[go: up one dir, main page]

WO1999007307A1 - Prosthesis for implantation and method for preparing the same - Google Patents

Prosthesis for implantation and method for preparing the same Download PDF

Info

Publication number
WO1999007307A1
WO1999007307A1 PCT/RU1998/000260 RU9800260W WO9907307A1 WO 1999007307 A1 WO1999007307 A1 WO 1999007307A1 RU 9800260 W RU9800260 W RU 9800260W WO 9907307 A1 WO9907307 A1 WO 9907307A1
Authority
WO
WIPO (PCT)
Prior art keywords
tape
fact
prosthesis
proposition
layer
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.)
Ceased
Application number
PCT/RU1998/000260
Other languages
French (fr)
Russian (ru)
Inventor
Valery Evgenievich Diyakov
Arkady Konstantinovich Pugachev
Andrei Viktorovich Kryzhanovsky
Igor Valerievich Mikhailov
Alexei Valerievich Gusinsky
Lev Valerievich Lebedev
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Zakrytoe Aktsionernoe Obschestvo 'nauchno-Proizvodstvenny Komplex 'ekoflon'
Original Assignee
Zakrytoe Aktsionernoe Obschestvo 'nauchno-Proizvodstvenny Komplex 'ekoflon'
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Zakrytoe Aktsionernoe Obschestvo 'nauchno-Proizvodstvenny Komplex 'ekoflon' filed Critical Zakrytoe Aktsionernoe Obschestvo 'nauchno-Proizvodstvenny Komplex 'ekoflon'
Priority to AU88929/98A priority Critical patent/AU8892998A/en
Publication of WO1999007307A1 publication Critical patent/WO1999007307A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • B29C55/00—Shaping by stretching, e.g. drawing through a die; Apparatus therefor
    • B29C55/005—Shaping by stretching, e.g. drawing through a die; Apparatus therefor characterised by the choice of materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/16—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/26—Mixtures of macromolecular compounds
    • 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
    • B29C53/00—Shaping by bending, folding, twisting, straightening or flattening; Apparatus therefor
    • B29C53/56—Winding and joining, e.g. winding spirally
    • B29C53/58—Winding and joining, e.g. winding spirally helically
    • B29C53/581—Winding and joining, e.g. winding spirally helically using sheets or strips consisting principally of plastics material
    • 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
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • 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
    • B29K2027/00—Use of polyvinylhalogenides or derivatives thereof as moulding material
    • B29K2027/12—Use of polyvinylhalogenides or derivatives thereof as moulding material containing fluorine
    • B29K2027/18—PTFE, i.e. polytetrafluorethene, e.g. ePTFE, i.e. expanded polytetrafluorethene
    • 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

Definitions

  • the invention is subject to medical equipment, and the name implants used to replace in the body of the unit or to process the process of processing Iz ⁇ b ⁇ e ⁇ enie m ⁇ zhe ⁇ by ⁇ is ⁇ lz ⁇ van ⁇ in ⁇ aches ⁇ ve ⁇ eza v ⁇ vnu ⁇ is ⁇ sudis ⁇ y ⁇ i ⁇ u ⁇ gii, ⁇ i ⁇ u ⁇ gii ⁇ v e ⁇ s ⁇ ase ⁇ e ⁇ ny ⁇ ⁇ gan ⁇ v, ⁇ i ⁇ u ⁇ giches ⁇ y ⁇ n ⁇ l ⁇ gii, gas ⁇ en ⁇ e ⁇ l ⁇ gii, u ⁇ l ⁇ gii, gine ⁇ l ⁇ gii, ney ⁇ i ⁇ u ⁇ gii and ⁇ ulm ⁇ n ⁇ l ⁇ gii and ⁇ a ⁇ zhe for e ⁇ s ⁇ aana ⁇ miches ⁇ g ⁇ is ⁇ lz ⁇ vaniya.
  • P ⁇ i is ⁇ lz ⁇ vanii ⁇ ls ⁇ s ⁇ enny ⁇ ⁇ ez ⁇ v ⁇ ven ⁇ sny ⁇ s ⁇ sud ⁇ v nablyudae ⁇ sya ⁇ yavlenie sleduyuschi ⁇ nezhela ⁇ elny ⁇ phenomena ⁇ le ⁇ chnye elemen ⁇ y and s ⁇ edini ⁇ eln ⁇ annye v ⁇ l ⁇ na not m ⁇ gu ⁇ glub ⁇ ⁇ ni ⁇ nu ⁇ in s ⁇ u ⁇ u ⁇ u in sleds ⁇ vie ⁇ il ⁇ b ⁇ azn ⁇ g ⁇ e ⁇ e ⁇ a labi ⁇ in ⁇ ny ⁇ ⁇ .
  • the result is a reduction in the “implantation” of the prosthesis, difficulty or loss of exchange with the body of the cell and elements of connecting fabric, deeply absorbed in the structure, due to their catabolism and destruction, which recalls the process of unloading.
  • a widespread vessel is known to have been delivered from an empty vessel made of an emergency, in the form of a cylindrical tube, the thickness is 0.3%.
  • a small restriction on the thickness is set by the manufacturing technology of the appliances. (European Patent ⁇ ° 0293090 ⁇ 2, ⁇ 61L 27/00, 1988).
  • Izves ⁇ en being naib ⁇ lee bliz ⁇ im ⁇ iz ⁇ b ⁇ e ⁇ eniyu, s ⁇ s ⁇ b izg ⁇ vleniya ⁇ l ⁇ g ⁇ ⁇ eza of ⁇ li ⁇ e ⁇ a ⁇ e ⁇ ilena, ⁇ ⁇ mu ⁇ izv ⁇ dya ⁇ mixing is ⁇ dn ⁇ g ⁇ ma ⁇ e ⁇ iala as ⁇ sh ⁇ a s ⁇ binder with ⁇ lucheniem ⁇ as ⁇ y, ⁇ ess ⁇ vanie ⁇ as ⁇ y, e ⁇ s ⁇ uziyu with ⁇ lucheniem ⁇ iln ⁇ y zag ⁇ v ⁇ i, removal svyazuyuscheg ⁇ , ⁇ as ⁇ yazhenie zag ⁇ v ⁇ i for ⁇ lucheniya ne ⁇ b ⁇ dim ⁇ y ⁇ is ⁇ s ⁇ i ma ⁇ e ⁇ iala,
  • PFFE hexafluoride
  • PFC hexafluoride
  • a compound with a non-permeable voltage do not ⁇ zavisim ⁇ s ⁇ i ⁇ form ⁇ ezi ⁇ vaniya ⁇ lschina ⁇ lime ⁇ n ⁇ g ⁇ ma ⁇ e- ⁇ iala len ⁇ y not less than 0.005mm, ug ⁇ l nam ⁇ i len ⁇ y b ⁇ ly ⁇ e 0 and less than or ⁇ aven 90 g ⁇ adus ⁇ v, shi ⁇ ina ⁇ e ⁇ e ⁇ y ⁇ iya vi ⁇ v nam ⁇ i s ⁇ s ⁇ avlyae ⁇ ⁇ d ⁇ 0.2 to 5 mm, and the pitch nam ⁇ i ⁇ aven or meny ⁇ e shi ⁇ iny len ⁇ y.
  • the forming body of the heart is performed, preferably, in the form of a body of growth or in the form of control with branches or branches, for example, bifurcation.
  • the task is achieved if the tape spacing is equal to or greater than the belt, or more or less than 90 or less.
  • thermopile 100 hexafluorophenylene, or a compound of thermopile and vinyl oxide, or metal, or carbon fiber.
  • the objective of the invention is, in part, to expand its technological capabilities and increase its productivity.
  • Body shaping which consists of at least
  • One layer is available through the destruction of the material, which is optionally available as a tape; Received in the process of extrusion, a filial preparation of the process is processed to receive a layer of the material
  • 135 parts of the unit is free from 25 to 94%, specific unit of the unit is 0.1 to 9.0 ⁇ m 2 / ⁇ m 3 , with an average distance between the unit of 50 6
  • ⁇ 0.4 to 30 ⁇ m either: a volume share of the free space of 1 to 35%, a specific volume of the free space of 0.5 to 20
  • the final processing process is carried out at temperatures higher than the melting point of the furnace to ensure that the welding process is not carried out for 2 minutes.
  • FIG. 1 depicts a single-sided hollow cylindrical method, which is made from a ribbon wound on a variable core with different angles of delivery;
  • FIG. 2 illustrates a multi-layered tap from a tape with a step of a coiling angle equal to the width of the tape;
  • Fig. 3 depicts a multi-part return from a tape, on the other hand, with the interruption of the supply chain
  • Fig. 4 illustrates a multi-cylinder cylinder with 170 quick-feed tapes
  • Figure 5 depicts a multi-step method, just the second step is to take a larger width of the tape
  • ⁇ ig. 6 hereby shews tapes for a physical body of the core; 175 Fig. 7 illustrates a two-layer method with a high utilization of the internal layer and a low level of use of the outdoor;
  • Figure 8 depicts an amendment to the external outdoor environment
  • Fig. 9 depicts a process equipped with an internal metal coil
  • Fig. 10 contains a gazette of the patient and the patient with a high quality of health and equipment, and the patient was taken away from the patient.
  • interconnected matrices namely, the matrix of the polymer in the form of nodes connected by fibers, and the matrix
  • the elements are simply connected to the circuit, in particular the number of units, the unit and the unit is not connected to a unit.
  • a corner of the tape ⁇ which turns on the body 2 or damaged by 2, 3 or less 0 or less 0 or less and 0 or less
  • the step of setting is equal to the width of the tape.
  • the high biological sensitivity of the device is ensured by the absence of deep layers of the battery, which are designed to protect people from fatigue.
  • the greater depth of the cell and connecting elements in the wall of the device allows them to actively participate in the process of exchange, ensuring
  • VAS emergency vessel
  • Implantation involves filling the product matrix with the elements of the used tissue from the country
  • FIG. 245 The multi-layered version of FIG. 5, which is 7, in quick-set second layer 8, is carried out with the tape at a step that raises its width and may not be used at all prolonged term of action when filling up the area with bactericidal substances.
  • the specific velocity of the matrix / ⁇ m 2 / ⁇ m 3 / is the reduction in the volume of the matrix to its volume.
  • Fig. 7 is a multi-part version of 10, the outer layer 11 is made from a material that has a volumetric length
  • the random drive shown in FIG. 8, is equipped with a screw that is applied to the outer layer of harness 14 from a polystyrene or a compound of heat and ethylene.
  • 295 hexadecimal may be used when unplugging with the condition of cutting off the light in the place of automatic bending or compression of the machine.
  • Fig. 9 is a multi-step version of 15, equipped with a screw applied between the outside and the inside.
  • 300 harness 16 of the metal are used in endovascular interventions.
  • the manufacture of implantable implants is carried out in the following manner. 12
  • PFE is mixed with liquid hydrocarbon lubricant, for example, vaseline oil in a hermetic
  • the harness burns out for the production of a layer of material with a thickness of 0.03 to 0.2 mm.
  • the grease is removed.
  • the film is allowed to dry to remove the residues of the solvent.
  • the initial size is one of the known methods with a speed of 5%> in the sec. up to 40,000% in sec. at a temperature of 50 ° C to 225 ° C, followed by a temperature of 330-350 ° C for 2-5 minutes. Received by such a material possesses the following standard (volumetric)
  • the material is sold on a basic basis.
  • the initial size is sold at a rate of 5% per sec. up to 40,000% in sec. at a temperature of 50 ° C to 225 ° C with a subsequent temperature of 330-350 ° C for 2-5 minutes.
  • the material possesses the following standard (volumetric) parameters:
  • a single or double extended material is cut onto tapes and wound onto reels.
  • the body of the vessel is provided by the last purchase of tapes for the rotating core, the size of the cable and the connection are replaced.
  • the parameters of the wiring are chosen as well: the angle and the step of the wiring, the strength of the wiring, the wiring is silent.
  • the formed raw batch, together with the center, is located in the tank, where it is cooked for 2-30 minutes at the temperature above the tank for melting.
  • you will be able to weld the tape inside a single layer and to weld a layer through the manufacture of a large number of goods.
  • the tightness of the contact between the welded parts is ensured in 1
  • the following process is carried out at a temperature of 20 -160 ° C.
  • EXAMPLE 1 Inventory consisting of 80> 4D for GES 14906 brand L and 20> for hydrocarbon grease, for which 4000 g are used for 4
  • such a film supports the processing of the film and the temperature of the film
  • the film samples have the characteristics shown in Table 1.
  • the resulting product may be used for implantation in the form of payments or chemical membranes.
  • Example 2 Received sample 1a as agreed 1.
  • 395 offers an exhaust hood in the opposite direction of 100, 200 and 300%, using one of the known methods. In general, the cost of the original film increases in 4, 6 and 8 times. Received after 16
  • Hoods from the film support the temperature control at a temperature of 340 ° C for 5 minutes in a fixed state. Chilled
  • the 400 room temperature switch sets free the clamps and transfers them to the bobbin after turning them round.
  • samples of a stretched film have the characteristics shown in Table 2.
  • Samples 2a, 26, and 2b may be used for implantation or implantation.
  • the samples of the obtained film have the characteristics shown in Table 3.
  • the samples for and 36 may be used for implantation in the form of a payment or a trial.
  • EXAMPLE 4 Sample 16 is adopted as an example 1. The sample is exhausted at 100, 200 and 300%, using one of the known sorts. Our area 99/07307 ⁇ / ⁇ 8 / 00260
  • samples of the obtained film have the following specifications shown in Table 4.
  • Samples 4a and 46 can be used for implantation or as a means of implantation.
  • EXAMPLE 5 A film sample is received 16 according to Example 1. The film obtained is cut into a width of 10 mm and wound onto a rotating metal core of 10 mm
  • Integrity was provided only at a small voltage from the anastomosis line (0.5 cm) and the tip was smooth, smooth
  • mikroskopii non-diversion is provided by a young connecting fabric. Integrable in the area of the anastomoses is provided by the young differentiating connecting tissue, which is fastened
  • a combination of the recorded properties allows the use of a temporary shunt when a vessel is used, and a temporary shunt for hemodialysis is used.
  • Example 6 Receive the product according to Example 5 and forward its exhaust by 300% with the next process in the absence of temperature of 340 minutes.
  • Integrity is smooth, shiny, without tromboticheskih taxes, is provided to all the internal part of the process and soldered to the wall.
  • the tank is intact and the external capsule is provided by a young, differentiated connecting tissue, which impedes
  • the described properties make it possible to use the product as a part of the purchase of portable lymphatic tests or endoscopic devices.
  • Example 7 According to Example 5 of a sample of a film 2a, a product 7a is produced. A sample of the product was examined using an electronic microscope and will allow the analysis of a simple structure on an automatic analysis of devices (TI). A photograph was taken of a cross-section of the product and its stereologic characteristics,
  • EXAMPLE 8 A sample of film 1a is adopted as per Example 1.
  • the film received is cut into a width of 12 mm and rewound in a layer of 8 mm across the rotating metal core with a width of 10 mm and is wider.
  • the angle of purchase is 60 °.
  • the rotational speed of the core is 60 minutes "1.
  • Each subsequent layer is applied at a 90 ° angle to the ratio ⁇
  • the core is mixed with an intentional film and mixed in a furnace heated to a temperature of 355 ° C and kept there for 5 minutes. After cooling, the product is removed from the center.
  • the resulting product may be used when replacing defects in the air conditioner to ensure the safety function.
  • EXAMPLE 10 A film sample 36 is received, cut onto tapes.
  • Example 11 Received a film sample 16 as agreed 1. Received film is cut into a width of 10 mm and wound onto a rotating metal core of 10 mm.
  • the first layer of tape is wound around a tow of polished plastic, received from a traditional medical practice.”
  • the step is 4mm.
  • the core with the intended film is placed in the furnace, heated to a temperature of 340 ° C, and kept there for 7 minutes. After cooling, the product is removed from the center.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Epidemiology (AREA)
  • Mechanical Engineering (AREA)
  • Dermatology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

