CN117984485A - Heart valve dip molding method and device - Google Patents
Heart valve dip molding method and device Download PDFInfo
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- CN117984485A CN117984485A CN202410404640.2A CN202410404640A CN117984485A CN 117984485 A CN117984485 A CN 117984485A CN 202410404640 A CN202410404640 A CN 202410404640A CN 117984485 A CN117984485 A CN 117984485A
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- heart valve
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- 238000000465 moulding Methods 0.000 title claims abstract description 46
- 210000003709 heart valve Anatomy 0.000 title claims abstract description 42
- 238000000034 method Methods 0.000 title claims abstract description 26
- 229920000642 polymer Polymers 0.000 claims abstract description 40
- 239000012528 membrane Substances 0.000 claims abstract description 20
- 230000002093 peripheral effect Effects 0.000 claims description 11
- 238000001035 drying Methods 0.000 claims description 6
- 239000011148 porous material Substances 0.000 claims description 6
- 230000009471 action Effects 0.000 claims description 4
- 238000007493 shaping process Methods 0.000 claims description 4
- 238000009966 trimming Methods 0.000 claims description 4
- 238000005452 bending Methods 0.000 claims description 3
- 239000000463 material Substances 0.000 claims description 3
- 229920001343 polytetrafluoroethylene Polymers 0.000 claims description 3
- 239000004810 polytetrafluoroethylene Substances 0.000 claims description 3
- 238000005530 etching Methods 0.000 claims description 2
- 238000010147 laser engraving Methods 0.000 claims description 2
- 238000001802 infusion Methods 0.000 claims 3
- 239000012466 permeate Substances 0.000 abstract 2
- 241000446313 Lamella Species 0.000 abstract 1
- 238000010030 laminating Methods 0.000 abstract 1
- 239000000243 solution Substances 0.000 description 30
- 230000008569 process Effects 0.000 description 7
- 238000012545 processing Methods 0.000 description 4
- 238000007598 dipping method Methods 0.000 description 3
- 239000004033 plastic Substances 0.000 description 3
- 229920006254 polymer film Polymers 0.000 description 3
- 230000007547 defect Effects 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- WSSSPWUEQFSQQG-UHFFFAOYSA-N 4-methyl-1-pentene Chemical compound CC(C)CC=C WSSSPWUEQFSQQG-UHFFFAOYSA-N 0.000 description 1
- 230000005856 abnormality Effects 0.000 description 1
- 239000003146 anticoagulant agent Substances 0.000 description 1
- 229940127219 anticoagulant drug Drugs 0.000 description 1
- 230000002308 calcification Effects 0.000 description 1
- 238000007675 cardiac surgery Methods 0.000 description 1
- 238000004891 communication Methods 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- 238000013461 design Methods 0.000 description 1
- 238000007599 discharging Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 208000018578 heart valve disease Diseases 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 238000001746 injection moulding Methods 0.000 description 1
- 238000009434 installation Methods 0.000 description 1
- 230000001788 irregular Effects 0.000 description 1
- 230000013011 mating Effects 0.000 description 1
- 230000000149 penetrating effect Effects 0.000 description 1
- 229920005597 polymer membrane Polymers 0.000 description 1
- -1 polytetrafluoroethylene Polymers 0.000 description 1
- 230000008439 repair process Effects 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 238000005507 spraying Methods 0.000 description 1
- 238000011282 treatment Methods 0.000 description 1
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C41/00—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor
- B29C41/02—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor for making articles of definite length, i.e. discrete articles
- B29C41/14—Dipping a core
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C41/00—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor
- B29C41/34—Component parts, details or accessories; Auxiliary operations
- B29C41/38—Moulds, cores or other substrates
- B29C41/40—Cores
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2031/00—Other particular articles
- B29L2031/753—Medical equipment; Accessories therefor
- B29L2031/7532—Artificial members, protheses
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Cardiology (AREA)
- Mechanical Engineering (AREA)
- Heart & Thoracic Surgery (AREA)
- Biomedical Technology (AREA)
- Transplantation (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Prostheses (AREA)
Abstract
The invention discloses a heart valve dip molding method and a device for dip molding, wherein the heart valve comprises a valve frame and valve leaflets, and the device for dip molding comprises: the mandrel is provided with at least two curved surfaces along the circumferential direction on one axial end surface, a plurality of through holes are formed in any curved surface, and a first connecting structure is arranged at the other end of the mandrel; the membrane is attached to the curved surface and can allow gas to permeate but can not permeate the polymer solution; the negative pressure component is provided with an outlet and an inlet which are communicated, a second connecting structure matched with the first connecting structure is arranged at the inlet, and a negative pressure space capable of forming negative pressure is defined between the outlet and the hole after the negative pressure component is connected with the mandrel. Through trompil on the curved surface of dabber, laminating membrane piece on the curved surface simultaneously utilizes the negative pressure to handle the bubble between the contact surface of polymer solution and curved surface to solve the bubble between polymer solution and the dabber contact surface among the prior art and lead to influencing the problem of the performance of lamella.
