CN117653416A - Ball-expanded high-molecular intervention valve and preparation method thereof - Google Patents
Ball-expanded high-molecular intervention valve and preparation method thereof Download PDFInfo
- Publication number
- CN117653416A CN117653416A CN202311626267.7A CN202311626267A CN117653416A CN 117653416 A CN117653416 A CN 117653416A CN 202311626267 A CN202311626267 A CN 202311626267A CN 117653416 A CN117653416 A CN 117653416A
- Authority
- CN
- China
- Prior art keywords
- valve
- polymer
- die
- bracket
- main shaft
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 238000002360 preparation method Methods 0.000 title claims abstract description 19
- 229920000642 polymer Polymers 0.000 claims abstract description 77
- 238000000034 method Methods 0.000 claims abstract description 13
- 238000001035 drying Methods 0.000 claims description 20
- 229920002635 polyurethane Polymers 0.000 claims description 12
- 239000004814 polyurethane Substances 0.000 claims description 12
- 238000003618 dip coating Methods 0.000 claims description 11
- 239000010935 stainless steel Substances 0.000 claims description 9
- 229910001220 stainless steel Inorganic materials 0.000 claims description 9
- 229910052751 metal Inorganic materials 0.000 claims description 7
- 239000002184 metal Substances 0.000 claims description 7
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 7
- WAIPAZQMEIHHTJ-UHFFFAOYSA-N [Cr].[Co] Chemical class [Cr].[Co] WAIPAZQMEIHHTJ-UHFFFAOYSA-N 0.000 claims description 6
- 239000000463 material Substances 0.000 claims description 6
- 238000004140 cleaning Methods 0.000 claims description 5
- 239000011248 coating agent Substances 0.000 claims description 4
- 238000000576 coating method Methods 0.000 claims description 4
- 210000003709 heart valve Anatomy 0.000 claims description 4
- -1 polydimethylsiloxane Polymers 0.000 claims description 4
- 238000007711 solidification Methods 0.000 claims description 3
- 230000008023 solidification Effects 0.000 claims description 3
- UHKPXKGJFOKCGG-UHFFFAOYSA-N 2-methylprop-1-ene;styrene Chemical compound CC(C)=C.C=CC1=CC=CC=C1.C=CC1=CC=CC=C1 UHKPXKGJFOKCGG-UHFFFAOYSA-N 0.000 claims description 2
- 229910000838 Al alloy Inorganic materials 0.000 claims description 2
- BVKZGUZCCUSVTD-UHFFFAOYSA-L Carbonate Chemical compound [O-]C([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-L 0.000 claims description 2
- 229910000881 Cu alloy Inorganic materials 0.000 claims description 2
- 229910000990 Ni alloy Inorganic materials 0.000 claims description 2
- 239000004372 Polyvinyl alcohol Substances 0.000 claims description 2
- XUIMIQQOPSSXEZ-UHFFFAOYSA-N Silicon Chemical compound [Si] XUIMIQQOPSSXEZ-UHFFFAOYSA-N 0.000 claims description 2
- 238000004873 anchoring Methods 0.000 claims description 2
- 239000004205 dimethyl polysiloxane Substances 0.000 claims description 2
- KPUWHANPEXNPJT-UHFFFAOYSA-N disiloxane Chemical class [SiH3]O[SiH3] KPUWHANPEXNPJT-UHFFFAOYSA-N 0.000 claims description 2
- 238000002386 leaching Methods 0.000 claims description 2
- 229920000435 poly(dimethylsiloxane) Polymers 0.000 claims description 2
- 239000004810 polytetrafluoroethylene Substances 0.000 claims description 2
- 229920001343 polytetrafluoroethylene Polymers 0.000 claims description 2
- 229920002451 polyvinyl alcohol Polymers 0.000 claims description 2
- 229910052710 silicon Inorganic materials 0.000 claims description 2
- 239000010703 silicon Substances 0.000 claims description 2
- 230000003746 surface roughness Effects 0.000 claims description 2
- 230000003028 elevating effect Effects 0.000 claims 2
- 239000002904 solvent Substances 0.000 claims 1
- 238000009966 trimming Methods 0.000 abstract description 4
- 238000004519 manufacturing process Methods 0.000 abstract description 2
- 239000000956 alloy Substances 0.000 abstract 1
- 229910045601 alloy Inorganic materials 0.000 abstract 1
- 239000000243 solution Substances 0.000 description 25
- FXHOOIRPVKKKFG-UHFFFAOYSA-N N,N-Dimethylacetamide Chemical compound CN(C)C(C)=O FXHOOIRPVKKKFG-UHFFFAOYSA-N 0.000 description 4
- 230000001174 ascending effect Effects 0.000 description 4
- 238000005259 measurement Methods 0.000 description 4
- 230000003287 optical effect Effects 0.000 description 4
- 238000009864 tensile test Methods 0.000 description 4
- 238000005266 casting Methods 0.000 description 3
- 238000010586 diagram Methods 0.000 description 3