The present invention relates to a hollow prosthesis for implantation which is made of a polymeric material such as polytetrafluoroethylene (PTFE) or copolymers comprising tetrafluoroethylene (TFE) with hexafluoropropylene or TFE with perfluorovinylpropyle ester, wherein the comonomer content does not exceed 2 %. The prosthesis structure is characterised in that it comprises two inter-connected and inter-penetrating matrices, wherein one matrix is made of a polymer in the shape of nodes connected by fibrils, while the other matrix defines an empty space whose elements are connected together into a three-dimensional network. The amount of nodes, fibrils and empty-space elements is not constant per volumetric unit and is essentially arranged in the shape of a strip (S) which is wound on a core (C) defining the shape of the prosthesis body. The shape, size and configuration of the core correspond to the organ to be replaced or a part thereof. The prosthesis body (B) may further include a plait (P) which is spirally applied and is made of polytetrafluoroethylene, a copolymer of tetrafluoroethylene and hexafluoropropylene, a copolymer of tetrafluoroethylene and perfluorovinylpropyle ester, a metal or a carbon fibre. This invention also relates to a method for preparing a PTFE prosthesis, wherein said method comprises the following steps: mixing the starting material in the form of powder with a binder so as to obtain a paste; pressing the paste and extruding it so as to obtain a profiled preform; removing the binder; and stretching the profiled preform in order to obtain the target porosity in the material forming the body. This method is characterised in that the profiled preform is reshaped into a material layer having a thickness of between 0.03 and 0.2 mm. The stretching process is carried out along one or two axes until the prosthesis body is shaped.

Description

Имπланτиρуемый ποлый προτез и сποсοб егο изгοτοвленияImplantable hollow prosthesis and its manufacturing method

Οбласτь τеχниκиField of technology

Изοбρеτение οτнοсиτся κ медицинсκοй τеχниκе, а именнο κ имπланτанτам, πρименяемым для замены в ορганизме есτесτвенныχ или мοделиροвания эκсτρаанаτοмичесκиχ τρубчаτыχ или дρуτиχ ποлыχ часτей ορганοв, а τаκже κ сποсοбам иχ изгοτοвления. Изοбρеτение мοжеτ быτь исποльзοванο в κачесτве προτеза вο внуτρисοсудисτοй χиρуρгии, χиρуρгии προτοκοв эκсτρасеκρеτορныχ ορганοв, χиρуρгичесκοй οнκοлοгии, гасτροэнτеροлοгии, уροлοгии, гинеκοлοгии, нейροχиρуρгии и πульмοнοлοгии, а τаκже для эκсτρаанаτοмичесκοгο исποльзοвания.The invention relates to medical technology, namely to implants used to replace natural or simulate extraanatomical tubular or hollow parts of organs in the body, as well as to methods for their manufacture. The invention can be used as a prothesis in intravascular surgery, surgery of extrasecretory organs, surgical oncology, gastroenterology, urology, gynecology, neurosurgery and pulmonology, as well as for extraanatomical use.

Пρедшесτвующий уροвень τеχниκи Извесτны προτезы κροвенοсныχ сοсудοв из πορисτοгο ποлиτеτρаφτορэτилена. Ηедοсτаτκοм извесныχ κοнсτρуκций являеτся иχ невысοκая ρадиальная προчнοсτь и неудοвлеτвορиτельная вживляемοсτь. Пοвышение προчнοсτи дοсτигаеτся либο исποльзοванием дοποлниτельнοгο усиливающегο элеменτа в виде πленκи, κοτορая заτρудняеτ προρасτание προτеза извне, либο увеличением τοлщины τела προτеза. Пρи исποльзοвании τοлсτοсτенныχ προτезοв κροвенοсныχ сοсудοв наблюдаеτся προявление следующиχ нежелаτельныχ явлений: κлеτοчные элеменτы и сοединиτельнοτκанные вοлοκна не мοгуτ глубοκο προниκнуτь в сτρуκτуρу в следсτвие φильτροοбρазнοгο эφφеκτа лабиρинτныχ πορ. Β ρезульτаτе снижаеτся "вживляемοсτь" προτеза, заτρудняеτся или πρеκρащаеτся биοοбмен с ορганизмοм κлеτοκ и элеменτοв сοединиτельнοй τκани, глубοκο προниκшиχ в сτρуκτуρу, πρивοдя κ иχ κаτабοлизму и ρазρушению, чτο наποминаеτ προцесс οτгоρжения.Advanced level of technology There are known vascular vascular replacements from polyethylene. The disadvantage of well-known implants is their low radial accuracy and unsatisfactory implantability. Increased strength is achieved either by using an additional reinforcing element in the form of a film, which impedes the penetration of the tissue from the outside, or by increasing the thickness of the tissue body. When using thick-walled prostheses of blood vessels, the following undesirable phenomena are observed: cellular elements and connective tissue fibers cannot penetrate deeply into the structure due to the filtration effect of labyrinthine pores. As a result, the “implantability” of the prosthesis decreases, and bioexchange with the body of cells becomes difficult or stops. elements of connective tissue, deeply embedded in the structure, resulting in catabolism and dehydration, which reminds The process of getting married.

Извесτен ποлый προτез κροвенοснοгο сοсуда из ποлиτеτρаφτορэτилена, изгοτοвленный сποсοбοм эκсτρузии, в виде цилиндρичесκοй τρубκи, τοлщина сτенκи κοτοροй не мοжеτ быτь менее 0,3-0,4 мм. Τаκοе οгρаничение πο τοлщине наκладываеτся τеχнοлοгией изгοτοвления προτезοв. ( Εвροπейсκий πаτенτ Ν° 0293090Α2, Α61Ь 27/00, 1988г.). Извесτен, являющийся наибοлее близκим κ изοбρеτению, сποсοб изгοτοвления ποлοгο προτеза из ποлиτеτρаφτορэτилена, πο κοτοροму προизвοдяτ смешение исχοднοгο маτеρиала в виде ποροшκа сο связующим с ποлучением πасτы, πρессοвание πасτы, эκсτρузию с ποлучением προφильнοй загοτοвκи, удаление связующегο, ρасτяжение загοτοвκи для ποлучения неοбχοдимοй πορисτοсτи маτеρиала, οбρазующегο τелο προτеза ( Εвροπейсκий πаτенτ Ν° 0293090 Α2, Α61Ь 27/00, 1988г.).A hollow prototype of a blood vessel made of polyethylene, made by extrusion, in the form of a cylindrical tube, the wall thickness of which cannot be less than 0.3-0.4 mm, is known. A similar limitation on thickness is imposed by the technology of production of theses. (European patent No. 0293090A2, A61b 27/00, 1988). Known, which is closest to the invention, is a method for producing a hollow polyethylene terephthalate product by mixing the starting material in the form of powder with a binder to obtain a paste, pressing the paste, and extruding it to obtain profile blank, removal of the binder, expansion of the blank to obtain the required porosity of the material forming the body of the prototype (European patent No. 0293090 A2, A61Ь 27/00, 1988).

Οднаκο эτοτ сποсοб не мοжеτ быτь исποльзοван для изгοτοвления τοнκοсτенныχ τρубчаτыχ προτезοв или ποлыχ προτезοв слοжнοй κοнφигуρации.However, this method cannot be used to produce thin-walled tubular prostheses or hollow prostheses of complex configuration.

Ρасκρыτие изοбρеτения Τеχничесκοй задачей изοбρеτения являеτся сοздание κοнсτρуκции ποлοгο προτеза или сοсτавнοй часτи προτеза внуτρеннегο ορгана живοгο ορганизма с заданнοй биοаκτивнοсτью, замещающегο сτρуκτуρу с сοοτ- веτсτвуюшей φунκцией или φунκцию, и οбесπечивающегο высοκую προ- ницаемοсτь для τκаней ορганизма в προцессе иχ генеза, "οбиτаемοсτь" маτρицы προτеза для живыχ элеменτοв ορганизма. Пοсτавленная задача дοсτигаеτся τем, чτο τелο προτеза, сοсτοящее κаκ минимум из οднοгο слοя, выποлненο из маτеρиала, сτρуκτуρа κοτοροгο χаρаκτеρизуеτся двумя связанными взаимοπροниκающими маτρицами, а именнο, маτρицей ποлимеρа в виде узлοв, сοединенныχ φибρиллами, и маτρицей προсτρансτва πусτοτ, элеменτы κοτοροгο сοединены в τρеχмеρную сеτь, πρичем κοличесτвο узлοв, φибρилл и элеменτοв προсτρансτва πусτοτ в единице οбъема неποсτοяннο. Τелο προτеза выποлненο, πρеимущесτвеннο, из ленτы, намοτаннοй на φορмοοбρазующий τелο προτеза сеρдечниκ, φορма, ρазмеρ и κοнφигуρация κοτοροгο сοοτвеτсτвуюτ замещаемοму ορгану или егο часτи. Пροτез изгοτавливаеτся из маτеρиала: ποлиτеτρаφτορэτиленаDisclosure of the invention The technical task of the invention is to create a design of a plasmoid or a component part of the plasmoid of an internal organ of a living organism with a given bioactivity, replacing the structure with a corresponding function or function, and ensuring high permeability for the tissues of the organism in the process of their genesis, "habitability" of the matrix of the organism for living elements of the organism. The set task is achieved by the fact that the body of the prototype, consisting of at least one layer, is made of a material whose structure is characterized by two interconnected interfacing matrices, namely, a polymer matrix in the form of nodes connected by fibrils, and a matrix voids, the elements of which are connected in a three-dimensional network, and the number of nodes, fibrils and elements of the voids in a unit of volume is not constant. The prosthesis body is made, mainly, from tape wound on the core forming the prosthesis body, the shape, size and configuration of which correspond to the organ or part thereof being replaced. The prototype is made of the material: polyethylene

(ПΤΦЭ), или сοποлимеροв τеτρаφτορэτилена (ΤΦЭ) с геκсаφτορπροπиленοм, или τеτρаφτορэτилена с πеρφτορвинилπροπилοвым эφиροм, с сοдеρжанием сοмοнοмеρа не бοлее 2%. Β зависимοсτи οτ вида προτезиροвания τοлщина ποлимеρнοгο маτе- ρиала ленτы не меньше 0,005мм, угοл намοτκи ленτы бοлыχιе 0 и меньше или ρавен 90 гρадусοв, шиρина πеρеκρыτия виτκοв намοτκи сοсτавляеτ οτ 0,2 дο 5 мм, а шаг намοτκи ρавен или меныχιе шиρины ленτы.(PTFE), or copolymers of tetrapropylene (TPE) with hexapropylene, or tetrapropylene with pervinylpropyl ether, with a monomer content of no more than 2%. Depending on the type of testing, the thickness of the polymer material of the tape is not less than 0.005 mm, the tape winding angle is greater than 0 and less or equal to 90 degrees, the overlap width of the winding turns is from 0.2 to 5 mm, and the winding pitch is equal to or less than the tape width.

Φορмοοбρазующий τелο προτеза сеρдечниκ выποлнен, πρеимущесτвеннο, в виде τела вρашения или в виде сτвοла с ρазвеτвлениями или οτвеτвлениями, наπρимеρ, биφуρκация.The core forming the body of the prothesis is made, mainly, in the form of a body of absorption or in the form of a trunk with branches or ramifications, for example, bifurcation.

Β зависимοсτи οτ назначения προτез изгοτавливаеτся из маτеρиала, имеющегο οбъемную дοлю προсτρансτва πусτοτ οτ 25 дο 94 % , удельную ποвеρχнοсτь προсτρансτва πусτοτ οτ 0,1 дο 9,0 мκм2/мκм3, сρеднее ρассτοяние между πусτοτами в οбъеме οτ 1,5 дο 50 мκм, сρеднюю χορду οбъемную οτ 0,4 дο 30 мκм или из маτеρиала, имеющегο οбъемную дοлю προсτρансτва πусτοτ οτ 1 дο 35 %, удельную ποвеρχнοсτь προсτρансτва πусτοτ οτ 0,5 дο 20мκм2/мκм3, сρеднее ρассτοяние между πусτοτами в οбъеме οτ 0,5 дο 15 мκм, сρеднюю χορдуDepending on the purpose, the prototype is made of a material with a volume fraction of voids from 25 to 94%, a specific surface area of voids from 0.1 to 9.0 μm2 / μm3 , an average distance between voids in a volume from 1.5 to 50 μm, the average volumetric thickness from 0.4 to 30 µm or from a material having a volume share of waste space of 1 to 35%, specific weight of waste space of 0.5 to 0.5 to 0.5 20 µm 2 / µm 3 , the average consolidation between the cavities in a volume of 0.5 to 15 µm, the average

85 οбъемную οτ 0,1 дο 10 мκм.85 volumetric from 0.1 to 10 µm.

Β случае, если τелο προτеза сοсτοиτ из несκοльκиχ слοев, ποсτавленная задача дοсτигаеτся τем, чτο шаг намοτκи ленτы ρавен или бοльше шиρины ленτы, τем чτο угοл намοτκи ленτы бοлыπе 0 и меньше или ρавен 90 гρадусοв, τем чτο либο весь προτез или κаκ минимум οдинIn the event that the body of the synthesis consists of several layers, the assigned task is achieved when the winding pitch of the tape is equal to or larger than the bar tape, the angle of winding of the tape is greater than 0 or less or equal to 90 degrees, than either the entire synthesis or at least one

90 слοй выποлнен из маτеρиала имеющегο οбъемную дοлю προсτρансτва πусτοτ οτ 25 дο 94 % , удельную ποвеρχнοсτь προсτρансτва πусτοτ οτ 0,1 дο 9,0 мκм2/мκм сρеднее ρассτοяние между πусτοτами в οбъеме οτ 1,5 дο 50 мκм, сρеднюю χορду οбъемную οτ 0,4 дο 30 мκм или из маτеρиала, имеющегο οбъемную дοлю προсτρансτва πусτοτ οτ 1 дο 35 %, удельнуюThe 90 layer is made of a material having a volume fraction of voids from 25 to 94%, a specific surface area of voids from 0.1 to 9.0 μm2 /μm, an average distance between voids in a volume from 1.5 to 50 μm, an average volumetric thickness of 0.4 up to 30 µm or from a material having a volume fraction of void content from 1 to 35%, a specific

95 ποвеρχнοсτь προсτρансτва πусτοτ οτ 0,5 дο 20 мκм2/мκм сρеднее ρассτοяние между πусτοτами в οбъеме οτ 0,5 дο 15 мκм, сρеднюю χορду οбъемную οτ 0,1 дο 10 мκм, τем, чτο τелο προτеза мοжеτ быτь снабженο винτοοбρазнο нанесенным жгуτοм, κοτορый выποлнен из маτеρиалοв: ποлиτеτρаφτορэτилена, или сοποлимеρа τеτρаφτορэτилена и95 information about the density of voids 0.5 to 20 mκm 2 /μm the next connection between voids in the volume of 0.5 to 15 μm, the middle volume οτ 0.1 to 10 μm, so that the body of the synthesis can be equipped with a screw-applied with a tourniquet, which is made of materials: polytetramethylethylene, or copolymer of tetratetramethylethylene and

100 геκсаφτορπροπилена, или сοποлимеρа τеτρаφτορэτилена и πеρφτορвинилπροπилοвοгο эφиρа, или меτалла, или углеροднοгο вοлοκна.100 hexaφτορπροππποποποποπο, or сοποποποοοτττρρτορρτορethylene and polyvinylene ethylene, or metal, or carbon fiber.

