart valve prostheses widely used in clinical applications mainly include both mechanical valves and biological valves. The mechanical valve is made of pyrolytic carbon material, the service life of the mechanical valve can be more than 30 years, but a patient implanted with the mechanical valve must receive long-term anticoagulation treatment, and the risk of infection of the patient with the artificial valve endocarditis is high. The biological valve is prepared by fixing porcine or bovine pericardium through glutaraldehyde, has good hemodynamic performance, low thrombosis incidence and no need of lifelong anticoagulation; however, biological valves have a limited life span, and tissue is subject to degradation and calcification after prolonged use, and the patient may be at risk of re-surgical valve replacement.
In recent years, polymeric prosthetic heart valves can have both excellent mechanical properties and blood compatibility, and are a promising and more affordable alternative to mechanical and biological valves. Among them, polyurethane is an elastomeric polymer composed of soft segments and hard segments, and it is considered that it is possible to apply to heart valves and the like. The preparation method of the polyurethane valve leaflet mainly comprises the steps of plastic dipping, thermoforming, injection molding and film casting. Compared with thermoforming, injection molding and film casting, dip molding is one of the methods that have been used to prepare the most durable valves so far due to its advantages of no residual stress (thermoforming and injection molding) and no need for sewing (film casting).
Currently, polyurethane valves deployed by strain Access Technologies in south africa and by Foldax corporation in the united states use a multiple dip process to achieve the desired thickness, but the solvent in the polymer solution also partially dissolves the existing layers before dip coating the polymer again, and thus the increased thickness is much less than expected. Generally, the preparation process can be accelerated and simplified by adopting a single-time plastic-dipping forming method. The inverted plastic dipping scheme adopted in the scheme is that one end of the valve frame used for dipping and coating the valve is downward and enters the dipping and coating liquid, and the polymer solution easily flows in a single direction due to the action of gravity, so that a rolling device is required to be installed to ensure the thickness uniformity of the valve leaflet, but the height of the valve leaflet formed in the way is not controlled, and further trimming is required. Unfortunately, valves made from many polymers such as polyurethane have limited tear strength and even laser cutting cannot ensure a perfect edge is cut, and the jagged edges and slight imperfections in the material are likely to cause tearing and ultimately failure of the leaflets. Therefore, there is a great need to redesign and develop a new integrated fabrication method and device for a durable prosthetic heart valve.
Disclosure of Invention
Aiming at the problems of long time consumption and higher operation difficulty when the secondary replacement operation is carried out on the surgical valve, the invention aims to: the integral manufacturing method and the integral manufacturing device for the durable artificial heart valve are provided, a one-step type upright plastic dipping method is adopted, the manufactured valve leaflet does not need to be cut at the later stage, and the edge of the valve leaflet does not have sawteeth, so that the tear resistance and the durability of the valve are improved; the combination of the upright plastic dipping method and the blowing or phase separation is adopted to solve the problem that the polymer solution flows downwards under the action of gravity and is easy to accumulate liquid at the joint of the mandrel and the valve frame, thereby preparing the valve leaf with relatively uniform thickness.
The technical scheme of the invention is as follows:
the invention discloses an integrated manufacturing method of a durable artificial heart valve, which comprises the following steps:
providing a valve frame and a mandrel, wherein the valve frame is hollow for the mandrel to penetrate and fix, two axial ends of the valve frame are respectively implemented as a valve leaf end for dip-coating valve leaflets and a connecting end for connecting with a sewing ring, the valve leaf end is circumferentially provided with a plurality of arc-shaped sections which are recessed towards the direction of the connecting end along the axial direction, one end of the mandrel is implemented as a clamping end, the clamping end extends out of the valve leaf end, the clamping end is circumferentially provided with a plurality of recessed parts which are recessed along the radial direction and extend along the axial line at intervals, the outer side of the bottom end surface of each recessed part is implemented as connecting curve sections which are in one-to-one correspondence with the arc-shaped sections, the inner side of the bottom end surface of any recessed part is implemented as a mandrel transverse line part, the position of the mandrel transverse line part is higher than that of the connecting curve sections, and a dip-coating area is formed between any mandrel transverse line part and the corresponding arc-shaped section;
the clamping and rotating unit clamps the clamping end of the mandrel and moves to the position above the dip-coating unit containing the polymer solution, wherein the valve leaf end is always upward when the clamping and rotating unit clamps the valve leaf;
the clamping and rotating unit vertically moves downwards at the speed of 1-10mm/s to immerse the valve frame and the mandrel into the polymer solution, and the liquid level of the polymer solution reaches the transverse line part of the mandrel and stops until valve leaflets are coated and formed in all the valve leaflet coating areas;
the clamping and rotating unit moves vertically upwards at the speed of 1-10mm/s to lift the valve frame coated and formed with the valve leaflets out of the polymer solution, and the dip coating process is completed;
the negative pressure drying unit dries the valve frame coated and molded with the valve leaflets, wherein the drying temperature is 30-120 ℃, and the negative pressure range is 1-50kPa;
and after drying, separating the valve frame coated and formed with the valve leaflets from the mandrel to obtain the durable artificial heart valve.
Optionally, the thickness of any one leaflet is 50-800 μm, and the difference in thickness between each leaflet is less than 20 μm.
Optionally, the clamping and rotating unit is a multi-axis mechanical arm, the end of the mechanical arm is provided with a clamp, the angle range between the end of the mechanical arm and the horizontal table top is 0-90 degrees, and the clamp and the mechanical arm are detachably connected.