- 238000005516 engineering process Methods 0.000 description 3
- 238000000465 moulding Methods 0.000 description 3
- 239000003146 anticoagulant agent Substances 0.000 description 2
- 229940127219 anticoagulant drug Drugs 0.000 description 2
- 239000008367 deionised water Substances 0.000 description 2
- 229910021641 deionized water Inorganic materials 0.000 description 2
- 238000009826 distribution Methods 0.000 description 2
- 230000005484 gravity Effects 0.000 description 2
- 238000001746 injection moulding Methods 0.000 description 2
- 238000013152 interventional procedure Methods 0.000 description 2
- 238000011031 large-scale manufacturing process Methods 0.000 description 2
- 208000003017 Aortic Valve Stenosis Diseases 0.000 description 1
- 206010010356 Congenital anomaly Diseases 0.000 description 1
- 208000007536 Thrombosis Diseases 0.000 description 1
- 201000001943 Tricuspid Valve Insufficiency Diseases 0.000 description 1
- 238000009825 accumulation Methods 0.000 description 1
- 230000006978 adaptation Effects 0.000 description 1
- 230000010100 anticoagulation Effects 0.000 description 1
- 206010002906 aortic stenosis Diseases 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 238000007664 blowing Methods 0.000 description 1
- 230000002308 calcification Effects 0.000 description 1
- 210000001715 carotid artery Anatomy 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 238000001816 cooling Methods 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 210000001105 femoral artery Anatomy 0.000 description 1
- 208000018578 heart valve disease Diseases 0.000 description 1
- 238000007654 immersion Methods 0.000 description 1
- 230000001788 irregular Effects 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 229920002521 macromolecule Polymers 0.000 description 1
- 238000000386 microscopy Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 239000002861 polymer material Substances 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
Landscapes
- Prostheses (AREA)
Abstract
The invention relates to a balloon-expanded high polymer intervention valve and a preparation method thereof. The forming process comprises the following steps: firstly, acquiring a ball-expanding alloy bracket and a die with valve blade shape details; secondly, assembling the bracket and the die, clamping the bracket and the die on a double-shaft rotating lifting device, and controlling the die to simultaneously rotate at a constant speed along the sub-shaft rotating unit and the main shaft rotating unit; and thirdly, controlling a lifting unit of the double-shaft rotary lifting device to descend at a constant speed, so that the die is completely immersed in the polymer solution, controlling the lifting unit to ascend, so that the die is immersed in the polymer solution, and separating the solution from the die and trimming valve leaves after the solution is solidified, so as to obtain the ball-expanded polymer intervention valve. The preparation method disclosed by the invention can obviously improve the uniformity of the structure and thickness of the polymer valve, improve the quality and durability of the polymer valve, and is convenient for mass production and preparation on a large scale.
Description
Technical Field
The invention relates to a ball-expanded high polymer intervention valve and a preparation method thereof, belonging to the technical field of medical appliances.
Background
Valvular heart disease is a disease with higher incidence rate of middle-aged and elderly people, the incidence rate of people over 75 years is up to 13%, and the mortality rate of five years without intervention is more than 50%, which seriously threatens the life health of middle-aged and elderly people. Currently, heart valve replacement by surgical or minimally invasive interventional procedures is the most accepted treatment, common replacement valves include mechanical and biological valves, but both types of valves have significantly shorter plates. The mechanical valve can only be implanted by surgical open chest surgery, and thrombus is easily caused, so that patients need to take anticoagulants for life. The biological valve has excellent anticoagulation property, can be implanted through a minimally invasive interventional operation, but valve tissues are easy to calcifie and decay, and the service life is short.