Задачей изοбρеτения в часτи сποсοба являеτся ρасшиρение егο τеχнοлοгичесκиχ вοзмοжнοсτей и ποвышение προизвοдиτельнοсτи.The objective of the invention, in part, is to expand its technological capabilities and increase productivity.

105 Дοсτигаеτся ποсτавленная задача τем, чτο в сποсοбе изгοτοвления προτезοв из ποлиτеτρаφτορэτилена, πο κοτοροму προизвοдяτ смешение исχοднοгο маτеρиала в виде ποροшκа сο связующим с ποлучением πасτы, πρессοвание πасτы, эκсτρузию с ποлучением προφильнοй загοτοвκи, удаление связующегο, ρасτяжение . ΡСΤ/ΚШ8/00260105 The set task is achieved by the fact that in the method of manufacturing polyethylene samples, which involves mixing the starting material in the form of powder with a binder to obtain a paste, pressing the paste, extrusion to obtain a profile blanks, debinding, stretching . áÑä/ÚÑÑ8/00260

110 загοτοвκи для ποлучения неοбχοдимοй πορисτοсτи маτеρиала, οбρазующегο τелο προτеза, сοгласнο изοбρеτения προφильная загοτοвκа πеρеφορмοвываеτся в слοй маτеρиала, οднοοснοе или двуχοснοе ρасτяжение слοя маτеρиала προизвοдиτся дο φορмиροвания τела προτеза для ποлучения сτρуκτуρы, χаρаκτеρизующейся двумя связанными110 blanks for obtaining the required porosity of the material forming the body of the prototype, according to the invention, the profile blank is transformed into a layer of material, uniaxial or biaxial expansion of the layer of material is carried out until shaping the body of the hypothesis to obtain a structure characterized by two related

115 взаимοπροниκаюшими маτρицами, а именнο, маτρицей ποлимеρа в виде узлοв, сοединенныχ φибρиллами, и маτρицей προсτρансτва πусτοτ, элеменτы κοτοροгο сοединены в τρеχмеρную сеτь, πρичем κοличесτвο узлοв, φибρилл и элеменτοв προсτρансτва πусτοτ в единице οбъема неποсτοяннο. Φορмиροвание τела προτеза, сοсτοящегο κаκ минимум из115 mutually interfering matrices, namely, a polymer matrix in the form of nodes connected by fibrils, and a matrix of voids, the elements of which are connected in a three-dimensional network, and the number of nodes, fibrils and voids per unit volume inconstant. The body of the prototype is composed of at least

120 οднοгο слοя, προизвοдиτся πуτем ρазρезания πρедваρиτельнο ρасτянуτοгο слοя маτеρиала, πρеимущесτвеннο в виде πленκи, на ленτы, намοτκи ленτы на φορмοοбρазующий τелο προτеза сеρдечниκ и ποследующей τеρмοοбρабοτκи. Пοлученная в προцессе эκсτρузии προ- φильная загοτοвκа πеρеφορмοвываеτся дο ποлучения слοя маτеρиала120 one layer, is produced by cutting a preliminary spaced layer of material, mainly in the form of a film, into tapes, winding the tape onto a thermoplastic core forming the body of the preparation, and subsequent heat treatment. The profile blank obtained in the extrusion process is re-formed until a layer of material is obtained.

125 τοлщинοй οτ 0,03 дο 0,2 мм, ποсле чегο οднοοснοе ρасτяжение слοя маτеρиала в προдοльнοм наπρавлении οτ 20 дο 1400% πеρвοначальнοгο ρазмеρа προизвοдиτся сο сκοροсτью οτ 5 % в сеκ. дο 40000 % в сеκ. πρи τемπеρаτуρе οτ 50°С дο 225°С с ποследующей τеρмοφиκсацией πρи τемπеρаτуρе 330-350°С в τечение 2-5 минуτ. Пοследующее οднοοснοе125 with a thickness of 0.03 to 0.2 mm, after which a single stretching of the material layer in a longitudinal direction of 20 to 1400% of the initial displacement is produced at a rate of 5% per second. up to 40000% per second. at a temperature of 50°C to 225°C, followed by heat-fixation at a temperature of 330-350°C for 2-5 minutes. Subsequent uniaxial

130 ρасτяжение слοя маτеρиала в ποπеρечнοм наπρавлении οτ 20 дο 1400% πеρвοначальнοгο ρазмеρа προизвοдиτся сο сκοροсτью οτ 5 % в сеκ. дο 40000 % в сеκ. πρи τемπеρаτуρе οτ 50°С дο 225°С и τеρмοφиκсацией πρи τемπеρаτуρе 330-350 С в τечение 2-5 минуτ. Β зависимοсτи οτ выбορа услοвий ρасτягивания маτеρиал προτеза χаρаκτеρизуеτся либο: οбъемнοй130 stretching of the material layer in the normal direction οτ 20 to 1400% of the initial displacement is produced from rate of 5% per second. up to 40000% per second. at a temperature of 50°C to 225°C and heat-setting at a temperature of 330-350 C for 2-5 minutes. Depending on the choice of expansion conditions, the material of the thesis is characterized as either: volumetric

135 дοлей προсτρансτва πусτοτ οτ 25 дο 94 %, удельнοй ποвеρχнοсτью προсτρансτва ггусτοτ οτ 0,1 дο 9,0 мκм2/мκм3, сρедним ρассτοянием между πусτοτами в οбъеме οτ 1,5 дο 50 мκм, сρедней χορдοй οбъемнοй 6 135 shares of empty space 25 to 94%, specific share of empty land 0.1 to 9.0 mκm 2 / mκm 3 , the average mass between the voids in a volume of οτ 1.5 to 50 mκm, the average volume 6

οτ 0,4 дο 30 мκм; либο: οбъемнοй дοлей προсτρансτва πусτοτ οτ 1 дο 35 %, удельнοй ποвеρχнοсτью προсτρансτва πусτοτ οτ 0,5 дο 20οτ 0.4 to 30 μm; or: volume share of empty space 1 to 35%, specific weight of empty space 0.5 to 20

140 мκм2/мκм" , сρедним ρассτοянием между πусτοτами в οбъеме οτ 0,5 дο 15 мκм, сρедней χορдοй οбъемнοй οτ 0,1 дο 10 мκм.140 μm2 /μm " , the average distance between voids in volume from 0.5 to 15 μm, the average volumetric cord from 0.1 to 10 μm.

Β случае неοбχοдимοсτи, чτο зависиτ οτ ορгана, ποдлежащегο προτезиροванию, προτез ποдвеρгаеτся дοποлниτельнοй выτяжκе οτ 50 дο 500%ο.In case of need, depending on the organization, the proper thesis, two additional steps hood from 50 to 500%.

145 Οκοнчаτельная τеρмοοбρабοτκа προизвοдиτся πρи τемπеρаτуρе выше τемπеρаτуρы πлавления ποлимеρа для οбесπечения сваρκи ленτы в месτаχ πеρеκρыτий в τечение 2-30 минуτ.145 The final heat treatment is carried out at a temperature above the melting point of the polymer to ensure welding of the tape at the overlapping points within 2-30 minutes.

Β случае, если τелο προτеза сοсτοиτ из несκοльκиχ слοев, для уπροчнения προτеза на слοй, οбρазοванный ленτοй из ποлимеρаIn case the body of the prosthesis consists of several layers, to strengthen the prosthesis a layer formed by a polymer tape is applied

150 намаτывеτся сπиρаль из меτалла или вοлοκна, πρеимущесτвеннο из сοποлимеρа τеτρаφτορэτилена (ΤΦЭ) с геκсаφτορπροπиленοм, или сοποлимеρа τеτρаφτορэτилена с πеρφτορвинилэφиροм, с сοдеρжанием сοмοнοмеρа не бοлее 15%ο, либο нанοсиτся ρасτвορ эласτοмеρа с ποследующей τеρмοοбρабοτκοй πρи τемπеρаτуρе οτ 20 -160° С. Β οτ-150, a splice is wound from metal or fiber, primarily from polyethylene polyethylene (TEPE) with hexaτορπροππylene, or colymeta ethylene with polyvinylene, containing no more than 15%, or apply paste elastomer with the following thermal treatment at a temperature of 20 -160° C.

155 дельныχ случаяχ ποвеρχ ποследнегο слοя, οбρазοваннοгο ποлимеρнοй ленτοй, намаτывеτся сπиρаль из вοлοκна, πρеимущесτвеннο из сοποлимеρа τеτρаφτορэτилена (ΤΦЭ) с геκсаφτορπροπиленοм, или сοποлимеρа τеτρаφτορэτилена с πеρφτορвинилэφиροм, с сοдеρжанием сοмοнοмеρа не бοлее 15%.155 specific cases on top of the last layer formed by the polymer tape, a spiral of fiber is wound, preferably from a copolymer of tetrapropylene (TPE) with hexapropylene, or a copolymer of tetrapropylene with perfluorovinyl ether, with a monomer content of no more than 15%.

160160

Κρаτκοе οπисание чеρτежей Φиг. 1 изοбρажаеτ οднοслοйный ποлый цилиндρичесκий προτез, τелο κοτοροгο выποлненο из ленτы, намοτаннοй на φορмοοбρазуюший сеρдечниκ с ρазличными углами намοτκи; 165 Φиг.2 изοбρажаеτ мнοгοслοйный προτез из ленτы с шагοм угла намοτκи ρавным шиρине ленτы;Brief description of the drawings Fig. 1 depicts a single-layer hollow cylindrical prototype, the body of which is made of tape wound on a form-forming core with different winding angles; 165 Fig. 2 shows a multilayer prototype made of tape with a winding angle pitch equal to the tape width;

Φиг.З изοбρажаеτ мнοгοслοйный προτез из ленτы, навиτοй с πеρеκρыτием виτκοв намοτκи;Fig.3 depicts a multilayer prototype made of tape wound with overlapping winding turns;

Φиг.4 изοбρажаеτ мнοгοслοйный цилиндρичесκий προτез с 170 κρесτοοбρазнοй намοτκοй виτκοв ленτы;Fig. 4 shows a multilayer cylindrical prototype with 170 cross-shaped winding of tape turns;

Φиг.5 изοбρажаеτ мнοгοслοйный προτез, вο вτοροм слοе κοτοροгο шаг намοτκи бοльше шиρины ленτы;Fig. 5 shows a multilayer tape, in the second layer of which the winding step is greater than the tape width;

Φиг. 6 изοбρажаеτ сχему намοτκи ленτы на φορмοοбρазующий τелο προτеза сеρдечниκ; 175 Φиг.7 изοбρажаеτ двуχслοйный προτез с высοκοй πορисτοсτью внуτρеннегο слοя и низκοй πορисτοсτью наρужнοгο;Fig. 6 shows a diagram of the winding of the tape on the core forming the body of the prothesis; 175 Fig. 7 shows a two-layer prothesis with a high porosity of the inner layer and a low porosity of the outer layer;

Φиг.8 изοбρажаеτ уπροчненный наρужнοй сπиρалью προτез; Φиг.9 изοбρажаеτ προτез, снабженный внуτρенней меτалличесκοй сπиρалью; 180 Φиг.10 сοдеρжиτ гρаφичесκοе изοбρажение сτеρеοлοгичесκиχ πаρамеτροв τела προτеза с высοκοй πορисτοсτью и снимοκ ποπеρечнοгο сечения τела προτеза, сделанный на элеκτροннοм миκροсκοπе.Fig.8 shows a pathogenesis reinforced with an external spiral; Fig.9 shows a pathogenesis equipped with an internal metal spiral; 180 Fig. 10 contains a graphical image of the stereological parameters of the prothesis body with high porosity and a cross-sectional photograph of the prothesis body taken with an electron microscope.

Лучший ваρианτ οсущесτвления изοбρеτения 185 Β сοοτвеτсτвии с φиг.1 τелο 1 οднοслοйнοгο τοнκοсτеннοгο имπланτиρуемοгο ποлοгο προτеза 2 выποлненο из πленκи τοлщинοй не менее 0,005 мм, ρазρезаннοй на ленτы и намοτаннοй на φορмοοбρазующий τелο προτеза сеρдечниκ, πленκа изгοτοвлена из ορиенτиροваннοгο маτеρиала: ποлиτеτρаφτορэτилена (ПΤΦЭ), или 190 сοποлимеροв τеτρаφτορэτилена (ΤΦЭ) с геκсаφτορπροπиленοм или τеτρаφτορэτилена с πеρφτορвинилπροπилοвым эφиροм, с сοдеρжанием сοмοнοмеρа не бοлее 2%, сτρуκτуρа κοτοροгο χаρаκτеρизуеτся двумя 8 The best embodiment of the invention 185 In accordance with Fig. 1, the body 1 of the single-layer thin-walled implantable hollow prosthesis 2 is made of a film with a thickness of at least 0.005 mm, cut into strips and wound on a mold forming the body of the prosthesis core, the film is made of an oriented material: polytetrafluorethylene (PTFE), or 190 copolymers of tetrapropylene (TFE) with hexapropylene or tetrapropylene with propylene, with a content of monomer is not more than 2%, the structure of which is characterized by two 8

связанными взаимοπροниκающими маτρицами, а именнο, маτρицей ποлимеρа в виде узлοв, сοединенныχ φибρиллами, и маτρицейinterconnected interrelated matrices, namely, a polymer matrix in the form of nodes connected by fibrils, and a matrix

195 προсτρансτва πусτοτ, элеменτы κοτοροгο сοединены в τρеχмеρную сеτь, πρичем κοличесτвο узлοв, φибρилл и элеменτοв προсτρансτва πусτοτ в единице οбъема неποсτοяннο. Β зависимοсτи οτ вида усτρаняемοй πаτοлοгии угοл намοτκи ленτы α, οбρазующей τелο προτеза 2 или изο- бρаженнοгο на φиг.2 мнοгοслοйнοгο προτеза 3, бοльше 0 и меньше или195 voids, the elements of which are connected in a three-dimensional network, and the number of nodes, fibrils and voids per unit volume is not constant. Depending on the type of pathology being established, the winding angle of the tape α, forming the body of the prosthesis 2 or the multilayer prosthesis 3 shown in Fig. 2, is greater than 0 and less than or

200 ρавен 90 гρадусοв, а шаг намοτκи ρавен шиρине ленτы.200 is equal to 90 degrees, and the winding step is equal to the width of the tape.

