US20040123435A1 - Machine and method for producing porous membranes for medical use - Google Patents
Machine and method for producing porous membranes for medical use Download PDFInfo
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- US20040123435A1 US20040123435A1 US10/733,258 US73325803A US2004123435A1 US 20040123435 A1 US20040123435 A1 US 20040123435A1 US 73325803 A US73325803 A US 73325803A US 2004123435 A1 US2004123435 A1 US 2004123435A1
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- fluid substances
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D69/00—Semi-permeable membranes for separation processes or apparatus characterised by their form, structure or properties; Manufacturing processes specially adapted therefor
- B01D69/04—Tubular membranes
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D67/00—Processes specially adapted for manufacturing semi-permeable membranes for separation processes or apparatus
- B01D67/0002—Organic membrane manufacture
- B01D67/0004—Organic membrane manufacture by agglomeration of particles
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D67/00—Processes specially adapted for manufacturing semi-permeable membranes for separation processes or apparatus
- B01D67/0002—Organic membrane manufacture
- B01D67/0004—Organic membrane manufacture by agglomeration of particles
- B01D67/00046—Organic membrane manufacture by agglomeration of particles by deposition by filtration through a support or base layer
-
- 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
- B29C41/08—Coating a former, core or other substrate by spraying or fluidisation, e.g. spraying powder
-
- 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
- B29C41/20—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 incorporating preformed parts or layers, e.g. moulding inserts or for coating articles
-
- 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
- B29C41/36—Feeding the material on to the mould, core or other substrate
- B29C41/365—Construction of spray-up equipment, e.g. spray-up guns
-
- 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
- B29C41/52—Measuring, controlling or regulating
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2323/00—Details relating to membrane preparation
- B01D2323/42—Details of membrane preparation apparatus
-
- 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
- B29C31/00—Handling, e.g. feeding of the material to be shaped, storage of plastics material before moulding; Automation, i.e. automated handling lines in plastics processing plants, e.g. using manipulators or robots
- B29C31/04—Feeding of the material to be moulded, e.g. into a mould cavity
- B29C31/10—Feeding of the material to be moulded, e.g. into a mould cavity of several materials
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2105/00—Condition, form or state of moulded material or of the material to be shaped
- B29K2105/06—Condition, form or state of moulded material or of the material to be shaped containing reinforcements, fillers or inserts
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2105/00—Condition, form or state of moulded material or of the material to be shaped
- B29K2105/06—Condition, form or state of moulded material or of the material to be shaped containing reinforcements, fillers or inserts
- B29K2105/20—Inserts
- B29K2105/206—Meshes, lattices or nets
Definitions
- the present invention relates to a machine and method for producing porous membranes for medical use.
- the present invention relates to a machine and method for producing biocompatible and heamocompatible membranes designed to constitute vascular prostheses and artificial tissues for medical use.
- a spray method for producing membranes is known, by which they are obtained, for example, from thermodynamically unstable polymeric solutions.
- the unstable solution is generated with the addition of a non-solvent to a dilute polymeric solution and the membranes are obtained with spray deposition, using a single spray means, or with simultaneous but separate spray deposition of the unstable polymeric and non-solvent solution by separate spray means, on a supporting element designed to define the shape of the membrane.
- the method described above allows the production, for example, of small-diameter vascular prostheses or flat membranes obtained by cutting tubular membranes with a larger diameter longitudinally.
- porous membranes obtained with the above-mentioned techniques, although having indisputable positive aspects, are not free of disadvantages.
- the main disadvantage consists of the fact that the chemico-physical properties of the porous membranes obtained with the spray method, particularly the porosity of the membrane structure, are difficult to control.
- the aim of the present invention is to provide a machine for producing porous membranes which are free of the above-mentioned disadvantage and, at the same time, are practical for use and simple and economical to produce.
- the present invention provides a machine for producing porous membranes for medical use as described in claim 1 .
- Another aim of the present invention is to provide a method for producing membranes for medical use, in particular tubular membranes, which can be used as prostheses, especially vascular prostheses, and more specifically small-diameter vascular prostheses, the method being simple and flexible to implement.
- the present invention also provides a method for producing porous membranes for medical use as described in claim 16 .
- FIG. 1 is a schematic illustration of a preferred embodiment of a machine for producing porous membranes, made in accordance with the present invention
- FIG. 2 is a top perspective view of a machine for producing membranes, made in accordance with the present invention.
- FIGS. 3, 4, 5 and 6 are front elevation views of a portion of the machine illustrated in FIG. 2 in as many different operating configurations;
- FIGS. 7, 8 and 9 are top plan views of a portion of the machine illustrated in FIGS. 1 and 2 in as many different operating configurations;
- FIG. 10 is an enlarged cross-section of the detail P illustrated in FIG. 3.
- the numeral 1 indicates as a whole a portion of a machine for producing porous membranes 2 made in accordance with the present invention.