Aiming at various limitations of mechanical valves and biological valves in clinic, a novel polymer valve formed by a polymer is expected to become an ideal alternative, and the polymer valve has excellent biocompatibility and calcification resistance, does not need to rely on anticoagulants like the mechanical valve, has a service life far longer than that of the biological valve, and can be rapidly implanted by a minimally invasive intervention means. At present, no polymer valve is approved to be marketed in the world, and the important reason for limiting the rapid clinical trend of the polymer valve is the restriction of manufacturing and molding technologies.
Injection molding and casting processes are attempted to be applied to polymer valve molding preparation, but injection molding is low in efficiency and small in applicable material range, and the casting process needs to be assembled with a bracket through stitching at a later stage, so that valve durability is insufficient. The dip-coating process has high efficiency and simple process, is a widely applied film material preparation method, and has the problem that the polymer solution is deposited downwards by gravity in a casting way and the thickness is difficult to accurately control during dip-coating. In recent years, the improved dip coating technology comprises the steps of rotating a transverse die and blowing an inclined die together with gas, so that the bottom accumulation of a solution is relieved to a certain extent, but the dip coating liquid amount in the warp direction/the axial direction is difficult to keep completely consistent due to the influence of gravity, so that the thickness of a finally obtained valve is uneven, and the consistency of valve products produced in batches cannot be ensured; meanwhile, the technology is only suitable for dip coating on the surface of a regular mold (such as a flat plate, a cylinder, a round tube and the like), and forming inside and outside a bracket with an irregular and complex structure is difficult to realize.
Disclosure of Invention
The invention aims to provide a ball-expanded polymer intervention valve with uniform thickness and a preparation method thereof, aiming at the defects of the prior art. Meanwhile, by arranging a plurality of sub-shaft rotating units, the uniform batch preparation and large-scale production of a plurality of polymer valves can be realized.
In order to achieve the above purpose, the technical scheme of the invention is as follows:
the balloon-expanded interventional high molecular heart valve comprises a metal bracket and high molecular valve leaflets, is used for interventional treatment of aortic valve stenosis, tricuspid valve insufficiency and congenital heart valve adhesion, and is prepared by a full-automatic rotary dip coating method, and specifically comprises the following steps of:
1) Acquiring a ball-expanding metal bracket and a die with valve blade shape characteristics;
2) Preparing a polymer solution for preparing the polymer valve;
3) Assembling the bracket and the die, clamping the bracket and the die on a double-shaft rotating and lifting device, starting the double-shaft rotating and lifting device, and controlling the die to simultaneously rotate along the sub-shaft and the main shaft at a constant speed;
4) The main shaft of the double-shaft rotary lifting device is controlled to descend at a constant speed, so that the die moves downwards and is completely immersed in the polymer solution, the main shaft is controlled to ascend at a constant speed, so that the die is immersed in the polymer solution and continuously rotates to finish solution solidification, and the die is separated from the bracket and trimmed to obtain the ball-expanded interventional polymer valve.
In the above technical scheme, further, the metal stent is at least one of cobalt-chromium alloy, nickel alloy and stainless steel, and can be expanded by a balloon; the high molecular valve leaflet material comprises at least one of polydimethylsiloxane, poly (styrene-isobutylene-styrene) triblock polymer, polyurethane, silicon-containing polyurethane, siloxane-containing polyurethane, carbonate-containing polyurethane and polyvinyl alcohol, and the concentration range of the high molecular solution is 5-40wt%; the die material can be at least one of stainless steel, aluminum alloy, copper alloy and polytetrafluoroethylene, and the surface roughness Ra of the die material is 0-5 mu m.
Further, the double-shaft rotary lifting device comprises a lifting unit, a main shaft rotary unit and one or more sub-shaft rotary units, wherein the sub-shaft rotary units are provided with limiting clamps capable of clamping the anchoring die; the main shaft rotating unit rotates around the main shaft, the sub-shaft rotating units are arranged on the main shaft rotating unit, each sub-shaft rotating unit rotates around each sub-shaft and synchronously rotates around the main shaft along with the main shaft rotating unit, and the main shaft and the movement direction of the lifting unit are vertical to each other and are controlled to lift by the lifting unit.
Further, the mold rotates at a constant speed along the sub-shaft and the main shaft, and the speed ranges are 30-150r/min and 5-30r/min respectively.