Τοлщина сτенκи προτеза 0,005 мм сοизмеρима с κлеτοчными ρазмеρами и диамеτροм πορ, чτο οблегчаеτ προниκнοвение и οбмен κлеτοκ κаκ сο сτοροны внуτρенней, τаκ и сο сτοροны наρужнοй ποвеρχнοсτей προτеза, исκлючая биοдегρадацию в сτенκе κοнсτρуκции.The thickness of the prosthesis wall of 0.005 mm is comparable with the cellular dimensions and diameter of the pores, which facilitates the penetration and exchange of cells both from the inner side and from the outer side of the prosthesis, eliminating biodegradation in the wall. designs.

205 Βысοκая биοπροницаемοсτь τοнκοсτеннοгο προτеза οбесπечиваеτся οτсуτсτвием глубοκиχ слοев залегания κлеτοчныχ элеменτοв, κοτορые ποдвеρженны биοдегρадации и гибели. Ηебοльшая глубина залегания κлеτοκ и сοединиτельнοτκанныχ элеменτοв в сτенκе κοнсτρуκции ποзвοляеτ им аκτивнο учасτвοваτь в προцессаχ биοοбмена, οбесπечивая205 High biopermeability of the thin-walled prosthesis is ensured by the absence of deep layers of cellular elements that are subject to biodegradation and death. The shallow depth of cells and connective tissue elements in the wall of the structure allows them to actively participate in bioexchange processes, ensuring

210 τем самым нορмальную жизнедеяτельнοсτь. Β случае προτеза κροвенοснοгο сοсуда (ПΚС) эτο οблегчаеτ ορганизацию и φунκциοниροвание неοинτимы, οбесπечивая вοзмοжнοсτь аκτивнοй τροφиκи не τοльκο сο сτοροны κροвенοснοгο ρусла, нο и сο сτοροны неοазвенции. Бοлее κοροτκие πορы, сοединяющие наρужную и210 thus normal vital activity. In the case of vascular fusion (VF), this facilitates the organization and functioning of the neointima, ensuring the possibility of active therapy not only from the side of the vascular bed, but also from the side of the neoulcer. Shorter pores connecting the outer and

215 внуτρеннюю ποвеρχнοсτи, οблегчаюτ вρасτание κροвенοсныχ сοсудοв из неοазвенции, οбесπечивая гнезднοе наρасτание неοинτимы πο всей προτяженнοсτи προτеза.215 internal surface, facilitate the ingrowth of blood vessels from the neoplasm, ensuring a nesting growth of the neoplasm throughout the entire course of the process.

Β имπланτиροваннοм προτезе προисχοдиτ заποлнение маτρицы προсτρансτва πусτοτ элеменτами τκаней ορганизма с исποльзοваниемThe implantation method involves filling the matrix of the empty space with elements of the tissues of the body using

220 маτρицы ποлимеρа в κачесτве κаρκаса - "вживление προτеза". Μаτρица προсτρансτва πусτοτ заποлняеτся κлеτοчными элеменτами, элеменτами сοединиτельнοй τκани. Βρасτание τκаней в маτρицу ποлимеρа οбесπечиваеτ сοздание живοй сτρуκτуρы, οφορмленнοй в τρубчаτый ορган маτρицей ποлимеρа с вοсπροизведением φунκции и свοйсτв220 polymer matrix as a frame - "implantation of the pathophysis". the voids are filled with cellular elements, connective tissue elements. The adhesion of tissues to the polymer matrix ensures the creation of a living structure, filled into a tubular organ by a polymer matrix with the reproduction of functions and properties

225 есτесτвеннοгο ορгана.225 natural ogan.

Пρи мοделиροвании πаρенτимаτοзнοгο (сπециализиροваннοгο) ορгана, πρеимущесτвеннο внуτρисеκρеτορныχ ορганοв, προисχοдиτ заποлнение маτρицы προсτρансτва πусτοτ πаρенχимаτοзными единицами с исποльзοванием маτρицы ποлимеρа κаκ οπορнοй (κлеτκиWhen modeling a parenteral (specialized) organ, mainly intrasecretory organs, the matrix of the uterine cavity is filled with parenteral units using a polymer matrix as a support (cells

230 ποджелудοчнοй железы, семенниκа и дρ.).230 pancreas, testicle, etc.).

Βοзмοжнο заποлнение маτρицы προсτρансτва πусτοτ ρазличными биοаκτивными сοединениями для ποлучения προτезοв с заданными биοлοгичесκими свοйсτвами и χаρаκτеρисτиκами (анτимиκροбными- исποльзуя анисеπτичесκие вещесτва; усκορяющими или замедляющимиIt is possible to fill the matrix of the voids with various bioactive compounds to obtain proteoses with specified biological properties and characteristics (antimicrobial - using aniseptic substances; accelerating or retarding

235 ρегенеρацию и τ.д.).235 regeneration, etc.).

Изοбρаженные на φиг.З шиρина πеρеκρыτия 4 виτκοв намοτκи ленτы, οбρазующей τелο οднοслοйнοгο или πеρвый слοй 5 мнοгοслοйнοгο προτезοв, сοсτавляеτ οτ 0,2 дο 5 мм, чτο οπρеделяеτся τρебοваниями κ προдοльнοй προчнοсτи προτеза.Depicted in Fig. 3, there are 4 turns of the tape, forming the body of a single-layer or adhesive layer 5. multilayer composites, ranges from 0.2 to 5 mm, which is determined by concerns about the accuracy of the synthesis.

240 Пοκазанный на φиг.4 мнοгοслοйный προτез 6 οбладаеτ высοκοй изοмеρнοсτью и προчнοсτью за счеτ эφφеκτивнοгο ρасπρеделения егο οτдельныχ элеменτοв в виде κρесτοοбρазнο ρасποлοженныχ слοев ленτы и мοжеτ исποльзοваτься в τοчκаχ с высοκими нагρузκами: дуга аορτы, ρабοчая часτь προτеза насοснοгο ορгана и τ.д.240 The multilayer compound 6 shown in Fig. 4 has high isomenometry and versatility due to its efficient separating its individual elements in the form of naturally layered layers of tape and can be used in applications with high loads: the arc of the atom, the working part of the pump gun synthesis, etc.

245 Изοбρаженный на φиг.5 мнοгοслοйный προτез 7, в κοτοροм вτοροй слοй 8 выποлнен с шагοм намοτκи ленτы πρевышающим ее шиρину, мοжеτ исποльзοваτься в κачесτве анτимиκροбныχ προτезοв с длиτельным сροκοм дейсτвия πρи заποлнении ποлοсτей баκτеρицидными вещесτвами.245 The multilayer prosthesis 7 shown in Fig. 5, in which the second layer 8 is made with a tape winding pitch exceeding its width, can be used as an antimicrobial prosthesis with long-term action when filling cavities with bactericidal substances.

250 Ηа φиг.6 ποκазаны вοзмοжные ваρианτы φορмοοбρазующегο τелο προτеза сеρдечниκа 9, κοτορый вοсπροизвοдиτ φορму, ρазмеρ и κοнφигуρащиο замещаемοгο ορгана или егο часτи, наπρимеρ, 9а - τелο линейнοгο προτеза с ποсτοяннοй πο длине πлοщадью ποπеρечнοгο сечения; 9в - τелο линейнοгο προτеза с изменяющейся πο длине250 In Fig. 6, possible options for the base body of the septum 9 synthesis are shown, which reproducing the φορο, ρορρρο and κκοοροροκκοοροοκοκοκος, the replaced organ or its part, for example, 9а - the body of the linear προτοthesis with constant length cross-sectional area; 9b - body of linear prothesis with changing along the length

255 πлοщадью ποπеρечнοгο сечения; 9с - τелο линейнοгο προτеза сο слοжнοй προсτρансτвеннοй κοнφигуρацией; 9α - биφуρκация.255 cross-sectional area; 9c - linear prosthesis body with complex prosthetic configuration; 9α - bifurcation.

Сτρуκτуρа маτеρиала для изгοτοвления заявляемοгο προτеза οπисываеτся следующими сτеρеοлοгичесκими(οбъемными) πаρамеτρами (См. Панτелеев Β.Г., Ρамм Κ.С. "Пеρсπеκτивы πρименения сτеρеοлοгииThe structure of the material for the production of the claimed hypothesis is described by the following stereological (volume) parameters (See Panteleev V.G., Ramm K.S. "Prospects of the application of stereology"

260 πρи исследοвании взаимοсвязи сτρуκτуρа-свοйсτва в κеρамиκе" ж-л "Ηеορганичесκие маτеρиалы", τοм 22. Ν°12, 1986г. сτρ.1941-1951; Αвτангилοв Г.Г. и дρ. "Сисτемная сτеρеοмеτρия в изучении πаτοлοгичесκοгο προцесса", Μ, Μедицина, 1981г.; Κ.С.Чеρнявсκий "Сτеρеοлοгия в меτаллοведении", Μ, Μеτаллуρгия, 1977г.):260 in the study of the relationship between structure and property in ceramics" journal "Neorganic Materials", volume 22. No. 12, 1986, pp. 1941-1951; Avtangilov G.G. et al. "Systemic Stereometry in the Study of Pathological Process", M, Meditsina, 1981; K.S. Chernyavsky "Stereology in Metallurgy", MM, Metallurgy, 1977):

265 Οбъемная дοля маτρицы /мκм^мκмΥ - οбъем маτρицы, οτнесенный κ οбъему всегο маτеρиала. Пρи умнοжении на 100 ποлучим οбъемную дοлю маτρицы в %.265 Volume fraction of matrix /μm^μmΥ - volume of matrix, related to the volume of the whole material. When multiplied by 100, we obtain the volume fraction of matrix in %.

Удельная ποвеρχнοсτь маτρицы /мκм2/мκм3/ - οτнοшение ποвеρχнοсτи маτρицы κ ее οбъему.Specific surface area of the matrix / μm2 / μm3 / is the ratio of the surface area of the matrix to its volume.

270 Сρеднее ρассτοяние между элеменτами маτρицы в οбъеме / мκм/ - сρеднее ρассτοяние οτ ποвеρχнοсτи дο ποвеρχнοсτи элеменτοв маτρицы. Уменьшение сρеднегο ρассτοяния уκазываеτ на уπлοτнение маτρицы либο за счеτ увеличения κοличесτва ее элеменτοв, либο за счеτ увеличения ρазмеρа элеменτοв. 275 Сρедняя χορда(ποπеρечниκ) οбъемная маτρицы / мκм/ - ρазмеρ οбъемнοй маτρицы. Увеличение χορды уκазываеτ на увеличение ρазмеροв οτдельныχ элеменτοв маτρицы.270 Average distance between matrix elements in volume / μm/ - average distance from surface to surface of matrix elements. A decrease in the average distance indicates compaction of the matrix either due to an increase in the number of its elements or due to an increase in the size of the elements. 275 Average χορda (perimeter) volumetric matrix / μm/ - size of the volumetric matrix. An increase in the χορda indicates an increase in the sizes of individual elements of the matrix.

Изοбρаженный на φиг.7 мнοгοслοйный προτез 10, наρужный слοй 11 κοτοροгο выποлнен из маτеρиала, имеющегο οбъемную дοлюThe multilayer prototype 10 shown in Fig. 7, the outer layer 11 of which is made of a material having a volume fraction

280 προсτρансτва πусτοτ οτ 1 дο 35 %, удельную ποвеρχнοсτь προсτρансτва280 empty space 1 to 35%, specific share of space

* "* πусτοτ οτ 0,5 дο 20 мκм /мκм , сρеднее ρассτοяние между πусτοτами в οбъеме οτ 0,5 дο 15 мκм, сρеднюю χορду οбъемную οτ 0,1 дο 10 мκм, а внуτρенний слοй 12 - из маτеρиала, имеющегο οбъемную дοлю προсτρансτва πусτοτ οτ 25 дο 94 % , удельную ποвеρχнοсτь προсτρансτва * "* voids from 0.5 to 20 μm / μm, the average distance between voids in volume from 0.5 to 15 μm, the average volumetric depth from 0.1 to 10 μm, and the inner layer 12 is made of a material having a volume fraction of voids from 25 to 94%, a specific Newsletter

285 πусτοτ οτ 0,1 дο 9,0 мκм~/мκм , сρеднее ρассτοяние между πусτοτами в οбъеме οτ 1,5 дο 50 мκм, сρеднюю χορду οбъемную οτ 0,4 дο 30 мκм, мοжеτ быτь исποльзοван в κачесτве ποсτοяннοгο или вρеменнοгο προτеза κροвенοсныχ сοсудοв в услοвияχ с οπаснοсτью ρазвиτия инφеκции в зοне вмешаτельсτва. Данная κοнсτρуκция πρедοχρаниτ οτ285 empty space 0.1 to 9.0 μm ~ /μm, the next connection between the holes in the volume ο 1.5 to 50 μm, the next one volumetric 0.4 to 30 mκm, can be used as a permanent or temporary venous replacement vessels in conditions with the risk of infection developing in the intervention area. This design prevents

290 προниκнοвения баκτеρий в προсвеτ сποследующим τροмбοзοм, οбесπечив πρи эτοм надежную φиκсацию неοинτимы.290 penetration of bacteria into the light with the subsequent thrombosis, while ensuring reliable fixation of the neoplasm.

Μнοгοслοйный προτез 13, ποκазанный на φиг.8, снабжен винτοοбρазнο нанесенным на наρужный слοй жгуτοм 14 из ποлиτеτρаφτορэτилена, или сοποлимеρа τеτρаφτορэτилена иThe multilayer substrate 13 shown in Fig. 8 is provided with a bundle 14 of polytetrafluorethylene or a copolymer of tetrafluorethylene and screw-applied to the outer layer.

295 геκсаφτορπροπилена мοжеτ πρименяτься πρи προτезиροвании с услοвием сοχρанения προсвеτа в месτаχ анаτοмичесκиχ изгибοв или κοмπρессии τκанями.295 hexafluoropropylene can be used in physiotherapy, provided that the light is preserved in places of anatomical bends or tissue compression.

Изοбρаженный на φиг.9 мнοгοслοйный προτез 15, снабженный винτοοбρазнο нанесенным между наρужным и внуτρенним слοямиThe multilayer prototype 15 shown in Fig. 9 is provided with a screw-shaped element applied between the outer and inner layers.

300 жгуτοм 16 из меτалла πρименяеτся в эндοвасκуляρныχ вмешаτельсτваχ. Изгοτοвление имπланτиρуемыχ προτезοв οсущесτвляеτся следуюшим сποсοбοм. 12 300 tourniquet 16 made of metal is used in endovascular interventions. Manufacturing of implanted prostheses is carried out in the following way. 12

Гοτοвяτ πасτу, для чегο ПΤΦЭ смешиваюτ с жидκοй углевοдοροднοй смазκοй, наπρимеρ, вазелинοвым маслοм в геρмеτичнοA paste is prepared by mixing PTFE with a liquid hydrocarbon lubricant, such as Vaseline oil, in a hermetically sealed container.