Optionally, the integrated manufacturing method further includes, after the step of lifting the valve frame formed with the valve leaflets out of the polymer solution vertically upward by the clamping and rotating unit and before the drying unit dries, the following steps:
the clamping and rotating unit rotates to enable the valve frame which is subjected to plastic dipping and formed with valve leaflets and the horizontal platform surface to be inclined at an angle of less than 90 degrees, and the rotating speed of 10-90rpm is used for rotating to drive the mandrel to rotate;
and the blowing unit continuously blows the connecting position of the mandrel and the valve frame at the wind speed of 1-8m/s for 5-30min.
Optionally, the clamping and rotating unit rotates to enable the valve frame with the valve leaflets formed through dip molding to be inclined at 45 degrees with the horizontal platform surface.
Optionally, the gas purged by the purging unit is air, nitrogen or oxygen.
Optionally, the integrated manufacturing method further includes, after the step of lifting the valve frame formed with the valve leaflets out of the polymer solution vertically upward by the clamping and rotating unit and before the drying unit dries, the following steps:
the clamping rotating unit is translated to be above the phase separation unit containing the second phase solvent of the poor solvent of the polymer solution;
the clamping and rotating unit moves vertically downwards at the speed of 1-10mm/s to immerse the valve coated with the formed valve leaflets in a second-phase solvent, wherein the liquid level of the second-phase solvent is not higher than the highest height of the polymer solution coated on the mandrel and is not lower than the lowest connecting position of the mandrel and the valve frame;
the clamping rotating unit rotates at the rotating speed of 10-90rpm for 1-10min, residual polymer solution is removed under the action of shear stress and inertia generated in the rotation process in the second phase solvent, and uniform coating layers on the surfaces of the mandrel and the valve frame are reserved;
the clamping and rotating unit moves vertically upwards at the speed of 1-10mm/s to lift the valve frame which is coated and formed with the valve leaflets and is finished with the phase separation treatment.
Optionally, the phase separation unit is provided with an openable and closable sealing cover, and the sealing cover is closed after the phase separation treatment process is finished; and/or
The dip-coating unit is provided with an openable and closable sealing cover, and the sealing cover is closed after the dip-coating process is finished.
Alternatively, the speed of descending and ascending of the clamping rotary unit decreases as the viscosity of the polymer solution in the dip coating bath increases.
The integrated manufacturing device of the durable artificial heart valve can execute any one of the integrated manufacturing methods of the durable artificial heart valve, and comprises:
the clamping and rotating unit is used for clamping the core shaft penetrating through the valve frame and driving the valve frame and the core shaft to move and rotate;
the dip-coating unit is placed on the horizontal table top and contains a polymer solution for dip-coating the valve frame to form the valve leaflets;
the device comprises a blowing unit or a phase separation unit, wherein the blowing unit is suitable for blowing gas to the joint of a valve frame and a mandrel which are dipped and coated with polymer solution and formed with valve leaflets so as to ensure that the joint of the valve frame and the mandrel is free from accumulated liquid, and the phase separation unit is internally provided with poor solvent of the polymer solution so as to remove residual polymer solution under the action of shear stress and inertia generated in the clamping rotation process of a clamping rotation unit by the valve frame which is dipped and coated with the polymer solution and formed with the valve leaflets and keep a uniform coating layer on the surfaces of the mandrel and the valve frame;
and the negative pressure drying unit is used for drying the heart valve without accumulated liquid at the joint of the valve frame and the mandrel obtained by the treatment of the blowing unit or the phase separation unit so as to completely volatilize the solvent in the polymer solution at the valve leaflet, and finally separating the valve frame coated and formed with the valve leaflet from the mandrel so as to obtain the required durable artificial heart valve.
Compared with the prior art, the invention has the advantages that:
the integral manufacturing method of the durable artificial heart valve creatively adopts a dip-coating method which is opposite to the prior art in that the valve leaf end of the valve frame is upwards immersed into the dip-coating liquid, so that the process is speeded up and simplified through one-step dip-coating. The prepared valve leaflet does not need to be cut at the later stage, and the edge of the valve leaflet has no sawtooth, so that the tear resistance and the durability of the valve leaflet are improved, and the problems that the tear resistance and the durability of the valve leaflet are reduced and the valve leaflet even loses efficacy due to the sawtooth and material defects generated at the edge because the valve leaflet needs to be cut and trimmed by laser when an inversion method, namely the valve leaflet end of a valve frame is downwards immersed into dip-coating liquid, is adopted in the prior art are solved. The preparation method of the artificial heart valve has low preparation cost, opens up a new way for replacing the traditional repeated plastic dipping or inverted plastic dipping and the like, and has great potential in the aspect of preparing polymer heart valves.
Drawings
The invention is further described with reference to the following figures and examples:
FIG. 1 is a perspective view of a three-leaflet prosthetic heart valve according to an embodiment of the present invention;
FIG. 2 is a perspective view of a mandrel according to an embodiment of the present invention;
FIG. 3 is a schematic view of an apparatus for integrally manufacturing a durable prosthetic heart valve according to an embodiment of the present invention;
FIG. 4 is a schematic view of the dipping of examples 1 to 3 of the present invention;
FIG. 5 is a schematic view of the dipping of examples 4 to 6 of the present invention;
FIG. 6 is a flow chart of the dipping of the plastic of examples 1 to 3 of the present invention;
FIG. 7 is a flow chart of the plastic dipping process in examples 4 to 6 of the present invention.