Description
Technical Field
The invention belongs to the technical field of heart valve processing, and particularly relates to a heart valve dip molding method and a dip molding device.
Background
Heart valve disease is a common disease of cardiac surgery, and structural or functional abnormalities of the heart valve can seriously affect the quality of life of a patient or even the life safety. Valve repair and prosthetic valve replacement are currently the two principal effective treatments. The main prosthetic valves at present are mainly mechanical valves and biological valves, the mechanical valves have excellent durability, but patients need to take anticoagulants for life, the biological valves have good compatibility but the durability is poorer and easy to decay and calcification, and the latest high molecular valves have the advantages of the mechanical valves and the biological valves and can become the first choice of the valves of the new generation.
The main molding modes of the polymer valve at present include dip molding, spray coating, injection molding and the like, wherein the dip molding is most commonly used, namely, a mandrel with a specific shape is immersed into a polymer solution with a certain concentration, and then a solvent is volatilized to obtain a polymer film, but the applicant finds that when the conventional molding device is adopted, tiny bubbles are easily introduced into the contact surface of the mandrel and the polymer solution in the dip molding process, so that the finally molded polymer film is defective, and the usability is affected. Therefore, it is highly necessary to redesign and develop a new device for molding heart valves.
Disclosure of Invention
In view of at least one of the above technical problems, the present invention aims to: the heart valve plastic dipping forming method and the device for plastic dipping forming solve the problem that the service performance of the valve leaves is affected due to air bubbles between the contact surface of the polymer solution and the mandrel in the prior art, the valve leaves are complete and free of defects, and the mechanical performance and fatigue performance of the heart valve are improved.
The technical scheme of the invention is as follows:
One of the objects of the present invention is to provide a device for dip molding a heart valve, the heart valve including a valve frame and valve leaflets dip molded on the valve frame, the device comprising:
The valve frame comprises a mandrel, at least two curved surfaces which are recessed towards the other axial end direction of the mandrel and have the same curved surface structure with a target valve blade are arranged on one axial end surface of the mandrel along the circumferential direction, a plurality of through holes are formed in any curved surface, a first connecting structure is arranged on the other end of the mandrel, and the valve frame is attached to the peripheral wall of the mandrel when in use;
The film piece is attached to the curved surface of the mandrel and can be permeable to gas under the action of pressure but impermeable to polymer solution of the plastic-impregnated valve leaflet;
The negative pressure component is provided with an outlet and an inlet which are communicated, a second connecting structure matched with the first connecting structure is arranged at the inlet, and a negative pressure space capable of forming negative pressure is defined between the outlet and the hole after the negative pressure component is connected with the mandrel.