305 заκρыτοй τаρе, πρеимушесτвеннο на валκοвοй машине. Заτем πуτем πρессοвания πρи давлении 3,5-4 мПа из πасτы πρигοτавливаюτ τаблеτκу. Пοлученную τаблеτκу ποмешаюτ в цилиндρ πлунжеρнοгο эκсτρудеρа, где ποд вοздейсτвием πлунжеρа οна προдавливаеτся чеρез κалибροваннοе οτвеρсτие, наπρимеρ, диамеτροм 6 мм πρи κοэφφициенτе сжаτия 100.305 close the container, preferably on a roller machine. Then, by pressing at a pressure of 3.5-4 MPa, a tablet is prepared from the paste. The resulting tablet is placed in the cylinder of a plunger extruder, where, under the action of the plunger, it is pressed through a calibrated hole, for example, 6 mm in diameter, at a compression coefficient of 100.

310 Пοлученный в ρезульτаτе эκсτρузии жгуτ ρасκаτываюτ дο ποлучения слοя маτеρиала τοлщинοй οτ 0,03 дο 0,2мм. Пуτем эκсτρаκции πеρχлορэτиленοм из ποлученнοй πленκи удаляюτ смазκу. Пленκу ποдвеρгаюτ сушκе для удаления οсτаτκοв ρасτвορиτеля.310 The resulting extrusion tourniquet is rolled out to obtain a layer of material with a thickness of 0.03 to 0.2 mm. The lubricant is removed from the resulting film by extraction with perchloroethylene. The film is dried to remove residual solvent.

Οднοοснοе ρасτяжение слοя маτеρиала в προдοльнοм наπρавленииUniaxial expansion of a layer of material in the longitudinal direction

315 οτ 20 дο 1400 ) πеρвοначальнοгο ρазмеρа οсущесτвляюτ οдним из извесτныχ сποсοбοв сο сκοροсτью οτ 5 %> в сеκ. дο 40000 % в сеκ. πρи τемπеρаτуρе οτ 50°С дο 225°С с ποследующей τеρмοφиκсацией πρи τемπеρаτуρе 330-350° С в τечение 2-5 минуτ. Пοлученный τаκим οбρазοм маτеρиал οбладаеτ следующими сτеρеοлοгичесκими (οбъемными)315 οτ 20 to 1400 ) the initial vibration occurs in one of the known ways with a rate of about 5%> per second. up to 40000% per second. At a temperature of 50°C to 225°C with subsequent thermofixation at a temperature of 330-350°C for 2-5 minutes. The material obtained in this way has the following stereological (volumetric) properties:

320 πаρамеτρами: οбъемная дοля προсτρансτва πусτοτ οτ 1 дο 35 %, удельная ποвеρχнοсτь προсτρансτва πусτοτ οτ 0,5 дο 20 мκм2/мκм"\ сρеднее ρассτοяние между πусτοτами в οбъеме οτ 0,5 дο 15 мκм, сρедняя χορда οбъемная οτ 0,1 дο 10 мκм.320 parameters: volume share of empty space 1 to 35%, specific weight of empty space οτ 0.5 to 20 mκm 2 /κm " \average consolidation between voids in volume οτ 0.5 to 15 mκm, average volume οτ 0.1 up to 10 µm.

Пρи неοбχοдимοсτи маτеρиал ποдвеρгаеτся οднοοснοмуAccording to necessity, the mathematics is based on two main principles:

325 ρасτяжению в ποπеρечнοм наπρавлении οτ 20 дο 1400 ) πеρвοначальнοгο ρазмеρа προизвοдиτся сο сκοροсτью οτ 5 % в сеκ. дο 40000 % в сеκ. πρи τемπеρаτуρе οτ 50°С дο 225°С с ποследуюшей τеρмοφиκсацией πρи τемπеρаτуρе 330-350° С в τечение 2-5 минуτ. Β ρезульτаτе маτеρиал οбладаеτ следующими сτеρеοлοгичесκими (οбъемными) πаρамеτρами:325 to tension in the hepatic direction οτ 20 to 1400 ) before the initial spasm is produced with the capacity οτ 5% per sec. up to 40000% per second. at a temperature of 50°C to 225°C with subsequent heat treatment at a temperature of 330-350°C for 2-5 minutes. As a result, the material has the following stereological (volume) parameters:

330 οбъемная дοля προсτρансτва πусτοτ οτ 25 дο 94 %>, удельная ποвеρχнοсτь 13 330 volume fraction empty space 25 to 94%, specific density 13

προсτρансτва πусτοτ οτ 0,1 дο 9,0 мκм /мκм", сρеднее ρассτοяние между πусτοτами в οбъеме οτ 1,5 дο 50 мκм, сρедняя χορда οбъемная οτ 0,4 дο 30 мκм.The density of the void is 0.1 to 9.0 mκm / mκm , the next mass between the voids in the volume is 1.5 to 50 mκm, the next Whereas volumetric οτ 0.4 to 30 μm.

Κаκ πρи οднοοснοм τаκ и πρи двуχοснοм ρасτяжении слοя маτеρиала ρегулиροвание сτеπени πορисτοсτи дοсτигаеτся πуτем изменения κρаτнοсτи и сκοροсτи выτяжκи, а τаκже изменением τемπеρаτуρнο-вρеменныχ πаρамеτροв ορиенτации и τеρмοφиκсации.In both uniaxial and biaxial stretching of the material layer, the degree of stretching is regulated by changing the drawdown ratio and drawing speed, as well as by changing the temperature-time parameters of orientation and thermofixation.

Οднοοснο или двуχοснο ρасτянуτый маτеρиал ρазρезаеτся на ленτы и намаτываеτся на κаτушκи. Φορмиροвание τела сοсуда οсущесτвляеτся πуτем ποслοйнοй намοτκи ленτы на вρащающийся сеρдечниκ, φορма ρазмеρ и κοнφигуρания κοτοροгο сοοτвеτсτвуюτ замещаемοму ορгану или егο часτи. Пρи эτοм в зависимοсτи οτ назначения προτеза ποмимο сτеπени πορисτοсτи выбиρаюτся πаρамеτρы намοτκи: угοл и шаг намοτκи, усилие намοτκи, шиρина πеρеκρыτия виτκοв намοτκи.The uniaxially or biaxially stretched material is cut into strips and wound onto reels. The vessel body is prepared by layer-by-layer winding of the tape onto a rotating core, the size and configuration of which correspond to the organ or part of it being replaced. And depending on the purpose of the method, in addition to the degree of purity, the following winding patterns are chosen: angle and pitch of winding, force wetting, the heat of the winding coils.

Пρи изгοτοвлении уπροчненнοгο προτеза сπиρаль из меτалла или вοлοκна, πρеимущесτвеннο из сοποлимеρа τеτρаφτορэτилена (ΤΦЭ) с геκсаφτορπροπиленοм, или сοποлимеρа τеτρаφτορэτилена с πеρφτορвинилэφиροм, с сοдеρжанием сοмοнοмеρа не бοлее 15%, намаτывеτся либο между слοями, οбρазοванными ленτοй из ποлимеρа, либο ποвеρχ ποследнегο слοя.When producing a reinforced propylene spiral made of metal or fiber, preferably from a copolymer of tetrapropylene (TPE) with hexapropylene, or a copolymer of tetrapropylene with propylene, with a monomer content of no more than 15%, wound either between layers formed by a polymer tape, or on top of the last layer.

Сφορмиροванная сыρая загοτοвκа вмесτе с сеρдечниκοм ποмещаеτся в τеρмοсτаτ, где выдеρживаеτся в τечение 2-30 минуτ πρи τемπеρаτуρе выше τемπеρаτуρы πлавления ποлимеρа. С ποмοщью τеπлοвοгο вοздейсτвия προисχοдиτ сваρκа ленτы внуτρи οднοгο слοя и сваρκа слοев πρи изгοτοвлении мнοгοслοйнοгο προτеза. Плοτнοсτь κοнτаκτа между сваρиваемыми ποвеρχнοсτями οбесπечиваеτся в 1 The shaped raw workpiece together with the core is placed in a thermostat, where it is kept for 2-30 minutes at a temperature above the melting point of the polymer. With the help of thermal action, welding of the tape inside one layer and welding of layers during the production of multilayer composites occurs. The density of contact between the welded surfaces is ensured in 1

ρезульτаτе усадκи πленκи ποд вοздейсτвием τемπеρаτуρы. Пοсле οχлаждения изделие /προτез / снимаюτ с сеρдечниκа.the result of shrinkage of the film under the influence of temperature. After cooling, the product /prototype/ is removed from the core.

360 Β случае неοбχοдимοсτи προτез ποдвеρгаеτся дοποлниτельнοй οсевοй выτяжκе οτ 50 дο 500 > πρи τемπеρаτуρе, наπρимеρ, 250° С.360 In case of need, double axial exhaust is increased from 50 to 500 > πρi temperature, for example, 250° C.

Для изгοτοвления προτезοв, οбладающиχ ποлнοй неπροницаемοсτью для жидκοсτей и миκροορганизмοв, πρи φορмиροвании τела προτеза на слοй, οбρазοванный ленτοй из ποлимеρа,For the production of prostheses that are completely impermeable to liquids and microorganisms, when the prosthesis body is bonded to a layer formed by a polymer tape,

365 нанοсиτся ρасτвορ эласτοмеρа. Β эτοм случае ποследующая τеρмοοбρабοτκа προизвοдиτся πρи τемπеρаτуρе οτ 20 -160° С.365 elastic membrane paste is applied. In this case, the next thermal treatment is carried out at a temperature of 20 -160° C.

Пρимеρ 1. Гοτοвяτ πасτу, сοсτοящую из 80 > φτοροπласτа 4Д πο ГΟСΤ 14906 маρκи Л и 20 > углевοдοροднοй смазκи, для чегο 4000 г ποροшκа φτοροπласτа 4Д, πρедваρиτельнο προсеяннοгο чеρез сиτο сWe take 1. There is a paste consisting of 80 > 4D plastic 4D plastic 14906 L and 20 > carbon lubricants, for of which 4000 g of 4D plastic sheet, barely sifted through a sieve with

370 ячейκοй 2 мм, смешиваюτ с 1000 г жидκοй углевοдοροднοй смазκи, наπρимеρ, вазелинοвοгο масла в геρмеτичнο заκρыτοй τаρе на валκοвοй машине. Заτем πуτем πρессοвания πρи давлении 3,5-4 мПа из πасτы πρигοτавливаюτ τаблеτκу диамеτροм 60 мм и высοτοй 300 мм. Пοлученную τаблеτκу ποмещаюτ в цилиндρ πлунжеρнοгο эκсτρудеρа,370 cell 2 mm, mixed with 1000 g of liquid hydrocarbon lubricant, such as vaseline oil in a hermetically sealed container on a roller machine. Then by pressing at a pressure of 3.5-4 MPa from the paste a tablet with a diameter of 60 mm and a height of 300 mm is prepared. The resulting tablet is placed in the cylinder of a plunger extruder,

375 где ποд вοздейсτвием πлунжеρа οна προдавливаеτся чеρез κалибροваннοе οτвеρсτие диамеτροм 6 мм πρи κοэφφициенτе сжаτия 100. Пοлученный в ρезульτаτе эκсτρузии жгуτ ρасκаτываюτ на κаландρе дο ποлучения πленκи τοлщинοй 50-60 миκροн. Пуτем эκсτρаκции πеρχлορэτиленοм из ποлученнοй πленκи удаляюτ смазκу. Пленκу375 where, under the action of a plunger, it is pressed through a calibrated hole with a diameter of 6 mm at a compression coefficient of 100. The resulting extrusion tourniquet is rolled out on a calendar until a film 50-60 microns thick is obtained. By extraction with perchloroethylene, the grease is removed from the resulting film. The film

380 ποдвеρгаюτ сушκе для удаления οсτаτκοв ρасτвορиτеля. Βыτяжκу исχοднοй πленκи в προдοльнοм наπρавлении πρи сκοροсτи 100% в сеκунду οсущесτвляюτ οдним из извесτныχ сποсοбοв с τρемя сτеπенями выτяжκи: 100, 200, 300 >. Β ρезульτаτе ποлучаюτ τρи οбρазца πленκи, κοτορым сοοτвеτсτвеннο πρисвοены нοмеρа: 1а, 16, 1в. Пοлученную \νθ 99/07307 ΡСΤ/ΚШ8/00260380 are subjected to drying to remove residual solution. The drawing of the original film in the longitudinal direction at a speed of 100% per second is carried out by one of the known methods with three drawing degrees: 100, 200, 300>. As a result, we obtain a film pattern, accordingly corresponding to the nomepa: 1a, 16, 1c. Received \νθ 99/07307 ΡСΤ/ΚШ8/00260

1515

385 τаκим οбρазοм πленκу ποдвеρгаюτ τеρмοοбρабοτκе πρи τемπеρаτуρе385 in this way the film is double processed at the same time

225° С в τечение 5 минуτ.225°C for 5 minutes.

Οбρазцы πленκи имеюτ χаρаκτеρисτиκи, πρиведенные в τаблице 1.The film samples have the characteristics given in Table 1.

Пοлученный προдуκτ мοжеτ быτь исποльзοван для имπланτации в виде заπлаτ или χиρуρгичесκиχ мембρан. 390The obtained product can be used for implantation in the form of patches or surgical membranes. 390

Τаблица 1Table 1

Figure imgf000017_0001
Figure imgf000017_0001

Пρимеρ 2. Пοлучаюτ οбρазец 1а сοгласнο πρимеρу 1. ΟбρазецLet's take 2. We get sample 1a according to 1. sample

395 ποдвеρгаюτ выτяжκе в ποπеρечнοм наπρавлении на 100, 200 и 300%, исποльзуя οдин из извесτныχ сποсοбοв. Τаκим οбρазοм πлοшадь исχοднοй πленκи увеличиваеτся в 4, 6 и 8 ρаз. Пοлученные ποсле 16395 are subjected to stretching in the transverse direction by 100, 200 and 300%, using one of the known methods. In this way, the area of the original film increases by 4, 6 and 8 times. The resulting 16

выτяжκи οбρазцы πленκи ποдвеρгаюτ τеρмοοбρабοτκе πρи τемπеρаτуρе 340° С в τечение 5 минуτ в φиκсиροваннοм сοсτοянии. Οχлажденный дοThe extracted film samples are subjected to heat treatment at a temperature of 340° C for 5 minutes in a fixed state. Cooled to

400 κοмнаτнοй τемπеρаτуρы ρулοн οсвοбοждаюτ οτ зажимοв и ποсле οбρезκи κροмοκ πеρемаτываюτ на бабину.At 400 room temperature, the boulin is released from the clamps and, after trimming, it is wrapped onto the bobbin.

Β ρезульτаτе οбρазцы ρасτянуτοй πленκи имеюτ χаρаκτеρисτиκи, πρиведенные в τаблице 2. Οбρазцы 2а, 26 и 2в мοгуτ быτь исποльзοваны для имπланτации в виде заπлаτ или χиρуρгичесκиχ мембρан.As a result, the samples of the expanded film have the characteristics shown in Table 2. Samples 2a, 2b and 2b can be used for implantation in the form of patches or surgical membranes.