Further, the rate of constant descent and constant ascent is 50-100mm/min.
Further, the bracket is subjected to the following operation steps in advance before being assembled with the die: immersing the bracket into a polymer solution after cleaning for 3-5min, taking out the bracket, drying and solidifying to enable the surface of the bracket to be coated with a polymer coating, wherein the thickness of the coating is 5-20 mu m.
Further, the steps of leaching the polymer solution from the die and continuing to rotate and solidify are carried out in a negative pressure drying box, wherein the negative pressure range is 1-5kPa, the drying temperature is 50-70 ℃, and the time is 20-60min.
Further, before the die is separated from the bracket, the die is soaked in water for 5-60min, then the macromolecular valve leaves on the surface of the die are peeled off, and the bracket is taken down to finish demoulding.
Further, the thickness of the prepared high molecular valve leaflet is 80-300 mu m, and the thickness tolerance of each valve leaflet is lower than 11%.
The balloon-expandable polymeric interventional valve may be delivered by a catheter-based minimally invasive interventional procedure through the femoral or carotid artery.
The invention has the beneficial effects that:
1) According to the stable and efficient ball-expanded polymer intervention valve and the preparation method thereof, the mold in the dip-coating process is subjected to uniform rotation of the sub-shaft matched with the main shaft, so that the thickness uniformity of the polymer valve is ensured, and a plurality of sub-shafts are arranged in the dip-coating device, so that the uniform preparation and the rapid large-scale production of the valve are realized;
2) According to the stable and efficient ball-expanded polymer intervention valve and the preparation method thereof, the problem of high polymer material deficiency at the joint surface of the stent and the die is solved by pre-dip-coating the stent and then performing die assembly rotary dip-coating, and the adhesion area of the high polymer on the surface of the stent is increased, so that the tearing resistance strength of the joint of the valve leaflet and the stent in the balloon expanding process is increased.
3) According to the stable and efficient ball-expanded polymer intervention valve and the preparation method thereof, aiming at the problems that the polymer is difficult to separate from the surface of the die and the die is easy to tear and damage during demolding, the high-temperature solidification is matched with water immersion cooling, the difference of thermal expansion capacities greatly reduces the operation difficulty of separating the polymer valve leaves from the metal die, avoids damage to the valve leaves during demolding, and greatly improves the yield of valve preparation.
Drawings
FIG. 1 is a schematic diagram of a dual-axis rotary lifting device according to the present invention;
FIG. 2 is a schematic diagram of a ball-expanding stent and mold assembly;
FIG. 3 is a schematic view of the appearance of a ball-expanded polymeric valve after dip molding and mold removal;
FIG. 4 is a physical diagram of the prepared ball-expanded polymer interventional valve;
fig. 5 is a cross-sectional thickness view of a polymer valve tested by light microscopy.
Wherein: 1. a polymer solution; 2. a ball-expanded high molecular valve stent; 3. a mold; 4. a sub-shaft rotation unit; 5. a main shaft rotating unit; 6. a lifting unit; 7. high molecular valve leaf.
Detailed Description
The examples are presented for better illustration of the invention, but the invention is not limited to the examples. Those skilled in the art will appreciate from the foregoing disclosure that various modifications and adaptations of the embodiments described herein are possible and can be made without departing from the scope of the invention.
Example 1
The invention relates to a ball-expanding type macromolecule intervention valve and a preparation method thereof, wherein a double-shaft rotating and lifting device mainly comprises a sub-shaft rotating unit 4, a main shaft rotating unit 5 and a lifting unit 6, one structural example of which is shown in figure 1, wherein the main shaft rotating unit 5 rotates around a main shaft, the sub-shaft rotating unit 4 is arranged on the main shaft rotating unit, each sub-shaft rotating unit rotates around each sub-shaft and synchronously rotates around the main shaft along with the main shaft rotating unit, the main shaft is vertical to the movement direction of the lifting unit 6, and the lifting unit 6 controls the main shaft to lift at a uniform speed; in addition, the related device also comprises a negative pressure drying box, the driving system is an existing conventional stepping motor, a permanent magnet driving motor and a PLC controller, the working principle and the detailed structure are not limited and described, and the device is known to a person skilled in the art and is easy to realize.