Another object of the present invention is to provide a method for dip molding a heart valve, wherein the device for dip molding is the above device, and the method comprises the following steps:
bending and tightly attaching the film piece to the curved surface of the mandrel, and ensuring flatness and no bubbles;
placing the valve frame on the outer side of the mandrel and attaching the valve frame to the peripheral wall of the mandrel, wherein the tips of the valve frame are aligned with the junction parts of two adjacent curved surfaces on the mandrel one by one;
The negative pressure component is connected with an external negative pressure generating device and is locked with the mandrel;
Vertically immersing the assembled valve frame and the mandrel into a polymer solution, wherein the polymer solution completely penetrates through the curved surface of the mandrel and the tip end part of the valve frame;
integrally lifting the mandrel and the petal rack which are coated with the polymer solution in a dip way, and standing to enable the polymer solution to be leveled until no more drops;
starting a negative pressure generating device to enable bubbles in the polymer solution attached to the tip end of the valve frame to be discharged through the membrane piece, the holes on the curved surface and the negative pressure space;
and (5) drying, shaping and trimming to obtain the required heart valve.
Compared with the prior art, the invention has the advantages that:
According to the heart valve plastic dipping forming device, the curved surface of the mandrel is perforated, the membrane is attached to the curved surface, and bubbles between the contact surface of the polymer solution and the curved surface are treated by utilizing negative pressure, so that the problem that the usability of the valve leaflet is affected due to the bubbles between the contact surface of the polymer solution and the mandrel in the prior art is solved. The heart valve obtained by the device and the method for dip molding provided by the embodiment of the invention has complete and flawless valve leaflets, and improves the mechanical property and fatigue property of the heart valve compared with the heart valve obtained by adopting the conventional device and the method for dip molding.
Drawings
The invention is further described below with reference to the accompanying drawings and examples:
FIG. 1 is a schematic view of the mandrel of a device for dip molding a heart valve according to an embodiment of the present invention;
FIG. 2 is a schematic view of a valve frame according to an embodiment of the present invention;
FIG. 3 is a schematic view of the structure of a membrane of a device for dip molding a heart valve according to an embodiment of the present invention;
FIG. 4 is a schematic view of the negative pressure component of the heart valve dip molding apparatus according to an embodiment of the present invention;
Fig. 5 is a schematic structural diagram of a film attaching process in the heart valve dip molding method according to an embodiment of the present invention ((a) the film is not attached to the curved surface, (b) the film is attached to the curved surface);
FIG. 6 is a schematic diagram of the assembled structure of the membrane, mandrel and valve frame in the heart valve dip molding method according to the embodiment of the invention;
FIG. 7 is a schematic view of the assembled structure of the membrane, mandrel, valve frame and negative pressure component in the heart valve dip molding method according to the embodiment of the invention;
Fig. 8 is a schematic structural view of a valve molding process in a heart valve dip molding method according to an embodiment of the present invention.
Wherein, in the figure: 1. a mandrel; 101. a curved surface; 102. a hole; 103. a first connection structure; 104. a triangular structure; 105 a first flange; 2. a valve frame; 201. a tip; 202. a second flange; 3. a membrane; 4. a negative pressure member; 401. a second connection structure; 402. an outlet end; 5. a container.
Detailed Description
The objects, technical solutions and advantages of the present invention will become more apparent by the following detailed description of the present invention with reference to the accompanying drawings. It should be understood that the description is only illustrative and is not intended to limit the scope of the invention. In addition, in the following description, descriptions of well-known structures and techniques are omitted so as not to unnecessarily obscure the present invention.