- the machine 1 comprises a frame 3 and a central body 4 extending longitudinally in a direction D.
- the central body 4 has a first and a second spindle 5 , 6 which are coaxial with one another, driven in synchronized rotation about an axis A parallel with the direction D, by respective toothed belts 7 , 8 .
- FIG. 2 fully illustrates only one, labeled 9 , keyed to opposite ends of a shaft 10 .
- the shaft 10 is turned by drive means of the known type which are not illustrated or described in any further detail.
- the shaft 10 has an axis of rotation B parallel with the above-mentioned axis A of the spindles 5 , 6 .
- Each spindle 5 , 6 supports one end of a supporting element 11 .
- the supporting element 11 consists of a cylindrical body 12 with a small diameter.
- the machine 1 comprises a first carriage 13 which slides longitudinally in the direction D, on guide parts 14 .
- a threaded rod 15 engages as it turns with the carriage 13 , to drive the carriage in the direction D.
- the threaded rod 15 is turned by drive means of the known type and not illustrated.
- the first carriage 13 comprises first and second guns 16 , 17 with nozzles 16 a , 17 a designed to spray fluid substances, respectively consisting of first and second mixtures 18 , 19 .
- the mixtures 18 and 19 are supplied to the guns 16 , 17 through pipes 20 by pumps 21 , 22 .
- the mixtures 18 , 19 are formed at and by mixer parts 23 , 24 to which a plurality of stored reserves of components designed to form the above-mentioned mixtures 18 , 19 are fluidly connected.
- FIG. 1 illustrates three reserves 25 a , 25 b , 25 c of components 18 a , 18 b , 18 c for the first mixture 18 and three reserves 26 a , 26 b , 26 c of components 19 a , 19 b , 19 c for the second mixture 19 .
- the machine 1 also comprises a source 27 of pressurized gas supplied to the guns 16 , 17 by pipes 28 to activate the nozzles 16 a , 17 a for spray emission of the mixtures 18 , 19 .
- the nozzles 16 a , 17 a of the two guns 16 , 17 are angled in such a way that they substantially converge on the same point of the cylindrical body 12 .
- the machine 1 comprises a second carriage 29 which also slides longitudinally in the direction D on respective guide parts 30 and is driven by a threaded rod 15 .
- the second carriage 29 is covered by an extractor hood 31 , one of whose intakes 32 is positioned over the guns 16 , 17 .
- the hood 31 is connected, by a manifold schematically illustrated with a line 33 , to a suction source, also schematically illustrated with a block 34 .
- the machine 1 also comprises a central control unit 35 designed to act on the above-mentioned mixer parts 23 , 24 as well as the guns 16 , 17 and on the drive means of the spindles 5 , 6 and carriages 13 , 29 .
- the guns 16 , 17 , together with the nozzles 16 a , 17 a , the source 27 of pressurized gas and the pumps 21 , 22 as a whole define, for the machine 1 , means 36 for spraying the mixtures 18 , 19 .
- the cylindrical body 12 is mounted on the central body 4 of the machine 1 , with its ends 12 a , 12 b fixed to the respective spindles 5 , 6 .
- the first nozzle 16 a is activated by a flow of pressurized gas from the source 27 through the pipe 28 .
- the pressurized gas in accordance with known methods which are not described in any further detail, causes the spray emission of the first mixture 18 from the nozzle 16 a , creating a first jet 16 b .
- the first mixture is supplied to the nozzle 16 a by the first pump 21 through the pipe 20 .
- the first pump 21 sends the first mixture 18 to the first nozzle 16 a , drawing it from the first mixer 23 to which the three reserves 25 a , 25 b , 25 c of the components 18 a , 18 b , 18 c are connected.
- the second nozzle 17 a is also activated by a flow of pressurized gas from the source 27 , through the pipe 28 .
- the pressurized gas causes the spray emission of the second mixture 19 from the nozzle 17 a , creating a second jet 17 b .
- the second mixture 19 is supplied to the nozzle 17 a by the second pump 22 through the pipe 20 .
- the second pump 22 sends the second mixture 19 to the second nozzle 17 a , picking it up from the second mixer 24 , to which the three reserves 26 a , 26 b , 26 c of the components 19 a , 19 b , 19 c are connected.
- the first carriage 13 begins to move, driven by the rotation of the threaded rod 15 which as it turns engages with the carriage 13 , in the direction D, as indicated by the arrow F 1 .
- the cylindrical body 12 which constitutes the supporting element 11 is turned by the spindles 5 , 6 about the axis A.
- the second carriage 29 begins to move, in the direction D as indicated by the arrow F 1 , driven by the rotation of the threaded rod 15 which as it turns engages with the carriage 29 .
- the extractor hood 31 integral with the second carriage 29 also moves in the direction D as indicated by the arrow F 1 , substantially synchronized with the first carriage 13 and remains over the nozzles 16 a , 17 a .