Wherein: 1. a flap frame; 2. a leaflet; 3. a mandrel; 31. a clamping end; 32. connecting the curves; 33. a mandrel crossline portion; 4. a control system; 5. a clamping rotation unit; 6. a dip coating unit; 7. a horizontal table top; 8. a phase separation unit.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention will be described in further detail with reference to the accompanying drawings in conjunction with the following detailed description. It should be understood that the description is intended to be exemplary only, and is not intended to limit the scope of the present invention. Moreover, in the following description, descriptions of well-known structures and techniques are omitted so as to not unnecessarily obscure the concepts of the present invention.
The embodiment is as follows:
referring to fig. 1 to 7, in the method for integrally manufacturing a durable prosthetic heart valve according to an embodiment of the present invention, a valve frame 1 and a mandrel 3 are provided, the valve frame 1 is hollow for the mandrel 3 to penetrate and fix, two axial ends of the valve frame 1 are respectively implemented as a leaflet 2 end for dip-coating the leaflet 2 and a connecting end for connecting with a sewing ring, the leaflet 2 end is circumferentially provided with a plurality of arc-shaped sections recessed in the direction of the connecting end along the axial direction, one end of the mandrel 3, i.e., the upper end shown in fig. 2, is implemented as a clamping end 31, the clamping end 31 extends out of the leaflet 2 end, the clamping end 31 is circumferentially provided with a plurality of recessed portions recessed along the radial direction and extending along the axial line at intervals, the outer side of the bottom end face of the recessed portions is implemented as curved sections corresponding to and connected with the arc-shaped sections one by one, that is, the outer peripheral wall of the recessed portion is formed as a matching surface for the valve frame 1, the matching surface is matched with the mandrel shape of the mandrel 1, the arc-shaped section corresponds to the mandrel 3, the inner side edge of the recessed portion of the valve frame 3 is formed as a horizontal line connecting curve 32 with the transverse line of the leaflet 3, and the bottom end portion of the valve frame 2;
the clamping and rotating unit 5 clamps the clamping end 31 of the mandrel 3 and moves to the position above the dip coating unit 6 containing the polymer solution (as shown in A in figure 4), wherein the valve leaf 2 end is always upward when the clamping and rotating unit 5 clamps;
the clamping and rotating unit 5 vertically moves downwards at a speed of 1-10mm/s to immerse the valve frame 1 and the mandrel 3 into the polymer solution (as shown in B in figure 4 and A in figure 5), the liquid level of the polymer solution reaches the transverse line part of the mandrel 3, and the polymer solution stops until all valve leaflets 2 are coated and formed in the coating area of the valve leaflets 2, wherein the thickness of any valve leaflet 2 is 50-800 μm, and the thickness difference between each valve leaflet 2 is less than 20 μm;
the clamping and rotating unit 5 moves vertically upwards at the speed of 1-10mm/s to lift the valve frame 1 coated and formed with the valve leaflets 2 out of the polymer solution (as shown in B in figure 5), and the dip coating process is completed;
a negative pressure drying unit (not shown) for drying the valve frame 1 coated and molded with the valve leaflet 2, wherein the drying temperature is 30-120 ℃, and the negative pressure range is 1-50kPa;
after drying, the valve frame 1 coated and molded with the valve leaflets 2 (namely, valve leaflets) is separated from the mandrel 3, and the durable artificial heart valve is obtained.
The artificial heart valve of the embodiment of the invention creatively adopts a positive dipping method that the end of the valve leaflet 2 of the valve frame 1 is upwards dipped into the dipping liquid, which is contrary to the prior art, so that the one-step dipping is adopted, the process is accelerated and simplified, the prepared valve leaflet 2 does not need to be cut at the later stage, and the edge has no saw teeth, thereby improving the tear resistance and durability of the valve, and solving the problems that the tearing resistance and durability of the valve leaflet 2 are reduced and the valve leaflet 2 even fails because the edge generates saw teeth and the material defect because the laser cutting trimming is needed when the valve leaflet 2 of the valve frame 1 is inverted and the end of the valve leaflet 2 is downwards dipped into the dipping liquid in the prior art. The preparation method of the artificial heart valve has low preparation cost, opens up a new way for replacing the traditional repeated plastic dipping or inverted plastic dipping and the like, and has great potential in the aspect of preparing polymer heart valves. In the dip coating process, the speed of the clamping and rotating unit 5 moving vertically downwards and vertically upwards is determined according to the viscosity of the polymer solution, so that the polymer solution on the surfaces of the mandrel 3 and the petal frame 1 is flat, smooth and bubble-free. Specifically, the speed at which the holding rotating unit 5 descends and ascends decreases as the viscosity of the polymer solution in the dip coating bath increases.
According to some preferred embodiments of the present invention, as shown in fig. 3 to 5, the clamping rotation unit 5 is a multi-axis robot arm such as a conventional six-axis robot arm, and the specific structure and operation principle are not described and defined, and can be easily known and implemented by those skilled in the art. The tail end of the mechanical arm is provided with a clamp, such as a conventional clamping jaw clamp, and the angle range between the tail end of the mechanical arm and the horizontal table-board 7 is 0-90 degrees (that is, the clamp at the tail end of the mechanical arm can rotate in the range of 0-90 degrees relative to the horizontal plane so as to adjust the angle of the flap frame 1), and the clamp and the mechanical arm are detachably connected, such as by a connection mode which is well known and easily realized by a person skilled in the art, such as a screw and a clamping and locking structure, so as to clamp mandrels 3 with different specifications and sizes.