Referring to fig. 1 to 8, a device for dip molding a heart valve according to an embodiment of the present invention includes a frame 2 and a polymer film, i.e., leaflets, dip molded on the frame 2. The device for dip molding comprises a mandrel 1, a film 3 and a negative pressure component 4. Wherein the mandrel 1 is of a cylindrical structure, and one axial end portion has a curved surface 101 having the same curved surface structure as the target leaflet, and the other axial end portion has a first connection structure 103. Specifically, for convenience of description, as shown in fig. 1, one end of the curved surface 101 of the mandrel 1 is described as a top end, and the other end is correspondingly a bottom end. More specifically, the top end surface of the mandrel 1 is provided with three curved surfaces 101 which are uniformly spaced along the circumferential direction and are recessed toward the other end in the axial direction, that is, toward the bottom end direction, and alternatively, the specific number of the curved surfaces 101 is not particularly limited, and may be two, four, or the like, specifically, three or two are generally used according to the existing heart valve. Each curved surface 101 has two curved edges, which are described as an upper curved edge and a lower curved edge for convenience of description and distinction, and the upper curved edges of two adjacent curved surfaces 101 and the lower curved edges of two adjacent curved surfaces 101 are not in contact, that is, the upper curved edges of three curved surfaces 101 define a triangle-like plane with a middle portion substantially triangular and each angle extending in an outward protruding manner to form two substantially parallel lines, and the lower curved edges of two adjacent curved surfaces 101 define a triangle structure 104 having a substantially triangular shape therebetween, and the triangle structure 104 can facilitate centering with the tip 201 of the valve frame 2 when the subsequent valve frame 2 is mounted. The first connection 103 at the other end of the mandrel 1 is provided to facilitate subsequent connection to the negative pressure component 4. The mandrel 1 may be a hollow shaft or a solid shaft. The mandrel 1 in the embodiment of the invention is preferably a hollow shaft. Each curved surface 101 is provided with a plurality of holes 102 penetrating to the other end of the mandrel 1. The membrane 3 is used for being tightly attached to the curved surface 101 of the mandrel 1, and is used for intercepting the polymer solution on the front surface of the membrane, namely the upper end surface as shown in fig. 6, and bubbles generated in the process of forming the polymer solution on the valve frame 2 can go out through the holes 102 on the curved surface 101 through the membrane 3, namely the membrane 3 can be penetrated by gas under the action of pressure but can not be penetrated by the polymer solution of the dip molding valve blade, so that the use performance is not affected due to the defect generated by the bubbles when the polymer solution is molded on the valve frame 2. The negative pressure part 4 has an outlet and an inlet which are in communication, and a second connecting structure 401 which cooperates with the first connecting structure 103 is provided at the inlet, i.e. the connection between the spindle 1 and the negative pressure part 4 is realized by the first connecting structure 103 and the second connecting structure 401. After the mandrel 1 is connected with the negative pressure component 4, a negative pressure space capable of forming negative pressure under the action of external force is defined between the outlet and the hole 102, and bubbles are led out through the negative pressure space. Through opening 102 on the curved surface 101 of the mandrel 1, and simultaneously attaching the membrane 3 on the curved surface 101, the bubbles between the contact surfaces of the polymer solution and the curved surface 101 are treated by utilizing the negative pressure generated in the negative pressure space of the negative pressure component, so that the problem that the usability of the valve leaflet is affected due to the bubbles between the contact surfaces of the polymer solution and the mandrel 1 in the prior art is solved.
According to some preferred embodiments of the present invention, as shown in fig. 1 and 4, the first connection structure 103 is an external thread formed on the outer circumferential surface of the bottom end of the mandrel 1, and correspondingly, the upper end of the negative pressure member 4 has a concave groove (not shown) recessed downward, and the second connection structure 401 is an internal thread formed on the inner wall surface of the groove. The threaded connection is adopted, so that the processing, the assembly and the disassembly are convenient, and the connection is reliable. As an alternative embodiment, the first connection structure 103 and the second connection structure 401 may also be other connection structures that are known and easily implemented by those skilled in the art, such as magnetic attraction or clamping, etc., and are not specifically described and limited in detail.
According to some preferred embodiments of the present invention, the pore 102 has a pore diameter on the order of micrometers or nanometers, preferably on the order of micrometers. The specific pore size is not described or defined and one skilled in the art can choose the design according to the needs. The holes 102 on each curved surface 101 are irregularly arranged, and the irregular arrangement in the embodiment of the invention not only includes the arrangement mode but also includes the aperture, that is, the aperture of each hole 102 is not required to be consistent, so that the processing difficulty is reduced. The manner of processing the hole 102 may be by etching or laser engraving processes in the prior art, and the specific process is not described or limited, and is easily known to those skilled in the art.