- the extractor action of the hood 31 is mainly intended to promote the regular emission of the jets 16 b , 17 b of the mixtures 18 , 19 directed onto the supporting element 11 .
- a first set of such feed cycles is performed by the machine 1 with the mixtures 18 , 19 having respective first compositions given by particular relative quantities for mixing of the components 18 a , 18 b , 18 c , 19 a , 19 b , 19 c stored in the reserves 25 a , 25 b , 25 c , 26 a , 26 b , 26 c.
- the mixtures 18 , 19 in their first configurations form a first layer 38 of the porous membrane 2 , this first layer 38 having predetermined chemico-physical properties.
- the central control unit 35 When executing the commands set on it, the central control unit 35 therefore acts on the mixer parts 23 , 24 to change the relative quantities of the components 18 a , 18 b , 18 c , 19 a , 19 b , 19 c stored in the reserves 25 a , 25 b , 25 c , 26 a , 26 b , 26 c and to create the second compositions of the mixtures 18 , 19 .
- the machine 1 performs a second set of cycles with the mixtures 18 , 19 with the second compositions.
- the mixtures 18 and 19 in their second compositions, create a second layer 39 of the porous membrane 2 , this second layer 39 having predetermined chemico-physical properties which are different to those of the first layer 38 below it.
- these chemico-physical properties include the porosity of the membrane 2 which, for example with reference to tubular membranes for vascular prostheses, advantageously involves two different layers, the first, internal layer 38 in contact with the hematic fluid and more porous, and the second, external layer 39 , more compact and with greater mechanical strength.
- the mixers 23 , 24 are of the solenoid valve type, programmable and allow sequential valve opening so that the nozzles 16 a , 17 a can be supplied with predetermined quantities of the components 18 a , 18 b , 18 c in the reserves 25 a , 25 b , 25 c and, at the same time, the components 19 a , 19 b , 19 c in the reserves 26 a , 26 b , 26 c.
- the element 37 on which the substances are deposited and build up is the cylindrical body 12 described above with reference to FIG. 2, designed for producing tubular porous membranes 2 suitable for use as vascular prostheses even with very small diameters.
- the ends of the cylindrical body 12 are connected to the machine 1 spindles 5 , 6 to turn about its axis A.
- the element 37 on which the substances are deposited and build up consists of a cylindrical drum 12 c with a diameter larger than that of the above-mentioned cylindrical body 12 .
- Use of the drum 12 c as an element 37 on which the substances are deposited and build up is intended to produce flat porous membranes obtained by cutting tubular membranes 2 produced with the above-mentioned method longitudinally.
- the element 37 on which the sprayed fluid substances are deposited and build up consists of a stent 40 .
- the stent 40 is a tubular element, made of metal or plastic for insertion, for example, in a blood vessel to hold it open and prevent constriction or pressure from the outside.
- the stent 40 is supported by a fine supporting wire 41 , advantageously made of polytetrafluoroethylene, which passes inside it and whose opposite ends, not illustrated in the drawing, are connected to the machine 1 spindles 5 , 6 to turn about its axis A. As it turns about the axis A, the wire 41 causes the stent 40 to rotate.
- the stent 40 is hit by one or both of the jets 16 b , 17 b from the nozzles 16 , 17 and, by means of the above-mentioned technique, a dense membrane 2 is formed on its surface, where the term dense refers to a membrane 2 whose porosity is very low, that is to say, which is substantially closed and impermeable. Since stents are tubular elements with gaps in the surface, the fluid substances sprayed can advantageously be deposited evenly on both the outer surface and in the inner tubular face, passing through the gaps in the outer surface.
- FIG. 6 illustrates a preferred embodiment of the configuration illustrated in FIG. 5.
- the machine 1 comprises a heating element 46 , schematically illustrated in the drawing.
- This element 46 is located below the stent 40 which is mounted on the supporting wire 41 .
- the heating element 46 is regulated by a temperature control unit 47 and powered by known means, not illustrated or described in further detail, for heating a zone 48 close to the stent 40 .
- the particles of fluid substances sprayed by the nozzles 16 a , 17 a make contact with the stent 40 , they form a substantially smooth and even layer on its surface.
- the higher temperature created in the zone 48 by the presence of the heating element 46 allows the solvents present in the fluids sprayed to rapidly evaporate, increasing adhesion to the stent 40 by the membrane 2 as it is formed.
- FIG. 7 illustrates an alternative embodiment of the machine 1 disclosed.
- This alternative embodiment allows the above-mentioned procedure for spray depositing the fluid substances to be performed at the same time as a filament 42 of a suitable strengthening material (polyester, polyurethane, silicone, etc.) is wound around the supporting element 11 .
- the filament 42 is incorporated in the porous membrane 2 being formed on the rotating cylindrical body 12 .