Dissolving polyurethane in dimethylacetamide to obtain a polymer solution 1 with the mass fraction of 20 wt%; immersing the processed cobalt-chromium alloy bracket 2 into a high polymer solution after cleaning for 3min, taking out and putting into a drying oven for curing, assembling the cured bracket 2 and the processed stainless steel die 3, and clamping all the bracket 2 and the processed stainless steel die 3 at a sub-shaft rotating unit position 4 of the device to totally clamp 4 bracket-dies (as shown in figure 1); setting the rotation rates of the sub-shaft rotation unit 4 and the main shaft rotation unit 5 to be 60r/min and 8r/min respectively, starting the lifting unit 6, enabling the main shaft 5 and the sub-shaft rotation unit 4 to descend at a constant speed of 60mm/min until the bracket 2 completely dips through the high polymer solution, and then ascending at a speed of 60 mm/min; after the bracket 2 is completely separated from the solution 1, the device is moved into a negative pressure drying box while maintaining rotation, negative pressure and environment temperature are respectively set at 2kPa and 60 ℃, the bracket 2 and the die 3 are taken down after curing for 40min, and the device is immediately immersed in water for 30min; the surface valve leaf of the stripping mould 3 is taken out, the bracket 2 is taken out from the mould 3, the edge of the valve leaf 7 is trimmed, and the needed ball-expanded polymer intervention valve is obtained (figure 4).
The ball-expanded polymer interventional valve prepared by the scheme is subjected to thickness measurement by an optical microscope on valves prepared in different batches with random selection of not less than 3. Each leaflet on the valve takes at least 3 positions as measuring points, the thickness average value of each measuring point is defined as the thickness of the leaflet, and the thickness average value of all the leaflets is defined as the thickness of the whole valve. The valve shown in fig. 4 has a thickness of 126.7 μm, wherein one leaflet has a thickness of 121.5 μm (as shown in fig. 5), and two other valves prepared in different batches have thicknesses of 122.6 μm and 128.3 μm, and the prepared valves have a thickness tolerance of less than 5% and are uniformly distributed. The tear strength between the valve leaflet and the bracket is 8.5+/-1.4 MPa measured by a universal tensile testing machine, and the valve leaflet and the bracket have strong bonding force.
Example 2
The device mainly comprises a sub-shaft rotating unit 4, a main shaft rotating unit 5, a uniform speed lifting unit 6 and a negative pressure drying box, wherein a mechanical system is an existing conventional stepping motor, a permanent magnet driving motor and a PLC (programmable logic controller), and the working principle and detailed structure are not limited and described, so that the device is known to a person skilled in the art and is easy to realize.
Dissolving polyurethane in dimethylacetamide to obtain a polymer solution 1 with the mass fraction of 25 wt%; immersing the processed cobalt-chromium alloy bracket 2 into a polymer solution after cleaning for 5min, taking out and putting into a drying oven for curing, assembling the cured bracket 2 and the processed stainless steel die 3, and totally clamping at a sub-shaft rotating unit position 4 of the device to totally clamp 4 bracket-dies (as shown in figure 1); setting the clockwise rotation rates of the sub-shaft rotation unit 4 and the main shaft rotation unit 5 to be 150r/min and 30r/min respectively, starting the lifting unit 6 to enable the main shaft 5 and the sub-shaft rotation unit 4 to descend at a constant speed of 50mm/min until the bracket 2 completely submerges the high polymer solution, and then ascending at a speed of 50 mm/min; after the bracket 2 is completely separated from the solution 1, the device is moved into a negative pressure drying box while maintaining rotation, negative pressure and environment temperature are respectively set at 1kPa and 50 ℃, the bracket 2 and the die 3 are taken down after curing for 30min, and the bracket is immediately immersed into deionized water for 30min; taking out and peeling the valve leaves on the surface of the die 3 by forceps, taking the bracket 2 out of the die 3, and trimming the edges of the valve leaves 7 to obtain the required ball-expanded polymer intervention valve.