According to some preferred embodiments of the present invention, the membrane 3 according to the embodiment of the present invention is an existing waterproof breathable polymer membrane, such as a PTFE (polytetrafluoroethylene) material or a PMP (poly 4-methylpentene-1) material, and has a smooth and flat surface. The average pore diameter of the membrane 3 is not particularly limited and may be selected according to the pore diameter of the polymer solution, so long as the permeation of air bubbles is ensured during use and the polymer solution for molding the valve leaflet is not permeable. The shape of the membrane 3 may be selected to be a triangular structure with three angular positions, circular arc shape, as shown in fig. 3.
According to some preferred embodiments of the present invention, as shown in fig. 4, the negative pressure member 4 is a funnel having an inverted cone shape at an inlet end and an elongated cylindrical through-column at an outlet end 402, and the apparatus for dip molding further includes a negative pressure generating device such as a vacuum pump or the like, which is connected to the outlet of the negative pressure member 4.
According to some preferred embodiments of the present invention, as shown in fig. 1 and 2 and fig. 6 and 7, a first flange 105 protruding radially outwards is provided on the outer peripheral wall of the end of the mandrel 1 away from the curved surface 101, i.e. the lower end as shown in fig. 1, the first connecting structure 103 is machined on the outer peripheral surface of the first flange 105, and a second flange 202 in abutting engagement with the first flange 105 and the inlet end wall surface of the negative pressure member 4 is provided on the outer peripheral wall of the end of the valve frame 2 facing away from the tip 201 thereof, i.e. the lower end as shown in fig. 2. Is convenient for positioning during installation.
The embodiment of the invention also discloses a heart valve dip molding method, wherein the dip molding device is the device of the embodiment, and the method comprises the following steps:
Bending and tightly attaching the film 3 to the curved surface 101 of the mandrel 1, and ensuring flatness and no bubbles;
placing the valve frame 2 outside the mandrel 1 and attaching the valve frame 2 to the peripheral wall of the mandrel 1, wherein the tips 201 of the valve frame 2 are aligned with the juncture of two adjacent curved surfaces 101 on the mandrel 1 one by one;
The negative pressure component 4 is connected with an external negative pressure generating device (not shown) and locked with the mandrel 1 (the first connecting structure 103 and the second connecting structure 401 are connected);
vertically immersing the assembled valve frame 2 and the mandrel 1 in a polymer solution, wherein the polymer solution completely penetrates through the curved surface 101 of the mandrel 1 and the tip 201 part of the valve frame 2;
Integrally lifting the mandrel 1 and the petal rack 2 which are coated with the polymer solution in a dip way, and standing to enable the polymer solution to be leveled until no more drops;
starting the negative pressure generating device to enable bubbles in the polymer solution attached to the tip 201 of the valve frame 2 to be discharged through the membrane 3, the hole 102 on the curved surface 101 and the negative pressure space;
and (5) drying, shaping and trimming to obtain the required heart valve.
Specifically, in the process of using the device to dip molding a polymer valve, that is, a leaflet, as shown in fig. 5, firstly, as shown in (a) of fig. 5, the film 3 is cut into a shape that can be attached to the curved surface 101 of the mandrel 1, and then bent, as shown in (b) of fig. 5, is tightly attached to the curved surface 101 at the top of the mandrel 1, so as to ensure that no air bubbles remain flat, and the outer edge of the film 3 is preferably (most preferably, the outer edge of the mandrel is flush as shown in (b) of fig. 5) after being attached to the curved surface 101 of the mandrel 1. The valve holder 2 is then placed on the mandrel 1 and the tip 201 of the valve holder 2 is positioned in alignment with the triangular structure 104 of the mandrel 1, completing the fit, as shown in fig. 6. Finally, as shown in fig. 7, the negative pressure component 4 is connected with an external negative pressure generating device, and the matched mandrel 1 and the negative pressure component 4 are rotationally locked.
