WO2009141715A2 - Braided corrugated textile vascular prosthesis and process of producing same - Google Patents

Braided corrugated textile vascular prosthesis and process of producing same Download PDF

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Publication number
WO2009141715A2
WO2009141715A2 PCT/IB2009/005669 IB2009005669W WO2009141715A2 WO 2009141715 A2 WO2009141715 A2 WO 2009141715A2 IB 2009005669 W IB2009005669 W IB 2009005669W WO 2009141715 A2 WO2009141715 A2 WO 2009141715A2
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WO
WIPO (PCT)
Prior art keywords
prosthesis
characterized
braided
biocompatible
mandrel
Prior art date
Application number
PCT/IB2009/005669
Other languages
French (fr)
Portuguese (pt)
Other versions
WO2009141715A3 (en
Inventor
Raul Manuel Esteves De Sousa Fangueiro
Celso José CANCELO CARRILHO
Juliana Antoniassi Luiz
Paula Cristina Martins Pina Marques
Original Assignee
Universidade Do Minho
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Filing date
Publication date
Priority to PT104067A priority Critical patent/PT104067B/en
Priority to PT104067 priority
Application filed by Universidade Do Minho filed Critical Universidade Do Minho
Publication of WO2009141715A2 publication Critical patent/WO2009141715A2/en
Publication of WO2009141715A3 publication Critical patent/WO2009141715A3/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/88Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C53/00Shaping by bending, folding, twisting, straightening or flattening; Apparatus therefor
    • B29C53/22Corrugating
    • B29C53/30Corrugating of tubes
    • B29C53/305Corrugating of tubes using a cording process
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/003Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in adsorbability or resorbability, i.e. in adsorption or resorption time
    • A61F2250/0031Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in adsorbability or resorbability, i.e. in adsorption or resorption time made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29KINDEXING 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
    • B29K2995/00Properties of moulding materials, reinforcements, fillers, preformed parts or moulds
    • B29K2995/0037Other properties
    • B29K2995/0059Degradable
    • B29K2995/006Bio-degradable, e.g. bioabsorbable, bioresorbable or bioerodible
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29LINDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00Other particular articles
    • B29L2031/753Medical equipment; Accessories therefor
    • B29L2031/7532Artificial members, protheses
    • B29L2031/7534Cardiovascular protheses

Abstract

The present invention relates to a braided corrugated vascular prosthesis with a textile structure consisting of at least two types of biocompatible fibres, of which one is absorbable by the human body, and to the process of producing same using conventional braiding equipment, by combining previously braided biocompatible threads so as to form strings, on a mandrel (4) and a (3), to ensure the necessary diameter and corrugation. The vascular prosthesis is homogeneously impregnated with a substance that promotes sealing. The corrugated structure confers to said prosthesis the necessary elasticity for use in blood vessels. The thus produced prosthesis re-establishes blood flow in damaged segments of a blood vessel, and is particularly useful in vascular surgery.

Description

description

Tit and of Invention: VASCULAR IMPLANT IN TEXTILE STRUCTURE WITH WAVES AND ITS plaited

PRODUCTION PROCESS

FIELD OF INVENTION

[1] The present invention relates to a vascular prosthesis in the woven textile structure with undulations, impregnated with biocompatible resin and its production process. Said process consists on the simultaneous production of a braided structure on a mandrel, and a spiral device with fiber properties and distinctive features, provided that they are biocompatible with the human body.

[2] The present invention is applicable as vascular grafts, vascular surgery, particularly in the replacement of vessels and vascular enhancement at the same supplementing the regenerative process in the body.

BACKGROUND OF THE INVENTION

[3] In the last four decades, the development and production of synthetic vascular prostheses has been putting enormous challenges to the field of surgery. Throughout these decades vascular disease seen its role grow in importance, whether the general level and particularly at the clinical level, due to the growing number of patients. Thus it becomes more effective because not only these factors but also the considerable advances in diagnosis and therapy. The vascular prosthesis must necessarily have very specific characteristics. Upon introduction of the vascular prosthesis, little attention was given to the physiological function of arterial tissue would be replaced. Thus, metal pipes, glass and ivory have been produced in an attempt to replace arteries. However, these products have not been as successful implants mainly due to the nature of its surface favoring the formation and growth of blood clots and lack of pliability / flexibility. Given these limitations, new solutions have been found, in particular textile structures. Currently, the textile structures are those materials which in general are used in replacement arteries. The most important features of these prostheses are related to the porosity properties, compatibility and biodegradability. The graft should be microporous to allow a stable attachment to vascular cells and stimulate their growth.