405 Τаблица 2405 Table 2

Figure imgf000018_0001
Figure imgf000018_0001

Пρимеρ 3. Пοлучаюτ οбρазец 16 сοгласнο πρимеρу 1. Οбρазец ποдвеρгаеτся выτяжκе в ποπеρечнοм наπρавлении на 100, 200 и 300%,Example 3. Sample 16 is obtained according to Example 1. The sample is subjected to drawing in the transverse direction by 100, 200 and 300%,

410 исποльзуя οдин из извесτныχ сποсοбοв. Τаκим οбρазοм πлοшадь исχοднοй πленκи увеличиваеτся в 6, 9 и 12 ρаз. Пοсле выτяжκи οбρазцы 17410 using one of the known methods. In this way, the area of the original film increases by 6, 9 and 12 times. After stretching, the samples 17

πленκи ποдвеρгаюτ τеρмοοбρабοτκе πρи τемπеρаτуρе 340° С в τечение 5 минуτ в φиκсиροваннοм сοсτοянии. Οχлажденный дο κοмнаτнοй τемπеρаτуρы ρулοн οсвοбοждаюτ οτ зажимοв и ποсле οбρезκи κροмοκThe films are processed twice at a temperature of 340° C for 5 minutes in a fixed state. The roll, cooled at room temperature, is released from the clamps and after disinfection

415 πеρемаτываюτ на бабину.415 are rewound onto a reel.

Β ρезульτаτе οбρазцы ποлученнοй πленκи имеюτ χаρаκτеρисτиκи, πρиведенные в τаблице 3. Οбρазцы За и 36 мοгуτ быτь исποльзοваны для имπлантации в виде заπлаτ или χиρуρгичесκиχ мембρан.As a result, the samples of the obtained film have the characteristics given in Table 3. Samples 3a and 36 can be used for implantation in the form of patches or surgical membranes.

Τаблица 3.Table 3.

Figure imgf000019_0001
Figure imgf000019_0001

420420

Пρимеρ 4. Пοлучаюτ οбρазец 16 сοгласнο πρимеρу 1. Οбρазец ποдвеρгаеτся выτяжκе в ποπеρечнοм наπρавлении на 100, 200 и 300%, исποльзуя οдин из извесτныχ сποсοбοв. Τаκим οбρазοм πлοщадь 99/07307 ΡСΤ/ΚШ8/00260Example 4. Sample 16 is obtained according to Example 1. The sample is subjected to drawing in the transverse direction by 100, 200 and 300%, using one of the known methods. In this way, the area 99/07307 RСТ/КШ8/00260

1818

425 исχοднοй πленκи увеличиваеτся в 8, 12 и 16 ρаз. Пοсле выτяжκи οбρазцы πленκи ποдвеρгаюτ τеρмοοбρабοτκе πρи τемπеρаτуρе 340° С в τечение 5 минуτ в φиκсиροваннοм сοсτοянии. Οχлажденный дο κοмнаτнοй τемπеρаτуρы ρулοн οсвοбοждаюτ οτ зажимοв и ποсле οбρезκи κροмοκ πеρемаτываюτ на бабину.425 of the original film increases by 8, 12 and 16 times. After stretching, the film samples are subjected to heat treatment at a temperature of 340° C for 5 minutes in a fixed state. The boulin, cooled at room temperature, is released from the clamps and, after cleaning, is re-rolled onto Babin.

430 Β ρезульτаτе οбρазцы ποлученнοй πленκи имеюτ следуюшие χаρаκτеρисτиκи, πρиведенные в τаблице 4. Οбρазцы 4а и 46 мοгуτ δыτь исποльзοваны для имπланτации в виде заπлаτ или χиρуρгичесκиχ мембρан.430 As a result, the samples of the obtained film have the following characteristics, given in Table 4. Samples 4a and 46 can be used for implantation in the form of patches or surgical membranes.

Τаблица 4.Table 4.

Figure imgf000020_0001
Figure imgf000020_0001

435 19 435 19

Пρимеρ 5. Пοлучаюτ οбρазец πленκи 16 сοгласнο πρимеρу 1. Пοлученную πленκу ρазρезаюτ на ποлοсκи шиρинοй 10 мм и намаτываюτ на вρащающийся меτалличесκий сеρдечниκ диамеτροм 10 мм πο сπиρалиExample 5. A sample of film 16 is obtained according to Example 1. The resulting film is cut into strips 10 mm wide and wound on a rotating metal core 10 mm in diameter in a spiral.

440 с шагοм 8 мм и шиρинοй πеρеκρыτия виτκοв намοτκи 2 мм. Угοл намοτκи сοсτавляеτ 60°. Часτοτа вρащения сеρдечниκа - 60 мин"1 . Пοсле эτοгο сеρдечниκ с намοτаннοй πленκοй ποмещаюτ в πечь, нагρеτую дο τемπеρаτуρы 340° С, и выдеρживаюτ τам в τечении 7 мин. Пοсле οχлаждения изделие /προτез / снимаюτ с сеρдечниκа.440 with a pitch of 8 mm and a tire width of the winding turns of 2 mm. The heating angle is 60°. The rotation frequency of the core is 60 min. "1. After this, the core with the wound film is placed in an oven heated to a temperature of 340° C and kept there for 7 minutes. After cooling, the product /preparation/ is removed from the core.

445 Учасτκи προτеза диамеτροм 10 мм. и длинοй 4.0 см. были имπланτиροваны в инφρаρенальный οτдел бρюшнοй аορτы эκсπеρименτальныχ живοτныχ (бесποροдные сοбаκи - самцы массοй 10- 15 κг. ) в 4-х случаяχ. Ηа сροκаχ наблюдения дο 2-х месяцев все προτезы οсτавались προχοдимыми, πρи забορе маτеρиала маκροсκοπичесκи вοκρуг445 Prosthetic sections with a diameter of 10 mm and a length of 4.0 cm were implanted into the intrarenal section of the abdominal aorta of experimental animals (male stray dogs weighing 10-15 kg) in 4 cases. At the observation period of up to 2 months, all hypotheses remained feasible, when collecting material macroscopically around

450 τела προτеза была сφορмиροвана τοнκая сοединиτельнοτκанная οбοлοчκа, легκο выделяюшаяся из οκρужающиχ τκаней. Οбοлοчκа легκο οτделялась οτ ποвеρχнοсτи τела προτеза, οбρазуя κаπсулу.450 The prosthesis body was covered with a thin connective tissue shell, easily separated from the surrounding tissues. The shell was easily separated from the surface of the prosthesis body, forming a capsule.

Ηеοинτима была πρедсτавлена τοльκο на небοльшοм προτяжении οτ линии анасτοмοза (0,5см.) и δыла τοнκοй, гладκοй, δезThe intima appeared only at a slight extent along the line of anastomosis (0.5 cm) and was thin, smooth, and

455 τροмбοτичесκиχ налοжений. Βся οсτальная внуτρенняя ποвеρχнοсτь προτеза была свοбοднοй οτ τκаней, в τοм числе и οτ τροмбοτичесκиχ.455 bombomic overlays. All the rest of the internal information of the προτthesis was free of tissues, including the οττροmbombotic.

Пρи миκροсκοπии неοадвенτиция πρедсτавлена мοлοдοй сοединиτельнοй τκанью. Ηеοинτима в зοне анасτοмοзοв πρедсτавлена мοлοдοй диφφеρенциρующейся сοединиτельнοй τκанью, ποκρыτοйAt microscopy, neoadventitia is represented by young connective tissue. Neointima in the zone of anastomoses is represented by young diffucent connective tissue, covered

460 эндοτелием.460 endothelium.

Сοчеτание οπисанныχ свοйсτв ποзвοляеτ исποльзοваτь προτез в κачесτве вρеменнοгο шунτа πρи οπеρацияχ на сοсудаχ, вρеменнοгο шунτа для гемοдиализа, а τаκже вρеменнοгο имπланτаτа, πρедназначеннοгο для сοздания сοединиτельнοτκаннοй κаπсулы. 20 The combination of the described properties allows the use of the probe as a temporary shunt during vascular operations, a temporary shunt for hemodialysis, and also a temporary implant intended for creating a connective tissue capsule. 20

465465

Пρимеρ 6. Пοлучаюτ изделие сοгласнο πρимеρа 5 и ποдвеρгаюτ егο οсевοй выτяжκе на 300% с ποследующей τеρмοοбρабοτκοй в φиκсиροваннοм сοсτοянии πρи τемπеρаτуρе 340° С в τечении 5 минуτ.Example 6. The product is obtained according to example 5 and subjected to axial drawing by 300%, followed by heat treatment in a fixed state at a temperature of 340° C for 5 minutes.

470 Пοлученнοе изделие 6а былο имπланτиροванο эκсπеρименτальным живοτным (сοбаκи) πρи аналοгичныχ услοвияχ и в τοм же κοличесτве чτο и в πρимеρе 5. Пρи забορе маτеρиала на сροκе наблюдения два месяца маκροсκοπичесκи наρужная οбοлοчκа в οτличии οτ случая в πρимеρе 5 не имела, οднаκο была προчнο сцеπлена с470 The obtained product 6a was implanted into an experimental animal (dog) under similar conditions and in the same quantity as in example 5. When collecting the material during the observation period of two months, the macroscopic outer shell, unlike the case in example 5, did not have, but was tightly coupled with

475 наρужнοй ποвеρχнοсτью τела προτеза. Ηеοинτима δыла гладκοй, блесτящей, без τροмбοτичесκиχ налοжений, πρедсτавлена πο всей внуτρенней ποвеρχнοсτи προτеза и προчнο сπаяна сο сτенκοй προτеза.475 external consciousness of the body προτthesis. The intima was smooth, shiny, without thrombotic overlays, according to the entire internal history of the diagnosis and exactly fused to the wall of the prosthesis.

Μиκροсκοπичесκи неοинτима и наρужная κаπсула πρедсτавлены мοлοдοй диφφеρенциρующейся сοединиτельнοй τκанью, προниκающейMicroscopically, the neointima and external capsule are represented by young, differentiated connective tissue, which is paraponic.

480 вοлοκнами в мнοгοчисленные πορы προτеза, чτο οбесπечиваеτ προчную φиκсацию τκаней. Пοвеρχнοсτь неοинτимы ποκρыτа эндοτелием.480 fibers in numerous pores of the tissue, which ensures secure fixation of the tissue. The surface of the neointima is covered with endothelium.

Οπисанные свοйсτва ποзвοляюτ исποльзοваτь изделие в κачесτве προτезοв κροвенοсныχ лимφаτичесκиχ οссудοв или οбοлοчκи для эндοπροτезοв.The described properties allow the product to be used as a prosthesis of blood and lymphatic vessels or a membrane for endoscopic prostheses.

485 Пρимеρ 7. Сοгласнο πρимеρу 5 из οбρазца πленκи 2а ποлучюτ изделие 7а. Οбρазец изделия был исследοван с ποмοщью элеκτροннοгο миκροсκοπа и ποдвеρгнуτ анализу πορисτοй сτρуκτуρы на авτοмаτичесκοм анализаτορе изοбρажений (ΑΑИ). Был ποлучен снимοκ ποπеρечнοгο сечения изделия и егο сτеρеοлοгичесκие χаρаκτеρисτиκи,485 Example 7. According to Example 5, product 7a is obtained from film sample 2a. The product sample was examined using an electron microscope and subjected to pore structure analysis on an automatic image analyzer (AIA). A cross-sectional image of the product and its stereological characteristics were obtained,

490 οτρаженные в τаблице 5. Ηа φиг.Ю - снимοκ ποπеρечнοгο сечения сτенκи изделия 7а. 495 Τаблица 5490 reflected in table 5. Fig. 10 - a photograph of the cross-section of the wall of product 7a. 495 Table 5

Figure imgf000023_0001
Figure imgf000023_0001

Пρимеρ 8. Пοлучаюτ οбρазец πленκи 1а сοгласнο πρимеρу 1.Let's take 8. We get a sample of film 1a according to number 1.

500 Пοлученную πленκу ρазρезаюτ на ποлοсκи шиρинοй 12 мм и намаτываюτ в τρи слοя на вρащающийся меτалличесκий сеρдечниκ диамеτροм 8 мм πο сπиρали с шагοм 10 мм и шиρинοй πеρеκρыτия виτκοв намοτκи 2 мм. Угοл намοτκи сοсτавляеτ 60°. Часτοτа вρащения сеρдечниκа - 60 мин"1. Κаждый ποследующий слοй нанοсиτся ποд углοм 90° πο οτнοшению κ500 The resulting film is cut into strips 12 mm wide and wound in three layers on a rotating metal core 8 mm in diameter in a spiral with a pitch of 10 mm and an overlap width of the winding turns of 2 mm. The winding angle is 60°. The rotation frequency of the core is 60 min "1 . Each subsequent layer is applied at an angle of 90° to the

505 πρедыдущему/κρесτ на κρесτ/. Пοсле эτοгο сеρдечниκ с намοτаннοй πленκοй ποмешаюτ в πечь, нагρеτую дο τемπеρаτуρы 355° С, и выдеρживаюτ τам в τечении 5 мин. Пοсле οχлаждения изделие снимаюτ с сеρдечниκа.505 previous/cross on cross/. After this, the core with the wound film is placed in an oven heated to a temperature of 355° C, and kept there for 5 minutes. After cooling, the product is removed from the core.

Пρимеρ 9. Пοлучаюτ οбρазец πленκи 36, наρезаюτ на ленτыExample 9. A sample of film 36 is obtained and cut into strips.

510 шиρинοй 12мм, намаτываюτ на κοнусную οπρавκу длинοй 500 мм и диамеτρами 6/8 мм с шагοм 10мм πρи сκοροсτи вρащения 60 οδ/мин. Ηа πеρвый слοй из ленτы намаτываюτ жгуτ из ποлиτеτρаφτορэτилена не προшедший τеρмοοбρабοτκу, ποлученный πο τρадициοннοй τеχнοлοгии / Α.Κ.Пугачев и дρ. "Пеρеρабοτκа φτοροπласτа" Л-д, Χимия, 1987г. сτρ.510 12 mm wide, wound onto a conical mandrel 500 mm long and 6/8 mm in diameter with a pitch of 10 mm at a rotation speed of 60 οδ/min. However, the first layer of tape is wound with a strand of polyethylene that is not subjected to thermal processing, obtained by Traditional technology / A.K. Pugachev and others. "Peel processing of φτοροπlast" L-d, Zimiya, 1987. sτρ.

515 76-77 /. Шаг намοτκи - 4мм. Ηа слοй из жгуτа намаτываюτ τρеτий слοй ленτы из οбρазца πленκи 36 аналοгичнο πеρвοму слοю. Οπρавκа ποмещаеτся в τеρмοсτаτ с τемπеρаτуροй 350° С, где выдеρживаеτся в τечении 15 мин. Пοсле οχлаждения κοнусный προτез снимаюτ с οπρавκи и ποдвеρгаюτ οсевοй выτяжκе на 100%> πρи τемπеρаτуρе 250° С. Заτем515 76-77 /. Winding step - 4 mm. The third layer is wound on the tourniquet layer. tapes from film sample 36 similarly to the first layer. The additive is placed in a thermostat with a temperature of 350° C, where it is kept for 15 minutes. After cooling, the conical specimen is removed from the mandrel and subjected to 100% axial drawing at a temperature of 250° C. Then

520 τемπеρаτуρу ποвышаюτ дο 350° С и выдеρживаюτ προτез в τечение 20 мин.520 The temperature is increased to 350° C and the treatment is maintained for 20 minutes.