- the filament 42 is wound in a spiral, with a predetermined pitch, by the respective movements of the rotating support 12 and of a rotary dispenser element 43 for the filament 42 .
- the element 43 can slide in the direction D, driven by drive means which are not illustrated.
- FIGS. 8 and 9 illustrate yet another embodiment of the machine 1 disclosed.
- a tubular strengthening mesh 44 is inserted on the cylindrical body 12 .
- the mesh 44 advantageously made of polyester, is then covered with another material, which may or may not be porous, again deposited with the spray technique described above.
- the tubular mesh 44 has substantially wide links, allowing substantial continuity between the material spray-deposited before insertion of the mesh 44 and that deposited over the mesh 44 .
- the mesh 44 is incorporated between two polymeric layers.
- tubular mesh 44 can also only be coated on its outer wall, by inserting the mesh 44 directly on the cylindrical body 12 without previously spray-depositing any material on the body 12 , as described above.
- control unit 35 acts upon the mixer parts 23 , 24 , altering the relative quantities of components 18 a , 18 b , 18 c , 19 a , 19 b , 19 c , for example, in a substantially instantaneous way, with a stepped function, or continuously with a gradual function.
- the first mixture 18 comprises a polymer and the second mixture 19 comprises a non-solvent for the polymer.
Abstract
The machine (1) for producing porous membranes (2) for medical use comprises a plurality of reserves (25 a , 25 b , 25 c , 26 a , 26 b , 26 c) of components (18 a , 18 b , 18 c, 19a , 19 b , 19 c) which constitute fluid substances, first and second guns (16, 17) supplied from the reserves (25 a , 25 b , 25 c , 26 a , 26 b , 26 c) for spraying the fluid substances onto an element (37) on which the substances are deposited and build up, the element (37) and the guns (16, 17) being mobile relative to one another for substantially even distribution of the fluid substances designed to form the membrane (2).
Description
- The present invention relates to a machine and method for producing porous membranes for medical use.
- In particular, the present invention relates to a machine and method for producing biocompatible and heamocompatible membranes designed to constitute vascular prostheses and artificial tissues for medical use.
- The prior art describes many techniques for the production, using polymers, of small-diameter porous or filamentous tubular tissues.
- In addition to the now consolidated production techniques using extrusion, a spray method for producing membranes is known, by which they are obtained, for example, from thermodynamically unstable polymeric solutions. Specifically, the unstable solution is generated with the addition of a non-solvent to a dilute polymeric solution and the membranes are obtained with spray deposition, using a single spray means, or with simultaneous but separate spray deposition of the unstable polymeric and non-solvent solution by separate spray means, on a supporting element designed to define the shape of the membrane.
- The method described above allows the production, for example, of small-diameter vascular prostheses or flat membranes obtained by cutting tubular membranes with a larger diameter longitudinally.
- The vascular prostheses or flat membranes, hereinafter generally referred to as porous membranes, obtained with the above-mentioned techniques, although having indisputable positive aspects, are not free of disadvantages.
- The main disadvantage consists of the fact that the chemico-physical properties of the porous membranes obtained with the spray method, particularly the porosity of the membrane structure, are difficult to control.
- Generally speaking, with the known methods, it is difficult to obtain membranes able to simultaneously fulfil haemocompatibility and biocompatibility requirements and provide adequate mechanical strength.
- Therefore, the aim of the present invention is to provide a machine for producing porous membranes which are free of the above-mentioned disadvantage and, at the same time, are practical for use and simple and economical to produce.
- Accordingly the present invention provides a machine for producing porous membranes for medical use as described in claim1.
- Another aim of the present invention is to provide a method for producing membranes for medical use, in particular tubular membranes, which can be used as prostheses, especially vascular prostheses, and more specifically small-diameter vascular prostheses, the method being simple and flexible to implement.
- Accordingly the present invention also provides a method for producing porous membranes for medical use as described in
claim 16. - The technical features of the present invention, in accordance with the above-mentioned aims, are set out in the claims herein and the advantages more clearly illustrated in the detailed description which follows, with reference to the accompanying drawings, which illustrate a preferred embodiment of the invention without limiting the scope of the inventive concept, and in which:
- FIG. 1 is a schematic illustration of a preferred embodiment of a machine for producing porous membranes, made in accordance with the present invention;
- FIG. 2 is a top perspective view of a machine for producing membranes, made in accordance with the present invention;
- FIGS. 3, 4,5 and 6 are front elevation views of a portion of the machine illustrated in FIG. 2 in as many different operating configurations;
- FIGS. 7, 8 and9 are top plan views of a portion of the machine illustrated in FIGS. 1 and 2 in as many different operating configurations;
- FIG. 10 is an enlarged cross-section of the detail P illustrated in FIG. 3.