[4] WO 92/16166 - 'Vascular Prosthesis "discloses a vascular prosthesis comprising a tubular braided structure. This comprises a large number of braided layers wherein each layer includes at least one wire extending interlaced this layer to another layer to form a bond. The prosthesis is

CONFIRMATION COPY consists of a large number of layers of stranded and may include a first surface layer of substantially non-absorbable and absorbable very secondary layers. Thus, the existence of multi-layer and material not totally absorbable and partially absorbable become in large disadvantages. The existence of multi means that the prosthesis is less flexible / malleable, the first layer material that is not totally absorbable not allow complete attachment thereof to the human tissue and the following layers are not fully absorbable by the human body.

[5] EP 0612229 - "Tliree-Diniensional Braided Soft Tissue Prosthesis" refers to a soft tissue prosthesis in the form of a three-dimensional braided structure preferably made of a synthetic material, which is preferably thermoplastic A. three-dimensional braided structure is a woven multilayer, although a solid three-dimensional braided structure can also be constructed. the braid includes a large number of layers wherein at least one yarn of each layer extends into an adjacent or contiguous layer to bond the adjacent layers. the multilayer braid should preferably include two to ten layers. This prosthesis presents several shortcomings, such as the use of mono-material, multi existence and absence of roughness on the outside of the prosthesis.

[6] WO 88/00813 discloses replacement prostheses vessels (arteries and veins) human, a tubular textile structure, and methods of producing these prostheses. The prosthesis includes a polyester braided thread as substrate, which is compact and without undulations in order to obtain a smooth inner surface. The vascular graft includes an external polypropylene support that wraps around the substrate by melting. The complex process of production of the prosthesis and its result does not guarantee the elasticity, suppleness and flexibility for the application in view, it is desirable to improve the fixation of the prosthesis to the body, allowing the growth and development of vascular cells.

[7] Moreover, this document does not disclose the use of biocompatible yarn,

absorbable and nonabsorbable in the production of the prosthesis. The present invention uses these wires, which being previously twisted to produce the prosthesis, thus constituting beads, confers greater resistance to the prosthesis.

[8] WO 94/06373 discloses a soft tissue implant in the form of a three-dimensional braided structure preferably made of a synthetic material having an inner surface and one outer. This structure should preferably be done in one of three ways: solid three-dimensional braid, in three-dimensional braid which must have at least one interlaced yarn whose purpose is to join adjacent layers or else in the form of a large number of layers of braided dimensional these layers may be connected by joining by fusion, separately stitched or otherwise connected so to form a three-dimensional braided prosthesis. For the development of the prosthesis of the present invention may be used or mixtures of different wires then wires of a single type. It is also possible to use bioabsorbable materials such as wires in forming a part of the three-dimensional braiding. The existence of multilayer and a surface without any ribs becomes less flexible prosthesis that patent, malleable and less adhesion to the tissue.

[9] EP 0 910 310 B1 - 'Shaped tubular woven soft tissue and methoás prothesis of manufacturing' describes an implantable tubular prosthesis of flat fabric, which is woven continuously until formai- a tubular product without seams and which exhibits variations diameter along its length. Furthermore, tube sections are also formed through a gradual change in the number of warp yarns selected or not selected upon insertion of the yarns during the weaving process. For the production of this prosthesis are used electronic jacquard looms controlled by software. This process is slow, complex and inflexible (not allow the use of various materials or multiple configurations), not allowing to optimize the architecture of the prosthesis, by varying the thickness where it is needed.

[10] The prostheses of arteries, in general, have several functions that can be made compatible so as to occur concurrently, such as strengthening the external wall of the artery and the blood flow property. Thus, in order to obtain maximum effectiveness in possible functions is a necessary condition that its features are as close as possible to the human body.

SUMMARY OF THE INVENTION

[11] The present invention has several advantages over previously mentioned. The biocompatibility of the fibers constituting the textile structure of prosthesis will allow the artery does not come into direct conflict with the human cells thus preventing the rejection, but will also allow the growth of cells surrounding the prosthesis is possible in order to fixarem- in the same, thereby preventing the displacement of the prosthesis which would be detrimental to the patient. The absorbed bility of the fibers reduces the amount of biomaterial in the host thus leading to a decrease in the phenomenon of rejection of a foreign body in addition to reducing the possible onset of fibrosis in tissue. On the other hand, the non-absorbed fiber will support the growth of regenerative cells of the blood vessel, so that these structure themselves in a sustained manner. Thus, it is possible to maintain the same blood pressure that is felt in the vessels of which the prosthesis is attached.