After the mating, the tip 201 of the valve holder 2 is directed downward and vertically into the polymer solution in the container 5, so that the polymer solution completely penetrates the curved surface 101 at the top of the mandrel 1 and the tip 201 portion of the valve holder 2, as shown in fig. 8. Then slowly extracting the solution from the whole body, standing for a certain time to enable the polymer solution to be leveled until no more drops, starting a negative pressure generating device, discharging bubbles in the polymer solution attached to the valve frame 2 through the membrane piece 3 and the holes 102 on the mandrel 1, then drying and shaping the valve frame 2 and the mandrel 1 at a certain temperature for a certain time (the temperature and the time for drying the conventional valve leaves are known to those skilled in the art, and are not specifically described and limited), and then trimming and the like to obtain the required heart valve.
It is to be understood that the above-described embodiments of the present invention are merely illustrative of or explanation of the principles of the present invention and are in no way limiting of the invention. Accordingly, any modification, equivalent replacement, improvement, etc. made without departing from the spirit and scope of the present invention should be included in the scope of the present invention. Furthermore, the appended claims are intended to cover all such changes and modifications that fall within the scope and boundary of the appended claims, or equivalents of such scope and boundary.
Claims (10)
1. A device for dip molding a heart valve, said heart valve comprising a valve frame and leaflets dip molded on said valve frame, said device comprising:
The valve frame comprises a mandrel, at least two curved surfaces which are recessed towards the other axial end direction of the mandrel and have the same curved surface structure with a target valve blade are arranged on one axial end surface of the mandrel along the circumferential direction, a plurality of through holes are formed in any curved surface, a first connecting structure is arranged on the other end of the mandrel, and the valve frame is attached to the peripheral wall of the mandrel when in use;
The film piece is attached to the curved surface of the mandrel and can be permeable to gas under the action of pressure but impermeable to polymer solution of the plastic-impregnated valve leaflet;
The negative pressure component is provided with an outlet and an inlet which are communicated, a second connecting structure matched with the first connecting structure is arranged at the inlet, and a negative pressure space capable of forming negative pressure is defined between the outlet and the hole after the negative pressure component is connected with the mandrel.
2. The device for dip molding a heart valve according to claim 1, wherein the first connecting structure is an external thread molded on an outer wall of the other end of the mandrel;
the second connecting structure is an internal thread which is formed on the inner wall of one end of the inlet of the negative pressure component and matched with the external thread.
3. The heart valve dip molding apparatus of claim 1, wherein the pores have a diameter on the order of microns or nanometers.
4. A device for dip molding a heart valve according to claim 1 or 3, wherein the holes are irregularly arranged on the curved surface.
5. A device for dip molding a heart valve according to claim 1 or 3, wherein the holes are machined by etching or laser engraving.
6. The device for dip molding a heart valve according to claim 1, wherein the membrane is made of PTFE or PMP material and has a smooth and flat surface.
7. The heart valve infusion molding apparatus of claim 1, wherein the negative pressure member is a funnel, the infusion molding apparatus further comprising a negative pressure generating device connected to the outlet of the negative pressure member.
8. The device for dip molding of a heart valve according to claim 1, wherein a first flange protruding radially outward is provided on an outer peripheral wall of an end of the mandrel away from the curved surface, the first connecting structure is formed on an outer peripheral surface of the first flange, and a second flange abutting against and fitted with the first flange and an inlet end wall surface of the negative pressure member is provided on an outer peripheral wall of an end of the tip of the valve frame facing away from the valve frame.