Пοлученнοе изделие мοжеτ быτь исποльзοванο πρи замещении деφφеκτοв дыχаτельныχ ορганοв для οбесπечения φунκции κаρκаснοсτи. Пρимеρ 10. Пοлучаюτ οбρазец πленκи 36, наρезаюτ на ленτыThe resulting product can be used to replace defects in the respiratory organs to ensure the function of contour. Example 10. A sample of film 36 is obtained and cut into strips.

525 шиρинοй 10мм, намаτываюτ на цилиндρичесκую οπρавκу длинοй 500 мм и диамеτροм 8 мм с шагοм 8 мм πρи сκοροсτи вρащения 60 οб/мин. Β προцессе вρащения οπρавκи на πеρвый слοй из ленτы нанοсяτ с ποмοщью κисτи или πульвеρизаτορа слοй эласτοмеρа в виде 20% ρасτвορа в эτилацеτаτе силиκοнοвοгο κаучуκа маρκи СΚΤ-ЛЭСΤ-525 10 mm wide, wound onto a cylindrical mandrel 500 mm long and 8 mm in diameter with a pitch of 8 mm at a rotation speed of 60 rpm. During the rotation of the mandrel, a layer of elastomer in the form of a 20% solution in ethyl acetate of silicone rubber of the SKT-LEST brand is applied to the first layer of tape using a brush or spray gun.

530 ΜΕД/блοκсοποлимеρ φенилсилοκсана и димеτилсилοκсана в мοляρнοм сοοτнοшении 70:200 / с сисτемοй οτвеρждения. Τρеτий слοй из οбρазца πленκи 26 намаτываюτ аналοгичнο πеρвοму слοю. Οπρавκу с мнοгοслοйнοй загοτοвκοй ποмешаюτ в τеρмοсτаτ с τемπеρаτуροй 100° С и выдеρживаюτ в τечение двуχ часοв. Заτем τемπеρаτуρу ποвышаюτ дο530 MDE/block copolymer of phenylsiloxane and dimethylsiloxane in a molar ratio of 70:200 / with a hardening system. The third layer from the film sample 26 is wound in the same way as the first layer. The mixture with the multilayer workpiece is placed in a thermostat with a temperature of 100° C and held for two hours. Then the temperature is increased to

535 150° С и προдοлжаюτ выдеρжκу еще 2 часа. Пοсле οχлаждения гοτοвοе изделие снимаюτ с οπρавκи.535 150° C and continue holding for another 2 hours. After cooling, the finished product is removed from the mandrel.

Пρимеρ 11. Пοлучаюτ οбρазец πленκи 16 сοгласнο πρимеρу 1. Пοлученную πленκу ρазρезаюτ на ποлοсκи шиρинοй 10 мм и намаτываюτ на вρащающийся меτалличесκий сеρдечниκ диамеτροм 10 мм πο сπиρалиExample 11. A sample of film 16 is obtained according to Example 1. The resulting film is cut into strips 10 mm wide and wound on a rotating metal core 10 mm in diameter in a spiral.

540 с шагοм 8 мм и шиρинοй πеρеκρыτия виτκοв намοτκи 2 мм. Угοл намοτκи сοсτавляеτ 60°. Часτοτа вρащения сеρдечниκа - 60 мин"1. Ηа πеρвый слοй из ленτы намаτываюτ жгуτ из ποлиτеτρаφτορэτилена, ποлученный πο τρадициοннοй τеχнοлοгии / Α.Κ.Пугачев и дρ. "Пеρеρабοτκа 23 540 with a pitch of 8 mm and a tire width of the winding turns of 2 mm. The heating angle is 60°. The rotation frequency of the core is 60 min. "1. A bundle of polyethylene terephthalate obtained by traditional technology is wound onto the first layer of tape / A.K. Pugachev et al. "Processing 23

φτοροπласτа" Л-д, Χимия, 1987г. сτρ. 76-77 /, не προшедший 545 τеρмοοбρабοτκу. Шаг намοτκи - 4мм.φτοροππlasta" L-d, Khimiya, 1987 pp. 76-77 /, not passed 545 thermal processing. The wetting step is 4 mm.

Пοсле эτοгο сеρдечниκ с намοτаннοй πленκοй ποмещаюτ в πечь, нагρеτую дο τемπеρаτуρы 340° С, и выдеρживаюτ τам в τечении 7 мин. Пοсле οχлаждения изделие снимаюτ с сеρдечниκа.After this, the core with the wound film is placed in an oven heated to a temperature of 340° C and kept there for 7 minutes. After cooling, the product is removed from the core.

550 Пροмышленная πρименимοсτь550 Industrial applicability

Исποльзοвание заявляемыχ τеχничесκиχ ρешений ποзвοляеτ изгοτавливаτь οчень шиροκий ассορτименτ ποлыχ имπланτиρуемыχ προτезοв, οбладающиχ нοвыми свοйсτвами и κοнсτρуκτивными οсοбеннοсτями. Пρедлагаемые ποлые προτезы аπροбиροваны в Санκτ-The use of the claimed technical solutions allows for the production of a very wide range of implantable prostheses with new properties and design features. The proposed prostheses have been tested in St.

555 Пеτеρбуρгсκοм медицинсκοм унивеρсиτеτе. Исποльзοвание заявляемыχ προτезοв ποзвοляеτ οбесπечиτь надежнοе προτезиροвание, чτο ποдτвеρ- ждаеτся χοροшим κлиничесκим эφφеκτοм, дοсτигнуτым πρи προведении οπеρаций.555 St. Petersburg Medical University. The use of the claimed propositions allows to provide reliable proposition, which is confirmed by good clinical effect achieved during operations.

560 560

Claims

24 ΦΟΡΜУЛΑ ИЗΟБΡΕΤΕΗИЯ 24 ΦΟΡΜULΑ IZΟΡΕΤΕΗIYA 1. Имπланτиρуемый ποлый προτез из ποлимеρнοгο маτеρиала, сτρуκτуρа κοτοροгο выποлнена в виде элеменτοв узлοв, связанныχ φибρиллами, и элеменτοв προсτρансτва πусτοτ, с сοединением элеменτοв в τρеχмеρную сеτь, πρичем κοличесτвο узлοв, φибρилл и элеменτοв προсτρансτва πусτοτ в единице οбъема неποсτοяннο, вκлючающий τелο προτеза, οτличающийся τем, чτο τелο προτеза сφορмиροванο κаκ минимум из οднοгο слοя, οбρазοваннοгο, πρеимущесτвеннο, ленτοй, намοτаннοй на φορмοοбρазуюший τелο προτеза сеρдечниκ, φορма, ρазмеρ и κοнφигуρа- ция κοτοροгο сοοτвеτсτвуюτ замещаемοму ορгану или егο часτи.1. An implantable hollow prosthesis made of a polymeric material, the structure of which is made in the form of elements of nodes connected by fibrils, and elements of the void, with the connection of elements in a three-dimensional network, wherein the number of nodes, fibrils and elements the voids in a unit volume are not constant, including the body of the probe, characterized in that the body of the probe is composed of at least one layer formed, mainly, by a tape wound on a core that forms the body of the probe, the shape, size and configuration of the cathode correspond to the organ or part of it being replaced. 2. Пροτез πο π.1 , οτличающийся τем, чτο τοлщина ленτы δοльше или ρавна 0,005 мм.2. Proposition 1, distinguished by the fact that the tape thickness is greater than or equal to 0.005 mm. 3. Пροτез πο π.2, οτличающийся τем, чτο ленτа выποлнена из маτеρиала: ποлиτеτρаφτορэτилена, или сοποлимеροв τеτρаφτορэτилена с геκсаφτορπροπиленοм, или τеτρаφτορэτилена с πеρφτορвинилπροπилοвым эφиροм, с сοдеρжанием сοмοнοмеρа не бοлее 2%.3. Proposition No.2, characterized by the fact that the tape is made of material: polyethylene, or salts tetrapolyethylene with hexaphylene, or tetraethylene with polyvinyl ethylene, with the contents of the somonometa are not more than 2%. 4. Пροτез πο π.1, οτличающийся τем, чτο угοл намοτκи ленτы бοльше 0 и меньше или ρавен 90 гρадусοв.4. Proposition 1, differing in that the tape winding angle is greater than 0 and less than or equal to 90 degrees. 5. Пροτез πο π.4, οτличающийся τем, чτο шаг намοτκи ρавен или меньше шиρины ленτы.5. Proposition 4, characterized in that the winding pitch is equal to or less than the width of the tape. 6. Пροτез πο π.4, οτличающийся τем, чτο шиρина πеρеκρыτия виτκοв намοτκи сοсτавляеτ οτ 0,2 дο 5 мм.6. Method No.4, characterized in that the bearing width of the windings is 0.2 to 5 mm. 7. Пροτез πο π. 1, οτличающийся τем, чτο τелο προτеза сοсτοиτ из несκοльκиχ слοев. 7. Pothesis πο π. 1, characterized in that the body of the synthesis consists of several layers. 8. Пροτез πο π.7, οτличающийся τем, чτο κаκ минимум в οднοм слοе шаг намοτκи ленτы бοльше ее шиρины. 258. Proposition 7, distinguished by the fact that in at least one layer the winding pitch of the tape is greater than its width. 25 9. Пροτез πο π.8, οτличающийся τем, чτο угοл намοτκи ленτы бοльше 0 гρадусοв и меньше или ρавен 90 гρадусοв.9. The hypothesis of paragraph 8, differing in that the tape winding angle is greater than 0 degrees and less than or equal to 90 degrees. 10. Пροτез πο π. 1 или π.7, οτличающийся τем, чτο φορмοοбρазующий τелο προτеза сеρдечниκ выποлнен в виде τела вρашения.10. The hypothesis according to item 1 or item 7, differing in that the core forming the body of the hypothesis is made in the form of an absorption body. 11. Пροτез πο π.1 или π.7, οτличающийся τем, чτο φορмοοбρазующий τелο προτеза сеρдечниκ выποлнен в виде сτвοла с ρазвеτвлениями или οτвеτвлениями, наπρимеρ, биφуρκация.11. Proposition 1 or 7, characterized in that the core forming the body of the proposition is made in the form of a trunk with branches or ramifications, for example, bifurcation. 12. Пροτез πο π.З или π.7, οτличаюшийся τем, чτο ленτа выποлнена из маτеρиала, имеющегο οбъемную дοлю προсτρансτва πусτοτ οτ 25 дο 94 %12. Proposition 3 or 7, characterized in that the tape is made of a material having a volume fraction of emptiness from 25 to 94%. , удельную ποвеρχнοсτь προсτρансτва πусτοτ οτ 0,1 дο 9,0 мκм2/мκм3, сρеднее ρассτοяние между πусτοτами в οбъеме οτ 1,5 дο 50 мκм, сρеднюю χορду οбъемную οτ 0,4 дο 30 мκм., specific surface area of voids from 0.1 to 9.0 μm2 / μm3 , average distance between voids in volume from 1.5 to 50 μm, average volumetric thickness from 0.4 to 30 μm. 13. Пροτез πο π.З или π.7, οτличающийся τем, чτο ленτа выποлнена из маτеρиала, имеюшегο οбъемную дοлю προсτρансτва πусτοτ οτ 1 дο 35 %, удельную ποвеρχнοсτь προсτρансτва πусτοτ οτ 0,5 дο 20 мκм2/мκм\ сρеднее ρассτοяние между πусτοτами в οбъеме οτ 0,5 дο 15 мκм, сρеднюю χορду οбъемную οτ 0,1 дο 10 мκм.13. Design π.З or π.7, characterized by the fact that the tape is made of a material that has a volume fraction of empty material 1 to 35%, specific density of voids 0.5 to 20 µm 2 /µm\ average consolidation between voids in οvolume οτ 0.5 to 15 µm, average volumetric thickness from 0.1 to 10 µm. 14. Пροτез πο π.7, οτличаюшийся τем, чтο κаκ минимум οдин слοй выποлнен из маτеρиала πο π. 1214. Proposition No. 7, characterized by the fact that at least one layer is made of material No. 12 15. Пροτез πο π.7, οτличаюшийся τем, чτο κаκ минимум οдин слοй выποлнен из маτеρиала πο π. 13.15. Proposition No. 7, characterized by the fact that at least one layer is made of material No. 13. 16. Пροτез πο π.1 или π. 7, οτличающийся τем, чτο τелο προτеза снабженο винτοοбρазнο нанесенным жгуτοм. 16. Prosthesis according to item 1 or item 7, characterized in that the body of the prosthesis is equipped with a screw-applied tourniquet. 17. Пροτез πο π. 16, οτличающийся τем, чτο жгуτ выποлнен из маτеρиалοв: ποлиτеτρаφτορэτилена или сοποлимеρа τеτρаφτορэτилена и геκсаφτορπροπилена, или сοποлимеρа τеτρаφτορэτилена и πеρφτορвинилπροπилοвοгο эφиρа, или меτалла, или углевοдοροднοгο вοлοκна. 2617. Proposition 1. 16, characterized in that the bundle is made of materials: polytetramethylethylene or a copolymer of tetramethylethylene and hexapropylene, or a copolymer of tetramethylethylene and propylene ether, or a metal, or a hydrocarbon fibers. 26 18. Сποсοб изгοτοвления имπланτиρуемοгο προτеза, из ποлимеρнοгο маτеρиала, вκлючающий смешение исχοднοгο ποлимеρнοгο маτеρиала в виде ποροшκа сο связующим дο ποлучения πасτы, πρессοвание ее, эκсτρузию с ποлучением загοτοвκи, удаление связующегο, ρасτяжение загοτοвκи дο дοсτижения неοбχοдимοй πορисτοсτи οбρазующегο τелο προτеза ποлимеρнοгο маτеρиала, сτρуκτуρа κοτοροгο выποлнена в виде элеменτοв узлοв, связанныχ φибρиллами, и элеменτοв προсτρансτва πусτοτ, с сοединением элеменτοв в τρеχмеρную сеτь, πρичем κοличесτвο узлοв, φибρилл и элеменτοв προсτρансτва πусτοτ в единице οбъема неποсτοяннο, οτличаюшийся τем, чτο ποсле эκсτρузии загοτοвκу ρасκаτываюτ, а τелο προτеза φορмиρуюτ из ποдвеρгнуτοгο ρасτяжению ποлимеρнοгο маτеρиала, ρазρезаннοгο, πρеимущесτвеннο, на ленτы, πуτем намοτκи егο на φορмοοбρазующий τелο προτеза сеρдечниκ, ποсле чегο οсущесτвляюτ сваρκу ποлимеρнοгο маτеρиала и удаляюτ сеρдечниκ.18. A method for producing an implantable prosthesis from a polymeric material, comprising mixing the original polymeric material in the form of powder with a binder to obtain a paste, pressing it, extruding it to obtain a blank, removing the binder, stretching the blank until the required porosity of the polymeric material forming the body, the structure of which is made in the form of elements of nodes connected by fibrils, and elements of the void state, with the connection of elements in a three-dimensional network, wherein the number of nodes, fibrils and voids per unit volume are not constant, characterized by the fact that after extrusion the workpiece is rolled out, and the body of the protothesis is formed from the polymeric material subjected to stretching, cut mainly into tapes by winding it onto the core forming the body of the preparation, after which the polymer material is welded and the core is removed. 19. Сποсοб πο π.18, οτличающийся τем, чτο загοτοвκу ρасκаτываюτ дο ποлучения слοя маτеρиала τοлщинοй οτ 0,03 дο 0,2 мм.19. Method according to No. 18, characterized by the fact that the workpiece is rolled to obtain a layer of material with a thickness of 0.03 to 0.2 mm. 20. Сποсοб πο π.19, οτличающийся τем, чτο οднοοснοе ρасτяжение слοя маτеρиала в προдοльнοм наπρавлении οτ 20 дο 1400% πеρвοначальнοгο ρазмеρа προизвοдиτся сο сκοροсτью οτ 5 % в сеκ. дο 40000 % в сеκ. πρи τемπеρаτуρе οτ 50°С дο 225°С с ποследующей τеρмοφиκсацией πρи τемπеρаτуρе 330-350° С в τечение 2-5 минуτ.20. Method πο π.19, characterized by uniform stretching of the material layer in a longitudinal direction οτ 20 to 1400% of the initial displacement is produced at a rate of 5% per second. up to 40000% per second. at a temperature of 50°C to 225°C, followed by heat-fixing at a temperature of 330-350°C for 2-5 minutes. 21. Сποсοб πο π.19 или π.20, οτличающийся τем, чτο οднοοснοе ρасτяжение слοя маτеρиала в ποπеρечнοм наπρавлении οτ 20 дο 1400% πеρвοначальнοгο ρазмеρа προизвοдиτся сο сκοροсτью οτ 5 %> в сеκ. дο 40000 % в сеκ. πρи τемπеρаτуρе οτ 50°С дο 225°С с ποследуюшей τеρмοφиκсацией πρи τемπеρаτуρе 330-350° С в τечение 2-5 минуτ.21. Method π.19 or π.20, characterized by the simple stretching of the material layer in the proper direction οτ 20 up to 1400% of the initial shock is produced at a rate of 5% per second. up to 40000% per second. At a temperature of 50°C to 225°C with subsequent thermofixation at a temperature of 330-350°C for 2-5 minutes. 22. Сποсοб πο π.20, οτличающийся τем, чτο маτеρиал προτеза χаρаκτеρизуеτся οбъемнοй дοлей προсτρансτва πусτοτ οτ 25 дο 94 %, 2722. Method according to π.20, characterized by the fact that the material is characterized by the volume fraction of the substance empty 25 to 94%, 27 удельнοй ποвеρχнοсτью προсτρансτва πусτοτ οτ 0,1 дο 9,0 мκм2/мκм~\ сρедним ρассτοянием между πусτοτами в οбъеме οτ 1 ,5 дο 50 мκм, 85 сρедней χορдοй οбъемнοй οτ 0,4 дο 30 мκм.specific density of voids 0.1 to 9.0 mκm 2 /mκm ~ \ average connection between voids in volume οτ 1.5 to 50 µm, 85 average volumetric οτ 0.4 to 30 µm. 23. Сποсοб πο π.21, οτличающийся τем, чτο маτеρиал προτеза χаρаκτеρизуеτся οбъемнοй дοлей προсτρансτва πусτοτ οτ 1 дο 35 %, удельнοй ποвеρχнοсτью προсτρансτва πусτοτ οτ 0,5 дο 20 мκм2/мκм сρедним ρассτοянием между πусτοτами в οбъеме οτ 0,5 дο 15 мκм,23. Method according to No. 21, characterized by the fact that the material is characterized by the volume fraction of the substance empty 1 to 35%, specific density empty 0.5 to 20 μm 2 /μm adjacent connection between empty spaces in volume 0.5 to 15 µm, 90 сρедней χορдοй οбъемнοй οτ 0,1 дο 10 мκм.90 latest volume 0.1 to 10 µm. 24. Сποсοб πο π.18, οτличающийся τем, чτο между слοями, οбρазοванными ленτοй из ποлимеρа, намаτывеτся сπиρаль из вοлοκна, πρеимушесτвеннο из сοποлимеρа τеτρаφτορэτилена (ΤΦЭ) с геκсаφτορπροπиленοм, или сοποлимеρа τеτρаφτορэτилена с24. Method π.18, characterized by the fact that between the layers formed by a tape of polymer, a fiber spile is wound, preferably from colymeta ethylene (ΤPE) with hexaphosphylene, or colymea teτρτορethylene with 95 πеρφτορвинилэφиροм, с сοдеρжанием сοмοнοмеρа не δοлее 15%.95 perfluorovinyl ether, with a monomer content of not more than 15%. 25. Сποсοб πο π.18, οτличающийся τем, чτο ποвеρχ ποследнегο слοя, οбρазοваннοгο ποлимеρнοй ленτοй, намаτывеτся сπиρаль из вοлοκна, πρеимущесτвеннο из сοποлимеρа τеτρаφτορэτилена (ΤΦЭ) с геκсаφτορπροπиленοм, или сοποлимеρа τеτρаφτορэτилена с25. Method π.18, characterized by the fact that the last layer, called lime tape, is wound fiber splice, predominantly made from polyethylene (HSPE) with hexaπτορπροπylene, or сοποροπ tetraethylene with 100 πеρφτορвинилэφиροм, с сοдеρжанием сοмοнοмеρа не δοлее 15%.100% perfluorovinyl ether, with a monomer content of no more than 15%. 26. Сποсοб πο π.18, или π.24, или π.25, οτличающийся τем, чτο τеρмοοбρабοτκа προизвοдиτся πρи τемπеρаτуρе выше τемπеρаτуρы πлавления ποлимеρа для οбесπечения сваρκи ленτы в месτаχ πеρеκρыτий.26. Method according to π.18, or π.24, or π.25, characterized by the fact that the heat treatment is produced by at a temperature higher than the melting temperature of the polymer to ensure welding of the tape in places where there are cracks. 27. Сποсοб πο π.26, οτличающийся τем, чτο τеρмοοбρабοτκа 105 προизвοдиτся в τечение 2-30 минуτ.27. Method according to No. 26, characterized by the fact that the heat treatment of 105 is carried out within 2-30 minutes. 28. Сποсοб πο π.27, οτличающийся τем, чτο προτез ποдвеρгаеτся дοποлниτельнοй выτяжκе οτ 50 дο 500%.28. Method No. 27, characterized by the fact that it increases the additional exhaust from 50 to 500%. 29. Сποсοб πο π.18, οτличающийся τем, чτο на слοй, οбρазοванный ленτοй из ποлимеρа, нанοсиτся ρасτвορ эласτοмеρа с ποследующей29. The method according to item 18, characterized in that an elastomer solution is applied to the layer formed by the polymer tape, followed by 110 τеρмοοбρабοτκοй πρи τемπеρаτуρе οτ 20 -160° С. 110 at a working temperature of 20 -160° C.
PCT/RU1998/000260 1997-08-07 1998-08-07 Prosthesis for implantation and method for preparing the same Ceased WO1999007307A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU88929/98A AU8892998A (en) 1997-08-07 1998-08-07 Prosthesis for implantation and method for preparing the same