The ball-expanded polymer interventional valve prepared by the scheme is subjected to thickness measurement by an optical microscope on valves prepared in different batches with random selection of not less than 3. Each leaflet on the valve takes at least 3 positions as measuring points, the thickness average value of each measuring point is defined as the thickness of the leaflet, and the thickness average value of all the leaflets is defined as the thickness of the whole valve. One of the valves had a thickness of 103.2 μm and one leaflet of 105.7 μm, and the other two valves prepared in different batches had thicknesses of 107.1 μm and 100.5 μm, and the valves prepared in accordance with the present invention had a uniform thickness distribution. The tear strength between the valve leaflet and the bracket is 7.7+/-1.5 MPa measured by a universal tensile testing machine, and the valve leaflet and the bracket have strong bonding force.
Example 3
The device mainly comprises a sub-shaft rotating unit 4, a main shaft rotating unit 5, a uniform speed lifting unit 6 and a negative pressure drying box, wherein a mechanical system is an existing conventional stepping motor, a permanent magnet driving motor and a PLC (programmable logic controller), and the working principle and detailed structure are not limited and described, so that the device is known to a person skilled in the art and is easy to realize.
Dissolving polysiloxane-polyurethane in dimethylacetamide to obtain a polymer solution 1 with the mass fraction of 30 wt%; immersing the processed cobalt-chromium alloy bracket 2 into a polymer solution after cleaning for 4min, taking out and putting into a drying oven for curing, assembling the cured bracket 2 and the processed stainless steel die 3, and totally clamping at a sub-shaft rotating unit position 4 of the device to totally clamp 4 bracket-dies (as shown in figure 1); setting the clockwise rotation rates of the sub-shaft rotation unit 4 and the main shaft rotation unit 5 to be 30r/min and 5r/min respectively, starting the lifting unit 6 to enable the main shaft 5 and the sub-shaft rotation unit 4 to descend at a constant speed of 100mm/min until the bracket 2 completely submerges the high polymer solution, and then ascending at a speed of 100 mm/min; after the bracket 2 is completely separated from the solution 1, the device is moved into a negative pressure drying box while maintaining rotation, negative pressure and ambient temperature are respectively set at 5kPa and 70 ℃, the bracket 2 and the die 3 are taken down after curing for 50min, and the device is immediately maintained in deionized water for 30min; taking out and peeling the valve leaves on the surface of the die 3 by forceps, taking the bracket 2 out of the die 3, and trimming the edges of the valve leaves 7 to obtain the required ball-expanded polymer intervention valve.
The ball-expanded polymer interventional valve prepared by the scheme is subjected to thickness measurement by an optical microscope on valves prepared in different batches with random selection of not less than 3. Each leaflet on the valve takes at least 3 positions as measuring points, the thickness average value of each measuring point is defined as the thickness of the leaflet, and the thickness average value of all the leaflets is defined as the thickness of the whole valve. One of the valves had a thickness of 146.5 μm and one leaflet on the valve had a thickness of 141.9 μm, and the other two valves prepared in different batches had thicknesses of 143.2 μm and 148.1 μm, and the valves prepared in accordance with the present invention had a uniform thickness distribution. The tear strength between the valve leaflet and the bracket is 9.3+/-1.6 MPa measured by a universal tensile testing machine, and the valve leaflet and the bracket have strong bonding force.
Comparative example 1:
the device mainly comprises a sub-shaft rotating unit 4, a main shaft rotating unit 5, a uniform speed lifting unit 6 and a negative pressure drying box, wherein a mechanical system is an existing conventional stepping motor, a permanent magnet driving motor and a PLC (programmable logic controller), and the working principle and detailed structure are not limited and described, so that the device is known to a person skilled in the art and is easy to realize.
Dissolving polyurethane in dimethylacetamide to obtain a polymer solution 1 with the mass fraction of 20 wt%; the processed cobalt-chromium alloy bracket 2 is directly assembled with a stainless steel die 3 after being cleaned, and is clamped at a sub-shaft rotating unit position 4 of the device, and 4 brackets-dies are clamped (as shown in figure 1); keeping the sub-shaft rotating unit 4 not rotating, setting the clockwise rotating speed of the main shaft rotating unit 5 to be 8r/min, starting the lifting unit 6, enabling the main shaft 5 and the sub-shaft rotating unit 4 to descend at a constant speed of 60mm/min until the bracket 2 completely submerges the high polymer solution, and then ascending at a speed of 60 mm/min; after the bracket 2 is completely separated from the solution 1, the device is moved into a negative pressure drying box while maintaining rotation, negative pressure and environment temperature are respectively set at 2kPa and 60 ℃, the bracket 2 and the die 3 are taken down after curing for 40min, and the device is immediately immersed in water for 30min; and taking out the surface valve leaves of the stripping mould 3, taking the bracket 2 out of the mould 3, and trimming the edges of the valve leaves 7 to obtain the required ball-expanded polymer intervention valve.