- With reference to FIG. 2, the numeral1 indicates as a whole a portion of a machine for producing
porous membranes 2 made in accordance with the present invention. - The machine1 comprises a
frame 3 and acentral body 4 extending longitudinally in a direction D. - The
central body 4 has a first and asecond spindle respective toothed belts - The
toothed belts shaft 10. Theshaft 10 is turned by drive means of the known type which are not illustrated or described in any further detail. - The
shaft 10 has an axis of rotation B parallel with the above-mentioned axis A of thespindles - Each
spindle element 11. In FIG. 2 the supportingelement 11 consists of acylindrical body 12 with a small diameter. - At the side of the
central body 4, the machine 1 comprises afirst carriage 13 which slides longitudinally in the direction D, onguide parts 14. A threadedrod 15 engages as it turns with thecarriage 13, to drive the carriage in the direction D. The threadedrod 15 is turned by drive means of the known type and not illustrated. - With reference to FIGS. 1 and 2, the
first carriage 13 comprises first andsecond guns nozzles second mixtures - The
mixtures guns pipes 20 bypumps - The
mixtures mixer parts mixtures - In particular, for example FIG. 1 illustrates three
reserves components first mixture 18 and threereserves components second mixture 19. - The machine1 also comprises a
source 27 of pressurized gas supplied to theguns pipes 28 to activate thenozzles mixtures - The
nozzles guns cylindrical body 12. - With reference to FIG. 2, on the side of the
cylindrical body 12 opposite thefirst carriage 13, the machine 1 comprises asecond carriage 29 which also slides longitudinally in the direction D onrespective guide parts 30 and is driven by a threadedrod 15. - The
second carriage 29 is covered by anextractor hood 31, one of whoseintakes 32 is positioned over theguns - As shown in FIG. 1, the
hood 31 is connected, by a manifold schematically illustrated with aline 33, to a suction source, also schematically illustrated with ablock 34. - Again with reference to FIG. 1, the machine1 also comprises a
central control unit 35 designed to act on the above-mentionedmixer parts guns spindles carriages - The
guns nozzles source 27 of pressurized gas and thepumps mixtures - In practice, as illustrated in FIG. 2, the
cylindrical body 12 is mounted on thecentral body 4 of the machine 1, with itsends respective spindles - Through the above-mentioned drive means, which are not illustrated, by means of the
shaft 10 andbelts cylindrical body 12 which forms the supportingelement 11 is turned about its axis A. - Starting with a first limit position of the
first carriage 13, illustrated in FIG. 2, thefirst nozzle 16 a is activated by a flow of pressurized gas from thesource 27 through thepipe 28. The pressurized gas, in accordance with known methods which are not described in any further detail, causes the spray emission of thefirst mixture 18 from thenozzle 16 a, creating a first jet 16 b. The first mixture is supplied to thenozzle 16 a by thefirst pump 21 through thepipe 20. - The
first pump 21 sends thefirst mixture 18 to thefirst nozzle 16 a, drawing it from thefirst mixer 23 to which the threereserves components - Similarly to the above description with reference to the
first nozzle 16 a, and substantially simultaneously with this, thesecond nozzle 17 a is also activated by a flow of pressurized gas from thesource 27, through thepipe 28. The pressurized gas causes the spray emission of thesecond mixture 19 from thenozzle 17 a, creating a second jet 17 b. Thesecond mixture 19 is supplied to thenozzle 17 a by thesecond pump 22 through thepipe 20. - The
second pump 22 sends thesecond mixture 19 to thesecond nozzle 17 a, picking it up from thesecond mixer 24, to which the threereserves components - Again starting from the limit position illustrated in FIG. 2, the
first carriage 13 begins to move, driven by the rotation of the threadedrod 15 which as it turns engages with thecarriage 13, in the direction D, as indicated by the arrow F1. At the same time, thecylindrical body 12 which constitutes the supportingelement 11 is turned by thespindles - Similarly to the above description, the
second carriage 29 begins to move, in the direction D as indicated by the arrow F1, driven by the rotation of the threadedrod 15 which as it turns engages with thecarriage 29. - The
extractor hood 31, integral with thesecond carriage 29 also moves in the direction D as indicated by the arrow F1, substantially synchronized with thefirst carriage 13 and remains over thenozzles hood 31 is mainly intended to promote the regular emission of the jets 16 b, 17 b of themixtures element 11. - The above-mentioned movements, simultaneously with the spraying action of the
nozzles mixtures element 11, the latter therefore constituting anelement 37 on which the fluid substances are deposited and build up. - While the supporting
element 11 carries on rotating about its own axis A continuously, the movement of the carriages in the direction D continues with an alternating motion. That is to say, when a second, opposite limit position, not illustrated and defined by the desired longitudinal dimensions for themembrane 2 being formed is reached, the direction ofcarriage - The repetition in succession of numerous cycles of
alternating carriage mixtures membrane 2. - In other words, according to the desired thickness of the
membrane 2 and considering the mixture fluid flow rate of nozzles 16 b, 17 b, the number of alternating motion feed cycles for thecarriages - A first set of such feed cycles is performed by the machine1 with the
mixtures components reserves - The values required of these first compositions are set on the
central control unit 35 which operates directly on themixer parts - As illustrated in FIG. 10, the
mixtures first layer 38 of theporous membrane 2, thisfirst layer 38 having predetermined chemico-physical properties. - When executing the commands set on it, the
central control unit 35 therefore acts on themixer parts components reserves mixtures - The machine1 performs a second set of cycles with the