[12] The wavy shape imparted by the mandrel assembly + spiral guarantees the elasticity necessary for the application as well as some roughness which facilitates the adhesion stability of some prosthesis, representing a significant improvement over the state of the art.

] The corrugated medium together with the fact that it consists of non-absorbable yarn allows for a proper fixation of the prosthesis to the body, giving the necessary elasticity which permits convenient movement of blood flow and ensures that occur not harmful movements during the vascular movements.] varying the thickness of the prosthesis allows it to be used for various

applications to replace or support the lumen such as the esophagus, intestines and others.

BRIEF DESCRIPTION OF THE FIGURES

] Fig. 1 - Schematic representation of entrançadeira used in the production of textile braided prosthesis with dimples.

] Fig. 2 - Schematic representation of the regular lattice structure.

] Fig. 3 - Schematic representation of textile vascular graft woven with

undulations, where the braid of biocompatible yarn (1) is made using coils (2).

] Fig. 4 - schematic representation of the device with a spiral form (3).

] Fig. 5 - schematic representation of the device in a spiral (3) and

mandrel (4).

GENERAL DESCRIPTION OF INVENTION

] The present invention relates to a vascular prosthesis in the woven textile structure with undulations, impregnated with resin for biocompatible vascular replacement vessels of the human body, and its production process. Said process consists on the simultaneous production of a braided structure on a mandrel, and a spiral device with fiber properties and distinctive features, provided that they are biocompatible with the human body.

] Generally, the braided vascular prosthesis containing dimples acquires a high elasticity and thus higher vascular adaptability to the vessel where it is associated. The said prosthesis consists of two types of textile materials, ensures the restoration of blood flow to an injured segment (vascular vessel) thereby contributing to the recovery of the patient.

] The concept of 'multifunctional structure' in this present invention, characterized by different parts of the prosthesis with different types of fibers

(Raw material) is possible due to the type of technology used for producing the same.

] The combination of different types of fibers may be desired for enhanced structure of the prosthesis after its application as a replacement of an injured arterial segment. Therefore, one of the textile materials used in the construction of the prosthesis is absorbed by the body, and the permanent structure guaranteed by this biocompatible wire.

[24] Thus, the fibers used in the present invention are biocompatible and one

absorbable and non-absorbable other. From the group of resorbable fibers, which includes polyglycols, polyamines, polylactic acid (PLA), polyglycol acid (PGA) collagen, alginates, among others, PLGA (poly (glycol lactic-co-acid)) is fiber prefer encial . From the group of non-absorbable fibers, which belong polytetrafluoroethylene (PTFE), polypropylene, polyesters, among others, polyester is preferred. The polyester fiber will form a permanent structure serving as support to the growth of the cells permitting the regeneration of blood vessels, while the PLGA fiber will allow not only reduce the amount of biomaterial in the patient avoiding the phenomenon of rejection, but also allow the cell growth and proliferation of different cell types. Taking into consideration the factors mentioned above the preferred composition will be in the ratio of 50% PES / 50% PLGA.

[25] The production sequence of the braided prosthesis with undulations, begins with the winding process the different threads to prepare the coils will feed entrançadeira for producing strands that subsequently will lead to the braided prosthesis. Thus one obtains a homogeneous cord in terms of distribution of fibers, which is a very important factor in ensuring the operation of the artificial vascular vessel.

[26] The vascular prosthesis of textile structure (Figure 1) plaited with dimples impregnated with biocompatible resin is made from braided strands of wire from two materials (fibers) biocompatible (1), one of which it is also absorbable by the body.

[27] Table 1 - Characteristics of the beads used and the braided vascular prosthesis with ripples

[Table 1]

[Table]

[28] The present invention is characterized in that it has, from the production of the strands to the prosthesis in its production process by braiding technology, a device in form of a spiral (3) and a mandrel (4) used in time production of braided prosthesis. The mandrel is first wrapped under tension with a string of the same composition that, after the fusing procedure, can be retirai- corrugated braided prosthesis. Subsequently, the braided prosthesis with a corrugated shape is impregnated with a biocompatible resin. In the impregnation process, the prosthesis again receives the mandrel, but without the spiraling device so that the resin can be applied on the outside of the prosthesis. The mandrel in this case is used so that the weight of the prosthesis with the same or liquid resin to the application process does not interfere with the mechanical properties. This operation is critical since improper application of the resin may result in a lack of homogeneity in the same prosthesis, and filling the interior channel of the prosthesis thus interfering in the mechanical properties and the functionality thereof.