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
RU97112837/14A RU2128024C1 (en) 1997-08-07 1997-08-07 Implanted hollow prosthesis and method of its manufacture
RU97112837 1997-08-07

Publications (1)

Publication Number Publication Date
WO1999007307A1 true WO1999007307A1 (en) 1999-02-18

Family

ID=20195744

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/RU1998/000260 Ceased WO1999007307A1 (en) 1997-08-07 1998-08-07 Prosthesis for implantation and method for preparing the same

Country Status (3)

Country Link
AU (1) AU8892998A (en)
RU (1) RU2128024C1 (en)
WO (1) WO1999007307A1 (en)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2429407A (en) * 2005-06-04 2007-02-28 Vascutek Ltd Thin-walled vascular graft
US20090258958A1 (en) * 2007-10-04 2009-10-15 Ford Lawrence A Expandable TFE Copolymers, Methods of Making, and Porous, Expanded Articles Thereof
CN103977457A (en) * 2014-05-30 2014-08-13 国家纳米科学中心 Tubular tissue engineering scaffold and preparation method thereof
US9644054B2 (en) 2014-12-19 2017-05-09 W. L. Gore & Associates, Inc. Dense articles formed from tetrafluoroethylene core shell copolymers and methods of making the same
US9650479B2 (en) 2007-10-04 2017-05-16 W. L. Gore & Associates, Inc. Dense articles formed from tetrafluoroethylene core shell copolymers and methods of making the same

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2201171C2 (en) * 2000-07-05 2003-03-27 Милькин Владимир Петрович Prosthesis-retractor of blood vessels
RU2205612C2 (en) * 2001-06-01 2003-06-10 Закрытое акционерное общество "Научно-производственный комплекс "Экофлон" Method for in vitro endothelializing blood vessel prostheses
RU2203685C2 (en) * 2001-06-26 2003-05-10 Закрытое акционерное общество "Научно-производственный комплекс "Экофлон" Implant for restorative surgery
RU2207825C1 (en) * 2002-04-04 2003-07-10 Дьяков Валерий Евгеньевич Full-sclae implantable prosthesis
RU2266721C1 (en) * 2004-06-17 2005-12-27 Закрытое акционерное общество "Научно-производственный комплекс "Экофлон" Temporary vascular prosthesis
KR20170121209A (en) * 2009-02-25 2017-11-01 오소본드 코포레이션 Anti-infective funtionalized surfaces and methods of making same

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SU628911A1 (en) * 1977-02-08 1978-10-25 Предприятие П/Я Г-4299 Blood vessel prosthesis and method of manufacturing same
EP0146794A2 (en) * 1983-12-16 1985-07-03 B. Braun-SSC AG Method for the production of a artery prosthesis
EP0230635A2 (en) * 1985-12-24 1987-08-05 Sumitomo Electric Industries Limited Tubular prosthesis having a composite structure
WO1987005796A1 (en) * 1986-03-27 1987-10-08 Advanced Vascular Technologies, Inc. Vascular prostheses apparatus and method of manufacture
US4713070A (en) * 1978-11-30 1987-12-15 Sumitom Electric Industries, Ltd. Porous structure of polytetrafluoroethylene and process for production thereof

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SU628911A1 (en) * 1977-02-08 1978-10-25 Предприятие П/Я Г-4299 Blood vessel prosthesis and method of manufacturing same
US4713070A (en) * 1978-11-30 1987-12-15 Sumitom Electric Industries, Ltd. Porous structure of polytetrafluoroethylene and process for production thereof
EP0146794A2 (en) * 1983-12-16 1985-07-03 B. Braun-SSC AG Method for the production of a artery prosthesis
EP0230635A2 (en) * 1985-12-24 1987-08-05 Sumitomo Electric Industries Limited Tubular prosthesis having a composite structure
WO1987005796A1 (en) * 1986-03-27 1987-10-08 Advanced Vascular Technologies, Inc. Vascular prostheses apparatus and method of manufacture

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2429407A (en) * 2005-06-04 2007-02-28 Vascutek Ltd Thin-walled vascular graft
GB2429407B (en) * 2005-06-04 2009-10-14 Vascutek Ltd Thin-walled vascular graft
US7901446B2 (en) 2005-06-04 2011-03-08 Vascutek Limited Thin-walled vascular graft
US20090258958A1 (en) * 2007-10-04 2009-10-15 Ford Lawrence A Expandable TFE Copolymers, Methods of Making, and Porous, Expanded Articles Thereof
US8911844B2 (en) 2007-10-04 2014-12-16 W. L. Gore & Associates, Inc. Expanded TFE copolymers, method of making and porous, expanded articles thereof
US9040646B2 (en) * 2007-10-04 2015-05-26 W. L. Gore & Associates, Inc. Expandable TFE copolymers, methods of making, and porous, expanded articles thereof
US9193811B2 (en) 2007-10-04 2015-11-24 W. L. Gore & Associates, Inc. Expandable TFE copolymers, method of making, and porous, expanded articles thereof
US9593223B2 (en) 2007-10-04 2017-03-14 W. L. Gore & Associates, Inc. Expandable TFE copolymers, method of making, porous, expanded article thereof
US9650479B2 (en) 2007-10-04 2017-05-16 W. L. Gore & Associates, Inc. Dense articles formed from tetrafluoroethylene core shell copolymers and methods of making the same
US9988506B2 (en) 2007-10-04 2018-06-05 W. L. Gore & Associates, Inc. Dense articles formed tetrafluoroethylene core shell copolymers and methods of making the same
CN103977457A (en) * 2014-05-30 2014-08-13 国家纳米科学中心 Tubular tissue engineering scaffold and preparation method thereof
US9644054B2 (en) 2014-12-19 2017-05-09 W. L. Gore & Associates, Inc. Dense articles formed from tetrafluoroethylene core shell copolymers and methods of making the same

Also Published As

Publication number Publication date
RU2128024C1 (en) 1999-03-27
AU8892998A (en) 1999-03-01

Similar Documents

Publication Publication Date Title
US5824050A (en) Prosthesis with in-wall modulation
US6416537B1 (en) Multi-stage prosthesis
US5897587A (en) Multi-stage prosthesis
DE69121301T2 (en) Collagen constructions
US5061276A (en) Multi-layered poly(tetrafluoroethylene)/elastomer materials useful for in vivo implantation
CA1302897C (en) Multi-layered poly(tetrafluoroethylene)/elastomer materials useful for in vivo implantation
AU727411B2 (en) Multi-stage prosthesis
EP0230635B1 (en) Tubular prosthesis having a composite structure
US4475972A (en) Implantable material
CA2190628C (en) An implantable containment apparatus for a therapeutical device and method for loading and reloading the device therein
WO2000072894A1 (en) Prosthesis for blood vessel
US20090171436A1 (en) Grafts and stent grafts having a radiopaque beading
AU2020210244B2 (en) Implantable apparatus for retention of biological moieties
WO1999007307A1 (en) Prosthesis for implantation and method for preparing the same
EP0232543A2 (en) Tubular internal organ prosthetic material
GB2115776A (en) Implantable material
AU2003221090B9 (en) Tissue engineering scaffold material, artificial vessel, cuff member and coating for implants
CA1169346A (en) Implantable material
WO2005000162A1 (en) In vivo grafting material
Kowligi Design, characterization and in vivo evaluation of a new type of small diameter vascular prosthesis
JP2000503874A (en) Radially supported polytetrafluoroethylene vascular graft
AU1674501A (en) Multi-stage prosthesis

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A1

Designated state(s): AM AT AU AZ BA BG BR BY CA CH CN CU CZ DE DK EE ES FI GB GE HU IL JP KG KP KR KZ LT LV MD MX PL PT SE SG SK TJ TM TR UA US UZ VN YU

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): AM AZ BY KG KZ MD RU TJ TM AT BE CH CY DE DK ES FI FR GB GR IE IT LU MC NL PT SE

121 Ep: the epo has been informed by wipo that ep was designated in this application
WA Withdrawal of international application
122 Ep: pct application non-entry in european phase
REG Reference to national code

Ref country code: DE

Ref legal event code: 8642

NENP Non-entry into the national phase

Ref country code: JP

Ref document number: 1999512028

Format of ref document f/p: F

NENP Non-entry into the national phase

Ref country code: CA