mixtures - As they are deposited on the
first layer 38, themixtures second layer 39 of theporous membrane 2, thissecond layer 39 having predetermined chemico-physical properties which are different to those of thefirst layer 38 below it. - In particular, as illustrated in FIG. 10, these chemico-physical properties include the porosity of the
membrane 2 which, for example with reference to tubular membranes for vascular prostheses, advantageously involves two different layers, the first,internal layer 38 in contact with the hematic fluid and more porous, and the second,external layer 39, more compact and with greater mechanical strength. - Advantageously, the
mixers nozzles components reserves components reserves - As illustrated in FIG. 3, the
element 37 on which the substances are deposited and build up is thecylindrical body 12 described above with reference to FIG. 2, designed for producing tubularporous membranes 2 suitable for use as vascular prostheses even with very small diameters. The ends of thecylindrical body 12, not illustrated, are connected to the machine 1spindles - With reference to FIG. 4, the
element 37 on which the substances are deposited and build up consists of acylindrical drum 12 c with a diameter larger than that of the above-mentionedcylindrical body 12. Use of thedrum 12 c as anelement 37 on which the substances are deposited and build up is intended to produce flat porous membranes obtained by cuttingtubular membranes 2 produced with the above-mentioned method longitudinally. - With reference to FIG. 5, the
element 37 on which the sprayed fluid substances are deposited and build up consists of astent 40. Thestent 40 is a tubular element, made of metal or plastic for insertion, for example, in a blood vessel to hold it open and prevent constriction or pressure from the outside. Thestent 40 is supported by a fine supportingwire 41, advantageously made of polytetrafluoroethylene, which passes inside it and whose opposite ends, not illustrated in the drawing, are connected to the machine 1spindles wire 41 causes thestent 40 to rotate. - During normal machine1 operation, the
stent 40 is hit by one or both of the jets 16 b, 17 b from thenozzles dense membrane 2 is formed on its surface, where the term dense refers to amembrane 2 whose porosity is very low, that is to say, which is substantially closed and impermeable. Since stents are tubular elements with gaps in the surface, the fluid substances sprayed can advantageously be deposited evenly on both the outer surface and in the inner tubular face, passing through the gaps in the outer surface. - FIG. 6 illustrates a preferred embodiment of the configuration illustrated in FIG. 5. In this improved configuration, the machine1 comprises a
heating element 46, schematically illustrated in the drawing. Thiselement 46 is located below thestent 40 which is mounted on the supportingwire 41. Theheating element 46 is regulated by atemperature control unit 47 and powered by known means, not illustrated or described in further detail, for heating azone 48 close to thestent 40. - Advantageously, thanks to the heat, when the particles of fluid substances sprayed by the
nozzles stent 40, they form a substantially smooth and even layer on its surface. Moreover, the higher temperature created in thezone 48 by the presence of theheating element 46 allows the solvents present in the fluids sprayed to rapidly evaporate, increasing adhesion to thestent 40 by themembrane 2 as it is formed. - FIG. 7 illustrates an alternative embodiment of the machine1 disclosed. This alternative embodiment allows the above-mentioned procedure for spray depositing the fluid substances to be performed at the same time as a
filament 42 of a suitable strengthening material (polyester, polyurethane, silicone, etc.) is wound around the supportingelement 11. In particular, thefilament 42 is incorporated in theporous membrane 2 being formed on the rotatingcylindrical body 12. Thefilament 42 is wound in a spiral, with a predetermined pitch, by the respective movements of therotating support 12 and of arotary dispenser element 43 for thefilament 42. Theelement 43 can slide in the direction D, driven by drive means which are not illustrated. - FIGS. 8 and 9 illustrate yet another embodiment of the machine1 disclosed. In this embodiment, once the
nozzles cylindrical body 12, providing a givenporous membrane 2 thickness, atubular strengthening mesh 44 is inserted on thecylindrical body 12. Themesh 44, advantageously made of polyester, is then covered with another material, which may or may not be porous, again deposited with the spray technique described above. Advantageously, thetubular mesh 44 has substantially wide links, allowing substantial continuity between the material spray-deposited before insertion of themesh 44 and that deposited over themesh 44. - Therefore, the
mesh 44 is incorporated between two polymeric layers. - Where special needs require it, the
tubular mesh 44 can also only be coated on its outer wall, by inserting themesh 44 directly on thecylindrical body 12 without previously spray-depositing any material on thebody 12, as described above. - The strengthening
filament 42 and thetubular mesh 44 together constitutemembrane 2stiffening elements 45. - The operations described above with reference to FIGS. 7, 8 and9 may also be performed with large deposit and build up
elements 37, such as thecylindrical drum 12 c, to obtain strengthened flatporous membranes 2. - Advantageously, depending on the required
membrane 2 composition, thecontrol unit 35 acts upon themixer parts components - Advantageously, but without limiting the scope of the present invention, in a preferred embodiment of the present invention the
first mixture 18 comprises a polymer and thesecond mixture 19 comprises a non-solvent for the polymer. - The invention described can be subject to modifications and variations without thereby departing from the scope of the inventive concept. Moreover, all the details of the invention may be substituted by technically equivalent elements.