[29] The prosthesis disclosed in the present invention is based on the concept of multifunctional structures, where different types of fibers (raw materials) are used in different parts of the prosthesis using the braiding technique.

[30] The braiding allows to produce structures with different geometries,

in particular braiding angles, depending on the number of coils (2) used, the position of the ring forming the braiding point and the drawing speed. If the number of coils, the position of the ring forming the braiding point and the draw rate are properly programmed, the angle and thickness of the braid can be controlled. Thus, a larger angle corresponds to a lower speed, higher density, and a more tight structure with less spaces. Increasing the number of coils and keeping the speed constant, increases the density of the structure. The twisted angle of the training is extremely important because it determines some of the particular characteristics of vascular prosthesis porosity of this.

[31] The direction of braiding is flexible and may be horizontal, vertical, upwards or backwards.

[32] A combination of different types of fibers may be desired for enhanced structure of the prosthesis after its application as a replacement of a damaged vascular vessel. Therefore, one of the textile materials used in the construction of the prosthesis is absorbed by the body, and the permanent structure guaranteed by this biocompatible wire.

[33] In practical terms, the insertion of different types of fibers may be carried out

entrançadeira through the coils of the premix or of the fibers in a

entrançadeira or other process used for its production.

[34] The production sequence of the braided prosthesis with dimples begins with

process of winding of different wires, to prepare the cops will feed entrançadeira for the production of cords, which subsequently will lead to the braided prosthesis. Thus one obtains a homogeneous cord in terms of distribution of fibers, which is a very important factor in ensuring the operation of artificial artery.

[35] The produced strand is subsequently broken down by different coils which will

entrançadeira feed in the production of braided prosthesis. This bead is then deposited on the braiding process, over a mandrel and a coil for producing braided prosthesis with corrugations.

[36] The woven vascular graft that comprises the object of the present invention is

comprising a set of strands that are distributed by braiding equipment, usually in a symmetrical manner, thus forming a half twisted wires give rise to a certain angle and the other half to give the symmetrical angle. Thus, the structure, diamond, regular or hercules, is composed of stranded wires, with two symmetrical angles. The structure has a diamond interlace 1 by 1, that is, each coil wire passes alternately over and under each of the wires comprising the braid. The entanglement has a regular structure 2 by 2, that is, each coil wire passes alternately over and under two twisted wires. Hercules has an interlacing structure 3 by 3, namely each coil wire passes alternately over and under braided wires 3. The diamond structure, used in the strands, due to their degree of entanglement, has greater structural stability when compared with other structures. On the other hand, the regular structure is used in the prosthesis allows for a compromise between stabil- ity and porosity control.

[37] The variation of the thickness of the structure is obtained from the change in the number of wires or linear density of these can vary between 50-330 dtex woven in. Thus, a greater number of wires and a greater linear density corresponds to a greater thickness.

[38] The present invention is applicable as vascular grafts, vascular surgery, particularly in the replacement of vessels and vascular reinforcement thereof complementing the regenerative process in the body.

DETAILED DESCRIPTION OF THE INVENTION

[39] 1. Process for the production of vascular prosthesis

The production of braided vascular prosthesis with dimples according to the present invention comprises the following steps:

1.1. Coil polyester yarns with a 3-wire coil and PGLA yarns (90% PGA / PLA 10%) with another coil cable 3 and so on to achieve the required number to complete the desired composition. In this case, a braiding machine with coils 6, charging with 3 polyester PGLA and 3, will result in a cord 50% polyester and 50% PGLA.

1.2. Weave diamond structure (Figure 2) with the braided strands 6 coils. The fed wire 3 is composed of polyester yarn and yarn 3 PGLA (90% PGA / PLA 10%) wound previously and described in the previous paragraph. In practice, the cord coils obtained 6 shows half of polyester yarn and the other half in PGLA (90% APG / 10% PGA).

1.3. Winding the cord composed of 50% polyester and 50% PGLA (90% PGA / PLA 10%) in the number of bobbins required for feeding the entrançadeira, 32 in this case.

1.4. Food braiding machine with 32 reels the rope consists of 50% polyester / 50% PLGA to produce a regular braided structure on a mandrel of 6 mm diameter and spiral-shaped device with internal diameter of 6,09mm and the external diameter of approximately 8mm.