According to some preferred embodiments of the present invention, as shown in fig. 4 and 6, after the step of lifting the valve frame 1 formed with the valve leaflets 2 out of the polymer solution vertically upward by the holding rotating unit 5, and before the drying by the negative pressure drying unit, the following steps are further included:
the clamping and rotating unit 5 rotates to enable the valve frame 1 which is subjected to plastic dipping and formed with the valve leaflets 2 and the horizontal table surface 7 to be arranged in an inclined mode at an angle of less than 90 degrees (the direction indicated by a black arrow at the position C in the figure 4 is the blowing direction of the purging unit, the purging unit is not shown in the figure), and rotates at the rotating speed of 10-90rpm to drive the mandrel 3 to rotate;
and a blowing unit (not shown) continuously blows the connecting position of the mandrel 3 and the valve frame 1 at a wind speed of 1-8m/s for 5-30min. Through setting up the unit of sweeping, adopt the unit of sweeping to blow up the hookup location of dabber 3 and valve frame 1, solve because polymer solution flows down easily and hoarded the problem of liquid at dabber 3 and valve frame 1 junction because of the action of gravity to prepare out the valve leaf 2 of thickness relative even. Further preferably, the clamping and rotating unit 5 rotates to enable the valve frame 1 which is subjected to plastic dipping and formed with the valve leaflets 2 to be inclined at an angle of 45 degrees with the horizontal table surface 7, and the arrangement is more favorable for storing and uniformly dispersing accumulated liquid. The gas purged by the purging unit is common gas such as air, nitrogen or oxygen. It should be noted that, during the blowing process of the blowing unit, the blowing speed and the blowing time of the blowing unit are determined according to the viscosity of the polymer solution. Specifically, the size of the wind speed and the purge time of the purge unit increase as the viscosity of the polymer solution in the phase separation cell increases.
According to some preferred embodiments of the present invention, as shown in fig. 5 and 7, after the step of lifting the valve frame 1 formed with the valve leaflets 2 out of the polymer solution vertically upward by holding the rotating unit 5, and before the drying by the negative pressure drying unit, the following steps are further included:
the holding and rotating unit 5 is translated above the phase separation unit 8 containing the second phase solvent of the poor solvent of the polymer solution;
the clamping and rotating unit 5 moves vertically downwards at a speed of 1-10mm/s to immerse the valve coated with the formed valve leaflets 2 in a second phase solvent (as shown in fig. 5C), wherein the liquid level of the second phase solvent is not higher than the highest height of the polymer solution coated on the mandrel 3 and is not lower than the lowest connection position of the mandrel 3 and the valve frame 1, namely the middle position of the connection curve section 32 shown in fig. 2;
the clamping and rotating unit 5 rotates at the rotating speed of 10-90rpm for 1-10min, residual polymer solution is removed under the action of shear stress and inertia generated in the rotation process in the second phase solvent, and uniform coating layers on the surfaces of the mandrel 3 and the petal frame 1 are remained;
the clamping and rotating unit 5 moves vertically upward at a speed of 1-10mm/s to lift out the valve frame 1 coated with the molded valve leaflets 2 after the phase separation process is completed (as shown by D in fig. 5). The poor solvent of the polymer solution is used as the phase separation liquid, the valve frame 1 is rotated in the phase separation treatment process, the residual polymer solution, namely the hoarding liquid at the joint of the valve frame 1 and the mandrel 3, is removed by utilizing the shear stress and the inertia force generated in the rotation process, and the uniform coating layers are remained on the surfaces of the mandrel 3 and the valve frame 1, so that the hoarding of the polymer solution at the joint of the mandrel 3 and the valve frame 1 is solved. It should be noted that the speed of the vertical upward and downward movement of the holding rotary unit during the phase separation depends on the viscosity of the second phase solvent. Specifically, the speed at which the holding rotating unit 5 descends and ascends increases as the viscosity of the second-phase solvent in the phase separation tank increases.
According to some preferred embodiments of the present invention, as shown in fig. 1 and 6, the phase separation unit 8 is provided with an openable and closable seal cover (not shown) that is closed during the phase separation process. The dip coating unit 6 is provided with an openable and closable seal cover (not shown) that is closed at the time of the dip coating process. The sealing cover is arranged, so that the dip-coating liquid and the phase separation liquid can be protected, and the heart valve is prevented from being stained due to impurities and the like in the dip-coating and phase separation processes. The sealing cover can be connected in a conventional door leaf type or direct press cover type cover plate. As for the dipping unit 6, as shown in fig. 4 and 5, there is a dipping bath which is opened at the top and provided with a sealing cover and is hollow inside to contain the polymer solution. As for the phase separation unit 8, as shown in FIG. 5, there is also a phase separation tank which is opened at the top and provided with a sealing lid and is hollow inside to contain the poor solvent of the polymer solution, and the two are placed side by side on the horizontal table 7 at a spacing.
The specific composition of the polymer solution is not limited, such as the conventional polyurethane solution. Similarly, the composition of the second phase solvent is not described or limited in detail, as long as it is compatible with the poor solvent of the corresponding polymer solution, such as commonly used solvents, e.g., ethanol, water, etc. The viscosity of the polymer solution and the second phase solvent are not described or limited, such as 4000 to 10000cps.
For a prosthetic valve that is prepared, the prosthetic valve has a support structure or frame coupled to two or more polymeric leaflets 2. Fig. 1 shows a perspective view of a prosthetic heart valve with a valve frame 1 and three valve leaflets, wherein the valve type is an aortic or mitral valve; blood flows from the downstream end of the valve to the upstream end, i.e. from bottom to top in the direction of the open arrows shown in figure 1; the valve frame 1 is provided with an annular bottom which is in a plane or saddle shape, in order to realize the detachable separation of the valve frame 1 and the suture ring and reduce the operation difficulty and time, an external thread (not shown) which is also a connecting end is formed on the outer wall of the annular bottom of the valve frame 1, a matched internal thread (not shown) is formed on the inner wall of the corresponding suture ring (not shown), and the rapid installation, the detachment and the replacement are realized through a threaded connection mode, or magnetic parts (not shown) can be respectively arranged on the connecting end and the suture ring, so that the connection is realized through a magnetic coupling connection mode; each polymeric leaflet 2 may be independent of each other or may be integral.
In the embodiment of the invention, the negative pressure drying unit is an outermost box body as shown in fig. 3, and negative pressure high-temperature drying is adopted, so that the temperature and the negative pressure range can be set. Compared with the traditional method that hot air is directly led into the box body, the drying time is shortened and the production efficiency is improved by negative pressure high-temperature drying, and after the solvent in the polymer solution is completely volatilized, the valve frame 1 can be connected with the valve leaf 2 and the mandrel 3 to separate, so that the artificial heart valve is prepared.
The embodiment of the invention also provides an integrated manufacturing device of the durable artificial heart valve, which mainly comprises a clamping rotating unit 5, a dip-coating unit 6, a blowing unit or a phase separation unit 8, a drying unit and a control system 4 electrically connected with the units, wherein the control system 4 is an existing conventional PLC (programmable logic controller), the specific structure and the working principle are not described or limited, and the device is known by those skilled in the art and is easy to implement.
Example 1
The integrated manufacturing method for preparing the high-durability artificial heart valve of the embodiment of the invention mainly comprises a clamping and rotating unit 5, a dip-coating unit 6, a purging unit (not shown), wherein a black arrow shown in fig. 4 is a blowing direction of the purging unit), a negative pressure drying unit (not shown), and a control system 4 electrically connected with each unit, wherein the control system 4 is an existing conventional PLC logic controller, and the specific structure and the operation principle are not described and limited, and are known and easily realized by those skilled in the art.
Firstly, matching a valve frame 1 with a mandrel 3, clamping the upper part of the mandrel 3 on six mechanical arms through a buckle, and ensuring that the tail end of each mechanical arm is vertical to a horizontal table-board 7; when a sealing cover (not shown) above the dip coating pool is opened, the mechanical arm drives the flap frame 1 and the mandrel 3 to vertically descend into the dip coating pool at the speed of 2mm/s, the surfaces of the mandrel 3 and the flap frame 1 are coated with polymer solution (viscosity 4000 cps), and the descending height of the mechanical arm reaches the horizontal line part of the mandrel 3 at the moment, as shown in fig. 2; the robot arm is then lifted out of the dip coating bath at a speed of 2 mm/s; after the mechanical arm is completely lifted, the angle between the mechanical arm and the horizontal table top is adjusted to be 45 degrees, as shown in C in fig. 4, the sealing cover above the dip coating pool is closed, the rotation function of the mechanical arm is started, the rotation speed is 20rpm, the purging unit is started at the same time, the angle between the purging unit and the horizontal table top 7 is 45 degrees, the air speed of the purging unit is set to be 3m/s, the purging gas is air, the connecting position of the mandrel 3 and the valve frame 1 is continuously purged for 10min, the thickness uniformity of the valve leaflets 2 is ensured, and the thickness difference of the change between the thicknesses of each valve leaflet 2 is smaller than 20 microns; and finally, automatically starting the negative pressure drying unit, setting the temperature of the negative pressure drying unit to be 40 ℃ and the negative pressure to be 10kPa, and after the solvents in the polymer solution on the surfaces of the mandrel 3 and the valve frame 1 are completely volatilized, connecting the valve frame 1 with the valve leaflet 2 and separating the valve leaflet 3 to obtain the required artificial heart valve.
Example 2
According to the integrated manufacturing method for preparing the high-durability artificial heart valve, the used device mainly comprises a clamping rotating unit 5, a dip coating unit 6, a purging unit (not shown, wherein a black arrow shown in fig. 4 is a blowing direction of the purging unit), a negative pressure drying unit and a control system 4 electrically connected with each unit, the control system 4 is a conventional PLC logic controller, and the specific structure and the working principle are not described and limited, and are known and easily realized by a person skilled in the art.
Firstly, matching a valve frame 1 with a mandrel 3, clamping the upper part of the mandrel 3 on a six-axis mechanical arm through a buckle, and ensuring that the tail end of the mechanical arm is vertical to a horizontal table-board 7; when the sealing cover above the dip-coating pool is opened, the mechanical arm drives the flap frame 1 and the mandrel 3 to vertically descend into the dip-coating pool at the speed of 1mm/s, the surfaces of the mandrel 3 and the flap frame 1 are coated with polymer solution (viscosity 7000 cps), and the descending height of the mechanical arm reaches the horizontal line part of the mandrel 3 at the moment, as shown in fig. 2; the robot arm is then lifted out of the dip coating bath at a speed of 1 mm/s; after the mechanical arm is completely lifted, adjusting the angle between the mechanical arm and the horizontal table top 7 to be 45 degrees, as shown in C in fig. 4, closing the sealing cover above the dip coating pool, starting the rotation function of the mechanical arm, starting the blowing unit at the rotation speed of 90rpm, starting the blowing unit at the same time, setting the angle between the blowing unit and the horizontal table top to be 45 degrees, setting the air speed of the blowing unit to be 8m/s, blowing gas to be nitrogen, continuously blowing the connecting position of the mandrel 3 and the valve frame 1 for 30min, ensuring the uniform thickness of the valve leaflets 2, and ensuring that the variation between the thicknesses of the valve leaflets 2 is less than 20 micrometers; and finally, automatically starting a negative pressure drying unit, setting the temperature of the box body at 120 ℃ and the negative pressure at 1kPa, and connecting the valve frame 1 with the valve leaflet 2 and separating the valve leaflet 3 after the solvent in the polymer solution on the surfaces of the mandrel 3 and the valve frame 1 is completely volatilized to obtain the required artificial heart valve.
Example 3
According to the integrated manufacturing method for preparing the high-durability artificial heart valve, the used device mainly comprises a clamping rotating unit 5, a dip coating unit 6, a purging unit (not shown), a drying unit and a control system 4 electrically connected with the units, wherein the black arrow shown in fig. 4 is the blowing direction of the purging unit, the control system 4 is an existing conventional PLC logic controller, the specific structure and the working principle are not described and limited, and the method is known and can be easily implemented by a person skilled in the art.
Firstly, matching a valve frame 1 with a mandrel 3, clamping the upper part of the mandrel 3 on six mechanical arms through a buckle, and ensuring that the tail end of each mechanical arm is vertical to a horizontal table-board 7; when a sealing cover (not shown) above the dip coating pool is opened, the mechanical arm drives the flap frame 1 and the mandrel 3 to vertically descend into the dip coating pool at the speed of 10mm/s, the surfaces of the mandrel 3 and the flap frame 1 are coated with polymer solution (the viscosity is 1000 cps), and the height of the mechanical arm descending at this time is up to the horizontal line part of the mandrel 3, as shown in fig. 2; the robot arm is then lifted out of the dip coating bath at a speed of 10 mm/s; after the mechanical arm is completely lifted, the angle between the mechanical arm and the horizontal table top 7 is adjusted to be 45 degrees, as shown in C in fig. 4, the sealing cover above the dip coating pool is closed, the rotation function of the mechanical arm is started, the rotation speed is 10rpm, the purging unit is started at the same time, the angle between the purging unit and the horizontal table top is 45 degrees, the wind speed of the purging unit is set to be 1m/s, the purging gas is oxygen, the connecting part of the mandrel 3 and the valve frame 1 is continuously purged for 5min, the uniform thickness of the valve leaflets 2 is ensured, and the variation between the thicknesses of the valve leaflets 2 is smaller than 20 microns; and finally, automatically starting a negative pressure drying unit, setting the temperature of the box body at 30 ℃ and the negative pressure at 100kPa, and connecting the valve frame 1 with the valve leaflet 2 and separating the valve leaflet 3 after the solvent in the polymer solution on the surfaces of the mandrel 3 and the valve frame 1 is completely volatilized to obtain the required artificial heart valve.
Example 4
According to the integrated manufacturing method for preparing the high-durability artificial heart valve, the used device mainly comprises a clamping rotating unit 5, a dip coating unit 6, a phase separation unit 8, a negative pressure drying unit (not shown) and a control system 4 electrically connected with the units, the control system 4 is an existing conventional PLC (programmable logic controller), the specific structure and the working principle are not described and limited, and the integrated manufacturing method is known by a person skilled in the art and is easy to implement.
Firstly, matching a valve frame 1 with a mandrel 3, clamping the upper part of the mandrel 3 on a six-axis mechanical arm through a buckle, and ensuring that the tail end of the mechanical arm is vertical to a horizontal table-board 7; a sealing cover above the dip-coating pool is opened, meanwhile, the mechanical arm drives the valve frame 1 and the mandrel 3 to vertically descend into the dip-coating pool at the speed of 2mm/s, polymer solution is coated on the surfaces of the mandrel 3 and the valve frame 1, and the descending height of the mechanical arm reaches the horizontal line part of the mandrel 3 at the moment, as shown in figure 2; then after the robot arm is lifted out and away from the dip bath at a speed of 2mm/s, a sealing cover (not shown) above the dip bath is closed; after the mechanical arm is completely lifted, the mechanical arm moves to a second-phase solvent (preferably water in the embodiment) pool, namely a phase separation pool in parallel, the mechanical arm drives the valve frame 1 soaked with the polymer solution, the mandrel 3 still vertically descends into the phase separation pool at the speed of 2mm/s, the descending height of the mechanical arm is 2mm above the connecting curve 32 of the mandrel 3 and the valve frame 1, as shown in fig. 2, meanwhile, the mechanical arm automatically starts a rotation function, the rotation speed is 50rpm, and after 5min, the mechanical arm automatically lifts; and finally, automatically starting a negative pressure drying unit, setting the temperature of the box body to be 40 ℃ and the negative pressure to be 10kPa, and after the solvent in the polymer solution on the surfaces of the mandrel 3 and the valve frame 1 is completely volatilized, connecting the valve frame 1 with the valve leaflet 2 and separating the valve leaflet 3 to obtain the required artificial heart valve.
Example 5
According to the integrated manufacturing method for preparing the high-durability artificial heart valve, the used device mainly comprises a clamping rotating unit 5, a dip coating unit 6, a phase separation unit 8, a negative pressure drying unit (not shown) and a control system 4 electrically connected with the units, the control system 4 is an existing conventional PLC (programmable logic controller), the specific structure and the working principle are not described or limited, and the integrated manufacturing method is known by a person skilled in the art and is easy to implement.
Firstly, matching a valve frame 1 with a mandrel 3, clamping the upper part of the mandrel 3 on a six-axis mechanical arm through a buckle, and ensuring that the tail end of the mechanical arm is vertical to a horizontal table-board 7; when a sealing cover (not shown) above the dip-coating pool is opened, the mechanical arm drives the flap frame 1 and the mandrel 3 to vertically descend into the dip-coating pool at the speed of 2mm/s, the surfaces of the mandrel 3 and the flap frame 1 are coated with polymer solution, and the descending height of the mechanical arm reaches the horizontal line part of the mandrel 3 at the moment, as shown in fig. 2; then after the robot arm is lifted out and away from the dip bath at a speed of 2mm/s, a sealing cover (not shown) above the dip bath is closed; when the mechanical arm is completely lifted, the mechanical arm moves to a second phase solvent (preferably ethanol in the embodiment) pool, namely above a phase separation pool in parallel, the mechanical arm drives the valve frame 1 soaked with the polymer solution, the mandrel 3 vertically descends into the phase separation pool at the speed of 10mm/s, the descending height of the mechanical arm is 2mm above the lowest part of a connecting curve 32 of the mandrel 3 and the valve frame 1, as shown in fig. 2, meanwhile, the mechanical arm automatically starts a rotation function, the rotation speed is 10rpm, and the mechanical arm automatically lifts after 1min; and finally, automatically starting a negative pressure drying unit, setting the temperature of the box body to be 40 ℃ and the negative pressure to be 10kPa, and after the solvent in the polymer solution on the surfaces of the mandrel 3 and the valve frame 1 is completely volatilized, connecting the valve frame 1 with the valve leaflet 2 and separating the valve leaflet 3 to obtain the required artificial heart valve.
Example 6
According to the integrated manufacturing method for preparing the high-durability artificial heart valve, the used device mainly comprises a clamping rotating unit 5, a dip coating unit 6, a phase separation unit 8, a negative pressure drying unit (not shown) and a control system 4 electrically connected with the units, the control system 4 is an existing conventional PLC (programmable logic controller), the specific structure and the working principle are not described and limited, and the integrated manufacturing method is known by a person skilled in the art and is easy to implement.
Firstly, matching a valve frame 1 with a mandrel 3, clamping the upper part of the mandrel 3 on six mechanical arms through a buckle, and ensuring that the tail end of each mechanical arm is vertical to a horizontal table-board 7; when the sealing cover above the dip-coating pool is opened, the mechanical arm drives the valve frame 1 and the mandrel 3 to vertically descend into the dip-coating pool at the speed of 2mm/s, the surfaces of the mandrel 3 and the valve frame 1 are coated with polymer solution, and the descending height of the mechanical arm reaches the horizontal line part of the mandrel 3 at the moment, as shown in figure 2; then after the mechanical arm is lifted out at the speed of 2mm/s and leaves the dip-coating pool, the sealing cover above the dip-coating pool is closed; when the mechanical arm is completely lifted, the mechanical arm moves to a second phase solvent (preferably glycerol in the embodiment) pool, namely above a phase separation pool in parallel, the mechanical arm drives the valve frame 1 soaked with the polymer solution, the mandrel 3 vertically descends into the phase separation pool at the speed of 1mm/s, the descending height of the mechanical arm is 2mm above the lowest part of a connecting curve 32 of the mandrel 3 and the valve frame 1, as shown in fig. 2, meanwhile, the mechanical arm automatically starts a rotation function, the rotation speed is 90rpm, and the mechanical arm automatically lifts after 10min; and finally, automatically starting a negative pressure drying unit, setting the temperature of the box body at 40 ℃ and the negative pressure at 10kPa, and connecting the valve frame 1 with the valve leaflet 2 and separating the valve leaflet 3 after the solvent in the polymer solution on the surfaces of the mandrel 3 and the valve frame 1 is completely volatilized to obtain the required artificial heart valve.
It should be understood that the above-described embodiments of the present invention are merely illustrative of or explaining the principles of the invention and are not to be construed as limiting the invention. Therefore, any modifications, equivalents, improvements and the like which are made without departing from the spirit and scope of the present invention shall be included in the protection scope of the present invention. Further, it is intended that the appended claims cover all such variations and modifications as fall within the scope and boundaries of the appended claims or the equivalents of such scope and boundaries.
Claims (10)
1. An integrated method of manufacturing a durable prosthetic heart valve, comprising the steps of: providing a valve frame and a mandrel, wherein the valve frame is hollow so that the mandrel can penetrate and be fixed, two axial ends of the valve frame are respectively implemented as a valve leaf end for dip-coating valve leaflets and a connecting end for connecting with a sewing ring, the valve leaf end is circumferentially provided with a plurality of arc-shaped sections which are axially recessed towards the connecting end, one end of the mandrel is implemented as a clamping end, the clamping end extends out of the valve leaf end, the clamping end is circumferentially provided with a plurality of recessed parts which are radially recessed and extend along the axis at intervals, the outer side of the bottom end surface of each recessed part is implemented as connecting curve sections which are in one-to-one correspondence with the arc-shaped sections, the inner side of the bottom end surface of any recessed part is implemented as a mandrel transverse line part, the position of the mandrel transverse line part is higher than the connecting curve sections, and a dip-coating area is formed between any mandrel transverse line part and the corresponding arc-shaped section;
the clamping and rotating unit clamps the clamping end of the mandrel and moves to the position above the dip-coating unit containing the polymer solution, wherein the valve leaf end is always upward when the clamping and rotating unit clamps the valve leaf;
the clamping and rotating unit vertically moves downwards at the speed of 1-10mm/s to immerse the valve frame and the mandrel into the polymer solution, and the liquid level of the polymer solution reaches the transverse line part of the mandrel and stops until valve leaflets are coated and formed in all the valve leaflet coating areas;
the clamping and rotating unit moves vertically upwards at the speed of 1-10mm/s to lift the valve frame coated and formed with the valve leaflets out of the polymer solution, and the dip coating process is completed;
the negative pressure drying unit dries the valve frame coated and molded with the valve leaves, the drying temperature is 30-120 ℃, and the negative pressure range is 1-50kPa;
and after drying, separating the valve frame coated and formed with the valve leaflets from the mandrel to obtain the durable artificial heart valve.