Claims (21)
1. A machine for producing porous membranes (2) for medical use, starting with fluid substances consisting of mixtures (18, 19) of two or more components (18 a, 18 b, 18 c, 19 a, 19 b, 19 c), the machine being of the type comprising:
reserves (25 a, 25 b, 25 c, 26 a, 26 b, 26 c) of said components (18 a, 18 b, 18 c, 19 a, 19 b, 19 c),
spray means (36) for the fluid substances, connected to the reserves (25 a, 25 b, 25 c, 26 a, 26 b, 26 c),
a support (11) constituting an element (37) on which the fluid substances sprayed by the means (36) are deposited and build up, the element (37) and the spray means (36) being mobile relative to one another for substantially even distribution of the fluid substances designed to form the membrane (2), the machine further comprising, upstream of the spray means (36), mixer means (23, 24) for mixing together the components (18 a, 18 b, 18 c, 19 a, 19 b, 19 c) which form the fluid substances, in the desired relative mixing quantities, these relative quantities providing the membrane (2) with given chemico-physical properties.
2. The machine according to claim 1 , further comprising a central control unit (35) designed to act upon the mixer means (23, 24) to alter the relative quantities for mixture of the components (18 a, 18 b, 18 c, 19 a, 19 b, 19 c) of the fluid substances, according to the desired values set on the control unit (35).
3. The machine according to claim 1 or 2, wherein the spray means (36) comprise at least a first nozzle (16 a) and a second nozzle (17 a) for spraying a first mixture (18) and a second mixture (19) at the support (11).
4. The machine according to claim 3 , further comprising at least one pump (21, 22) for supplying the fluid substances to the nozzles (16 a, 17 a).
5. The machine according to claim 3 or 4, further comprising at least one source (27) of pressurized gas for activating the nozzles (16 a, 17 a).
6. The machine according to any of the foregoing claims from 1 to 5, wherein the support (11) comprises a cylindrical element (12, 12 c) for producing tubular porous membranes (2), the cylindrical element (12, 12 c) being designed to turn about an axis of rotation (A).
7. The machine according to any of the foregoing claims from 1 to 5, wherein the element (37) on which the fluid substances sprayed are deposited and build up is a stent (40) designed to be covered by the substances, the stent (40) being supported by the machine using a wire (41) passing inside it and made to rotate about an axis of rotation (A).
8. The machine according to claim 7 , further comprising a heating element (46) designed to heat a given zone (48) close to the stent (40).
9. The machine according to claim 6 , wherein the spray means (36) comprise a first carriage (13) supporting the nozzles (16 a, 17 a), the first carriage (13) and the cylindrical element (12, 12 c) being mobile relative to one another in a direction (D) substantially parallel with the axis of rotation (A) of the cylindrical element (12, 12 c).
10. The machine according to claim 9 , wherein the first carriage (13) is driven by drive means so that it slides in the direction (D) substantially parallel with the axis of rotation (A) of the cylindrical element (12, 12 c).
11. The machine according to any of the foregoing claims from 6 to 10, further comprising a second carriage (29) supporting an extractor hood (31), the second carriage (29) sliding in the direction (D) substantially parallel with the axis of rotation (A) and the extractor hood (31) being positioned over the nozzles (16 a, 17 a).
12. The machine according to any of the foregoing claims from 1 to 11, wherein one of the mixtures (18, 19) comprises a polymer and the other mixture (18, 19) comprises a non-solvent for the polymer.
13. The machine according to any of the foregoing claims from 1 to 12, further comprising means (43) for the insertion of membrane (2) stiffening elements (45) during membrane (2) formation.
14. The machine according to claim 13 , wherein the stiffening elements (45) comprise a filament (42) designed for insertion in the membrane (2).
15. The machine according to claim 13 , wherein the stiffening elements (45) comprise a tubular mesh (44) designed for insertion in the membrane (2).