[40] The inner diameter of the structure is predefined by the diameter of the mandrel, while the outer diameter is regulated by the density of the yarn.

[41] In the production process itself, the mandrel is introduced into the spiral-shaped device and positioned on the braider in the immediately preceding time to the start of production.

[42] The output or drawing speed is adjusted according to the gear ratio put the machine being constant throughout the process. The tuning of this parameter can be accomplished by varying the transmission ratio between the gears that make up the gear system. After braiding over the mandrel, it is removed from the braiding machine.

1.5. The assembly composed mandrel and braided coil is then wrapped with cord produced in the first two points, making the braided structure approaches the mandrel is then used in a loop for fastening ends of the wire on the mandrel.

1.6. The following is the preparation of heat setting assembly according to the previous item in an oven at about 100 ° C for about 10 min.

1.7. The assembly thus termofixado is cooled in a chamber at a temperature of about 0 ° C, for a period of at least 24 hours.

1.8. After the cooling period, is removed from the wire that surrounds the assembly and then performs the separation of the braided prosthesis with the mandrel assembly undulations + spiral.

1.9. To finish the process of producing vascular graft woven with dimples applies a biodegradable and biocompatible resin, 2% chitosan concentration. Thus, the prosthesis is impregnated manually by means of a solution containing 2% chitosan in order to control the porosity of the structure.

Claims

Claims
[Claim 1] Implant vasculai 'woven with corrugations characterized by being composed of biocompatible yarn (1), half of which are absorbable material by the human body and the other half of a non-absorbable material, associated with braided strands forming a tubular structure with villus in the form of waves, impregnated with a biocompatible resin.
[Claim 2] vascular stent woven with dimples according to the preceding claim, characterized in that the constituent material of biocompatible absorbable yarn by the human organism is selected from the group of synthetic biodegradable polymers, preferably PGLA - (poly (lactic-co -acid glycol)).
[Claim 3] braided vascular prosthesis with dimples according to claim 1, characterized in that the constituent material of the yarn biocompatible nonabsorbable by the human organism is selected from the group of polyesters, polyester preferably biocompatible.
[Claim 4] braided vascular prosthesis with dimples according to claims 1 to 3, characterized in that the constituent material of the human body absorbable sutures and PGLA be the constituent material of the non-absorbable yarn is polyester.
[Claim 5] braided vascular prosthesis with dimples according to claim 1, characterized in that the strands have a regular structure, or diamond Hercules, preferably diamond.
[Claim 6] braided vascular prosthesis with dimples according to claim 1, characterized in that the resulting tubular structure of braiding be regular or hercules diamond, preferably regular.
[Claim 7] prosthesis according to claim 1, characterized by having a diameter between 2 and 9 mm.
[Claim 8] braided vascular prosthesis with dimples according to claim 1, wherein the biocompatible resin selected from the group of biocompatible resins are preferably chitosan.
[Claim 9] braided vascular prosthesis with dimples according to claim 1, wherein the biocompatible resin is 2% chitosan concentration.
Braided prosthesis according to claim 1, characterized in that the strands have a corrugated biocompatible four corrugations per centimeter density.
Prosthesis according to claim 1, characterized in that the biocompatible strands having a thickness of 1.59 mm after heat setting in its preferred form, which is obtained from the number of wires and cords and their linear density. A method of producing dentures, described in the preceding claims, characterized in that it comprises the following steps:
(I) braiding biocompatible yarn (1), one being absorbable, the composition 50% polyester / 50% PGLA in strands produced in entrançadeira, which can have various forms of single wire, multiple wires, hybrid or roving in linear density and any number compatible with the splicing process; (Ii) a braiding of strands which entrançadeira in place of formation of the braid was placed in a mandrel (4) and a spiral-shaped device (3) to assign to a corrugated tubular braid; (Iii) simultaneously with the braiding mandrel is wrapped with a wire of the same composition with the set application voltage, the prosthesis being removed after the thermal fixing process; (Iv) thermal treatment for fixing the assembly obtained by the introduction of the mandrel (4) in a spiral shape device (3) and covered with a braided structure; (V) removing the bead surrounding the joint obtained by the introduction of the mandrel (4) in a spiral shape device (4) and covered with a braided structure, as well as the mandrel and coiled device; (Vi) applying a biocompatible resin.
Process according to claim 12, characterized in that the braiding yarns be made of a biocompatible entrançadeira with a number of 6 or more coils.
Process according to the preceding claim, characterized in that the biocompatible yarn (1) of natural or chemical fibers, in the form of single wire, multiple wires, hybrid, or roving, are in multiple number, of length and linear density compatible with the braiding process.
Process according to claim 12, characterized in that the braiding of the strands is performed in entrançadeira with a number of coils (2) not less than 16.
Process according to claim 12, characterized in that the mandrel (4) has cylindrical shape and is constituted by inert material in relation to beads with a diameter between 2 and 9 mm, preferably exceeding 6 mm, and resistant to thermal and chemical treatments .
Process according to claim 12, characterized in that the device in form of a spiral (4) has an internal diameter exceeding 6 mm and a thickness comprised between 0 and 1 mm with a density between 2:08 turns per centimeter, but in its preferentially with 4 turns per cm with resistance to thermal and chemical treatments.
dentures production process according to the
preceding claims, characterized in that the direction of braiding is flexible and be horizontal, vertical, upward or downward.
Process according to claim 12, characterized in that the heat treatment for fixing the assembly obtained by the introduction of the mandrel (4) in a device with spiral form (3) and covered with a braided structure consists of: (i) heating a heat engine with sufficient heating capacity for heat treatment for 10 to 30 minutes at a temperature between 100 and 140 ° C (ii) a cooling chamber at approximately 0 ° C, for a period of at least 24 hours.
Process according to claim 12, wherein the biocompatible and biodegradable resin, preferably 2% chitosan concentration homogeneously be applied by immersion or by applying to the outside with a soft brush.
The use of braided prosthesis described in claims 1 to 11, characterized by applying said prosthesis in
replacement vessels and vascular reinforcement thereof.
PCT/IB2009/005669 2008-05-21 2009-05-21 Braided corrugated textile vascular prosthesis and process of producing same WO2009141715A2 (en)

Priority Applications (2)

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PT104067A PT104067B (en) 2008-05-21 2008-05-21 Vascular prosthesis in textile structure engaged with curling and respective production process
PT104067 2008-05-21

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4670286A (en) * 1983-09-20 1987-06-02 Allied Corporation Method of forming prosthetic devices
WO1987005796A1 (en) * 1986-03-27 1987-10-08 Advanced Vascular Technologies, Inc. Vascular prostheses apparatus and method of manufacture
EP0397500A2 (en) * 1989-05-10 1990-11-14 United States Surgical Corporation Synthetic semiabsorbable yarn, fabric and tubular prosthesis
EP0464755A1 (en) * 1990-06-29 1992-01-08 Nissho Corporation Artificial tubular organ
WO1996008149A1 (en) * 1994-09-16 1996-03-21 Beatrice Haimovich Thromboresistant surface treatment for biomaterials
US20040171978A1 (en) * 2002-12-16 2004-09-02 Shalaby Shalaby W. Composite vascular constructs with selectively controlled properties
US20050228486A1 (en) * 2004-04-13 2005-10-13 Case Brian C Implantable frame with variable compliance
US20060190017A1 (en) * 2004-11-19 2006-08-24 Cyr John S Fibrin sealants and platelet concentrates applied to effect hemostasis at the interface of an implantable medical device with body tissue

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4670286A (en) * 1983-09-20 1987-06-02 Allied Corporation Method of forming prosthetic devices
WO1987005796A1 (en) * 1986-03-27 1987-10-08 Advanced Vascular Technologies, Inc. Vascular prostheses apparatus and method of manufacture
EP0397500A2 (en) * 1989-05-10 1990-11-14 United States Surgical Corporation Synthetic semiabsorbable yarn, fabric and tubular prosthesis
EP0464755A1 (en) * 1990-06-29 1992-01-08 Nissho Corporation Artificial tubular organ
WO1996008149A1 (en) * 1994-09-16 1996-03-21 Beatrice Haimovich Thromboresistant surface treatment for biomaterials
US20040171978A1 (en) * 2002-12-16 2004-09-02 Shalaby Shalaby W. Composite vascular constructs with selectively controlled properties
US20050228486A1 (en) * 2004-04-13 2005-10-13 Case Brian C Implantable frame with variable compliance
US20060190017A1 (en) * 2004-11-19 2006-08-24 Cyr John S Fibrin sealants and platelet concentrates applied to effect hemostasis at the interface of an implantable medical device with body tissue

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PT104067B (en) 2011-04-18
PT104067A (en) 2009-11-23

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