9. A method for dip molding a heart valve, wherein the device used for dip molding is the device of any one of claims 1-8, said method comprising the steps of:
Bending and tightly attaching the film piece on the curved surface of the mandrel, and ensuring flatness and no bubbles;
placing the valve frame on the outer side of the mandrel and attaching the valve frame to the peripheral wall of the mandrel, wherein the tips of the valve frame are aligned with the junction parts of two adjacent curved surfaces on the mandrel one by one;
The negative pressure component is connected with an external negative pressure generating device and is locked with the mandrel;
Vertically immersing the assembled valve frame and the mandrel into a polymer solution, wherein the polymer solution completely penetrates through the curved surface of the mandrel and the tip end part of the valve frame;
integrally lifting the mandrel and the petal rack which are coated with the polymer solution in a dip way, and standing to enable the polymer solution to be leveled until no more drops;
starting a negative pressure generating device to enable bubbles in the polymer solution attached to the tip end of the valve frame to be discharged through the membrane piece, the holes on the curved surface and the negative pressure space;
and (5) drying, shaping and trimming to obtain the required heart valve.
10. The heart valve infusion molding method of claim 9, wherein the assembled valve frame and mandrel are immersed vertically in a polymer solution with the tip of the frame facing downward; and/or
During drying, the valve frame and the mandrel are dried and shaped together.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202410404640.2A CN117984485B (en) | 2024-04-07 | 2024-04-07 | Heart valve dip molding method and device |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202410404640.2A CN117984485B (en) | 2024-04-07 | 2024-04-07 | Heart valve dip molding method and device |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN117984485A true CN117984485A (en) | 2024-05-07 |
| CN117984485B CN117984485B (en) | 2024-07-02 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202410404640.2A Active CN117984485B (en) | 2024-04-07 | 2024-04-07 | Heart valve dip molding method and device |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4222126A (en) * | 1978-12-14 | 1980-09-16 | The United States Of America As Represented By The Secretary Of The Department Of Health, Education & Welfare | Unitized three leaflet heart valve |
| US4473423A (en) * | 1982-05-03 | 1984-09-25 | University Of Utah | Artificial heart valve made by vacuum forming technique |
| CA2426643A1 (en) * | 2000-11-28 | 2002-06-13 | St. Jude Medical, Inc. | Polymer valve prostheses by dip coating |
| CN1449267A (en) * | 2000-10-09 | 2003-10-15 | 阿迪亚姆生命科学股份公司 | Cardiac valve prosthesis, especially mitral cardiac valve and method for producing the same |
| CN1449266A (en) * | 2000-10-09 | 2003-10-15 | 阿迪亚姆生命科学股份公司 | Method for producing thin membrance-type structure components |
| US20060241744A1 (en) * | 2003-03-20 | 2006-10-26 | Aortech International Plc | Valve |
| WO2013019416A1 (en) * | 2011-07-29 | 2013-02-07 | St. Jude Medical, Inc. | Dipping mandrel with a gap |
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| CN112972770A (en) * | 2021-02-22 | 2021-06-18 | 南通纺织丝绸产业技术研究院 | Artificial heart valve with composite reinforced structure and preparation method thereof |
| CN115709153A (en) * | 2022-11-01 | 2023-02-24 | 苏州心锐医疗科技有限公司 | Integrated manufacturing method and device for durable artificial heart valve |
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| WO2023168270A2 (en) * | 2022-03-01 | 2023-09-07 | Arizona Board Of Regents On Behalf Of The University Of Arizona | Polymeric heart valve system and methods of making and using thereof |
| CN117653416A (en) * | 2023-11-30 | 2024-03-08 | 浙江大学 | Ball-expanded high-molecular intervention valve and preparation method thereof |
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2024
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| CN111200993A (en) * | 2017-08-04 | 2020-05-26 | 福达斯公司 | Systems, devices, and methods related to the manufacture of prosthetic valves |
| CN112972770A (en) * | 2021-02-22 | 2021-06-18 | 南通纺织丝绸产业技术研究院 | Artificial heart valve with composite reinforced structure and preparation method thereof |
| WO2023168270A2 (en) * | 2022-03-01 | 2023-09-07 | Arizona Board Of Regents On Behalf Of The University Of Arizona | Polymeric heart valve system and methods of making and using thereof |
| CN115709153A (en) * | 2022-11-01 | 2023-02-24 | 苏州心锐医疗科技有限公司 | Integrated manufacturing method and device for durable artificial heart valve |
| 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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| CN117984485B (en) | 2024-07-02 |
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