16. A method for producing porous membranes (2) for medical use starting with fluid substances consisting of mixtures (18, 19) of two or more components (18 a, 18 b, 18 c, 19 a, 19 b, 19 c), comprising the steps of:
supplying the fluid substances to spray means (36),
depositing and building up the fluid substances sprayed by the spray means (36) on a supporting means (11),
providing drive means for the spray means (36) and the supporting means (11) for substantially even distribution of the substances designed to form the membrane (2), wherein the supply step comprises the further step of changing the relative quantities for mixture of the components (18 a, 18 b, 18 c, 19 a, 19 b, 19 c), according to the desired values, relative to the chemico-physical properties required of the membrane (2).
17. The method according to claim 16 , wherein the step of changing the relative quantities for mixture of the components (18 a, 18 b, 18 c, 19 a, 19 b, 19 c) occurs substantially instantaneously according to a stepped function.
18. The method according to claim 16 , wherein the step of changing the relative quantities for mixture of the components (18 a, 18 b, 18 c, 19 a, 19 b, 19 c) occurs continuously according to a gradual function.
19. The method according to any of the foregoing claims from 16 to 18, wherein the chemico-physical properties comprise the level of porosity of the membrane (2).
20. The method according to any of the foregoing claims from 16 to 19, further comprising the step of inserting stiffening elements (45) in the membrane (2) during membrane (2) formation.
21. The method according to any of the foregoing claims from 16 to 19, further comprising the step of heating a zone (48) close to a support (11) forming an element (37) on which the fluid substances sprayed are deposited and build up.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP02425778A EP1431019B1 (en) | 2002-12-17 | 2002-12-17 | Apparatus and its use for producing porous membranes for medical use |
EP02425778.4 | 2002-12-17 |
Publications (1)
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US20040123435A1 true US20040123435A1 (en) | 2004-07-01 |
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Family Applications (1)
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US10/733,258 Abandoned US20040123435A1 (en) | 2002-12-17 | 2003-12-12 | Machine and method for producing porous membranes for medical use |
Country Status (11)
Country | Link |
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US (1) | US20040123435A1 (en) |
EP (1) | EP1431019B1 (en) |
JP (1) | JP2006509658A (en) |
CN (1) | CN1726118A (en) |
AT (1) | ATE355950T1 (en) |
AU (1) | AU2003303043A1 (en) |
DE (1) | DE60218712T2 (en) |
DK (1) | DK1431019T3 (en) |
ES (1) | ES2283517T3 (en) |
RU (1) | RU2005122463A (en) |
WO (1) | WO2004054775A1 (en) |
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CN101884573A (en) * | 2010-05-27 | 2010-11-17 | 清华大学 | Multi-nozzle injection device for complex organ prosoma three-dimensional controlled forming machine |
KR101254707B1 (en) * | 2011-10-12 | 2013-04-15 | 전북대학교산학협력단 | Nano-fiber coating apparatus and method |
EP2777543A1 (en) * | 2013-03-12 | 2014-09-17 | DePuy Synthes Products, LLC | Method of fabricating modifiable occlusion device |
US20150367542A1 (en) * | 2013-03-07 | 2015-12-24 | S.M. Scienzia Machinale S.R.L. | Apparatus and method for producing a biocompatible three-dimensional object |
US20160001469A1 (en) * | 2013-03-07 | 2016-01-07 | S.M. Scienzia Machinale S.R.L. | Apparatus and method for producing a biocompatible three-dimensional object |
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US7901740B2 (en) | 2004-11-05 | 2011-03-08 | Tamicare Ltd. | Methods to produce stretchable products |
JP5132315B2 (en) | 2004-11-05 | 2013-01-30 | タミケア リミテッド | Method and apparatus for manufacturing extensible products |
US9731319B2 (en) | 2004-11-05 | 2017-08-15 | Tamicare Ltd. | Stretchable sheets comprising a variety of layers and zones and methods to produce such products |
US20080226693A1 (en) * | 2007-03-14 | 2008-09-18 | Vipul Bhupendra Dave | Apparatus and Method for Making a Polymeric Structure |
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Also Published As
Publication number | Publication date |
---|---|
DE60218712D1 (en) | 2007-04-19 |
EP1431019B1 (en) | 2007-03-07 |
CN1726118A (en) | 2006-01-25 |
WO2004054775A1 (en) | 2004-07-01 |
AU2003303043A1 (en) | 2004-07-09 |
DK1431019T3 (en) | 2007-07-09 |
RU2005122463A (en) | 2006-02-20 |
ATE355950T1 (en) | 2007-03-15 |
WO2004054775A8 (en) | 2005-04-14 |
JP2006509658A (en) | 2006-03-23 |
ES2283517T3 (en) | 2007-11-01 |
EP1431019A1 (en) | 2004-06-23 |
DE60218712T2 (en) | 2007-11-08 |
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