The ball-expanded polymer interventional valve prepared by the scheme is subjected to thickness measurement by an optical microscope on valves prepared in different batches with random selection of not less than 3. Each leaflet on the valve takes at least 3 positions as measuring points, the thickness average value of each measuring point is defined as the thickness of the leaflet, and the thickness average value of all the leaflets is defined as the thickness of the whole valve. One of the valves had a thickness of 103.2 μm and one leaflet on the valve had a thickness of 95.7 μm, and the other two valves prepared in different batches had thicknesses of 147.1 μm and 130.5 μm, with poor uniformity in thickness. The tear strength between the valve leaflet and the support is 5.1+/-1.1 MPa measured by a universal tensile testing machine, and the binding force is weak.
Claims (10)
1. The preparation method of the ball-expanded interventional polymer valve is characterized in that the ball-expanded interventional polymer heart valve comprises a metal bracket and polymer valve leaflets, is a non-sewed integrated polymer valve, and is a full-automatic rotary dip coating method, and specifically comprises the following steps:
1) Acquiring a ball-expanding metal bracket and a die with valve blade shape characteristics;
2) Preparing a high molecular solution;
3) After precoating, the bracket is assembled with a die and clamped on a double-shaft rotating and lifting device, the double-shaft rotating and lifting device is started, and the die is controlled to rotate along a sub-shaft and a main shaft at a constant speed; wherein, biax rotation elevating gear includes elevating unit.
4) The main shaft of the double-shaft rotary lifting device is controlled to descend at a constant speed, so that the die moves downwards and is completely immersed in the polymer solution, the main shaft is controlled to ascend at a constant speed, so that the die is immersed in the polymer solution and continuously rotates to finish solution solidification, and the die is separated from the bracket and trimmed to obtain the ball-expanded interventional polymer valve.
2. The method for preparing a balloon expandable interventional polymer valve according to claim 1, wherein the metal stent is at least one of cobalt-chromium alloy, nickel alloy and stainless steel, and can be expanded by a balloon; the high molecular leaflet material comprises at least one of polydimethylsiloxane, poly (styrene-isobutylene-styrene) triblock polymer, polyurethane, silicon-containing polyurethane, siloxane-containing polyurethane, carbonate-containing polyurethane and polyvinyl alcohol; the polymer solution is prepared from one or more of the solutions with the concentration ranging from 5 to 40 weight percent, and the polymer solutions in the steps 3) and 4) can be solutions containing the same polymer, solutions containing different polymers or solutions prepared from the same polymer by using different solvents; the die is made of at least one of stainless steel, aluminum alloy, copper alloy and polytetrafluoroethylene, and the surface roughness Ra of the die is 0-5 mu m.
3. The method for preparing the ball-expanded polymer interventional valve according to claim 1, wherein the mold rotates at a constant speed along the sub-axis and the main axis, and the speed ranges are 30-150r/min and 5-30r/min respectively.
4. The method for preparing a balloon expandable polymeric interventional valve of claim 1, wherein the rate of constant descent and constant ascent is 50-100mm/min.
5. The method for preparing a balloon expandable polymeric interventional valve according to claim 1, wherein the stent is pre-assembled with a mold by performing the following steps: immersing the bracket into a polymer solution after cleaning for 3-5min, taking out the bracket, drying and solidifying to enable the surface of the bracket to be coated with a polymer coating, wherein the thickness of the coating is 5-20 mu m.
6. The method of claim 1, wherein the drying step is spin-curing after leaching the polymer solution from the mold.
7. The method for preparing the balloon expandable polymer interventional valve according to claim 1, wherein the drying process is performed in a negative pressure drying oven, the negative pressure ranges from 1 to 5kPa, the drying temperature ranges from 50 to 70 ℃, and the drying time ranges from 20 to 60min.
8. The method for preparing the balloon expandable polymer interventional valve according to claim 1, wherein before the mold is separated from the stent, the mold is soaked in water for 5-60min, then the polymer valve leaves on the surface of the mold are peeled off, and the stent is taken down to finish demolding.