2. The integrated method of manufacturing a durable prosthetic heart valve of claim 1, wherein the thickness of any leaflet is 50-800 μ ι η and the difference in thickness between each leaflet is less than 20 μ ι η.
3. The integrated manufacturing method of the durable artificial heart valve as claimed in claim 1, wherein the clamping and rotating unit is a multi-axis robot arm, the end of the robot arm is provided with a clamp, the angle between the end of the robot arm and the horizontal table is in the range of 0-90 °, and the clamp and the robot arm are detachably connected.
4. The integrated manufacturing method of a durable prosthetic heart valve according to any one of claims 1-3, characterized in that, after the step of lifting the valve frame formed with the valve leaflets out of the polymer solution vertically upwards by the clamping rotating unit and before the drying unit is dried by the negative pressure, the integrated manufacturing method further comprises the following steps:
the clamping and rotating unit rotates to enable the valve frame which is subjected to plastic dipping and formed with valve leaflets and the horizontal platform surface to be inclined at an angle of less than 90 degrees, and the rotating speed of 10-90rpm is used for rotating to drive the mandrel to rotate;
and the blowing unit continuously blows the connecting position of the mandrel and the valve frame at the wind speed of 1-8m/s for 5-30min.
5. The integrated manufacturing method of a durable prosthetic heart valve according to claim 4, wherein the clamping and rotating unit rotates to set the valve frame with the valve leaflet molded by dip molding to be inclined at 45 ° from a horizontal plane.
6. The integrated method of manufacturing a durable prosthetic heart valve of claim 4, wherein the gas purged by the purge unit is air, nitrogen, or oxygen.
7. The integrated manufacturing method of a durable prosthetic heart valve according to any one of claims 1 to 3, further comprising the following steps after the step of lifting the valve frame formed with the valve leaflets out of the polymer solution in a vertical direction by the holding and rotating unit and before the drying by the negative pressure drying unit:
the clamping and rotating unit translates to the upper part of the phase separation unit containing the second phase solvent of the poor solvent of the polymer solution;
the clamping and rotating unit moves vertically downwards at the speed of 1-10mm/s to immerse the valve coated with the formed valve leaflets in a second-phase solvent, wherein the liquid level of the second-phase solvent is not higher than the highest height of the polymer solution coated on the mandrel and is not lower than the lowest connecting position of the mandrel and the valve frame;
the clamping rotating unit rotates at the rotating speed of 10-90rpm for 1-10min, residual polymer solution is removed under the action of shear stress and inertia generated in the rotation process in the second phase solvent, and a uniform coating layer on the surfaces of the mandrel and the petal frame is reserved;
the clamping rotary unit moves vertically upwards at the speed of 1-10mm/s to lift the valve frame coated and molded with the valve leaflets, which is subjected to the phase separation treatment.
8. The integrated manufacturing method of a durable prosthetic heart valve according to claim 7, wherein the phase separation unit is provided with an openable and closable sealing cover which is closed after the phase separation process is finished; and/or
The dip-coating unit is provided with an openable and closable sealing cover, and the sealing cover is closed after the dip-coating process is finished.
9. The integrated method of manufacturing a durable prosthetic heart valve of claim 1, wherein the speed of the clamping rotation unit descending and ascending decreases with increasing viscosity of the polymer solution in the dip coating bath.
10. An integrated manufacturing apparatus for a durable prosthetic heart valve, capable of performing the integrated manufacturing method for a durable prosthetic heart valve according to any one of claims 1 to 9, comprising:
the clamping and rotating unit is used for clamping the core shaft penetrating through the valve frame and driving the valve frame and the core shaft to move and rotate;
the dip-coating unit is placed on the horizontal table top and contains a polymer solution for dip-coating the valve frame to form the valve leaflets;
the device comprises a blowing unit or a phase separation unit, wherein the blowing unit is suitable for blowing gas to the joint of a valve frame and a mandrel which are dipped and coated with polymer solution and formed with valve leaflets so as to ensure that the joint of the valve frame and the mandrel is free from accumulated liquid, and the phase separation unit is internally provided with poor solvent of the polymer solution so as to remove residual polymer solution under the action of shear stress and inertia generated in the clamping rotation process of a clamping rotation unit by the valve frame which is dipped and coated with the polymer solution and formed with the valve leaflets and keep a uniform coating layer on the surfaces of the mandrel and the valve frame;
and the negative pressure drying unit is used for drying the heart valve without accumulated liquid at the joint of the valve frame and the mandrel obtained by the treatment of the blowing unit or the phase separation unit so as to completely volatilize the solvent in the polymer solution at the valve leaflet, and finally separating the valve frame coated with the formed valve leaflet from the mandrel to obtain the required durable artificial heart valve.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN116352940A (en) * | 2023-05-10 | 2023-06-30 | 乐普（北京）医疗器械股份有限公司 | Dip-coating type macromolecule heart valve forming device |
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