9. A balloon-expanded interventional polymer valve, characterized in that the valve is prepared by the method of any one of claims 1-8, the thickness of the polymer valve is controllable and is 80-300 μm, and the thickness of different valves prepared in the same batch is uniform, and the thickness of each valve leaflet in the valve is uniform.
10. A preparation device for preparing the ball-expanded polymeric valve according to claim 9, wherein the preparation device comprises a biaxial rotation lifting device comprising a main shaft rotation unit and one or more sub-shaft rotation units; the sub-shaft rotating unit is provided with a limiting clamp capable of clamping the anchoring die; the main shaft rotating unit rotates around the main shaft, the sub-shaft rotating units are arranged on the main shaft rotating unit, and each sub-shaft rotating unit rotates around each sub-shaft and synchronously rotates around the main shaft along with the main shaft rotating unit; the main shaft is perpendicular to the movement direction of the lifting unit and is controlled to lift by the lifting unit.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311626267.7A CN117653416A (en) | 2023-11-30 | 2023-11-30 | Ball-expanded high-molecular intervention valve and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311626267.7A CN117653416A (en) | 2023-11-30 | 2023-11-30 | Ball-expanded high-molecular intervention valve and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN117653416A true CN117653416A (en) | 2024-03-08 |
Family
ID=90070732
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202311626267.7A Pending CN117653416A (en) | 2023-11-30 | 2023-11-30 | Ball-expanded high-molecular intervention valve and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN117653416A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN117984485A (en) * | 2024-04-07 | 2024-05-07 | 浙江大学医学院附属第二医院 | Heart valve dip molding method and device |
-
2023
- 2023-11-30 CN CN202311626267.7A patent/CN117653416A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN117984485A (en) * | 2024-04-07 | 2024-05-07 | 浙江大学医学院附属第二医院 | Heart valve dip molding method and device |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN117653416A (en) | Ball-expanded high-molecular intervention valve and preparation method thereof | |
| AU2004222506B2 (en) | Valve | |
| CA1322834C (en) | Biocompatible microporous polymeric materials and methods of making same | |
| AU625341B2 (en) | Method of manufacturing an implantable article provided with a micropillared surface | |
| EP1337386B1 (en) | Mandrel and method for moulding polymer valve prostheses by dip coating | |
| US8906282B2 (en) | Micro-structured and nano-structured surfaces on biodegradable polymers | |
| JP2000511095A (en) | Expandable bioprosthetic valve stent | |
| Sodha et al. | Microfabrication of a three-dimensional polycaprolactone thin-film scaffold for retinal progenitor cell encapsulation | |
| EP2379298B1 (en) | System and method for molding soft fluid-filled implant shells | |
| CN115709153B (en) | Integrated manufacturing method and device for durable artificial heart valve | |
| EP3157467A1 (en) | A process of manufacturing a heart valve made of a polymeric material and the heart valve thereby obtained | |
| SE452404B (en) | MULTILAYER PROTEST MATERIAL AND PROCEDURE FOR ITS MANUFACTURING | |
| Brash et al. | Development of block copolyether‐urethane intra‐aortic balloons and other medical devices | |
| WO2020069152A1 (en) | Spin cleaning method and apparatus for additive manufacturing | |
| CN102501344A (en) | Method for constructing hemocompatible material surface with bionic periodic structure | |
| CN111000661A (en) | Composite artificial blood vessel and preparation method thereof | |
| US8007821B2 (en) | Substrates containing polyphosphazene as matrices and substrates containing polyphosphazene with microstructured surface | |
| CN111660558A (en) | Method for preparing nano microneedle template by laser direct writing | |
| GB2192547A (en) | Polyurethane medical prostheses and methods for their manufacture | |
| SE514064C2 (en) | Film for medical use consisting of linear block polymers of polyurethanes and method of making such a film | |
| CN107185038A (en) | A kind of surface immobilized modified cornea repair material and preparation method thereof | |
| CN109331230B (en) | Preparation method of bionic artificial blood vessel | |
| CN110065186B (en) | Preparation method of degradable ureteral catheter | |
| CN111393691B (en) | Method for preparing biodegradable film | |
| CN111331871A (en) | Mold surface treatment method and microneedle manufacturing method |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination |