Textile products having sealant or coating and manufacturing method

Abstract

To provide a vascular graft which does not hinder the ingrowth of tissue and which allows the ingrowing tissue layer to adhere to the inner surface.SOLUTION: A method of manufacturing a tubular graft may comprise the steps of: providing a textile comprising a tubular wall disposed between a first open end and an opposed second open end, an inner surface and an opposed outer surface defining an interior wall portion therebetween, the tubular wall comprising a textile construction of one or more filaments or yarns, the textile construction by itself being permeable to liquid; applying a substantially water-soluble material to at least a portion of the tubular wall; and applying a substantially water-insoluble sealant to at least a part of the outer surface of the tubular wall, the substantially water-insoluble sealant being configured to mitigate movement of fluid through the wall of the conduit. The water-soluble material is configured to mitigate penetration of the sealant to the inner surface of the conduit.SELECTED DRAWING: Figure 1c

Description

[Technical Field]

[0001] The present invention provides a vascular prosthesis or endovascular device having a selectively applied sealing layer or coating. Textiles such as prostheses, and in particular, but not exclusively, textiles such as prostheses a kit of parts for manufacturing textile products such as prosthetic organs; The present invention relates to a vascular system comprising the same, a method for implanting a prosthesis and a method for implanting a vascular system. [Background technology]

[0002] Artificial blood vessels, or grafts, are used in surgical procedures, such as in treating abdominal and thoracic vascular disease. Vascular grafts are typically used to treat blood leakage after implantation. To prevent leakage, the graft must be sealed before implantation. Known techniques for this include the use of bovine gelatin, bovine albumin or uv gelatin to seal the graft. Biodegradable (or bioresorbable) or Includes the use of bioabsorbable animal-derived materials. Vascular grafts Other techniques for sealing the vein use synthetic materials, some of which are suitable for human or animal use. It cannot biodegrade when implanted in the body.

[0003] After the sealed graft is implanted in the human or animal body, the inner surface of the vascular graft The ingrowth of tissue in the graft is then allowed to adhere to the inner surface of the vascular graft. However, conventional techniques for sealing vascular grafts The procedure often results in the penetration of sealant into the inner surface of the vascular graft. This adversely affects the growth of tissue on the inner surface of the graft. The presence of sealing material in the graft may also cause poor adhesion between the ingrowth tissue and the vascular graft. This can reduce the vascular performance of the vascular graft. and providing a vascular graft that does not obstruct the flow of blood and allows an ingrowth tissue layer to adhere to the inner surface. desirable.

[0004] To better allow for tissue growth and attachment on the inner surface of the graft, Biodegradable animal-derived materials, such as those used in the art, can be used to seal the graft. When such a graft is implanted, the ingrowth tissue layer must be allowed to mature sufficiently before the sealant material is applied. However, conventional methods for sealing vascular grafts have The lack of consistent and predictable degradation times significantly impacts the performance of some vascular grafts. For example, the sealant material may degrade before the ingrowth tissue layer develops into a pseudointima. (Example of tissue layer on the inner surface of a vascular graft) If the sealant material degrades too slowly, the ingrowth tissue will Insufficient adhesion to the inner surface (the inner surface of the graft is still covered with sealing material) Therefore, it is prone to detachment from the vascular graft. Second, bleeding dissection can occur in the pseudointima. Thus, a vascular graft is created that allows for predictable growth and attachment of tissue to the inner surface of the vascular graft. There is a need to provide a method for sealing a vascular graft.

[0005] A further problem with existing vascular grafts is that some animal models of the type typically used that sealants derived from cereals are thought to increase the risk of transmission of bovine spongiform encephalopathy (BSE) This risk is typically mitigated by extensive supply chain regulatory requirements, which New materials and designs are enabling faster and more cost-effective Provide vascular grafts with less onerous regulatory requirements so they can be used in a more convenient manner It is desirable to do so.

[0006] Furthermore, animal-derived sealants are not compatible with a range of processing techniques and therefore are not suitable for vascular grafts. Limited options available to designers. Vessels sealed with animal-derived sealants Grafts are also typically temperature and humidity controlled to prevent degradation of the sealant material. Therefore, less stringent transport and packaging requirements are required. It would also be desirable to provide a vascular graft having

[0007] Additionally, elastomeric coatings can alter the flexibility of the fabric, potentially affecting vascular grafting. When tailored into medical devices such as rafts, the handling characteristics are very important to surgeons. Therefore, sufficient shielding by an elastomer coating on the outer surface is required. the opposite, e.g., luminal, side being substantially free of the same coating material, or In addition, it is possible to provide a vascular graft having flexibility and handling characteristics that are acceptable to surgeons. It would be desirable to Summary of the Invention [Means for solving the problem]

[0008] The masking agent may be a water-soluble polymer layer, a water-soluble polymer, a water-soluble material, or a water-soluble coating. The layer may be a water-soluble and / or a non-water-soluble layer.

[0009] The sealant may be a water-insoluble material, a water-insoluble sealant, a water-insoluble coating, and / or can be a water-insoluble layer.

[0010] For purposes of this invention, the water soluble and water insoluble layers are used in textile fabrics, medical device fabrics, implantable It applies to various forms of medical device textiles, as well as medical and non-medical textiles.

[0011] One object of the present invention is to provide a vascular graft and / or a method for producing a vascular graft. The inner surface of the artificial blood vessel is more suitable for the ingrowth of living tissue. The present invention relates to an implantable textile, such as a vascular graft, and / or a method for manufacturing an implantable textile, such as a vascular graft. The present invention provides a method for producing a vascular prosthesis with an inner surface that is more suitable for the ingrowth of living tissue. A further aspect of the present invention is an implantable fabric, such as a vascular prosthesis, and / or an artificial The present invention provides a method for producing an implantable fabric such as a blood vessel, the inner surface of which is Another aspect of the present invention is a method for treating a vascular graft in which the ingrowth tissue is substantially free of sealing material. and / or a method for manufacturing a vascular prosthesis that better promotes adhesion to the A further aspect of the present invention is the predictable growth and maintenance of tissue on the inner surface of the vascular prosthesis. and a method for producing the artificial blood vessel, which allows for better adhesion and adhesion. Yet another aspect of the present invention is the prevention of too much masking agent and too little masking agent. The objective of the present invention is to provide a vascular prosthesis that strikes a balance between the amount of masking agent and the amount of the agent. Allows sealant to migrate through the graft wall. Too much mass on the outside The sealing agent prevents sealant adhesion and therefore the permeability required in vascular prostheses. The amount and quality of the masking agent ultimately present on the outer graft surface will affect the ability of the There must be sufficient masking agent present to prevent sealant penetration. An aspect of the present invention also provides the sealant coating and sealant required to achieve a sufficient seal. The amount of runt adhesion and too much sealant that impairs the flexibility and handling characteristics of the prosthesis It is about striking a balance between

[0012] A further aspect of the present invention also provides a kit of parts for manufacturing a vascular prosthesis. A further aspect of the present invention is, for example, that the synthetic cardiac assist component is The goal is to provide a vascular system that allows the blood vessels to be connected to the

[0013] A further aspect of the present invention is to alleviate or reduce at least some of the problems in the prior art. Further aspects and embodiments of the present invention will become apparent from reading this specification. It will become clear from this.

[0014] According to a first aspect of the present invention, there is provided a method for producing an artificial blood vessel, comprising the steps of: (i) providing a conduit including a wall, the wall of the conduit including an inner surface and an outer surface, at least a portion of which is porous; (ii) applying a masking agent to at least a portion of the porous portion of the conduit; (iii) applying a sealant to at least a portion of the porous portion of the conduit; the sealant is configured to reduce fluid migration through the wall of the conduit; the masking agent is configured to reduce the presence of the sealant on the interior surface of the conduit; A method is provided.

[0015] The artificial blood vessel or endovascular prosthesis of the present invention is not limited to prostheses that include a conduit or tubular portion. The artificial blood vessels or endovascular prostheses of the present invention do not include non-vascular or non-tubular structures or portions. Therefore, artificial materials that are subject to masking agents and sealants may or may not contain The walls of blood vessels or endovascular prostheses are not limited to vascular walls. Additionally, medical textiles are within the scope of the present invention.

[0016] The sealant may form a sealing layer on at least a portion of the outer surface of the wall of the conduit.

[0017] The sealant may form a sealing layer over substantially all of the exterior surface of the wall of the conduit.

[0018] The maskant may form a maskant layer on at least a portion of the interior surface of the wall of the conduit.

[0019] The maskant may form a maskant layer on substantially all of the interior surface of the wall of the conduit.

[0020] Substantially all of the conduit may be porous.

[0021] The method may include one or more masking agent removal steps, The or each removing step includes removing at least a portion of the masking agent from the conduit.

[0022] The method further comprises applying a sealant to the porous portion of the conduit by applying a small amount of sealant to the outer surface of the wall of the conduit. The method may include removing at least a portion of the masking agent from at least a portion of the substrate.

[0023] The method further comprises applying the sealant to at least a portion of the porous portion of the conduit after the step of applying the sealant to at least a portion of the porous portion of the conduit. The step may include removing at least a portion of the maskant from the interior surface of the wall of the tube.

[0024] The method further comprises applying a sealant to at least a portion of the porous portion of the conduit, followed by The step of removing substantially all of the masking agent from the tube may be included.

[0025] At least one of the masking agent removal steps may be performed at a temperature of about 15° C. to about 140° C. .

[0026] At least one of the masking agent removal steps removes the maskant by applying a solvent thereto. The method may include removing at least a portion of the coating agent.

[0027] The solvent may include water.

[0028] The conduit is stirred, rotated, spun, and shaken during at least one of the masking agent removal steps. It can be at least one of the following:

[0029] At least one of the maskant removal steps involves etching the maskant, plasma etching, etc. This may be done by chipping, ablation and / or polishing.

[0030] The inner surface of the wall of the conduit may be configured to promote growth of biological tissue thereon.

[0031] The masking agent may include a polymer.

[0032] The masking agent may include a water-soluble polymer.

[0033] The masking agents are polyvinylpyrrolidone, glycerol, methylcellulose, poly(ethylene glycol) at least one of poly(ethylene glycol) and poly(ethylene glycol) hydrogel The masking agent may include polyvinylpyrrolidone (PVP), glycerol, methyl Cellulose, poly(ethylene glycol) (PEG), polyethylene oxide (PEO) and poly(ethylene glycol) hydrogel. The coating agent may also include other biohydrophilic polymers described herein.

[0034] The masking agent may be biocompatible.

[0035] The maskant may form a biocompatible maskant layer when applied to the conduit.

[0036] The maskant is applied to at least a portion of the porous portion of the conduit from a maskant solution. As used herein, porosity refers to the ability of a blood vessel to absorb blood under normal physiological conditions in a human patient. This refers to the permeability to the passage of liquids such as

[0037] The maskant solution can be a polymer solution.

[0038] The step of applying a masking agent to at least a portion of the porous portion of the conduit comprises applying a masking agent solution to the porous portion of the conduit. This may be done by spraying the liquid onto at least a portion of the porous portion of the conduit.

[0039] The maskant solution is sprayed onto at least a portion of the inner surface of the wall of the conduit. It can be added to the conduit by

[0040] The step of applying a masking agent to at least a portion of the porous portion of the conduit comprises applying a masking agent to the porous portion of the conduit. This may be done by immersing at least a portion of the surface in a maskant solution.

[0041] Substantially all of the conduit may be immersed in the maskant solution.

[0042] The masking agent solution ranges from about 5% weight / volume (w / v) polymer in solution to about 30% % w / v of the polymer.

[0043] The method further comprises applying a sealant to at least a portion of the porous portion of the conduit. This may be done in a manner that does not result in removal of the maskant from the porous portion.

[0044] The masking agent is designed to biodegrade when the vascular prosthesis is implanted in the human or animal body. It can be configured as follows.

[0045] The conduit may be a woven fiber polymer conduit.

[0046] The sealant may include a polymer.

[0047] The sealant may be a water-insoluble polymer.

[0048] The sealant may form a sealing layer when applied to the conduit, the sealing layer being a polymer layer. be.

[0049] The sealants are silicone, room temperature curing silicone, thermoplastic polyurethane, aliphatic polyurethane. at least one of a polyethylene terephthalate (PE), a polyethylene glycol (PE), one or more thermoplastic elastomers, and a polycarbonate It may contain at least one

[0050] The sealant may be applied to the conduit from a sealant solution.

[0051] The sealant solution may be a polymer solution.

[0052] The sealant solution may include an organic solvent.

[0053] The sealant solution may include at least one of heptane and xylene.

[0054] The sealant is applied to the conduit by brushing and / or spraying the sealant onto the It may be added to at least a portion of the porous portion.

[0055] The sealant may be configured to reduce the movement of blood through the wall of the conduit.

[0056] The weight ratio of sealant to masking agent can be from about 0.1:1 to about 100:1. The weight ratio of sealant to masking agent can be from about 0.1:1 to about 71:1. The weight ratio of the masking agent can be from about 0.1:1 to about 31:1.

[0057] The method may include the further step of sterilizing the vascular prosthesis. The method may include the further step of sterilizing the vascular prosthesis and / or medical device containing the compound.

[0058] Artificial blood vessels are sterilized by gamma rays, electron beams, and ethylene oxide. The container may be sterilized by at least one of the processes.

[0059] The conduit may be movable between a contracted state and an extended state. The conduit may include, for example, a flexible material to provide flexibility for expanding and contracting the conduit or prosthesis. The crimp may include multiple crimps.

[0060] The step of applying the masking agent to at least a portion of the porous portion of the conduit comprises applying the masking agent to at least a portion of the porous portion of the conduit. In general, the conduit may be in a contracted state, an expanded state, and / or between a contracted state and an expanded state. This can be done when the object is moved.

[0061] The step of applying the sealant to at least a portion of the porous portion of the conduit comprises at least partially The conduit is in a contracted state, an expanded state, and / or between a contracted state and an expanded state. This can be done when the device is moved.

[0062] The method includes adding an amount of masking agent to at least a portion of the porous portion of the conduit; and and / or weighing the conduit to at least partially determine the amount of sealant; The method may include one or more steps of measuring the length of the conduit and / or measuring the length of the conduit.

[0063] The step of applying a masking agent to at least a portion of the porous portion of the conduit may include providing a gas to the conduit. The method may include a step of providing the

[0064] The gas may be directed against the exterior surface of the wall of the conduit.

[0065] The gas may be air.

[0066] The method may include adding a support member to the conduit.

[0067] The support member may be applied to the exterior surface of the wall of the conduit.

[0068] The support member may be wrapped around the exterior surface of the wall of the conduit.

[0069] The conduit may include a plurality of crimps, and the support member may be disposed between the plurality of crimps. It can be arranged to be a child.

[0070] The step of applying the support member to the conduit may occur before the step of applying the sealant to the conduit.

[0071] The step of applying the sealant to the conduit may include at least partially attaching a support member to the conduit. It can be used for

[0072] The support member may be a flexible polymeric member.

[0073] The method comprises providing a conduit having at least two sections thereon having substantially different amounts of sealant. and one or more steps of selectively applying a sealant to one or more portions of the conduit, such as to include obtain.

[0074] The artificial blood vessel is reversibly sealable. The masking agent may be selectively removable from the conduit. The sealant may be selectively removable from the conduit. The sealant may be applied to the conduit and then removed from the conduit. The masking agents and sealants may be selectively removable from the conduit. The agent may be added to the conduit and then removed from the conduit.

[0075] The method may include one or more steps of applying a sealant to the conduit. The method may include providing one or more portions of a conduit with a variable flexibility. reducing the flexibility of one or more portions of the conduit by adding a sealant. The method may include providing the conduit with at least two sealant layers having substantially different amounts of sealant thereon. selectively applying a sealant to one or more portions of the conduit to include the The method includes one or more steps of selectively applying a sealant to one or more portions of the conduit. The one or more steps of selectively applying a sealant to one or more portions of the conduit may include: This may include adding a sealant onto the sealant present on the conduit. Different portions of the may be configured to have different degrees of flexibility.

[0076] The artificial blood vessel may be configurable to be implantable within the human or animal body. The vessel may be configurable to be implantable or deliverable within the human or animal body The artificial blood vessel may be configured to be implantable within the human or animal body. , may be configured to be implantable or deliverable within the human or animal body.

[0077] The vascular prosthesis may be biocompatible. As used herein, the term biocompatible The term refers to materials that are compatible with implantation into the human or animal body, i.e., that are not harmful or toxic to surrounding tissue. The artificial blood vessel is made of a biocompatible material that can be implanted in the human or animal body. The vascular prosthesis may be made substantially entirely from biocompatible materials.

[0078] The artificial blood vessel may be a vascular graft. The artificial blood vessel may be configured to be flexible. The vascular prosthesis may be flexible.

[0079] The artificial blood vessel may have an inlet and an outlet. The graft may be configurable to allow fluid to flow to the port. The graft may be configured to prevent the blood vessel from leaking out from the graft inlet to the graft outlet. The sealing layer may be configured to allow fluid to flow through the graft and prevent fluid from leaking out of the graft. The step of adding the porous portion to the graft structure prevents fluid from leaking out of the graft. The fluid may be a liquid. The fluid may be blood. The artificial blood vessel may be the fluid, as long as it is configured to prevent and / or prevent it from passing through the walls of the conduit. It is understood that the present invention may be configured to prevent and / or prevent leakage from the vascular prosthesis. It would be.

[0080] The step of applying a sealant to at least a portion of the porous portion of the conduit comprises attaching the conduit to the vascular graft. can be converted to:

[0081] The vascular prosthesis may be made substantially entirely from polymeric materials.

[0082] The artificial blood vessel is designed to have a blood pressure of less than about 300 mmHg (40 kPa), or optionally, less than about 200 mmHg The artificial blood vessel may be configured to prevent leakage at blood pressures below 26.7 kPa.

[0083] The conduit may be made from a polymeric material. The conduit may be a polymeric conduit. The conduit may be The conduit may be made of one or more polymers. The conduit may be a woven conduit. The conduit may be a braided The conduit may be made from woven fibers. The conduit may be made from woven, polymeric, fibrous The conduit may be a conduit. The conduit may comprise polyester. The conduit may comprise polytetrafluoroethylene. The conduit may comprise polyethylene terephthalate (PET). The conduit may comprise polyurethane (PU).

[0084] The method may include applying heat to the conduit. The method may include changing the shape of the conduit by

[0085] The conduit may be substantially cylindrical. The conduit may be substantially tubular. The conduit may be approximately 44 m long. The conduit may have a diameter of approximately 1 / 4 inch (2 mm) or less, optionally from about 8 mm to about 32 mm. It may have a uniform cross section.

[0086] The conduit may include one or more crimps. The method includes adding one or more crimps to the conduit. The method may include the step of mounting the conduit on a frame member. The method may include securing the conduit to a frame member, the frame member securing the conduit in a collapsed state. The frame member may be configurable to move the conduit from the extended state to the extended state. In the contracted state, the conduit may be configured to move from a contracted state to a contracted state. Approximately 7 crimps per cm of conduit length to approximately 10 crimps per cm of conduit length In the stretched state, the conduit may include approximately 4 crimp-to-conduit per cm of conduit length. There may be about 6 crimps per cm of tubing length.

[0087] The conduit may include a twill weave portion. The conduit may be a twill weave conduit. The conduit may be a 1 / 1 twill weave. The conduit may include a plain weave portion. The conduit may be a plain weave conduit. The weft pick of the conduit The pick-rate is about 25ppm to about 50ppm, optionally about 36ppm. The fiber density may be from about 45 ppm to about 45 ppm. Useful yarns may include multifilament yarns.

[0088] The conduit or medical fabric is not limited to woven fabrics. It may also be knitted fabrics, braided fabrics, woven webs, woven felts, etc. Other woven structures such as woven fabrics, spun filament fabrics, etc. may be used. The configurations are intended to be illustrative of the present invention in both medical (including vascular and non-vascular) and non-medical applications. The method, coating, and / or masking agent may be used.

[0089] Generally, useful thread materials include, but are not limited to, polyester, polypropylene, Examples include polyethylene, polyurethane, polytetrafluoroethylene, and combinations thereof. The yarns may be of the monofilament, multifilament, or spun type. The multifilament yarn may have from about 8 filaments to about 96 fiber filaments, preferably , about 20 filaments to about 40 filaments, more preferably about 25 filaments to about The yarn may contain about 18 denier (about 20 decitex) to about 14 filaments. 0 denier (about 154 decitex), more preferably about 30 denier (about 33 decitex) denier (about 67 decitex) to about 60 denier (about 67 decitex), more preferably about 40 denier ( The yarn may have a linear density of about 44 dtex to about 45 denier (50 dtex). The yarn may be flat, twisted, and / or textured and may be high, low, or medium The twisted yarns may have different shrinkage and / or bulk and crimp properties. The number of twists per inch ranges from about 2 twists / inch (about 0.8 twists / cm) to about 15 twists / inch. inch (about 6 twists / cm), more preferably about 5 twists / inch (about 2 twists / cm) to about The yarn may vary from 12 twists per inch (approximately 5 twists per cm). Preferably, the yarn is a single-ply yarn. multi-ply yarn or multi-ply yarn. The yarns may contain from about 2 yarns per layer or bundle to about 4 yarns per layer or bundle.

[0090] Woven fabric grafts of the present invention include simple plain weaves, basket weaves, twill weaves, velour weaves, etc. The fabric may be woven from yarns using any known weave pattern. and fill yarns that extend around the width or circumference of the woven product. The warp and weft yarns exit the machine in the machine direction. The weave is about 80 to about 325 threads per inch (about 30 ~ about 128 warp threads / cm) and about 80 to about 200 fill or weft threads ft yarn / inch (about 30 to about 80 weft yarns / cm). The thickness may be any conventionally useful thickness, for example, from about 0.04 mm to about 1 mm.

[0091] Knitting is the process of interlooping fibers to form a knitted fabric structure. (interlooping), or looping yarn into vertical rows (wale) and horizontal rows (course) In warp knitting, the loops are sewn along the length of the fabric, i.e., along the length or length of the fabric. Non-limiting stitch counts are from about 20 to about 60 warps per inch (ply). Approximately 8 to 25 lines per cm) and 30 to 80 lines per inch (approximately 12 lines per layer) The total number of stitches may be from about 600 to about 5,000. Varies from 0 stitches per square inch (approximately 100 to 900 stitches per square centimeter) Useful stitches include, but are not limited to, interlock knit (tricot or jersey knit) Also known as reverse lock knit, sharkskin knit, and queen's cord knit. (queenscord knit), atlas knit, velour The wall thickness may be any conventional useful thickness, for example, from about 0.1 mm to about 1. It can be 5mm.

[0092] The conduit may include one or more inlets. The conduit may include one or more outlets. The conduit may include a Y The conduit may be a cylindrical, tubular, Y-shaped, or T-shaped conduit. The conduit may be one or more of a T-shaped and a multi-channel conduit. The bulb shape may be bulbous or have a portion with a bulbous shape. Such bulbous shapes include, but are not limited to: However, the present invention is not limited to the use of a conduit-shaped woven fabric. Other forms of fabric, such as flat or formed sheets or tapes, may be used in this invention. It can be used in the invention.

[0093] The conduit may be a porous conduit. The conduit may have a thickness of, for example, 0.16 m at 120 mm Hg pressure. l / min / cm 2 The porous conduit may have a water permeability of 0.1 to 0.2 MPa.

[0094] The inner surface of the wall of the conduit may be configured to promote the growth of biological tissue thereon. The inner surface of the wall may be configured to have biological tissue growing thereon. and a sealant configured to at least partially support the surface of the sealant. The inner surface of the wall of the conduit may be configured to promote pseudointima growth. The inner surface of the wall of the conduit may be configured to allow pseudointimal growth thereon. The inner surface of the wall of the conduit may be configured to promote the attachment of biological tissue thereto. The inner surface of the wall of the conduit may be configured to have a platelet-like structure thereon. The adhesive layer may be configured to promote adhesion of the adhesive layer.

[0095] The inner surface of the wall of the conduit may be fibrous. The inner surface of the wall of the conduit may comprise woven fibers. The inner surface of the wall of the conduit may include a braided portion. The inner surface of the wall of the conduit may be a substantially braided surface.

[0096] The masking agent may form a sacrificial layer.The masking agent may form a masking layer. The masking agent may form a sacrificial masking layer over at least a portion of the conduit. The agent may be reversibly applicable to the conduit.

[0097] The masking layer may be an oleophobic layer.

[0098] The masking agent may be applied to at least a portion of the conduit. The masking agent may be applied to substantially all of the porous portion of the conduit. The masking agent may be applied to the interior surface of the wall of the conduit.

[0099] The method may include the further step of removing at least a portion of the masking agent from the conduit. The method may include one or more masking agent removal steps. The masking agent may be removed from the conduit by applying an agent remover to the masking agent.

[0100] The method further comprises a step of applying a sealant to at least a portion of the porous portion prior to the step of applying a sealant to at least a portion of the porous portion. The method may include a step of removing the masking agent in the first place. The method may include a second masking agent removal step performed after the step of adding at least a portion of the masking agent. The method includes a first masking step performed before the step of applying a sealant to at least a portion of the porous portion. removing the sealant and applying a sealant to at least a portion of the porous portion of the conduit; The method may include a second masking agent removal step performed after the masking step.

[0101] The method includes removing at least a portion of the maskant from an exterior surface of a wall of the conduit. The method includes removing at least a portion of the masking agent from the exterior surface of the wall of the conduit prior to the addition of the sealant. The method may include removing at least a portion of the outer surface of the wall of the conduit. removing at least a portion of the masking agent from the exterior surface of the wall of the conduit so that it is free of the masking agent; In this configuration, the sealant may be applied to at least a portion of the outer surface of the wall of the conduit. can be added to

[0102] The step of removing at least a portion of the maskant from the exterior surface of the wall of the conduit may include etching, plating, or the like. This can be done by plasma etching, ablation and / or polishing.

[0103] The step of removing at least a portion of the masking agent comprises applying a solvent to the masking agent. The solvent may be water.

[0104] The method may include removing substantially all of the masking agent from the conduit. The step of removing substantially all of the masking agent allows the sealant to penetrate into the less porous portions of the conduit. The step of removing substantially all of the masking agent may be performed after the step of adding at least a portion of the masking agent. If this is done after the application of a sealant to at least a portion of the porous portion of the conduit, may be performed in a manner that does not result in removal of the sealant from the conduit.

[0105] The step of removing substantially all of the masking agent includes applying a solvent to the masking agent. The solvent may be water.

[0106] The step of removing at least a portion of the masking agent may be carried out at a temperature of from about 15°C to about 140°C, optionally at about It may be carried out at a temperature of from 15°C to about 95°C, optionally from about 35°C to about 45°C, optionally about 40°C. The step of removing at least a portion of the masking agent may be carried out for about 40 minutes to about 300 minutes, optionally , about 40 minutes to about 60 minutes, optionally about 45 minutes to about 55 minutes, optionally about 51 minutes This can be done at will.

[0107] The step of removing at least a portion of the masking agent comprises applying a gas to the conduit. The step of removing at least a portion of the masking agent may be performed by applying steam to the conduit. The step of removing at least a portion of the masking agent may be carried out by autoclaving. This can be done in a

[0108] The method may include the step of agitating the conduit. The step of agitating the conduit may be performed in a manner similar to other steps of the method. The step of removing at least a portion of the masking agent may be carried out during any of the steps of The process may be carried out while stirring the conduit in a solution containing the solvent. The solvent may be water.

[0109] When applied to the conduit, the masking agent may form a masking agent layer. The layer may be a polymer layer. The maskant is applied to the conduit using a maskant solution. The method may include applying a maskant solution to the conduit. The method may include the further step of removing the solvent from the coating agent solution.

[0110] The maskant solution may include a solvent. The maskant solution may include a polar solvent. The skimming agent solution may include water.

[0111] The step of removing the solvent from the maskant solution includes evaporating the solvent from the maskant solution. This method can be carried out by heating at about 15°C to about 80°C, optionally at about 50°C to about 80°C. The method may include the further step of evaporating the solvent from the maskant solution at a temperature of 0.5°C.

[0112] The maskant may be applied to the conduit by dipping the conduit into the maskant. The maskant may be applied to the conduit by immersing the conduit in a solution of the maskant. The masking agent is applied by immersing the conduit in a solution of the masking agent while agitating the conduit. The masking agent may be added to the conduit for up to about 1 minute. The masking agent may be applied to the conduit by immersion in a solution of the masking agent. The agent is applied to the conduit for up to about 1 minute while stirring the conduit, and the conduit is then filled with the masking agent or masking agent. The scouring agent may be added to the conduit by immersion in a solution.

[0113] The masking agent is applied to the interior surface of the conduit wall by applying a masking agent solution to the interior surface of the conduit wall. The maskant may be added to the outer surface of the conduit wall by applying a maskant solution to the outer surface of the conduit wall. can be added to the conduit by

[0114] The masking agent is applied by immersing the conduit in the masking agent. By spray coating the masking agent onto the conduit by dipping and / or by brushing a masking agent onto the conduit. obtain.

[0115] The maskant solution is sprayed onto at least a portion of the porous portion of the conduit. The conduit may be added by

[0116] The masking agent may include polyvinylpyrrolidone (PVP). ,000 g / mol to about 15,000 g / mol, optionally from about 8,000 g / mol to about PVP having a molecular weight of about 12,000 g / mol, optionally about 10,000 g / mol The masking agent may include glycerol. The masking agent may include PVP and glycerol. May contain cerol.

[0117] The masking agent may be water-soluble.

[0118] The masking agent solution may include PVP and water. The roller and water may be included.

[0119] The masking agent may be about 3% w / v to about 30% w / v of a polymer in solution, optionally about 5% w / v to about 30% w / v of the polymer, optionally about 5% w / v to about 20% in solution w / v of the polymer, optionally about 5% w / v to about 10% w / v of the polymer in solution, optionally , about 5% w / v to about 7% w / v of polymer in solution, optionally about 7% w / v of polymer in solution polymer, optionally about 6% w / v of polymer in solution, optionally about 5% w / v of polymer in solution polymer, optionally about 4% w / v of polymer in solution, optionally about 3% w / v of polymer in solution The masking agent may comprise about 3% w / v to about 80% w / v of a polymer in solution. may include:

[0120] The masking agent solution may contain about 3% w / v PVP to about 30% w / v PVP in solution, optionally about 5% w / v to about 30% w / v PVP in solution, optionally about 5% w / v to about 30% w / v PVP in solution about 20% w / v PVP, optionally about 5% w / v to about 10% w / v PVP in solution, optionally Optionally, about 7% w / v PVP in solution, optionally about 6% w / v PVP in solution, optionally , about 5% w / v PVP in solution, optionally about 4% w / v PVP in solution, optionally The solution may contain about 3% w / v PVP.

[0121] The masking agent solution may include about 1% w / v glycerol in solution. The solution contained approximately 6% w / v PVP in solution and approximately 1% w / v glycerol in solution. The ratio of glycerol to masking agent in the masking agent solution is about 1% to about 100%. The ratio of glycerol to masking agent in the masking agent solution can be from about 1% to about 30%, optionally from about 1.5% to about 30%, optionally from about 5% to about 30%, optionally from about 1% to It can be about 20%, optionally about 1% to about 15%, and optionally about 1% to about 10%.

[0122] The masking agent may include methylcellulose. The masking agent may include poly(ethylene glycol). The masking agent may include PEG (polyethylene glycol). The masking agent may include PEG hydrogel.

[0123] The masking agent can be made from one biocompatible material or multiple biocompatible materials. A masking agent may be applied to the conduit to form a biocompatible layer.

[0124] Biodegradable, biodegradable, bioabsorbable The terms "bioabsorbable" and "bioresorbable" are used herein. Used to refer to materials that degrade over time when implanted within the human or animal body. will be done.

[0125] The masking agent may comprise a bioabsorbable or biodegradable material. The masking agent may be biodegradable when implanted in the human or animal body. The masking agent may be configured to be biocompatible when implanted in the human or animal body. The masking agent may be a biodegradable polymer. The masking agent may comprise a biodegradable polymer. The masking agent is configured to be biodegradable. It may be possible.

[0126] During the step of applying the masking agent to at least a portion of the porous portion of the conduit, the conduit is in a contracted state. The masking agent can be transferred from the extended state to the extended state. During the process of adding the masking agent to the conduit, the conduit may be moved from an extended state to a contracted state. The step of applying to at least a portion of the porous portion of the conduit allows the conduit to transition between a contracted state and an expanded state. The masking agent may be applied to at least a portion of the porous portion of the conduit. The process may be carried out with the conduit in a contracted state. The at least partially applying step may be performed with the conduit in an elongated state. may be performed while the conduit is moved between a contracted state and an extended state.

[0127] The step of moving the conduit between the contracted and elongated states may extend the conduit by up to about 100%. The process of moving the conduit between the contracted and extended states can be about 45% to about 55%. The process of moving the conduit between the contracted and extended states is approximately 50%. In the contracted state, the length of the conduit can be extended by about 20% to about 80%, optionally reduced from its fully extended length by about 20% to about 40%, optionally about 40% to about 60%. In the elongated state, the length of the conduit may be reduced by about 20% to about 80%, optionally by about 20%. may be reduced from its fully extended length by about 40%, optionally by about 40% to about 60%. do.

[0128] The step of applying a masking agent to at least a portion of the porous portion of the conduit may be performed to provide a gas to the conduit. The gas may be configured to flow toward an outer surface of a wall of the conduit. In this configuration, the step of adding the masking agent to the conduit causes the masking agent to adhere to the walls of the conduit. In this configuration, the outer surface of the conduit wall is preferentially coated with the masking agent. The gas may be substantially free of air.

[0129] The sealant is applied to the porosity of the conduit so as to reduce fluid flow through the porous portion of the conduit. The sealant may be configured to substantially block a portion of the fluid passing through the wall of the conduit. The fluid may be blood.

[0130] The sealant may be applied to at least a portion of the outer surface of the wall of the conduit. The outer surface of the wall may be substantially entirely covered.

[0131] The method further comprises applying the sealant to at least a portion of the porous portion of the conduit by a masking agent. In this configuration, the sealant and mass The sealant and masking agent are compatible with each other, i.e., the sealant and masking agent are compatible with each other. When the adhesive or masking agent is damaged or applied to the conduit, it may be removed from the conduit. They can be in contact with each other without being touched.

[0132] The sealant may be biocompatible. The sealant may be a single biocompatible material or multiple biocompatible materials. The sealant may be made from a number of biocompatible materials. The sealant may form a sealing layer. The sealant may form the biocompatible layer.

[0133] The sealant may be a polymer. The sealing layer may be a polymer layer. The sealant may include a polyurethane. The sealant may include a thermoplastic polyurethane (TPU). The sealant may include silicone. The sealant may be a mixture of polyurethane and silicone. The sealant may include TPU and silicone. The sealant may include aliphatic poly The sealant may comprise a polyurethane and an aliphatic polycarbonate. The sealant may include TPU and aliphatic polycarbonate. The sealant may include a room temperature vulcanizing (RTV) silicone. The sealant may comprise a polymer. The sealant may comprise a polycarbonate. The sealant may comprise one or more The thermoplastic elastomer may include the above.

[0134] The sealant solution may include polyurethane. The sealant solution may include TPU. The sealant solution may include silicone. The sealant solution may include polyurethane and silicone. The sealant solution may include TPU and silicone. The sealant solution may include a polyurethane and an aliphatic polycarbonate. The sealant solution may contain TPU and aliphatic polycarbonate. The sealant solution may include an RTV silicone. The sealant solution may include a polycarbonate. The coolant solution may include one or more thermoplastic elastomers.

[0135] The organic solvent may be an aprotic solvent. The organic solvent may be a non-polar solvent. The runt solution may include heptane. The sealant solution may include xylene. The sealant solution may include silicone and heptane. The sealant solution may contain an RTV silicone elastomer and heptane. The sealant solution may include an RTV silicone elastomer and xylene. The sealant solution may include polyurethane and heptane. and xylene. The sealant solution may include polycarbonate and heptane. The sealant solution may include polycarbonate and xylene.

[0136] The sealant solution may include a polar solvent. The sealant solution may include tetrahydrofuran (THF). The sealant solution may include TPU and DMAC. It may contain ethane and THF.

[0137] The sealant may be configurable to mitigate environmental stress cracking. When applied to pipes, it can be configured to mitigate environmental stress cracking.

[0138] The method may include removing the solvent from the sealant. The step of removing the solvent may include evaporating the solvent from the sealant. The step of removing the solvent can be carried out by evaporating the solvent from the sealant solution. This can be done by making

[0139] The sealant may be applied to the conduit by brushing the sealant onto the conduit. The sealant is applied to the conduit by spray coating the sealant onto the conduit. The sealant may be applied to the conduit by dipping the conduit into the sealant. The sealant may be added to the conduit by casting the sealant onto the conduit. The sealant may be applied to the conduit by dipping the conduit into the sealant. The sealant may be applied by vapor deposition. The sealant may be applied by chemical vapor deposition. The sealant may be applied by electrospinning and / or filament spinning. The sealant may be applied to the conduit by wiping the conduit with the sealant. The sealant may be applied to the conduit while the conduit is rotated about its longitudinal axis. The conduit is rotated at a maximum of about 2,000 rpm, optionally between 700 rpm and 2,000 rpm, optionally Optionally, the rotor is rotated about its longitudinal axis at about 40 rpm to about 80 rpm, optionally at about 60 rpm. The fluid may be added to the conduit while being rotated.

[0140] Before applying the masking agents and sealants, the textile, medical textile or medical device (e.g. The surface of the prosthesis may be treated with an elastomer. It may be the same elastomer or it may be a different elastomer. Surface treatments such as This surface treatment is designed to be a very light application of light surface spray, selective It can be applied by area coating or by applying thin elastic fibers before hardening. The purpose of the surface treatment is to remove excess If the masking agent unintentionally interferes with the sealant, the sealant may adhere reliably. The surface treatment is to repel the masking agent, so the sealant provides a binding / attachment site for

[0141] Surface treatments can also be used to improve the properties of fabrics, for example to promote adhesion of sealants to the fabric. This can be used to change the viscosity of the sealant in the fabric for improved fixation. This may include surface activation to alter the chemical adhesion properties of the fabric. The hydrophilicity and / or hydrophobicity of portions of the fabric may also enhance the masking agent and / or sealant. Non-limiting techniques include, but are not limited to, However, plasma generation (including low pressure or vacuum generation), atmospheric pressure generation, high pressure generation (e.g., Examples of such uses include the use of a discharge generator, a corona discharge generator, a dielectric barrier discharge generator, etc. Additionally, ultraviolet radiation and laser treatment may be used. Masking agents and / or sealants Such preconditioning before application of the coating is essential for the fabric substrate. Physical and / or chemical modifications may be used to promote sealant bonding. The sealant itself has raised yarns to secure it to the graft. The raised threads or velour surface provide greater access points for the It can be modified to include a higher degree of thread lift.

[0142] During the process of applying the sealant to the conduit, the conduit may be moved from a contracted state to an extended state. During the process of applying the sealant to the conduit, the conduit may be moved from an extended state to a contracted state. During the process of applying the refrigerant to the conduit, the conduit may be moved between a contracted state and an extended state.

[0143] The step of applying the sealant to the conduit comprises at least partially applying the sealant while the conduit is in a contracted state. The step of applying the sealant to the conduit may be carried out at least in part by applying the sealant to the conduit while the conduit is in an elongated state. The step of applying a sealant to the conduit may be performed at least in part when the conduit is , can occur when the actuator is moved between a contracted state and an extended state.

[0144] The step of moving the conduit between the contracted and elongated states may extend the conduit by up to about 100%. The process of moving the conduit between the contracted and extended states can be about 45% to about 55%. In the contracted state, the length of the conduit can be extended by about 20% to about 80%, optionally reduced from its fully extended length by about 20% to about 40%, optionally about 40% to about 60%. In the elongated state, the length of the conduit may be reduced by about 20% to about 80%, optionally by about 20%. may be reduced from its fully extended length by about 40%, optionally by about 40% to about 60%. do.

[0145] The sealant was applied to the conduit at approximately 4 mg / cm 2 ~19mg / cm 2 Silicone optionally, about 8 mg / cm 2 may include:

[0146] The method may include the further step of drying the vascular graft. The additional step may be carried out at a temperature of about 15° C. to about 45° C. The additional step of drying the artificial blood vessel may be The step may be performed after the step of removing at least a portion of the masking agent from the conduit. A further step of drying the tube may be performed after the step of applying the sealant to the conduit. The process is configured to at least partially remove residual solvent, such as water, from the vascular graft. It is possible.

[0147] The further step of drying the vascular graft may include providing a gas to the vascular graft. The gas may be air.

[0148] The method may include multiple drying steps.

[0149] The or each drying step may be carried out at a temperature of from about 15°C to about 45°C.

[0150] The method may include the step of weighing the conduit. The step of weighing the conduit may include introducing a masking agent. The step of weighing the conduit may be performed prior to the step of applying the sealant to the conduit. The step of metering the conduit may be performed at least in part prior to the step of metering the conduit. The step of weighing the conduit may be used to determine the amount of skinning agent. Essentially, it can be used to determine the amount of sealant to be applied to the conduit.

[0151] The method may include measuring a length of the conduit. The length of the conduit can be used to determine the amount of masking agent to be added to the conduit. The measurement of is used, at least in part, to determine the amount of sealant to be added to the conduit. It can be done.

[0152] The weight of the conduit and the length of the conduit are determined, at least in part, by the amount of masking agent added to the conduit. The weight of the conduit and the length of the conduit may be used to determine the amount of This can be used to determine the amount of sealant to be added to the conduit.

[0153] The support member may be applied to the wall of the conduit. The support member may be applied to the interior surface of the wall of the conduit. The support members may be applied to the interior and exterior surfaces of the walls of the conduit. A sealant may be applied to the support members to attach them to the conduit. In this configuration, the support member is applied to the conduit and then A sealant is applied to the conduit to seal the conduit and attach the support member to the conduit. do.

[0154] The support member may be a cable, a wire, etc. The support member may be a polymeric material, a metallic material, etc. , a shape memory alloy, and a superelastic alloy. Ethylene terephthalate, polytetrafluoroethylene, polyurethane, polycarbonate Silicone, Stainless Steel, Titanium, Nickel, and Nickel Titanium (Nitinol) The support member may include at least one of: The support member may be capable of being wrapped around the conduit. The support member may be nested between the crimps of the conduit. The support member may be a flexible polymer wire. may be a metal or polymer member, such as a shape-memory metal or polymer member. The material may be disposed within the interior portion of the conduit, the exterior portion of the conduit, within the fabric wall of the conduit, and combinations thereof. The support member may be secured to the conduit by a sealant, for example a sealant The support member may be encapsulated or embedded in the sealant. In embodiments, the support member may be secured to the conduit by other means such as suturing, adhesive, etc. The support members may be disposed around the conduit longitudinally, radially, or a combination thereof. .

[0155] The support member can be biocompatible.

[0156] The artificial blood vessel may be connected to one or more further prostheses or artificial organs ( The inlet of the artificial blood vessel may be connectable to the outlet of a further artificial blood vessel. The outlet of the vascular prosthesis may be connectable to the inlet of a further prosthesis. The artificial blood vessel may be connectable to one or more heart valves or synthetic heart valves. is an artificial heart, ventricular assist device, left ventricular assist device, and / or right ventricular assist device, biocompatible heart The prosthesis may be connectable to a tissue valve, etc. A further prosthesis may be a biological heart valve.

[0157] The vascular graft may be connectable to one or more blood vessels. The vascular graft may be connected to one or more blood vessels by sutures. It may be connectable to the superior blood vessel.

[0158] The vascular prosthesis can be placed between a first end and a second end of a severed or diseased blood vessel. The inlet of the vascular prosthesis can be connected to a first end of the severed or diseased blood vessel. The outlet of the vascular prosthesis can be connected to the second end of the severed or diseased blood vessel. It is possible.

[0159] The method may include sterilizing the vascular prosthesis. The step of sterilizing the vascular prosthesis may include sterilizing the vascular prosthesis with gamma radiation. A further step of sterilizing the vascular prosthesis can be performed by an electron beam sterilization process. A further step of sterilizing the vascular prosthesis may be performed by ethylene oxide sterilization. The method may include one or more sterilization steps. The vascular prosthesis may be sterilized. The graft is sterilized to prevent damage or structural changes to the graft. The process of sterilizing the vascular prosthesis may be performed by sterilizing the vascular prosthesis in a manner that allows the sterilization of ... The artificial blood vessel may be configured to be suitable for implantation into the body.

[0160] According to a second aspect of the present invention, A conduit comprising a wall, the wall of the conduit comprising an inner surface and an outer surface, at least a portion of the conduit being multi-walled. A porous vascular prosthesis including a conduit; At least a portion of the porous portion is configured to reduce fluid movement through the wall of the conduit. Contains a sealant; A vascular prosthesis is provided in which the inner surface of the wall of the conduit is substantially free of sealant.

[0161] The sealant may form a sealing layer on at least a portion of the outer surface of the wall of the conduit.

[0162] The sealant may form a sealing layer over substantially all of the exterior surface of the wall of the conduit.

[0163] Substantially all of the conduit may be porous.

[0164] The inner surface of the wall of the conduit may be configured to promote ingrowth of living tissue thereon.

[0165] The conduit may be a woven fiber polymer conduit.

[0166] The sealant may form a sealing layer, which is a polymer layer.

[0167] The sealants are silicone, room temperature curing silicone, thermoplastic polyurethane, aliphatic polyurethane. at least one of a polyethylene terephthalate (PE), a polyethylene glycol (PE), one or more thermoplastic elastomers, and a polycarbonate It may contain at least one

[0168] The sealant may be configured to reduce the movement of blood through the wall of the conduit.

[0169] The vascular graft may be sterilized.

[0170] Artificial blood vessels are sterilized by gamma ray sterilization, ethylene oxide sterilization, and electron beam sterilization. The container may be sterilized by at least one of the processes.

[0171] The conduit may be movable between a contracted state and an extended state.

[0172] The conduit may include a support member.

[0173] The support member may be located substantially adjacent an outer surface of the wall of the conduit.

[0174] The support member may be wrapped around the exterior surface of the wall of the conduit.

[0175] The conduit may include a plurality of crimps, and the support member may be disposed between the plurality of crimps. are positioned to be children.

[0176] The sealant may be disposed to at least partially attach the support member to the conduit. .

[0177] The support member may be a flexible polymeric member.

[0178] The conduit is configured to have at least two portions having substantially different amounts of sealant thereon. It can be configured as follows.

[0179] An embodiment of the second aspect of the invention may comprise one or more of the first aspect of the invention or its embodiments. Similarly, an embodiment of the first aspect of the invention may include features of the second aspect of the invention or may include one or more features of the above embodiments.

[0180] According to a third aspect of the present invention, there is provided a kit of parts for manufacturing a vascular graft, comprising: The sports kit (i) a conduit including a wall, the wall of the conduit including an inner surface and an outer surface, and The part is porous, and the conduit; (ii) a masking agent; (iii) a sealant; When applied to at least a portion of the porous portion of the conduit, the masking agent forms a coating on the interior surface of the conduit. configured to reduce the presence of a sealant in the When applied to at least a portion of the porous portion of the conduit, the sealant penetrates the wall of the conduit. A kit of parts is provided that is configured to mitigate fluid migration.

[0181] The application of the sealant to at least a portion of the porous portion of the conduit reduces the surface area of ​​the outer wall of the conduit. A sealing layer may be formed on at least a portion of the surface.

[0182] Addition of a masking agent to at least a portion of the porous portion of the conduit prevents the inner surface of the wall of the conduit from being damaged. A masking agent layer may be formed on at least a portion.

[0183] Substantially all of the conduit may be porous.

[0184] The kit of parts may include a maskant remover. The bar is operable to remove the applied maskant from the conduit.

[0185] The maskant remover may include a solvent.

[0186] The solvent may include water.

[0187] The masking agent remover is applied from the conduit at a temperature of about 15°C to about 140°C. The device may be operable to remove the blocking agent.

[0188] The kit of parts may include a grinder, the grinder being adapted to remove the mask applied from the conduit. The filter is operable to remove the coating agent.

[0189] The inner surface of the wall of the conduit may be configured to promote ingrowth of living tissue thereon.

[0190] The masking agent may include a polymer.

[0191] The masking agent may include a water-soluble polymer.

[0192] The masking agent applied to the conduit may form a masking agent layer, and the masking agent layer is the polymer layer.

[0193] The masking agent may be polyvinylpyrrolidone, glycerol, methylcellulose, or poly The masking agent may comprise at least one of the following: (ethylene glycol) hydrogel. , polyvinylpyrrolidone, glycerol, methylcellulose, polyethylene oxide, and and poly(ethylene glycol) hydrogels, as well as collagen and gelatin. The therapeutic agent may include at least one of the biological agents further described in the document.

[0194] The masking agent may be biocompatible.

[0195] The maskant applied to the conduit may form a biocompatible maskant layer.

[0196] The kit of parts may include a maskant solution, the maskant solution The device is operable to apply a sealing agent to the conduit.

[0197] The maskant solution can be a polymer solution.

[0198] The conduit may be immersible in a maskant solution.

[0199] The masking agent solution ranges from about 5% w / v polymer in solution to about 30% w / v polymer in solution. It may contain a polymer.

[0200] When the maskant and sealant are applied to the conduit, the sealant acts as a sealant to the conduit. The addition of the masking agent is configured so as not to result in removal of the applied masking agent from the conduit. It is possible.

[0201] The masking agent is constructed to be biodegradable when implanted in the human or animal body. It can be done.

[0202] The conduit may be a woven fiber polymer conduit.

[0203] The sealant may comprise a polymer, optionally a water-insoluble polymer.

[0204] The sealant may form a sealing layer when applied to the conduit, the sealing layer being a polymer. -layer.

[0205] The sealants are silicone, room temperature curing silicone, thermoplastic polyurethane, aliphatic polyurethane. at least one of a polyethylene terephthalate (PE), a polyethylene glycol (PE), one or more thermoplastic elastomers, and a polycarbonate It may contain at least one

[0206] The kit of parts includes a sealant solution operable to apply the sealant to the conduit. It can be seen.

[0207] The sealant solution may be a polymer solution.

[0208] The sealant solution may include an organic solvent.

[0209] The sealant solution may include at least one of heptane and xylene.

[0210] The kit of parts includes a sealant applicator operable to apply sealant to a conduit. and / or a masking agent applicator operable to apply the masking agent to the conduit. It may include data.

[0211] The sealant applicator comprises a device for spray coating a sealant; and / or a brush.

[0212] Masking agent applicator is a brush, for spray coating masking agent a device for dipping or immersing a conduit in a masking agent, and / or a masking agent The device may be a device for wiping the conduit with a cleaning agent.

[0213] The sealant, when applied to at least a portion of the porous portion of the conduit, penetrates the wall of the conduit. It may be configured to reduce blood movement.

[0214] The conduit may be movable between a contracted state and an extended state.

[0215] The kit of parts may include additional prosthetic devices.

[0216] Further prosthetic devices include bioprosthetic heart valves, synthetic heart valves, ventricular assist devices, and ventricular assist devices. It can be at least one of:

[0217] The kit of parts may include a metering device and / or a device for measuring the length of the conduit.

[0218] The kit of parts includes a gas flow device operable to provide a gas flow to the conduit. It can be seen.

[0219] The gas may be air.

[0220] An embodiment of the third aspect of the invention is a method for treating a cancer cell comprising administering to a patient ... Similarly, the first and / or second aspects of the present invention may include one or more features of the above-mentioned embodiments. Embodiments of may include one or more features of the third aspect of the invention and / or embodiments thereof. .

[0221] According to a fourth aspect of the present invention, there is provided a method for producing an artificial blood vessel according to the second aspect of the present invention. It is served.

[0222] An embodiment of the fourth aspect of the present invention is a method for producing a composition comprising the steps of the first, second and / or third aspects of the present invention and / or Similarly, the first, second and / or third embodiments of the present invention may include one or more features of those embodiments. Embodiments of the third aspect may also be combined with one or more features of the fourth aspect of the invention and / or its embodiments. may include signs.

[0223] According to a fifth aspect of the present invention, there is provided an artificial blood vessel manufactured using the method of the first aspect of the present invention. is provided.

[0224] An embodiment of the fifth aspect of the invention is a method for producing a composition comprising the steps of the first, second, third and / or fourth aspects of the invention and and / or one or more features of the first, second and third embodiments of the present invention. Embodiments of the third and / or fourth aspect may be modified from the fifth aspect of the invention and / or embodiments thereof. It may include one or more features.

[0225] According to a sixth aspect of the present invention, there is provided a vascular system comprising: a vascular prosthesis manufactured according to the first aspect of the present invention; and including further prosthetic devices; The artificial blood vessel may be provided with a prosthesis, such that fluid can flow between the artificial blood vessel and the further artificial device. A vasculature is provided which is connected to a further prosthesis.

[0226] Further prosthetic devices include bioprosthetic heart valves, synthetic heart valves, ventricular assist devices, and ventricular assist devices. It can be at least one of:

[0227] Further prosthetic devices include left ventricular assist devices, right ventricular assist devices, and / or synthetic heart valves. could be.

[0228] An embodiment of the sixth aspect of the present invention is a method for producing a medicament according to the first, second, third, fourth and / or fifth aspect of the present invention. The present invention may also include one or more features of the aspects and / or embodiments thereof. Embodiments of the second, third, fourth and / or fifth aspects may be combined with the sixth aspect of the invention and / or It may include one or more features of the embodiments.

[0229] According to a seventh aspect of the present invention, there is provided a vascular system comprising: a vascular prosthesis according to the second aspect of the present invention; and including further prosthetic devices; The artificial blood vessel may be provided with a prosthesis, such that fluid can flow between the artificial blood vessel and the further artificial device. A vasculature is provided which is connected to a further prosthesis.

[0230] Further prosthetic devices include bioprosthetic heart valves, synthetic heart valves, ventricular assist devices, and ventricular assist devices. It can be at least one of:

[0231] Further prosthetic devices include left ventricular assist devices, right ventricular assist devices, and / or synthetic heart valves. could be.

[0232] An embodiment of the seventh aspect of the present invention is the first, second, third, fourth, fifth and / or The present invention may also include one or more features of the sixth aspect and / or embodiments thereof. Embodiments of the first, second, third, fourth, fifth and / or sixth aspects may be combined with the seventh aspect of the invention. and / or may include one or more features of the embodiments.

[0233] According to an eighth aspect of the present invention, there is provided a method for implanting an artificial blood vessel, comprising the steps of: providing a vascular prosthesis manufactured according to the first aspect of the present invention; connecting an inlet of the vascular graft to a first blood vessel; connecting the outlet of the vascular graft to a second blood vessel; Blood is allowed to flow between the first and second blood vessels through the artificial blood vessel. A method is provided.

[0234] The first and second vessels may be diseased, severed, bisected, etc. It can be formed from

[0235] An embodiment of the eighth aspect of the present invention is the first, second, third, fourth, fifth, sixth and and / or the seventh aspect and / or one or more features of those embodiments. Embodiments of the first, second, third, fourth, fifth, sixth and / or seventh aspects of the invention are and / or one or more features of the eighth aspect of the present invention.

[0236] According to a ninth aspect of the present invention, there is provided a method for implanting an artificial blood vessel, comprising the steps of: providing a vascular prosthesis according to the second aspect of the present invention; connecting the artificial blood vessel to the first blood vessel; connecting the artificial blood vessel to a second blood vessel; Blood is allowed to flow between the first and second blood vessels through the artificial blood vessel. A method is provided.

[0237] The first and second vessels may be diseased, severed, bisected, etc. It can be formed from

[0238] Embodiments of the ninth aspect of the present invention are the first, second, third, fourth, fifth, sixth and seventh aspects of the present invention. The present invention may include one or more features of the seventh and / or eighth aspects and / or embodiments thereof. and embodiments of the first, second, third, fourth, fifth, sixth, seventh and / or eighth aspects of the present invention. This aspect may include one or more features of the ninth aspect of the invention and / or embodiments thereof.

[0239] According to a tenth aspect of the present invention, there is provided a method of transplanting vasculature, comprising the steps of: Providing a vascular system, the vascular system comprising: a vascular prosthesis manufactured according to the first aspect of the present invention; and including further prosthetic devices; the artificial blood vessel is connectable to a further artificial organ; Connecting the artificial blood vessel to a further artificial organ so that blood can flow between them and connecting the end of the blood vessel to the artificial blood vessel; connecting a further prosthesis to the heart; A method that allows blood to flow between the blood vessels and the heart through the vascular system. The law is provided.

[0240] The additional prosthesis may be a heart valve, a ventricular assist device, and / or a ventricular assist device. Further prosthetic devices include left ventricular assist devices, right ventricular assist devices, and / or synthetic heart valves. could be.

[0241] An embodiment of the tenth aspect of the present invention is the first, second, third, fourth, fifth, sixth, It may include one or more features of the seventh, eighth and / or ninth aspects and / or embodiments thereof. Similarly, the first, second, third, fourth, fifth, sixth, seventh, eighth and / or ninth aspects of the present invention Embodiments of this aspect may comprise one or more features of the tenth aspect of the invention and / or embodiments thereof. It may include.

[0242] According to an eleventh aspect of the present invention, there is provided a method of transplanting vasculature, comprising the steps of: Providing a vascular system, the vascular system comprising: a vascular prosthesis according to the second aspect of the present invention; and including further prosthetic devices; the artificial blood vessel is connectable to a further artificial organ; Connecting the artificial blood vessel to a further artificial organ so that blood can flow between them and connecting the end of the blood vessel to the artificial blood vessel; connecting a further prosthesis to the heart; A method that allows blood to flow between the blood vessels and the heart through the vascular system. The law is provided.

[0243] Further prosthetic devices include bioprosthetic heart valves, synthetic heart valves, ventricular assist devices, and ventricular assist devices. It can be at least one of:

[0244] Further prosthetic devices include left ventricular assist devices, right ventricular assist devices, and / or synthetic heart valves. could be.

[0245] An embodiment of the eleventh aspect of the present invention is the first, second, third, fourth, fifth, sixth, One or more features of the seventh, eighth, ninth and / or tenth aspects and / or embodiments thereof Similarly, the first, second, third, fourth, fifth, sixth, seventh, eighth, and ninth aspects of the present invention may be included. and / or an embodiment of the tenth aspect of the invention, It may include one or more features.

[0246] According to a twelfth aspect of the present invention, there is provided a method for producing an artificial blood vessel, comprising the steps of: (i) providing a conduit including a wall, the wall of the conduit including an inner surface and an outer surface, at least a portion of which is porous; (ii) applying a masking agent to at least a portion of the porous portion; The method further comprises: providing a masking agent configured to reduce fluid migration through the wall of the conduit; will be done.

[0247] Embodiments of the twelfth aspect of the present invention are the first, second, third, fourth, fifth, sixth and One or more of the seventh, eighth, ninth, tenth and / or eleventh aspects and / or embodiments thereof Similarly, the first, second, third, fourth, fifth, sixth, seventh and seventh features of the present invention may be included. Embodiments of the eighth, ninth, tenth and / or eleventh aspects may be combined with the twelfth and / or eleventh aspects of the invention. may include one or more features of the embodiments.

[0248] According to a thirteenth aspect of the present invention, A conduit comprising a wall, the wall of the conduit comprising an inner surface and an outer surface, at least a portion of the conduit being multi-walled. A porous vascular prosthesis including a conduit; At least a portion of the porous portion is configured to reduce fluid movement through the wall of the conduit. A vascular prosthesis is provided that includes a masking agent.

[0249] Embodiments of the thirteenth aspect of the present invention are the first, second, third, fourth, fifth, sixth and Seventh, eighth, ninth, tenth, eleventh and / or twelfth aspects and / or embodiments thereof Similarly, the present invention may include one or more of the first, second, third, fourth, fifth, sixth, Embodiments of the seventh, eighth, ninth, tenth, eleventh and / or twelfth aspects are the first aspect of the invention. The present invention may include one or more features of the three aspects and / or embodiments thereof.

[0250] In another aspect or embodiment, the method of making a tubular graft includes: and a second open end of the first opening, the inner surface and the opposite outer surface defining an inner wall portion therebetween. providing a woven fabric comprising a tubular wall having one or more filaments or or a woven structure of yarns, the woven structure itself being permeable to liquids; applying a substantially water-soluble material to at least a portion of the tubular wall; applying a sealant to at least a portion of the exterior surface of the tubular wall, the sealant being substantially water-insoluble; a synthetic sealant configured to reduce fluid migration through the wall of the conduit; wherein the water-soluble material reduces penetration of the sealant into the interior surface of the conduit. It is configured to:

[0251] The step of applying the water-soluble material to at least a portion of the tubular wall comprises applying the water-soluble material to the interior of the tubular wall. The method may further include applying a water-soluble material to at least a portion of the surface and a portion of the interior of the pipe. The step of applying the water-soluble material to at least a portion of the outer surface of the tubular wall comprises applying the water-soluble material to at least a portion of the outer surface of the tubular wall. The method may further include applying

[0252] The water-soluble material may be a solution of the water-soluble material and a solvent. The solvent may be water, a lower alcohol, and combinations thereof. The solvent may be selected from the group consisting of a substantially water-insoluble synthetic sealant. It may be at least partially removed before applying the runt.

[0253] The method involves removing at least some of the water-soluble material by dissolving, abrading, stripping, decomposing, and combinations thereof. It may also include partial removal.

[0254] The water-soluble materials are polyvinylpyrrolidone, glycerol, methylcellulose, poly(ethylene Poly(ethylene glycol), poly(ethylene glycol) hydrogel, polyethylene oxide, The water may be selected from the group consisting of collagen, albumin, gelatin, and combinations thereof. The water-soluble material may have a molecular weight of about 400 to about 1,000,000. It does not contain plasticizers such as poly(ethylene glycol) and polyethylene oxide. obtain.

[0255] Substantially water-insoluble synthetic sealants include moisture-curable, light-curable, heat-curable, platinum-catalyzed, An elastomer selected from the group consisting of anaerobic curing materials or combinations of these cure mechanisms The elastomeric material may be silicone, polyurethane, polycarbonate, The polymer may be selected from the group consisting of thermoplastic elastomers, thermoplastic elastomers, and combinations thereof.

[0256] One or more of a substantially water-soluble coating or a substantially water-insoluble coating further comprising a component selected from the group consisting of a colorant, a therapeutic agent, a dye, and a fluorescent indicator. obtain.

[0257] The water-soluble material has a molecular weight of about 6,000 g / mol to about 15,000 g / mol. It may contain polyvinylpyrrolidone.

[0258] The water-soluble material may be applied to form a layer on substantially all of the interior surface of the tubular wall.

[0259] The method may further include curing the substantially water-insoluble synthetic sealant.

[0260] The method comprises curing a substantially water-insoluble synthetic sealant; and thereafter applying a water-soluble material. The method may further include removing at least a portion of the aqueous solution from the inner surface of the tubular wall. The method may further include removing substantially all of the reactive material.

[0261] The method comprises sealing at least part of the outer surface of the tubular wall prior to applying a substantially water-insoluble synthetic sealant. The method may further include removing at least a portion of the water-soluble material from both portions.

[0262] Removing at least a portion of the water-soluble material is carried out at a temperature of about 15° C. to about 140° C. obtain.

[0263] Removing at least a portion of the water-soluble material further includes applying a solvent thereto. The solvent may include water, a lower alcohol, and combinations thereof.

[0264] The tubular fabric may be subjected to agitation, rotation, spinning, shaking, etc. during removal of the water-soluble material. .

[0265] Water-soluble materials can be removed by dissolving the water-soluble material, etching, plasma etching, or abrading. This may include polishing, grinding, and combinations thereof.

[0266] The step of applying the water-soluble material may include spraying the water-soluble material, brushing the water-soluble material, or the like. immersing at least a portion of the tubular wall in a solution of a water-soluble material; It may further include combining.

[0267] The substantially water-insoluble synthetic sealant may be a polymer solution. The organic solvent may include at least one of heptane and xylene. do.

[0268] The substantially water-insoluble synthetic sealant is a substantially water-insoluble synthetic sealant. It may be applied by wiping, spraying or roller coating.

[0269] The method comprises forming a tubular wall having substantially different amounts of a substantially water-insoluble synthetic sealant thereon. a substantially water-insoluble synthetic sealant and a tubular wall, the sealant comprising at least two portions The method may further include one or more steps of selectively applying the

[0270] The tubular wall having a coating of the substantially water-insoluble synthetic sealant thereon, after curing, The sealant may be substantially impermeable to liquids. Afterwards, the tubular wall is about 0.16 ml / min / cm at 120 mm Hg pressure. 2 Or 120mm H 0.16 ml / min / cm at g pressure 2 It may have a water permeability of less than 1000 .mu.m.

[0271] In another aspect or embodiment, the fabric has a first open end and an opposite second open end. and having an inner surface and an opposite outer surface, the tubular wall comprising: It comprises a woven structure of one or more filaments or threads, the woven structure itself being permeable to liquids. a portion of the interior surface includes a coating of a substantially water-soluble material thereon; further comprising a coating of a substantially water-insoluble synthetic sealant disposed thereon; The tubular wall, which has a coating of a qualitatively water-insoluble synthetic sealant, after its hardening, It is substantially impermeable to

[0272] The water-soluble materials are polyvinylpyrrolidone, glycerol, methylcellulose, poly(ethylene Poly(ethylene glycol), poly(ethylene glycol) hydrogel, polyethylene oxide, and and combinations thereof. The water-soluble material may be selected from the group consisting of about 400 to about 1,000 It may have a molecular weight of 1,000.

[0273] The coating of water-soluble material may include an oleophobic layer.

[0274] The water-soluble material has a molecular weight of about 6,000 g / mol to about 15,000 g / mol. It may contain polyvinylpyrrolidone.

[0275] The water-soluble material may include polyvinylpyrrolidone and glycerol.

[0276] Substantially water-insoluble synthetic sealants include moisture-curable, light-curable, heat-curable, platinum-catalyzed, An elastomer selected from the group consisting of anaerobic curing materials or combinations of these cure mechanisms The elastomeric material may be silicone, polyurethane, polycarbonate, The polymer may be selected from the group consisting of thermoplastic elastomers, thermoplastic elastomers, and combinations thereof.

[0277] One or more of a substantially water-soluble coating or a substantially water-insoluble coating may include a component selected from the group consisting of a colorant, a therapeutic agent, a dye, and a fluorescent indicator.

[0278] After curing of the substantially water-insoluble synthetic sealant, the tubular wall is approximately 0.16ml / min / cm 2 or 0.16 ml / min / cm at 120 mm Hg pressure 2 Less than It may be water permeable.

[0279] A woven structure is a weave of one or more filaments or yarns, or braiding of yarn, one or more filaments or braiding of yarn, and one or more filaments or a web of yarn.

[0280] The tubular wall may be a crimped wall having a series of peaks and valleys. is the square root of the area of ​​the tubular wall 2 Approximately 8 mg per cm of tubular wall area 2 8m per It can be placed at more than g.

[0281] The tubular wall may be a non-crimped wall that is substantially free of peaks and valleys. Synthetic sealant is applied to cm of tubular wall area 2 Approximately 4 mg per cm of tubular wall area 2 Hit It can be placed at more than 4 mg.

[0282] The substantially water-insoluble synthetic sealant is applied to cm of tubular wall area. 2 Approximately 14 mg per tube Wall area cm 2 It can be placed at less than 14 mg per dose.

[0283] The fabric has a first level of substantially water insoluble polymer to provide a first soft and flexible region. a portion of the tubular wall having a rigid synthetic sealant; and providing a second region that is more rigid than the first region. and coating another portion of the tubular wall with a second level of substantially water-insoluble synthetic sealant. wherein the second level of the substantially water-insoluble synthetic sealant comprises More than a first level of a substantially water-insoluble synthetic sealant.

[0284] Different regions are formed along the length of the device (e.g., prosthesis or graft) to The device can be designed to accommodate a variety of uses and body structures, for example, to accommodate the function of the device within the body. The device can be rotated and curved to properly perform its function and to match the patient's physiology. There may be a particular need for the device to be twisted or torn. The medical device of the present invention can be used in such areas. All of the embodiments involve the formation of one or more sealant layers in all or part of the graft. Thus, and further, the support member further described herein (which, as described (which may be attached to or embedded in the sealant material) As described, the support member may be a polymer or The material may be metal and may be an elongated member, a coil, a wrap, a ring or a combination of such forms. An important feature of all embodiments of the present invention is that the sealant material The excellent adhesion of the base sealant layer to the graft substrate allows for the application of additional coatings. The advantage of this method is that it can act as a base layer for a supporting or support member.

[0285] Furthermore, the present invention and its various embodiments provide a sealant in which the coefficient of friction of the sealant surface is varied. , preferably low enough so that the sealant does not stick to itself, and / or The amount of ATP delivered and released within the body can be low enough to be used in devices such as It is envisioned that the sealant surface will be prepared to have sufficient lubricity to facilitate transfer. For example, the sealant surface desirably slides into the delivery sheath and is itself slippery. It does not stick to itself, other parts of the device, other devices or the body. The surface properties of the sealant may be adjusted to provide the desired coefficient of friction characteristics required. The surface is chemically or physically treated with a lubricous group or coating. Such surface properties can be imparted by chemical modification. This may be in addition to other properties that the runt possesses.

[0286] At least a portion of the coating of the substantially water-insoluble synthetic sealant comprises one or more flame retardants. It may involve at least a portion of the filament or thread.

[0287] The woven structure can be an implantable medical device. The implantable medical device can be a surgical vascular graft. grafts, endovascular grafts, ventricular assist devices, artificial cardiac conduits, meshes, patches, hernias It may be selected from the group consisting of plugs, vascular wraps, heart valves, filters, and the like.

[0288] The woven structure may be a medical delivery device such as a catheter.

[0289] In another embodiment, the woven structure is a flow resistant structure having opposite first and second surfaces and a length. a liquid-permeable polymeric fabric layer; and when cured, the liquid-permeable polymeric fabric layer is resistant to fluids. a crosslinkable water-insoluble synthetic elastomeric layer on the first textile surface configured to render the first textile surface substantially impermeable to water; a substantially dried water-soluble polymer layer on the second fabric surface, a water-soluble polymer layer to effect transfer of a water-insoluble synthetic elastomer layer onto a second surface; Qualitatively inhibiting; the water-soluble polymer layer is substantially removable by exposure to water.

[0290] In another embodiment, the woven structure is a flow resistant structure having opposite first and second surfaces and a length. a liquid-permeable polymeric fabric layer; and when cured, the liquid-permeable polymeric fabric layer is resistant to fluids. a crosslinkable water-insoluble synthetic elastomeric layer on the first textile surface configured to render the first textile surface substantially impermeable to water; a substantially dried water-soluble polymer layer on the second fabric surface, a water-soluble polymer layer to effect transfer of a water-insoluble synthetic elastomer layer onto a second surface; Qualitatively inhibits; the water-soluble polymer layer is substantially removable by exposure to water. The weight ratio of the water-insoluble elastomeric polymer to the water-soluble polymer is from about 0.1:1 to about 100. :1, including from about 1:1 to about 20:1.

[0291] In another embodiment, the woven structure is a flow resistant structure having opposite first and second surfaces and a length. a body-permeable polymeric fabric layer; and on the first fabric surface forming a substantially fluid-impermeable barrier. a crosslinked water-insoluble elastomeric polymer layer attached to the first fabric surface by elastic contraction; a crosslinked water-insoluble elastomer layer deposited on the second fabric surface; and a water-soluble polymer layer dried on the second fabric surface. and a weight ratio of the crosslinked water-insoluble elastomeric polymer to the water-soluble polymer. The ratio of the crosslinked water-insoluble elastomeric polymer to the water-soluble elastomeric polymer can be from about 0.1:1 to about 100:1. The weight ratio of the carboxylic acid polymer to the carboxylic acid polymer may be from about 1:1 to about 20:1.

[0292] In another embodiment, the graft is disposed between a first open end and an opposite second open end. and a tubular wall disposed on the one side of the tubular member and having an inner surface and an opposite outer surface, a woven structure of the above filaments or yarns; a coating or layer of a water-insoluble sealant; substantially free of phosphates; the tubular wall has a flow rate of approximately 0.16 ml / min / cm at 120 mm Hg pressure 2 or 0.16 ml / min / cm at 120 mm Hg pressure 2 Woven fabric structure with water permeability of less than 10 ... is a weave of one or more filaments or yarns, a braid of one or more filaments or yarns braids of one or more filaments or yarns, and braids of one or more filaments or yarns The web may be selected from the group consisting of:

[0293] The coating or layer may be disposed within an intermediate portion of the tubular wall between the inner surface and the opposing outer surface. do.

[0294] The tubular wall may be a crimped wall having a series of peaks and valleys. pts is cm of tubular wall area 2 Approximately 8 mg per cm of tubular wall area 2 More than 8 mg per serving It can be arranged in.

[0295] The tubular wall may be a non-crimped wall that is substantially free of peaks and valleys. The sealant is applied to cm of the tubular wall area 2 Approximately 4 mg per cm of tubular wall area 2 4 Wins It can be placed in excess of mg.

[0296] The substantially water-insoluble sealant is applied to cm of tubular wall area. 2 Approximately 14 mg per tube wall Area in cm 2 It can be placed at less than 14 mg per dose.

[0297] Virtually water-insoluble sealants include moisture-curable, light-curable, heat-curable, platinum-catalyzed, and anaerobic-curable sealants. an elastomeric material selected from the group consisting of a thermosetting material or a combination of these curing mechanisms; The elastomeric material may be silicone, polyurethane, polycarbonate, thermoplastic The polymer may be selected from the group consisting of: thermoplastic elastomers, thermoplastic elastomers, and combinations thereof.

[0298] A substantially water-soluble coating (masking agent coating or layer) or a substantially One or more of the water-insoluble coatings (sealant coatings or layers) The composition may include a component selected from the group consisting of a coloring agent, a therapeutic agent, a dye, and a fluorescent indicator.

[0299] The substantially water-insoluble sealant (sealant coating or layer) is a silicone , room temperature curing silicone, thermoplastic polyurethane, aliphatic polycarbonate, one or more a thermoplastic elastomer, a polycarbonate, and a combination thereof; obtain.

[0300] The graft comprises a first amount of substantially water-insoluble cellulose to provide a first soft and flexible region. a portion of the tubular wall having a sealant (sealant coating or layer); and a first region a second amount of a substantially water-insoluble sealant ( Alternatively, the tubular wall may include another portion having a sealant coating or layer; a second amount of a water-insoluble sealant (sealant coating or layer) in a substantially water-insoluble state; The graft comprises a first amount of soluble sealant (sealant coating or layer). It may include multiple regions with soft, flexible regions and more rigid regions. The region can act as a foundation for building engineered structures on the graft.

[0301] In another embodiment, the implantable or deliverable medical fabric has a woven structure and The device may include a wall having a first surface and an opposite second surface; the first surface comprising a coating of a substantially water-insoluble sealant disposed thereon; Substantially free of qualitatively water-insoluble sealants; walls have a water resistance of approximately 0.1 at 120 mm Hg pressure 6ml / min / cm 2 or 0.16 ml / min / cm at 120 mm Hg pressure 2 Permeability less than It has.

[0302] A selectively applied water-insoluble sealant layer and / or a selectively applied water-soluble mask The assembly for producing an implantable or deliverable medical fabric having a coating layer is a length of the tube, a hollow lumen disposed within a portion of the length, at least one open end, and a wall a mandrel having a plurality of perforations; a reservoir in fluid communication with the open lumen of the mandrel; and a water-soluble polymer disposed within the reservoir. The assembly includes a matrix having a plurality of perforations. The assembly may further include a tubular graft fixedly positioned over a portion of the endoprosthesis. The mandrel includes a vacuum source in fluid communication with the hollow lumen of the mandrel and a vacuum source in fluid communication with the hollow lumen of the mandrel and the reservoir. a manifold configured to provide selective fluid communication between the nozzle and / or the vacuum source; The assembly may further include a pressurized and and / or may further comprise a source of blown air.

[0303] However, embodiments of the present invention are not limited to artificial blood vessels, and the methods, coatings, and The masking agents may be used in applications including, but not limited to, clothing, geotextiles, transportation textiles, etc. tiles, military and / or protective textiles, safety and / or protective textiles, Other textiles, including medical and non-medical textiles, such as sports and / or recreational textiles Furthermore, the textile product is not limited to a tubular conduit, and may be, for example, a shell. Any shape including but not limited to cards, tapes, or 3-dimensional shaped products could be.

[0304] Embodiments of the various aspects of the invention described herein may be combined with other aspects of the invention and / or It may include one or more features of those embodiments.

[0305] Embodiments of the present invention will now be described, by way of example, with reference to the drawings in which: [Brief explanation of the drawings]

[0306] [Figure 1a] 1 shows a perspective view of a conduit viewed from both the inlet and outlet, according to one embodiment of the present invention. [Figure 1b] FIG. 1b shows a perspective view of the conduit of FIG. 1a after addition of a masking agent. [Figure 1c] FIG. 1b shows a perspective view of the conduit of FIG. 1b after addition of a sealant. [Figure 1d] 1c shows a perspective view of the conduit of FIG. 1c after removal of substantially all of the masking agent. [Figure 2] 1b shows a detailed view of the inner surface of the wall of the conduit of FIG. 1a. [Figure 3] 1b shows a detailed view of the inner surface of the wall of the conduit of FIG. 1b after addition of a masking agent. [Figure 4a] FIG. 1d shows a detailed view of the inner surface of the wall of the conduit. [Figure 4b] FIG. 1d shows a detailed view of the inner surface of the wall of the conduit. [Figure 5a] 1d shows a detailed view of the outer surface of the wall of the conduit of FIG. [Figure 5b] 1d shows a detailed view of the outer surface of the wall of the conduit of FIG. [Figure 6a] 1d shows a detailed view of the outer surface of the wall of the conduit of FIG. [Figure 6b] FIG. 1d shows a detailed view of the inner surface of the wall of the conduit. [Figure 7] 1b illustrates the addition of a support member to the conduit shown in FIG. 1a. [Figure 8] 1a-1d show an alternative embodiment of a conduit manufactured according to the process of FIGS. [Figure 9a] FIG. 1 is a perspective view of a hollow drilling mandrel for use with the present invention. [Figure 9b] 9b is a cross-sectional view of the mandrel of FIG. 9a taken along axis 9b-9b, showing the hollow lumen passage through the mandrel. [Figure 9c] 9c is a partial cutaway view of the wall of the mandrel of FIG. 9a taken along axis 9c-9c, showing perforations or holes through the mandrel wall. [Figure 10a] 1 is a photograph of a cross section of a woven graft of the present invention showing a sealing layer or coating on an outer surface portion of the woven graft and showing an inner surface portion of the woven graft that is substantially free of a sealing layer or coating. [Figure 10b] 10b is a photograph of a portion of the inner surface of the woven graft of FIG. 10a, showing the inner surface portion of the woven graft substantially free of a sealing layer or coating. [Figure 10c] 10b is a photograph of a portion of the outer surface of the woven graft of FIG. 10a showing the portion of the outer surface of the woven graft that is substantially covered with a sealing layer or coating. [Figure 11] 1 is a photograph of a dried 40% PVP masking agent concentration applied to a grafted sample. [Figure 12] 1 is a scanning electron microscope (SEM) photograph of a cross-sectional portion of woven fabric sample 2, which will be described later together with Tables 10 to 14. [Figure 13] 1 is an SEM photograph of the inner surface of woven fabric sample 2, which will be described below in conjunction with Tables 10-14. [Figure 14] 1 is an SEM photograph of a cross-sectional portion of woven fabric sample 9, which will be described later together with Tables 10 to 14. [Figure 15] 1 is an SEM photograph of the inner surface of woven sample 9, which will be described below in conjunction with Tables 10-14. [Figure 16-18] 1 is an SEM photograph of a cross-sectional portion of woven fabric sample 7, which will be described later together with Tables 10 to 14. [Figure 19]1 is an SEM photograph of a cross-sectional portion of woven fabric sample 15, which will be described later together with Tables 10 to 14. DETAILED DESCRIPTION OF THE INVENTION

[0307] As used herein, the term "substantially" and its equivalents mean At least 70% of the stated value, preferably at least 80% of the stated value, More preferably, it means that the value is within 90% or 95% of the stated value.

[0308] As used herein, the terms "about" or "approximately" and their equivalents The terms "variable" and "variables" refer to values ​​within (plus and / or minus) at least 20% of the stated value, preferably is at least 10% of the stated value, more preferably within 5% of the stated value. It refers to something.

[0309] As used herein, the terms "layer" and "coating" refer to a textile substrate. may be used interchangeably to refer to the deposition of a material on, under, or in a substrate such as do.

[0310] As used herein, a masking agent is any suitable non-biological, e.g., synthetic, It refers to a hydrophilic polymer and any suitable biohydrophilic polymer. It should be understood that other masking agents may be used.

[0311] 1a-1d, four stages of the fabrication of the vascular prosthesis 16 are shown. In each of the figures, two perspective views of the conduit 10 and / or vascular graft 16 are shown. The figure on the right shows the inlet 10c positioned in the front direction of the figure, and the figure on the right shows the outlet 10d is positioned in the front direction in the figure.

[0312] Figure 1a shows a conduit 10 suitable for implantation within the human or animal body. The conduit 10 has a shape similar to that of a pipe, and includes a wall 10f. The wall 10f includes an inner surface 10a and an outer surface 10b. The conduit 10 also includes an inlet 10c and an outlet 10d. Substantially all of the conduit 10 is porous 10e. However, at least some of the conduit 10 is porous. It should be understood that the porous 10e may also be partially porous. The conduit 10 is a woven fibrous polymer conduit 10. The woven nature of the conduit 10 allows the conduit Substantially all of the tube 10 becomes porous 10e.

[0313] Conduit 10 comprises polyethylene terephthalate (PET). However, conduit 10 It is understood that the material may include other materials such as polytetrafluoroethylene (PTFE). Other suitable polymers for medical textile applications include, but are not limited to: , polyolefins, polyesters, poly(ether amides), poly(ether esters) , poly(ether urethane), poly(ester urethane), poly(ethylene-styrene / butylene-styrene), and other block copolymers.

[0314] In the embodiment shown and described herein, the weft pick count of the conduit 10 is about 45 However, the weft pick count of the conduit 10 is about 25 ppcm to about 50 ppcm. It should be understood that the signal may be PCM.

[0315] The conduit 10 is movable between a contracted state and an extended state.

[0316] Here, Figure 1a shows a raw conduit 10. In its raw form, blood (an example of a fluid) ) can flow between the outer surface 10b of the wall 10f and the inner surface 10a of the wall 10f. That is, when fluid flows into the inlet 10c, the blood flows through the porous portion 10e of the conduit 10. Therefore, the conduit 10 shown in FIG. 1a is intended to be used as an implantable artificial blood vessel 16. Must be sealed before use.

[0317] The conduit 10 shown in Figure 1a is cut to size. The length may need to be altered depending on the size of the graft 16 required. The artificial blood vessel 16 is connected to at least one assist cardiac component (another example of a prosthesis). This also allows different sizes or lengths of conduit 10 to be used. The conduit 10 is also weighed during this step in the manufacturing process.

[0318] In the embodiment shown herein, the conduit 10 has a substantially uniform cross section throughout. However, the conduit 10 may have an irregular cross section throughout. It should be understood that, for example, the conduit 10 may be connected to an additional prosthesis, such as a heart valve, or to a separate When the conduit 10 is to be connected between the ends of a blood vessel, the conduit 10 may be irregularly shaped throughout. As described in more detail below, in some embodiments, conduit 1 0 can be achieved by selectively applying sealant 14 to different portions of conduit 10 or by other In this way, they can be configured to have different degrees of flexibility.

[0319] As mentioned above, the inner surface 10a of the wall 10f of the conduit 10 is used to seal the conduit 10. It is desirable that the composition remain free or substantially free of materials used in the manufacture of the product. The reason for this is that the inner surface 10a of the wall 10f of the conduit 10 ensures that the woven nature of the porous 10e is maintained. When the artificial blood vessel 16 is implanted in the human or animal body, the living tissue of the conduit 10 This is to ensure that the growth occurs on the inner surface 10a of the wall 10f. Importantly, the biological tissue is carefully selected to ensure that it forms a pseudointima (an example of an inner biological tissue layer within a vascular prosthesis). Furthermore, in addition to promoting biological tissue growth on the inner surface 10a of the wall 10f of the conduit 10, Thus, the biological tissue layer growing on the inner surface 10a of the wall 10f of the conduit 10 provides good adhesion to the inner surface 10a. It is also advantageous to have adhesive properties. If this occurs, complications such as bleeding incisions can occur.

[0320] Figure 1b shows the conduit 10 after the addition of the masking agent 12. In this embodiment, The masking agent 12 forms a masking agent layer on the inner surface 10a of the wall 10f of the conduit 10. The coating layer is applied to the inner surface 10a of the conduit 10 during the manufacturing process shown and described herein. In particular, the masking agent 12 is designed to protect the inner surface 10f of the wall 10f of the conduit 10. It is designed to mitigate the presence of sealant 14 in a.

[0321] Prior to the addition of the masking agent 12 to the conduit 10, the conduit 10 is weighed. The weight of the masking agent 12 is used, at least in part, to determine the amount of masking agent 12 added to the conduit 10. Determine.

[0322] In this embodiment, the maskant 12 is applied from a maskant solution. In the embodiments shown and described herein, the coating agent solution is a polymer solution. The polymer solution is approximately 7% w / v PVP (an example of a water-soluble polymer) in water (an example of a solvent). However, other polymers such as glycerol, methylcellulose and / or PEG may also be used. It should be understood that polymers can be used. Furthermore, the polymer solution can be used in a solution containing about It will be appreciated that the PVP content can range from 5% w / v to about 30% w / v of PVP in solution. Additionally, the polymer solution may be prepared from a mixture of approximately 5% w / v polymer in solution to approximately 30% w / v polymer in solution. The masking agent 12 may comprise about 1% w / v glycerol in solution. It should be understood that this may include. Without wishing to be bound by theory, The advantage of adding glycerol to the masking agent 12 is that the masking agent 12 is It is believed that this reduces cracking of the maskant 12 when the maskant is heated.

[0323] In the embodiment described herein, the masking agent 12 has a coating weight of about 10,000 g / m However, the masking agent 12 contains PVP having a molecular weight of about 6,000. It is understood that the PVP may include PVP having a molecular weight of from about 15,000 g / mol to about 15,000 g / mol. It should be.

[0324] In the embodiment described herein, the masking agent 12 comprises PVP, but The binder 12 may be glycerol, methylcellulose, PEG, PEO, and / or PEG It should be understood that the composition may include a hydrogel.

[0325] In the embodiments shown and described herein, the masking agent 12 is biocompatible. However, in some embodiments, the masking agent 12 does not need to be biocompatible. It should be understood that it is not necessary to If substantially all of the masking agent 12 is to be removed from the conduit 10, the masking agent Agent 12 does not need to be biocompatible. In one embodiment, masking agent 12 is In some embodiments, only a portion of the masking agent 12 is removed. In these configurations, the masking agent 12 is biocompatible and is suitable for use when the conduit 10 is human or It is advantageous to be able to be implanted into the body of an animal.

[0326] In this embodiment, the masking agent 12 is biodegradable. Residual masking agent 12 present on the conduit 10 will be removed once the conduit 10 is implanted into the human or animal body. However, the masking agent 12 may be non-biodegradable. In this configuration, substantially all of the masking agent 12 is removed from the conduit 10 prior to implantation, and Therefore, the masking agent 12 does not need to be biodegradable. It may be advantageous for the coating agent 12 to be biodegradable.

[0327] Referring to FIG. 1b, a maskant 12 is applied to the conduit 10 from a polymer solution. However, it is understood that the masking agent 12 may be applied to the conduit 10 in other ways. It would be.

[0328] In this embodiment, the conduit 10 is stirred while the mass of the conduit 10 is heated for approximately 1 minute. The maskant solution is applied to the conduit 10 by immersion in the maskant solution. However, the maskant solution can be applied by dipping, spray coating, or brushing. It should be understood that the conduit 10 may be added in other ways, such as by It should be understood that the scouring agent 12 may be added to the conduit 10 without agitating the conduit 10. During the process of immersing the conduit 10 in the masking agent solution, the conduit 10 is in a contracted state and an expanded state. However, when the conduit 10 is in a contracted and / or extended state, It should be understood that the conduit 10 may be immersed in the maskant solution.

[0329] In this embodiment, when the maskant solution is added to the conduit 10, the solvent The masking agent solution is evaporated, thus removing the solvent from the masking agent solution. The masking agent 12 remains on the conduit 10 .

[0330] In this embodiment, the addition of the masking agent 12 to the conduit 10 involves directed voiding. An airflow (e.g., a gas) is provided to the conduit 10. The directed airflow is directed through the masking agent 1 2 is preferentially formed on the inner surface 10a of the wall 10f of the conduit 10. The airflow is directed towards the outer surface 10b of the Although a gas such as HCl is used, it should be understood that other gases may be used.

[0331] In this embodiment, the masking agent 12 is substantially on the inner surface 10f of the wall 10f of the conduit 10. However, the masking agent 12 is formed on or applied to the wall of the conduit 10. It should be understood that the masking agent 12 may be applied to the outer surface 10b of the 10f. In other embodiments, the masking agent 12 is applied to the porous portion 10e of the conduit 10. may be added to at least a portion of the porous portion 10e of the conduit 10. In this embodiment, The masking agent 12 is then applied to the inner surface 10a of the wall 10f of the conduit 10. However, the masking agent 12 may be applied to other portions of the conduit 10. and that the masking agent 12 may form a masking agent layer on other portions of the conduit 10. It should be understood that:

[0332] In the manufacturing process shown and described herein, the outer surface 10 of the wall 10f of the conduit 10 The residual masking agent 12 on b is a sealant 14 (when applied to the conduit 10) and a conduit 1 The addition of sealant 14 to improve adhesion between the outer surface 10b of the wall 10f of the In this embodiment, the residual masking agent 12 on the outer surface 10b is removed before However, the masking agent is removed by the masking agent removal step. The masking agent 12 may be applied by applying a solvent, heating, etching, plasma etching, or polishing. It should be understood that the surface area may be removed by other techniques.

[0333] In the embodiment shown in FIG. 1b, the masking agent 12 is applied to the inner surface of the wall 10f of the conduit 10. 10a。 Formed on substantially all of 10a.

[0334] Figure 1c shows the conduit 10 after the addition of the maskant 12 and sealant 14. In the embodiment described above, the sealant 14 is applied to the conduit 10 from a sealant solution. In the embodiments described herein, the sealant solution is a room temperature curing silicone. However, the sealant solution is a polymer solution containing a rubber elastomer and xylene. Liquid, polycarbonate, silicone, silicone elastomer, polyurethane, TPU , one or more thermoplastic elastomers, and / or aliphatic polycarbonates It should be understood that the sealant 14 may include both a polyolefin and a xylene. The polymer solution is added to conduit 10, but heptane can be used instead of xylene. It should also be understood that in certain embodiments, the sealant solution may be Contains polar solvents such as diethyl acetamide (DMAC) or tetrahydrofuran (THF) obtain.

[0335] When the sealant solution is applied to the conduit 10, the solvent evaporates from the sealant solution. , thereby forming the sealant 14 .

[0336] In the embodiment shown and described herein, the sealant 14 is a sealant solution Although the sealant 14 is applied to the conduit 10 via a sealant pipe, the sealant 14 may be applied to the conduit 10 in other ways. It will be appreciated that it may not be necessary to add the refrigerant from a solution.

[0337] The sealant 14 is applied to the porous portion 10e of the conduit 10. In configuration, the conduit 10 is entirely porous 10e, so in this embodiment: The sealant 14 is applied to substantially all of the conduit 10. Runts 14 may be added to a portion of the porous portion 10e.

[0338] The presence of the masking agent 12 allows the sealant 14 to adhere to the inner surface 10a of the wall 10f of the conduit 10. The sealant 14 is applied to the outer portion 10b of the conduit 10 to prevent adhesion or formation of pores. The sealant 14 is applied to the conduit 10 by spraying it onto the Brush coating, wiping, dipping, dipping, deposition such as chemical vapor deposition, electrospinning, and / or casting It is understood that other techniques for applying the sealant 14 to the conduit 10 may be used, such as by forming a sealant 14 over the conduit 10. It should be.

[0339] In this embodiment, with the conduit 10 in an elongated state, the sealant 14 is However, when the conduit 10 is in a contracted state or when the conduit 10 is in a contracted state, The sealant 14 can be applied to the conduit 10 when moved between a compressed state and an extended state. It should be understood that:

[0340] In this embodiment, the conduit 10 is rotated about its longitudinal axis at approximately 60 rpm. However, the sealant 14 is applied to the conduit 10. However, the conduit 10 may be up to about It should be understood that the rotor may be rotated about its longitudinal axis at 2,000 rpm.

[0341] In the embodiment described herein, the sealant 14 has a thickness of about 8 mg / cm 2 Siri However, the sealant is approximately 4 mg / cm 2 Silicone ~ approx. 19m g / cm 2 It should be understood that the silicone may include

[0342] Spraying and / or brushing sealant 14 onto the outer surface 10b of the wall 10f of the conduit 10. This is an advantage over some sealant application techniques because Sealant 14: It is applied substantially only to the outer surface 10b of the conduit 10 and substantially only to the inner surface 10a of the conduit 10. In this configuration, the masking agent 12 and the spray and / or brush The application of the sealant 14 to the conduit 10 by painting the sealant 14 on the conduit 10 This reduces the presence of the sealant 14 on the inner surface 10a of the wall 10f of the pipe 10. Alternatively, other sealant 14 application techniques may be used, such as wiping the conduit 10 with the sealant 14. It should be understood that

[0343] In the embodiment shown and described herein, the sealant 14 is applied to the conduit 10. When the maskant 12 is applied, it is substantially covered or blocked by the sealant 14. This is because at least a portion of the masking agent 12 is not absorbed by the conduit 10. When the masking agent 12 is to be removed from the masking material, the masking agent 12 is removed when at least a portion of the masking agent 12 is exposed. This is because the scouring agent 12 is easy to remove. For example, by applying a solvent, When removing at least a portion of the masking agent 12 from the masking agent 10, at least a portion of the masking agent 12 is removed. This is easily accomplished when a portion of the substrate is exposed. Since a significant amount of masking agent 12 is exposed, various masking agent 12 removal techniques are required. It is relatively easy to use.

[0344] In this embodiment, the addition of sealant 14 to the porous portion 10e of the conduit 10 In this embodiment, a sealing layer is formed on the outer surface 10b of the wall 10f of the conduit 10. The sealant 14 is biocompatible.

[0345] In this embodiment, the sealant 14, when applied to the conduit 10, is environmental stress crack resistant. The system is configured to reduce the

[0346] FIG. 1d shows a vascular graft 16 (an example of an artificial blood vessel 16). Substantially all of the masking agent 12 has been removed from the conduit 10. Leakage of blood (an example of a fluid) passing through the conduit 10 is mitigated here by the addition of a sealant 14 to the conduit 10. Furthermore, the inner surface 10a of the wall 10f of the conduit 10 is made of a porous woven material. The inner surface 10a of the wall 10f of the conduit 10 allows for the ingrowth of living tissue and It allows the body tissue to have good adhesion thereto. The presence of the duct 14 prevents blood from flowing through the wall 10f of the vessel 10, but the blood is able to pass through the inlet It will be understood that there is flow between the inlet 10c and the outlet 10d.

[0347] In the embodiment described herein and shown in FIG. 1d, water is delivered at a temperature of about 95° C. By applying the masking agent 12 to the conduit 10, substantially all of the masking agent 12 is removed from the conduit 10. (An example of the second masking agent removal process) In this second masking agent removal process, The masking agent 12 is then applied to the conduit 10 after the step of applying the sealant 14 to the conduit 10 has been performed. In this process, water (an example of a solvent) is used to remove the masking agent from the conduit 10. Substantially all of the masking agent 12 was removed. However, the masking agent 12 was removed from the conduit 10. It is not necessary for the masking agent 12 to be substantially completely removed from the substrate. The masking agent 12 can be used for the purpose of: Other methods, such as by etching, plasma etching, ablation, and / or polishing It should be understood that the masking agent 12 may be removed from the conduit 10 by any suitable method. The masking agent 12 was substantially removed from the conduit 10 at a temperature of about 15°C to about 15°C. It should be understood that the material may be removed from the conduit 10 at a temperature of 40° C. In this embodiment, the process of removing the masking agent 12 from the conduit 10 is more efficient. It is also used to cure the sealant 14.

[0348] In the embodiment shown in FIG. 1d, the maskant removal step is carried out as described above. This is carried out for approximately 51 minutes while the conduit 10 is being stirred. Although not required, agitating the conduit 10 may improve the efficiency of the masking agent 12 removal process. In this embodiment, the masking agent removal step is performed for approximately 51 minutes. The masking agent removal process is carried out over a period of about 40 minutes to about 300 minutes. It will be understood that multiple maskant removal steps may be performed. It will be understood.

[0349] In the embodiment shown and described herein, the masking agent 12 is removed from the conduit 10. The qualitative total removal process does not result in the removal of sealant 14 from conduit 10 .

[0350] As described in detail above, the manufacturing process involves the adhesion of the sealant 14 to the conduit 10. The first masking agent removal step is designed to improve the a second masking layer 10f designed to remove the masking agent 12 from the inner surface 10a of the However, it is understood that multiple masking agent removal steps may be performed. In some embodiments of the present invention, it may be possible to avoid the need for a masking agent removal step. It should also be understood that there are

[0351] In the embodiment shown and described herein, the vascular prosthesis 16 is reversibly sealable. That is, the sealant 14 can be removed from the conduit 10, and the sealant 14 can be This may be necessary in the case of manufacturing errors, for example. A masking agent 12 is added to the conduit 10, removed from the conduit 10, and then added to the conduit 10. This may be necessary if more than one masking agent addition step is performed. .

[0352] In the embodiment shown and described herein, the vascular prosthesis 16 is sterilized using a gamma sterilization process. However, the vascular prosthesis 16 can be sterilized by an electron beam sterilization process. It should be understood that the graft 16 may be sterilized by the following method. The preferred method is to use ethylene oxide sterilization. Other sterilization techniques are also available, as described herein. It will be appreciated that the present invention may be applied to the vascular graft 16 as an alternative or in addition to the above. It would be.

[0353] The artificial blood vessel 16 shown in FIG. 1d is configured to be implantable within the human or animal body. The artificial blood vessel 16 is made substantially entirely of biocompatible materials. It is not harmful or toxic to tissues and can be implanted into the human or animal body.

[0354] The artificial blood vessel 16 shown in FIG. 1d is flexible, which allows the artificial blood vessel 16 to be more flexible. In this embodiment, the conduit 10 can be efficiently operated by a physician. The application of sealant 14 to substantially all of the porous portion 10e renders the raw conduit 10 Converted to artificial blood vessel 16.

[0355] 2a and 2b show the inner surface 10a of the wall 10f of the conduit 10 in more detail. b indicates the porous nature of the conduit 10. The conduit 10 is a woven structure, and in this embodiment As mentioned above, the raw woven conduit 10 is The blood is then allowed to leak through gaps in the fibers of the conduit 10 into the human or animal body. The catheter must be sealed before implantation.

[0356] The woven nature of the conduit 10 means that it is flexible. After applying the sealing layer 14, the vascular graft 16 remains flexible, thereby allowing blood The vascular graft 16 is, for example, easier for a physician to manipulate and handle.

[0357] 3a and 3b show details of the inner surface 10a of the wall 10f of the conduit 10 after the addition of the masking agent 12. In this embodiment, the masking agent 12 is about 5% w / v PV in solution. A polymer solution containing P (an example of a masking agent solution) was added to the conduit 10. In this embodiment, the conduit 10 was immersed in a polymer solution. As described above, the masking agent 12 may be added to the conduit 10 in other ways, such as by adding a polymer solution. can contain about 5% w / v and about 30% w / v of polymer in solution. In the embodiment shown, the conduit 10 is immersed in the maskant solution for approximately 1 minute. However, the conduit 10 was immersed in the maskant solution for other durations. It should be understood that

[0358] In the embodiment shown in FIGS. 3a and 3b, the masking agent 12 is When the sealant 14 is applied to the conduit 10, it substantially blocks the portion 10e. The sealant 12 reduces the presence of the sealant 14 on the inner surface 10a of the wall 10f of the conduit 10. In this embodiment, the masking agent 12 is an oleophobic layer (an example of a masking layer). Without wishing to be bound by theory, it is believed that the oleophobicity of the masking layer This is believed to help mitigate the presence of sealant 14 on the inner surface 10a of wall 10f of the housing. In some embodiments, the masking agent 12 does not need to form an oleophobic layer. It should be understood that:

[0359] 4a and 4b show a sealant 14 applied to the outer surface 10b of the wall 10f of the conduit 10. 4a and 4b show the inner surface 10a of the wall 10f of the conduit 10. To enhance the effectiveness of the masking agent 12 in mitigating the presence of the sealant 14 on the inner surface 10a. In this embodiment, the masking agent 12 is about 7% w / v PV in solution. The maskant was applied to the conduit 10 from a solution containing P. The embodiment shown in Figures 4a-5b In the sealant, a sealant solution is sprayed onto the outer surface 10b of the wall 10f of the conduit 10. The outer surface 10b of the wall 10f of the conduit 10 was coated with a .alpha.-coating.

[0360] 5a and 5b show the outer surface 10f of the wall 10f of the conduit 10 of the embodiment shown in FIGS. 4a and 4b. 5a and 5b show the presence of sealant 14 in FIG. The sealant solution contains approximately 15% w / v silicone in xylene.

[0361] 4a and 4b, and 5a and 5b show the conduit 10 after application of sealant 14 thereto. The contrast between the inner surface 10a and the outer surface 10b of the wall 10f of the conduit 10 is emphasized. The outer surface 10b of the conduit 10 is substantially coated with the sealant 14, while the wall 10 The inner surface 10a of the wall 10f of the conduit 10 is substantially free of the sealant 14. 10a maintains the porous characteristics of the fabric of the conduit 10. The masking agent 12 is The presence of the sealant 14 on the inner surface 10a of the wall 10f of the nozzle 10 is reduced. The inner surface 10a of the wall 10f promotes the growth of living tissue thereon and provides a barrier for the growing living tissue therein. The wall of the conduit 10 is configured to allow good adhesion between the body tissue and the inner surface 10a. The presence of the sealant 14 on the inner surface 10a of the wall 10f of the conduit 10 and between the tissue and the inner surface 10a of the wall 10f of the conduit 10. This can adversely affect the adhesion of the

[0362] FIG. 6a shows a detailed view of the outer surface 10b of the wall 10f of the conduit 10 after the addition of the sealant 14. In this embodiment, the sealant 14 reduces fluid movement through the wall 10f of the conduit 10. The wall 10f of the conduit 10, after addition of the sealant 14, is configured to reduce It is blood impermeable (i.e., blood does not pass or leak through the wall 10f at a significant rate). (Cannot be done).

[0363] FIG. 6b shows the inner surface 10a of the wall 10f of the conduit 10 after the addition of the sealant 14 to the conduit 10. A detailed diagram is shown.

[0364] In the embodiment shown in FIGS. 6a and 6b, the maskant 12 is Prior to addition, the polymer is applied to the conduit 10 from a polymer solution containing approximately 30% w / v PVP in solution. As described above, the masking agent 12 is present in a concentration of about 5% w / v to about 30% w / v in the solution. The polymer may be applied to the conduit 10 from a polymer solution containing the polymer.

[0365] One desirable feature for a sealed graft is that it is leak-proof during the implantation procedure. The objective of ISO 7198 is to provide a material that has a sufficiently low level of permeability to maintain its overall integrity. Whole Graft Permeability (Whole Gr) is an applicable test method specified in After Permeability is the test pressure of a reverse osmosis (RO) filter at 120 mmHg. This parameter is based on the results of a biologically sealed glass test. Based on industry standards established by the manufacturers of gelatin and collagen . 0.16ml / min / cm 2 The limit value of the graft is used to determine whether the graft has the sealing ability described above. However, different applications require different penetration Different permeability requirements may be present, and such different permeability requirements are within the scope of the present invention.

[0366] A further embodiment is shown in Figures 1a-6b and follows the manufacturing process described above. Further embodiments are described in Table 1 below. The manufacturing process used to make the embodiments may involve different masking agents 12 and 1a-6b, except for the use of sealant 14. is substantially the same as

[0367] Commercially available woven vascular grafts were used in the tests described below. More details about the rules are provided below: First commercial sample of woven graft fabric: (a) Warp: twisted, textured, PET, 2 layers / 44 per layer (or bundle) 27 filaments per denier / layer or bundle. (b) Weft: twisted, textured, PET, 2 layers / 44 per layer (or bundle) 27 filaments per denier / layer or bundle. (c) Number of picks per cm, approximately 40–46.

[0368] Second commercial sample of woven graft fabric: (a) Warp: 80 denier, 2 layers / layer (or bundle) per 40 denier / layer (or 27 filaments per bundle, PET, draw spun, textured, 7.5 twist / Inch, Z twist yarn. (b) Weft: 2 layers / 40 denier per layer (or bundle), 2 layers / 40 denier per layer (or bundle) 40 denier per layer or 27 filaments per bundle, PET, TXT, S and Z twist thread. (c) Number of picks per inch, approximately 155.

[0369] The tests performed in Table 1 below were performed on a first commercial sample of woven graft fabric. And went.

[0370] [Table 1] TIFF2025148446000003.tif246170TIFF2025148446000004.tif90170

[0371] A hobby spray gun was used for all spray application tests, where the sealant was applied to the glass. The spray distance from the grafted sample was approximately 50 mm. The graft was held horizontally on a mandrel and rotated on a rotisserie. The spray rate was , but not measured, nozzle lateral velocity (estimated at 2 sec / cm), graft rotation speed (estimated at 1-3 revolutions per second) and total spray volume flow rate ( A craft bristle brush was used for all brush application tests. where the sealant was brushed onto the grafted samples.

[0372] As shown in Table 1, the wall 10f is 0.16 ml / min / cm 2 Has a leak rate of If so, the conduit 10 is considered suitable for implantation and is considered substantially impermeable. In a further embodiment, the masking agent 12 comprises glycerol. Without wishing to be bound, the presence of glycerol in masking agent 12 may: It is believed to reduce cracking of the maskant 12 when applied to the conduit 10 .

[0373] The masking agents described herein are suitable for use with sealants such as liquid silicone elastomer dispersions. The graft may penetrate through the thickness of the graft wall and reach the lumen or blood-contacting surface of the graft. Silicone and other sealants act on the outer surface of the graft via two mechanisms: It is believed to be attached to the graft fibers: a. The grafted fibers are stripped of masking agents or otherwise free of masking agents. If not, the liquid silicone elastomer dispersion adheres to the surface of grafted fibers such as PET fibers. Adhere to. b. When surface fibers are individually covered by a masking agent, these fibers are sealed. The resulting interlocking is mechanical rather than surface attachment.

[0374] Silicone adheres to the PET fiber surface in the absence of a masking agent, but also PET fibers covered with a masking agent are encapsulated.

[0375] The masking agent is believed to act like a slurry when applied to the woven fabric, and It can flow between the yarn bundles, cover the gaps between the yarn bundles, and penetrate between the yarn fibers. The particles act as a sticky mixture that moves through the fabric, settling and collecting in areas of low energy. Rather than bonding to individual fibers, the masking agent is applied to the surface of the material as the masking agent drying process begins. The masking agent begins to solidify wherever it has collected, due to evaporation of its solvent, such as water. Continue moving and pooling until

[0376] Elastomeric sealants (e.g., silicones) may be susceptible to excessive concentrations of masking agents. The masking agent may be too sticky and may not bond well to the fabric surface. If the area is completely encapsulated and then dried, the silicone is mechanically encapsulated and solidifies. There may be no exposed yarn filaments to bond to. Without this mechanical encapsulation, there would be poor adhesion after the maskant was removed, possibly resulting in It may suddenly cease to exist.

[0377] The masking agent dissolves in the individual filaments as it migrates or washes through the fabric. While it may appear as a thin coating of grease, after drying these well-cleaned areas The concentration remaining in the fiber bundle is sufficient to prevent subsequent encapsulation and adhesion of the silicone adhesive to the fiber bundle. No.

[0378] Any synthetic hydrophilic polymer and any biological hydrophilic polymer, e.g., gelatin, partially hydrophilic polymer Hydrolyzed collagen, dextran, hyaluronic acid, alginate and starch (e.g., hydroxyethyl starch) and chitosan can be used as masking agents. Pluronic F127 PEG, which is soluble in cold water but insoluble in hot water, is also , can be used as a masking agent. Desirably, the masking agent derived from an animal product is Therefore, the masking agent, including the animal-derived masking agent, may be removed prior to vascular application. If any, they will be removed from the final product and such grafts will not be used in vascular applications. Additionally, the masking agent may be suitable for any patient-related application, including vascular applications. The masking agent must be biocompatible because it will be removed from the woven graft prior to application. There is no.

[0379] Desirably, the masking agent is highly soluble in water. Any polymer that can expand in a liquid with a Hildebrand solubility parameter (δ SI units) It can be a rimmer.

[0380] Masking agents useful in the present invention have a molecular weight of from about 400 or 1,000 to about 1,000,000. Preferably, the molecular weight is about 3,000 to about 30,000, more preferably can vary from about 6,000 to about 15,000.

[0381] One useful sealant is a dispersion of silicone in a non-polar "solvent" or carrier medium. Useful crosslinking is by acetoxy "room temperature cure" chemistry, but two-part platinum Curing chemistries as well as ultraviolet (UV) curing may also be used.

[0382] Polymers supplied as dispersions, such as NuSil MED 6605 and Med For samples using 6606, individual amounts of polymer dispersion were applied directly to the graft. Addition of individual potions by weight either for centrifugation or further addition of solvent by weight The mixture was decanted during the incubation.

[0383] All silicone dispersions used were acetoxy curable. Cure Schedule Although 72 hours is recommended, complete hardening may not be achieved due to the extremely thin cross section / large surface area of ​​the graft. Curing was clearly observed within 24 hours. Subsequent washing of the device in water accelerated curing. However, these times are not critical. However, other curing times and conditions may be suitably used.

[0384] A soft and flexible graft with handling characteristics similar to those of a gelatin-sealed graft. To obtain a raft, the preferred polymer for the coating has a very low Shore hardness. The preferred silicone elastomers are MED 6605 and MED 6605 have durometer Type A values ​​of 25 and 20, respectively. Both of these have suitable flexibility and handling properties when applied as thin coatings. Multiple coatings can be applied to provide a graft that is stiffer and more flexible. The strain may increase and the flexibility may decrease.

[0385] As an alternative to thicker coatings to create a more rigid graft if desired. Therefore, harder grades can be used.

[0386] TPU-silicone (Advansource Chronosil 75A or Ao Alternative coatings such as r-Tech Elast-Eon E5-130 are used These have durometer hardnesses of 75A and 77A respectively, and therefore to produce a graft that may be more rigid than current gelatin-sealed grafts, if desired. Such stiffer grafts may have some advantages for certain applications. While this may be possible, it may not meet the expectations of a conventional surgeon for handling.

[0387] Additional useful sealant materials include, but are not limited to: : (a)Applied Silicone Corporation, PN 4002 1. A graft-grade high-strength RTV silicone elastomer dispersion in xylene. This material is of any shape and thickness using processes such as dipping, casting, spraying or brush application. It is suitable for use in making high strength elastic membranes. After the solvent has evaporated, the Silicones are room temperature cured (RTV) by exposure to high Strength, low durometer (Shore A 24), ISO 10993 testing and submission Supported by abstracts to support the class. (b)AdvanSource Biomaterials Corporation , ChronoFlex AR, and polycarbonate-based thermoplastic urethane. It can be used for molding, casting and dip coating, and is fully synthesized in liquid form, providing long-term The enduring durability and resistance to environmental stress cracking (ESC) inherent in polycarbonate They offer high strength and elongation while maintaining the benefits of electrospun and can be used in the water emulsion process. Examples of particularly useful materials include, but are not limited to: However, ChronoFlex C80A 5% and ChronoFlex AR 23 % are listed.

[0388] A suitable sealant is a low durometer elastomer (preferably about 40A durometer). Durometer or Shore hardness of 40A or less, more preferably about 30A or less Durometer 30A, and even more preferably about 20A or less (Shore hardness 20A). and has good in vivo stability.

[0389] One parameter that may be considered in selecting a sealant is stiffness or modulus. Typically, in elastomers, the modulus is not linear, so at each elongation, the stress (or force) is measured. Materials with lower stress in % strain have lower resistance to elongation This results in a softer feel and easier handling of the gelatin-sealed graft. It almost matches the original.

[0390] Preferred materials are low stress silicon such as NuSil MED 6605 and MED 6606. It is a ricone rubber and has a stress at 200% strain value of <180.

[0391] Useful polyurethane and silicone-polyurethane grades include, but are not limited to: However, the following can be mentioned:

[0392] [Table 2]

[0393] The present invention is not limited to the use of silicone as a polymer sealant. Other useful coating materials for both medical and non-medical textiles include, for example, polytetrafluoroethylene (PTFE) and tetrafluoroethylene (PTFE). Fluoroethylene, polyethylene, poly(hydroxyethyl methacrylate), poly(vinyl Poly(D,L-lactic acid), Poly(L-lactic acid), Polycaprolactone Poly(lactide-co-glycolide), Poly(hydroxybutyrate), Poly(hydroxybutyrate) thiazolate-co-valerate), polydioxanone, polyorthoester, polyanhydride, poly Poly(glycolic acid), Poly(glycolic acid-co-trimethylene carbonate), Polyphosphorus Acid ester, polyphosphate ester urethane, poly(amino acid), cyanoacrylate, poly Poly(trimethylene carbonate), poly(iminocarbonate), copoly(ether-ethylene carbonate) ester), polyalkylene oxalate, polyphosphazene, polyiminocarbonate, Aliphatic polycarbonate, polyethylene oxide, polyethylene glycol, poly(propylene) pyrene oxide), polyacrylamide, polyacrylic acid (30-60% solution), poly Methacrylic acid, poly(N-vinyl-2-pyrrolidone), polyurethane, poly(amino acid) , cellulose polymers (e.g., sodium carboxymethylcellulose, hydroxyethyl cellulose), collagen, carrageenan, alginate, starch, dextrin, Gelatin, poly(lactide), poly(glycolide), polydioxanone, polycaprolactone ton, polyhydroxybutyrate, poly(phospazazene) , poly(phosphate ester), poly(lactide-co-glycolide), poly(glycolide-co) -trimethylene carbonate), poly(glycolide-co-caprolactone), polyanhydride , polyamide, polyester, polyether, polyketone, polyether elastomer, Parylene, polyetheramide elastomer, polyacrylate elastomer, polyethylene Examples include, but are not limited to, polyethylene, polypropylene, and / or their derivatives. However, other useful coating materials, particularly for non-medical textiles, include natural rubber, natural gum, acrylic polymer, polybutadiene, styrene-butadiene copolymer or rubber, Butadiene-acrylonitrile copolymer, polyisobutylene, isoprene-isobutylene Polyvinyl chloride copolymer, polysulfide rubber, chloroprene rubber (neoprene), chlorosulfonated polyethylene Examples of coating materials include polyethylene, fluorinated polymers, and vinyl resins. , metallic materials and powdered materials.

[0394] Figure 7 shows a further embodiment of conduit 10. As best seen in Figure 7, conduit 1 0 includes a number of crimps 10g. In this embodiment, the support member 18 In particular, the support member 18 is attached to the outer surface 10b or wall 10f of the multi-stage sealer. For example, the sealant may be applied to the exterior surface of the conduit 10 as described above. The support member 18 may then be placed over the sealed graft, and another The sealant application step is followed by drying and / or curing. However, the support member 18 may be attached to the conduit 10 in other ways. It should be understood that the support member 18 is attached to the outer surface 10b of the wall 10f of the conduit 10. The step of adding the sealant 14 to the conduit 10 is performed before the step of adding the sealant 14 to the conduit 10. , configured to attach the support member 18 to the conduit 10. In this embodiment, the support The member 18 is applied to the conduit 10 and then the sealant 14 seals and supports the conduit 10. To attach the member 18 to the conduit 10, it is applied to the conduit 10. Furthermore, drying before application is required. and / or multiple applications of maskants and / or sealants, either before or after curing. It should be understood that it is within the scope of the present invention to have various uses.

[0395] The support member 18 is a flexible polymer wire, which in this embodiment is The conduit 10 is wrapped around the outer surface 10b of the wall 10f of the conduit 10 and nested between the crimps 10g of the conduit 10. One advantage of adding support members 18 to conduit 10 is that As shown and described herein, the conduit 10 is more flexible while retaining many of its flexible characteristics. As described above, the conduit 10 is flexible and therefore can be used in medical applications. It can be manipulated more efficiently by the master.

[0396] In the embodiment shown in FIG. 7, the support member 18 is made of polyethylene terephthalate (P However, the support member 18 may be made of a polymer material, a metal material, or a shape It is understood that the material may include at least one of a memory alloy and a superelastic alloy. In this embodiment, the support member 18 is made of polyethylene terephthalate, polytetrafluoroethylene, Styrene, polyurethane, polycarbonate, silicone, stainless steel, titanium, nickel and nickel titanium (nitinol).

[0397] FIG. 8 shows an alternative embodiment of a conduit 10 manufactured according to the process shown in FIGS. 1a-1d. The conduit 10 shown in Figure 8 is similar to that shown in Figure 1d, with the following differences: The conduit 10 has three sections 10h, 10i, and 10j. Each of the portions 10h, 10i, 10j has a different amount of sealant 14a present thereon. , 14b, 14c, the sealants 14a, 14b, and 14c are formed on the portion 10h. , 10i, 10j. In this embodiment, portions 10h, 10i, Each of the first and second portions 10h and 10j has a substantially different degree of flexibility. Similarly, the second portion 10i has a higher flexibility than the third portion 10j. As shown in FIG. 8, the crimp 10g of the first portion 10h is The first part 10i and the third part 10j are more visible than the first part 10i and the third part 10j because 10i and 10j have a larger amount of sealant added, which allows these This is because the crimp 10g in the portions 10i and 10j becomes less noticeable. In applications where the prosthesis is connected to the distal end of the vascular graft 16, the distal end of the third section 10j may be further These are more suitable for connection to prosthetic devices.

[0398] An example of how the vascular graft 16 can be used will now be given.

[0399] The blood vessel shown in FIGS. 1a-6b can be thought of as a sealed, engineered conduit 10. The vascular graft 16 can be implanted within the human or animal body for long-term use. This is because the vascular graft 16 is biocompatible, i.e., it is compatible with human or does not induce a foreign body reaction in the animal's body and is not toxic to surrounding biological tissues.

[0400] The masking agent 12 is configured to biodegrade within the body. Any residual masking agent 12 present will biodegrade in the body. As described, in some embodiments, the masking agent 12 is substantially Since it will be removed entirely, the masking agent 12 does not need to be biodegradable. In other embodiments, the masking agent 12 need not be removed from the conduit 10 .

[0401] The vascular graft 16 may be used to bypass a region or portion of a blood vessel. For example, a physician may identify an occluded, diseased, or partially occluded area of ​​a blood vessel. In this case, the physician may bypass the area by using a vascular graft 16. In this example, the inlet 10c of the vascular graft 16 is located at one point of the blood vessel. and the outlet 10d of the vascular graft 16 may be attached to another location in the blood vessel. In another example, the blood vessel is diseased or the vascular graft 16 is It may be cut or bisected to connect the two ends of the vessel. The valve 16 is sealed so that blood can pass through the occluded, diseased, or partially occluded blood vessel. blood can flow through the vascular graft 16 to bypass the damaged area of ​​the conduit 10. Blood leakage through wall 10f is reduced by the presence of sealant 14.

[0402] Once the vascular graft 16 is in place, the living tissue will adhere to the vascular graft to form a pseudointima. Over time, the inner portion 10a of the vascular graft 16 grows. During this time, the vascular graft 16 allows blood to pass through the wall 10f. It prevents fluid leakage and acts as a scaffold for the living tissue growing inside.

[0403] The vascular graft 16 may also be used to provide a further human heart valve, such as a cardiac assist device, a biological heart valve, or a synthetic heart valve. For example, the inlet 10c of the vascular graft 16 may be , can be connected to the outlet of the synthetic heart valve, and the outlet 10d of the vascular graft 16 can be connected to the end of the blood vessel. The advantage of this use of the vascular graft 16 is that the vascular graft 16 can be made in a variety of sizes. Because cardiac assist components can be provided, they can be used in a wide variety of vessel shapes and sizes. In doing so, the physician will determine whether the particular vascular graft 16 is a synthetic heart valve and blood vessel. This allows you to choose which blood types and sizes you want to interact with. Ability to use standard components and customize by adding a vascular graft 16 This eliminates the need for a variety of different forms of cardiac assist devices. It is understood that multiple vascular grafts 16 may be used in a cardiac assist device, depending on the nature of the device. It will be understood.

[0404] The embodiment shown and described herein is a cylindrical tube having an inlet 10c and an outlet 10d. Although the conduit 10 is shown, other shapes of conduit 10 may be used. For example, a Y-shape, a T-shape, or A multi-channel conduit 10 may be used.

[0405] FIG. 9a illustrates a system of the present invention for processing a textile substrate in accordance with the present invention and / or 9a and 9b are perspective views of a perforated mandrel 20 useful in the kit. As such, mandrel 20 may be a hollow mandrel having an open lumen 24. One or both ends 25, 27 of the mandrel 20 may be open ended. One or both ends 25, 27 may be closed ends (not shown). Perforations or holes 23 may be disposed in the tubular wall of the mandrel 20 so as to allow for the insertion of a hole therein.

[0406] The mandrel 20 can be used for a variety of purposes. For example, the mandrel 20 can be used to It can be used to deliver skinning agents or water-soluble materials to tubular fabrics such as grafts. In such use, a tubular fabric (not shown) is disposed over the outer surface 22 of the mandrel 20. The masking agent or water-soluble material may be applied to the open lumen 24 of the mandrel 20, e.g. The fluid can be delivered into the open lumen 24 through the open end 25. The opposite end 27 is The system may be closed or open, such as in the case of a circulation system for a drug or water-soluble material. The fluid masking agent or water-soluble material passes through the perforations or holes 23 and into the mandrel 20. It will flow over and into a graft (not shown) placed over it.

[0407] The mandrel 20 is a fluid masking agent or water-soluble material that is exposed to the graft (not shown). A controlled amount of fluid masking agent or water-soluble material is provided within lumen 24 to control the amount of The fluid masking agent or water-soluble material contained within the mandrel 20 may act as a pressure differential ( By using a pressure greater than the pressure outside the lumen 24 or by rotating the mandrel 20 or by rotational force when placed on or in a spinning device, to deliver to the graft. It can be embedded.

[0408] A mandrel (not shown) without perforations 20 would have a fluid mass across the outer surface of the mandrel. The masking layer may be used to apply a layer of a masking agent or water-soluble material. or may be disposed on the mandrel until the graft is placed over the mandrel. The masking layer can then be partially cured as follows: can be placed in

[0409] The mandrel 20 can also be used to control fluid movement. For example, The pressure may be lower than the pressure outside the lumen 24. Such negative pressure or vacuum may be used to Move the skinning agent or water-soluble material away from the outer surface of the graft (not shown) It is possible.

[0410] The mandrel 20 may also be used to dry fluid maskants or water-soluble materials. Warm gas, such as air, is introduced into lumen 24 and flows through perforations or holes 23, Alternatively, a heat source may be applied to the outside of the mandrel 20 to dry the masking agent or water-soluble material. The flow of heat, such as heated air, may be applied to the lumen 24 to increase the negative pressure. Thus, it can be controlled.

[0411] The same or different mandrels may be used for, but are not limited to, maskant application and / or dispersion. , drying of masking agent, application and / or dispersion of sealant, drying and / or curing of sealant, It can be used across the different applications and techniques described herein, such as textile cleaning. The fabric may be disposed substantially over the mandrel, or only a portion of the tubular fabric may be disposed over the mandrel. For example, one end of the tubular fabric may be supported by a mandrel. The other end of the tubular fabric may be supported by a different mandrel or the like.

[0412] The substantially water-insoluble sealant also has the advantage that the graft is secured to a solid or non-perforated mandrel or The substantially water-insoluble silica may be applied to the graft while it is on the perforated mandrel 20. The sealant is a substantially water-insoluble sealant that is brushed, sprayed, or rolled onto the graft. The graft may be applied by any suitable means, such as by coating, spinning, etc. It can be used.

[0413] Additionally, if desired, the substantially water-insoluble sealant may be used to seal the graft against the mandrel. It can be cured in an upright position.

[0414] Additionally, other materials such as colorants, therapeutic agents, dyes, fluorescent indicators, etc. may be applied to the graft. .

[0415] Therapeutic agents include, but are not limited to, antithrombotic agents (heparin, heparin derivatives, urokinase, enzyme, and PPack (dextrophenylalanine proline arginine chloromethyl ketone antiproliferative agents (enoxaprin, angiopeptin, or The present study is directed to the development of monoclonal antibodies, hirudin, and acetonitrile, which are capable of blocking smooth muscle cell proliferation. thyrosalicylic acid, etc.); anti-inflammatory agents (dexamethasone, prednisolone, corticosterone , budesonide, estrogen, sulfasalazine, and mesalamine); antitumor / anticoagulant Proliferative / antimitotic agents (paclitaxel, 5-fluorouracil, cisplatin, vincristine, statin, vincristine, epothilone, endostatin, angiostatin and thymidylate kinase inhibitors, etc.); anesthetics (such as lidocaine, bupivacaine, and ropivacaine) Anticoagulant (D-Phe-Pro-Arg chloromethyl ketone, RGD peptide-containing compound) substances, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet Receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors and tick antiplatelet receptors peptides, etc.); vascular cell growth promoters (growth factor inhibitors, growth factor receptor antagonists, transcriptional activators vascular cell growth inhibitors (growth factor inhibitors, growth factor receptors, etc.); receptor antagonists, transcriptional repressors, translational repressors, replication inhibitors, inhibitory antibodies, antibodies against growth factors Bifunctional molecules consisting of growth factors and cytokines, and bifunctional molecules consisting of antibodies and cytotoxins. Cholesterol-lowering agents; vasodilators; drugs that interfere with endogenous or vasoactive mechanisms agents; and combinations thereof.

[0416] Masking agent drying and uniformity testing How long does it take for a standard woven fabric graft immersed in PVP to dry at various concentrations? To determine whether the PVP dries uniformly throughout the fabric, A series of tests at various concentrations of PVP were carried out to determine whether the concentration affected the drying properties of the material. This was done to determine if there was a difference.

[0417] The test used 15%, 10%, and 5% PVP solution profiles. A 15% solution of P was made using 15 g of PVP and 100 mL of water. Stir until VP is completely dissolved in the solution. Cut a commercially available tubular graft approximately 50 mm long. The grafted sample was prepared by the above procedure. The grafted sample was dried, if necessary. The grafted sample was then immersed in a 15% PVP solution. The graft was weighed to obtain the initial weight. The sample was placed vertically near a running fan. The grafted sample was weighed at 5 minute intervals until a constant weight was observed. The sample was cut into four labeled pieces. Each quarter piece was weighed. One piece of the graft was washed, dried, and reweighed once completely dry. The length was measured.

[0418] Next, 50 mL of water was added to the 15% PVP solution to make a 10% PVP solution. The above fabric treatment process was repeated with a 10% PVP solution.

[0419] Next, 150 mL of water was added to the 10% PVP solution to make a 5% PVP solution. The above fabric treatment process was repeated with a 5% PVP solution.

[0420] Result: 15% PVP profile.

[0421] [Table 3]

[0422] Table 3 shows that the time it took for the 15% PVP coated graft to dry completely in ambient air. It took more than an hour to coat, wash, and dry the grafts. After drying, the samples showed an average weight gain of 18.2g. Furthermore, the distribution of PVP in the samples was substantially consistent. Grafted samples or pieces 2 and 3 had slightly higher PVP levels. These pieces had graft seams on them, so the seams were probably more numerous. Therefore, the 15% PVP solution was When the PVP was deposited on the graft, about 15 to about 21 weight percent of the PVP was deposited on the graft.

[0423] Result: 10% PVP profile.

[0424] [Table 4]

[0425] Table 4 shows that the grafts coated with 10% PVP took only less than an hour to dry completely. It was shown that coating with 10% PVP solution, washing and drying also improved the graft length. The slightly elevated PVP in sections 2 and 3 caused a slight increase in the The lower wt% also indicates that the graft seams absorb more PVP than the rest of the graft. After drying, the samples contained an average of 14.4 weight percent Therefore, when immersed in a 10% PVP solution, the Amount of PVP was deposited on the graft.

[0426] Result: 5% PVP profile.

[0427] [Table 5]

[0428] Table 5 shows that the graft coated with 5% PVP took the least time to dry completely. and that the length did not seem to change after coating, washing, and drying. The PVP was slightly "sunk" at the bottom of the graft. When the polymer is immersed in a PVP solution of about 2 to about 8 weight percent of PVP is deposited on the graft. It was piled up.

[0429] conclusion The 15% PVP coated graft took approximately 25 minutes longer to dry. All of these concentrations were acceptable in terms of drying uniformity.

[0430] A variety of drying techniques are suitable for use in the present invention, including, for example, textile grafts and / or The fabric substrate is then dried at room temperature to remove the deposited maskant solution and / or sealant solution. One or more fans or other sources of air movement and / or a means for removing solvent from the liquid. Alternatively, forced air, such as by using a source of pressurized air, may be used to expedite drying. The controlled air, if any, may be applied at any suitable angle or combination of angles. The forced air may or may not flow into the lumen of the raft. For example, the forced air may flow into the lumen of the raft. Oriented perpendicularly, substantially perpendicularly, at an acute angle, and / or at an obtuse angle toward the outer surface of the Additionally, forced air may be directed toward the lumen of the tubular graft, e.g., The airflow may be directed toward one open end or from within the lumen of the tubular graft. The direction and amount of airflow spread can be adjusted to control drying time and also to affect the resulting graft. The forced airflow can also be directed toward the interior of the graft. This is useful in aiding migration of the masking agent away from the exterior of the graft. The masking agent preferably retracts upon drying. This prevents the masking agent from being absorbed into the interior of the graft. sealant on the exterior of the woven graft, helping to block sealant migration towards This will help fix the material. However, the present invention does not rely on the use of air as the drying medium. Other suitable media may be used, including, but not limited to, gaseous media. The drying is not limited to, and high drying temperatures above room temperature may be suitably used.

[0431] Additionally, fluids such as water, including hot water, may be used in the present invention as described below. The use of hot water helps remove the water-soluble masking agent from the textile. It may also aid in the curing of the grease or sealant.

[0432] Additionally, drying and / or curing of the sealant material may also be accomplished by forced air or other media, ambient air, or other suitable means. Compressed air or other medium, heated forced air or other medium, unforced ambient air or other medium, unforced The cure time of the sealant material can be controlled using heated air or other media. Not only can the properties of the sealant layer be controlled to some extent, but the properties of the sealant layer can also be controlled to some extent. As the sheet expands, it shrinks around the outer surface of the woven substrate, e.g., the woven graft. Runt materials can be selected, dried or cured, and / or selectively deposited.

[0433] Masking agent removal test Various washing methods for grafting were investigated to determine which method could extract the highest level of PVP. Determine whether the method selected affects graft length and crimp. I went there to

[0434] Two cleaning methods are considered: an Ultrawave ultrasonic bath and a domestic washing machine.

[0435] procedure Part 1: No sealant coating To determine whether 100% of the PVP could be removed by the selected cleaning method, To test this, the test was first performed on six grafts that were not coated with silicone. Ta.

[0436] Prepare the graft by cutting a commercially available woven fabric graft approximately 6 x 60 mm in length. All six grafts were measured, weighed, and marked with a lateral notch. A PVP solution was made with 15 g of PVP and 100 mL of water. All six samples were All six samples were submerged in 15% PVP in solution. Dry vertically. All dried samples were weighed.

[0437] The ultrasonic bath was set to 40°C. Samples 1, 2, and 3 were submerged in the ultrasonic bath. Samples 1 to 3 were placed in an ultrasonic bath for 15 minutes. The samples were removed from the bath and dried vertically near a fan. One to three dried samples were measured. The weights were measured and their lengths were recorded.

[0438] Samples 4, 5, and 6 were placed in a laundry bag and then placed in a washing machine. The wool wash setting was set at 800 RPM for 51 minutes. Samples 4-6 were removed from the washing machine. Samples 4 to 6 were weighed and their lengths were recorded.

[0439] Part 2: Silicone in Heptane Sprayed Sealant Coating Samples 1 to 3 were again washed, dried, measured, and weighed. All six samples were placed in a 15% PVP solution and then suspended near a running fan. The dried sample was weighed.

[0440] All six samples were stretched and sprayed with a silicone in heptane coating. The six samples were then allowed to return to a relaxed state under a fume hood and allowed to dry. The ultrasonic water bath was set at 40°C. After drying, samples 1 to 3 were heated for 15 minutes. The samples were then removed from the bath and dried vertically near a fan. The dried samples 1 to 3 were weighed, and their lengths were measured and recorded.

[0441] After drying, Samples 4 to 6 were placed in a laundry bag and then placed in a washing machine. The wool wash setting was set at 0°C, 800 RPM, and 51 minutes. The samples were removed from the washing machine. After drying, samples 4 to 6 were weighed, their lengths were measured, and the results were recorded. It was recorded.

[0442] result

[0443] [Table 6]

[0444] The majority of the samples placed in the washing machine had PVP removed, while the samples placed in the ultrasonic bath All of the samples collected still had some traces of PVP on the samples after washing. had.

[0445] [Table 7]

[0446] Some PVP remained on the grafts that had been placed in the washing machine, but was removed by washing in an ultrasonic bath. In contrast to the grafts that were removed, significantly less PVP was left on them. More than 0 weight percent of the PVP was removed. In fact, in all cases, about 95 weight percent was removed. Over 100 PVPs have been eliminated.

[0447] In Table 7, the weight ratio of PVP to silicone applied ranged from about 2.5:1.0 to about 4. Conversely, the weight ratio of silicone to PVP applied varied from about 0.40:3.0. It varied from 1.0 to approximately 0.23:1.0.

[0448] Further ratios are set out in Table 11 below.

[0449] The ratios set forth in Tables 7 and 11 are non-limiting.

[0450] The weight ratio of PVP (or other masking agent) to silicone (or other sealant agent) is: Approximately 10:1 by weight PVP (or other masking agent) to by weight silicone (or other sealant) masking agent) to about 0.01:1 by weight PVP (or other masking agent) / by weight silicone (or other sealant), preferably about 1:1 by weight PVP (or other masking agent) / weight Amount of silicone (or other sealant) to weight of PVP (or other masking agent) is about 0.05:1. silicone (or other sealant), more preferably about 0.5:1 by weight. Weight PVP (or other masking agent) / weight silicone (or other sealant) ~ approx. 0 May vary from 1:1 weight PVP / weight silicone.

[0451] Conversely, the weight of silicone (or other sealant) to PVP (or other masking agent) The ratio is about 0.1:1.0 by weight silicone (or other sealant) / by weight PVP (or Other masking agents) to about 100:1 by weight silicone (or other sealant) / weight P VP (or other masking agent), preferably about 1:1 by weight silicone (or other sealant) Masking agent) / weight PVP (or other masking agent) to weight silicone (or other silicone) of about 20:1 masking agent) / weight PVP (or other masking agent, more preferably about 2:1 weight ratio Polycorn (or other sealant) / weight PVP (or other masking agent) ~ approx. 10:1 weight Varies by weight of silicone (or other sealant) / weight of PVP (or other masking agent) obtain.

[0452] Mask and dye test material Fabrics - 22mm diameter, flat tube twill and 10mm diameter, crimped twill. Silicone - NuSil Med16-6606 (temporary implant grade). Solvent - n-heptane, silicone dispersion 50:50. Dye - Easy Composites Royal Blue Pigment for RTV Silicones , mixed with about 10% silicone solids.

[0453] Sample Description For flat 22 mm fabric samples, the following maskant formulation was used: #71A-Unprocessed fabric #71B - 6% PVP #71C - 6% PVP + 1.5% glycerol (by volume of mask solution) #71D - 6% PVP + 1.5% glycerol + 4% PVP (total 10% PVP) ).

[0454] Flat fabric samples #71B to #71D were immersed in the PVP solution and then removed. All #71 samples were mounted on a hanging mandrel (after masking, before coating). ).

[0455] For crimped 10 mm diameter fabric samples, the following masking agent formulation was used: Ta: #70A - Untreated fabric #70B - 6% PVP #70C - 6% PVP + 1.5% glycerol (by volume of mask solution) #70D - 6% PVP + 1.5% glycerol + 4% PVP (total 10% PVP) ).

[0456] The crimped fabric samples #70B to #70D were immersed in the PVP solution and then removed. The #70 sample was mounted on a hanging mandrel (after masking, before coating).

[0457] Preparation of masking agent The masking agents were prepared using the same method as described above, except that Samples B and C (# For sample D (both #70 and #71), glycerol was added, and then sample D (both #70 and #71) For both #71) there was an additional step of adding more PVP.

[0458] The target weight of PVP was weighed into a plastic beaker on a balance. 100 ml A masking agent solution of 4 g was prepared, for which a target mass of 4 g of PVP was required (4% (concentration). Weigh the target volume of deionized water into a 100 ml plastic measuring cylinder. To prepare 100 ml of mask solution, a target volume of 96 ml is required. Deionized water was added to the PVP in a plastic beaker. The beaker was placed on a magnetic stirrer. Rotate the stirrer at a speed of 350-450 RPM to ensure that the stirrer is in the center of the beaker. Stirring was carried out at room temperature until the PVP solute was no longer visible or at least slightly Stirring was continued for at least 2 minutes. After stirring, the masking agent solution was and used for graft preparation, Sample B.

[0459] An additional step was used for sample C, namely the addition of glycerol. Place the cuber back on the balance, tare it, and add the required amount of glycerol as the masking agent. The target glycerol content was 1.5% by volume of the masking agent solution. This corresponded to a target weight of 1.5g (note: this was a 25% glycerin to PVP ratio). The beaker was placed on a stirrer and stirred for at least 2 minutes. This masking agent solution was used for Sample C.

[0460] Further steps were taken for Sample D, i.e., further PVP. Place the weigher back on the balance, tare it, and add the required amount of PVP to the masking agent solution. The target PVP content was 10% by volume of the mask solution. This was equivalent to adding PVP (Note: This resulted in a (The ratio was effectively reduced from 25% to 15%). Used for D.

[0461] Preparation of sealant The silicone sealant dispersion as supplied had a solids content of 30% and the dispersion was It was diluted with an additional 100% solvent, which reduced the solids content to 15%. , blue dye is added to the silicone dispersion to improve the coverage and penetration depth of the silicone into the fabric structure. gave a visual indication of

[0462] In particular, 20 ml of the silicone dispersion is measured from its container as supplied and poured into a The mixture was placed in a plastic beaker. An additional 20 ml of n-heptane solvent was added. Place in a beaker, place on a balance, tare, and add a few drops of dye. The recommended dye concentration range is 0.3% to 5%, depending on the section thickness. Therefore, a target of 5% was set to obtain a strong blue color for visualization. The deviation from the target was due to a calculation of 30% solids instead of 15%; Therefore, the actual concentration of dye to silicone was 10% instead of 5%.

[0463] Sample preparation Individual samples were prepared with maskant formulations according to the table below.

[0464] [Table 8]

[0465] Samples B to D were immersed in the masking agent solution as shown in the table above. held diametrically by the plugs at the ends, but not internally supported. The inner surface of each fabric was then inspected for mask performance, positioning, and There was no contact with the mandrel so as not to affect the density.

[0466] Dispersion drop evaluation was performed as described below.

[0467] Each sample was completely coated with at least two coats of the silicone dispersion. There was no concern of a lack of silicone during evaluation, and sufficient silicone was present to provide suitable coverage. The brush coating was applied approximately once. The grafting was performed by rotating in a rotisserie at 1000 rpm / sec. The grafting was performed for solvent evaporation. The graft was left overnight at RT. The graft was left for the recommended 72 hours to fully cure. The graft was then removed from the mandrel for cleaning. The graft was then placed in a protective bag and left for approximately 2 hours. Tumble Machine Wash cycle at 95°C for 30 minutes .

[0468] The samples were masked, coated, washed and cut flat.

[0469] Dispersion dripping evaluation Before full coating, one drop of polymer dispersion was applied to each sample and masked. To visually assess whether there were any significant differences in the behavior of the dispersions on the selected fabrics, video It was recorded at.

[0470] Sample A - No mask. Slow spreading of a drop of polymer dispersion across the fabric. It appeared to soak into and through the fabric.

[0471] Sample B - 6% PVP mask. Rapid spreading of a single drop of polymer dispersion across the fabric. It appeared to spread more easily into and through the fabric than soaking.

[0472] Sample C - 6% PVP + 1.5% glycerol mask. 1 drop of polymer dispersion The first drop had a rapid spread across the fabric. The second drop of one drop of polymer dispersion was uncertain, possibly due to the hanging fabric holding the pool.

[0473] Sample D - 10% PVP + 1.5% glycerol mask. Indeterminate - Possibly pro This is due to the hanging fabric that holds the cord in place.

[0474] Dispersion drip evaluation across the surface of the graft Sample A - No mask. Slow spreading of a drop of polymer dispersion across the fabric. It seemed to soak into the fabric.

[0475] Sample B - 6% PVP mask. Rapid spreading of a single drop of polymer dispersion across the fabric. The coating was more uneven with pooling of dispersion in the valleys.

[0476] Sample C - 6% PVP + 1.5% glycerol mask. The fabric was immersed in the dispersion. He clearly resisted.

[0477] Sample D - 10% PVP + 1.5% glycerol mask. The fabric was immersed in the dispersion. clearly resisted.

[0478] In summary, this dispersion droplet evaluation was performed using a lower concentration of masking agent (Sample B, 6% Even the masked fabric (PVP) elicited a significantly different response when compared to the unmasked fabric. This showed that it seemed that

[0479] The "pooling" effect was observed in the flat fabric, samples 71C and 71D, where excessive dispersion was present in the fabric. This effect was most likely the result of an inability to wick from or through the fabric. This is probably also evident in the crimped fabrics, especially samples 70B and 70D, and the valleys There is a pool of dispersion in the mask, which makes the color / coverage look much more uniform. Unlike sample 70A, which does not have a chromatic aberration, this is highlighted by a darker color.

[0480] Sealant Coverage and Penetration Evaluation After a wash cycle to remove the masking agent, the graft is cut longitudinally to expose the inner surface. The inner and outer surfaces of each graft were visualized by light microscopy: (b) exterior - to verify the presence and uniformity of the sealant coating; (c) interior - to inspect the fabric. To check for the presence or penetration of blue silicone through or between the yarn filaments; and c) Cross section - to assess the level of penetration through the yarn bundle.

[0481] result Both unmasked samples showed that the dyed blue silicone dispersion had penetrated the yarn bundle and was applied to the inner surface. While the application of the mask appeared to allow the It appears to have prevented an intrusion.

[0482] [Table 9]

[0483] Photographs of crimped fabric sample 70D are shown in Figures 10a-10c. 10a-10c are photographs of a portion of the cross section of the tubular wall of fabric sample 70D. The fabric sample or woven graft 30 has an outer woven surface 32 and an opposite inner woven surface 33. 4, and a fabric wall 36 disposed therebetween. As shown in FIGS. 10a and 10c Additionally, a sealing layer or coating 38 is disposed over the exterior surface 32. As shown in Figure 1a, the sealing layer or coating 38 extends to a portion of the fabric wall. As shown in 10a and 10b, the inner surface 34 is substantially (e.g., completely) formed from a sealing layer. Or does not include coating 38.

[0484] Figure 11 shows the dry 40% PVP masking agent concentration applied to grafted sample 40. The dried masking agent slurry is shown in a micrograph or scanning electron microscope (SEM) at various temperatures. The ribs 44 gathered and encapsulated the thread structure 42 and had cracks 46. The maskant provides a permanent attachment or encapsulation to this surface, completely encapsulated by the masking agent. It is clear that this will not be possible.

[0485] The masking agent solution can mask the entire yarn bundle and individual yarn fibers depending on the concentration of the masking agent solution. As shown in FIG. 11, the masking agent solution with higher concentration (i.e., water) PVP (more than 30% w / w, PVP glycerol (more than 20% w / w) in the The viscosity appears to be too high to penetrate and coat the individual fibers. The masking solution dries as a highly viscous, brittle mask layer, as shown in Figure 11. Many samples develop microcracks 46 through the masking layer 44. Low liquid concentrations (less than 10% w / w PVP, with or without glycerol in water) The masking agent may encapsulate the yarn bundles and individual fibers, but at low concentrations A limitation of using solutions is the lack of complete and consistent coverage around each yarn bundle and / or fiber. In this case, portions of the fiber are exposed to a surface for potential sealant bonding. Some results show that the sealant is able to penetrate the masking agent using a low concentration solution. The masking layer is shown to encapsulate and capture the masking layer; therefore, the masking is completely removed from the final product. The key to a suitable masking solution that works is the The goal is to have a controlled application process with a target concentration for each application.

[0486] The overall mechanism of masking agents can be divided into two main concepts depending on the size of the void or gap: May include: (1) macro pathways (i.e., voids between fiber bundles) ), and (2) micro pathways (i.e. The chemical influence on the voids between the fibers and in the microcracks in the masking layer sound.

[0487] (1) Physical effect: Filling of the macro-paths is caused by the masking agent solution filling the large gaps between the yarn bundles. It is based on the physical ability to penetrate and flow. The fiber bundles are completely encapsulated in the masking agent layer. When the masking agent is applied, the masking agent layer fills the gaps between the yarn bundles and blocks the penetration of the masking agent into the yarn bundles. The sealant then fills these gaps, creating a gap between each thread. It will not be able to penetrate into the tracts or micro-channels between the individual fibers.

[0488] (2) Chemical effects: For micro-pathways throughout the fabric, the micro-pathways are masked This refers to either microcracks within the fiber layer, microvoids between the yarn bundles, or microvoids between individual fibers. Regardless of the chemical repelling effect or ability of the masking solution to repel the sealant The repulsion mechanism prevents the sealant from filling microscopic voids. This occurs when the masking layer comes into contact with or approaches the hydrophilic masking layer. The theory of solution solubility and solubility parameters developed by Joel H. Hildebrand The SI Hildebrand value (δ[SI]) is the value of the masking solution. and sealant solubility parameters are determined by their specific solvents when they come into contact with each other. Handbook of Solubility Masking solution as shown in Parameters, CRC Press, 1983 The solvents in (water and glycerol) are at the hydrophilic end of the solubility parameter range, while the The solvent (heptane) is at the opposite end of the solubility parameter range. δ[SI] of glycerol is 36.2, and δ[SI] of n-hepta The δ[SI] of α is 15.3.

[0489] Thus, the masking agents of the present invention have both a physical mechanism (e.g., blocking) and a repulsion mechanism. Therefore, the solvent is about 20δ[SI ], for example, a sealant having a solubility parameter of about 10δ[SI] to about 20δ[SI] and solvents with a δ[SI] of more than about 30, for example, from about 30 to about 50. It may be desirable to use a maskant solution with solution parameters.

[0490] conclusion The use of blue dye in silicone dispersions provides an excellent visual assessment of silicone penetration into fabric. Both samples coated without prior mask application showed no significant difference in the inner fabric. All three maskant formulations showed significant penetration of the blue silicone sealant through the The material appeared to substantially prevent silicone from penetrating the interior surface.

[0491] Silicone seal testing on commercially available vascular grafts. The following equipment and materials were used to test the seal of a commercially available graft in accordance with the present invention: Used. Commercially available grafting of 8mm crimped polyester fabric Commercially available grafting of 14mm crimped polyester fabric Polyvinylpyrrolidone (PVP) powder NuSil MED-6606 RTV Silicone N-Heptane Royal Blue Pigment Deionized water Magnetic stirrer.

[0492] Coating Variability The following values ​​were used in testing the sealing technology according to the present invention: The PVP concentrations in deionized water were 1%, 2%, 4%, 6%, 8%, 10%, and 1% by weight. It is varied by 5%, 20%, 25%, and 30%. The glycerol and silicone dispersion concentrations were adjusted to 4%, 8%, 15%, and 30% PVP concentrations. Glycerol concentrations were used at PVP concentrations of 5%, 15%, and 30%. These concentrations were the percentage of glycerol to PVP.

[0493] The PVP, glycerol, and silicone variations tested were as follows:

[0494] [Table 10]

[0495] Sample preparation Each sample was prepared from a section of commercially available graft. The graft was first prepared by First cut to length by fully stretching and removing the crimp, then mm long sections were cut with a single-edged razor. Each sample was weighed.

[0496] Preparation of masks A measured amount of deionized water was placed in a 100 ml plastic beaker. The stirrer was placed in deionized water. While stirring, PVP and glycerol (if (if any) was added. Stirring was continued until no more solute was visible.

[0497] Preparation of masking agent The grafted sample was immersed in the mask solution until the sample was completely coated inside and out. Coat the graft sample by stirring the graft with a gloved hand to did.

[0498] After the graft was completely coated, excess mask solution, if any, was removed. Each graft was attached to a mandrel using cable ties. One end is secured to the mandrel with a cable tie, and the graft is then stretched to its full extended length. The graft was stretched to 60% of its original length (108 mm) and the other end of the graft was secured to the mandrel with another cable tie. The mandrel was then placed horizontally on a rotating mount and allowed to air dry. After drying, the masked graft was weighed.

[0499] Preparation of sealant The silicone dispersion was supplied as 30% solids. An additional amount of n-heptane was added. In addition, the solids were reduced to 22.5% and then to 15. A blue dye was added to the silicone dispersion. I got it.

[0500] Applying the sealant The mandrel with the graft attached is rotated to slowly rotate the graft. Apply the sealant to the paint block, starting at one end and working your way to the other end. This was repeated until there was no excess sealant dispersion on the graft. After applying the desired level of silicone onto the graft, the graft was transferred to a rotation mount. After drying, the sealed graft was weighed.

[0501] Removal of masking agent After the graft was completely dry, the masking agent was removed. The graft was then washed in a washing machine at 90°C. This was done by washing with water (without detergent), which dissolved the PVP in water. The temperature of 90°C also prevented the complete hardening of the silicone. When the washing was complete, the graft was hung up to air dry. The completed graft was then weighed.

[0502] Silicone adhesion A good coating is achieved if the graft coating maintains its integrity under high pressure. Graft adhesion can also be demonstrated. The majority of the circumferential stress is on the stiffer fabric material of the graft. Therefore, pressure can be used as a measure across all sizes of grafts. The structure of the graft does not affect the silicone coating, as it does not change the diameter of the graft. Most of the force that peels off the silicone coating occurs in the gaps between the fiber bundles. The area, and therefore the forces acting on it, are then consistent. Regardless of the size of the raft, the same pressure will create the same force, pushing the silicone coating Peel off.

[0503] To ensure that the position of the bundles within the fabric is as uniform as possible across all diameters, To do this, the fabric is decrimped, allowing the graft to reach its full extension. When doing this, the pressure applied is equal to the pressure required to fully stretch the graft. This pressure is different for each size of graft and may require further adjustment to fully secure the graft. The grafts requiring the most pressure to stretch (i.e., those with the smallest diameter) Once this worst case pressure is determined, the factor of safety (FOS ) is applied and this FOS correction is used as the minimum requirement for all grafts. The grafting is performed without any visible signs of coating delamination (bubbles). If it can be pressurized to this FOS corrected pressure, the coating will have sufficient and acceptable adhesion / It can be assumed to have completeness.

[0504] One method for testing peel is as follows: ·Connecting the graft to the pressure rig to ensure one end is sealed; · Apply pressure gently to the graft; · Stop at 120mmHg (critical pressure) and look for signs of delamination (bubbles); Measure the leakage rate and express it in mm / cm 2 Record in minutes; · Gradually increase the pressure until the FOS correction number is reached; If signs of delamination are visible at any time, stop the test and mark as fail; Hold the FOS corrected pressure for 1 minute; and If no signs of delamination are present, mark the graft as pass.

[0505] The following pressure tests were performed: The graft was then placed on the graft to observe if there was any sign that the silicone had lost its bond. The lid was pressurized with water. The pressure was slowly increased to a maximum pressure of 600 mmHg. The adhesion was recorded as follows: 0 - silicone is well adhered to the graft and shows no signs of failure; 1 - the graft reached maximum pressure, but the leak rate increased obviously; 2 - The silicone coating begins to break down, showing gushes of water coming out of the graft; and 3- The silicone coating is damaged and bubbles are visible on the surface.

[0506] Penetration Depth The effectiveness of the mask was determined by how much silicone soaked into the fabric. Alternatively, the silicone may remain on the outer surface of the graft and not penetrate excessively into the graft structure. If the masking agent is not effective, the silicone will be visible within the fabric and at the inner edge. To visualize this, the grafts were cut longitudinally and the cross sections were examined at high magnification. .

[0507] Penetrance was shown as follows: 0 - silicone visible only on the outer surface of the graft; 1 - Silicone is visible between the fibers of the graft, but only up to 50% of the thickness ; 2 - Silicone is visible penetrating the inner surface; and 3 - Silicone is visible everywhere and the entire graft structure is blue in color.

[0508] Summary of test results

[0509] [Table 11]

[0510] The ratio of sealant to maskant on a gram-for-gram or dry weight basis is from about 1:1 to about Useful ratios ranged from about 2:1 to about 20:1 (about 2:1 to about 70:1) on a dry weight basis. This also includes sealant to maskant ratios of about 10:1. The ratio is non-limiting. Silicone (or other sealant) to PVP (or other The weight ratio of silicone (or other sealant) to the masking agent is about 0.1:1.0. Masking agent) / weight PVP (or other masking agent) to weight silicon (or other masking agent) in a ratio of about 100:1 masking agent) / weight PVP (or other masking agent, preferably silicone) in a ratio of about 1:1 by weight. PVP (or other sealant) / weight PVP (or other masking agent) ~ approximately 20:1 weight sealant Polycorn (or other sealant) / weight PVP (or other masking agent, preferably The ratio is approximately 2:1 by weight silicone (or other sealant) to weight PVP (or other masking agent). About 10:1 by weight silicone (or other sealant) / by weight PVP (or other sealant) May vary with masking agent.

[0511] [Table 12]

[0512] The results, presented in order of PVP masking agent concentration, indicate that higher levels of PVP and The results showed a clear correlation between the reduced penetration of silicone sealant into the lumen of the sample and the increased penetration of the silicone sealant into the lumen of the sample.

[0513] Generally, PVP mask concentrations of 10% or more result in bulk silicone thicknesses of more than 50% of the fabric thickness. In some samples, they were formed by warp and weft bundles. Small "fingers" of silicone evident between the yarn bundles in the gaps between The silicone in these gaps was the It occupied a very small percentage of the total inner surface area.

[0514] [Table 13]

[0515] The results above, presented in order of PVP masking agent concentration, indicate that higher levels of PVP and The results show a clear correlation between the reduced adhesion of silicone sealants to the Two mechanisms for penetration into the inner surface of the fabric have been observed: through the yarn bundle fibers or through the yarn. Either by passing through gaps in the bundle. (>4% PVP) appeared to inhibit the flow of polymer through the yarn fibers, but all In some cases, the gaps in the bundle, i.e., the closely juxtaposed yarns in the weave pattern, The penetration of small "fingers" or "slivers" of silicone polymer into the gaps between the Slightly higher concentrations of masking agent (>15%) were not sufficient to substantially prevent the fiber bundles from required to completely block the passage of silicone polymer through the gaps in It seemed that way.

[0516] Handling evaluation The handling characteristics of the graft depend on the fabric structure, graft diameter, crimp pitch number and configuration, and A series of complexities between the thickness profile of the polymer sealant and the amount of sealant penetration into the yarn bundle were investigated. It is the result of complex interactions.

[0517] The following evaluation parameters, while subjective, are intended to consider all of the following: The bending radius, flexibility, and circumferential stiffness (ability to remain fully open) when twisted are considered. force) and elongation.

[0518] Handling characteristics were evaluated using a rating score (1–4); The 1-graft was judged to be more flexible than the reference sample. The 2-graft was judged to be equivalent to the reference sample. The 3-graft was judged to be stiffer than the reference sample, but had usable properties. there was. 4- The graft was deemed too stiff for comparable use.

[0519] The reference sample has excellent overall handling and is comparable to currently commercially available gelatin seals. The grafts were considered to be at least equivalent to those obtained by the procedure.

[0520] Polymer sealant coating The amount of polymer sealant coverage on each sample was expressed in mg / cm 2 Reported in units of The total mass of polymer applied to each graft is divided by the surface area of ​​the graft. The previous crimp prototype was calculated as about 14 mg / cm 2 At least in the range Approximately 8 mg / cm 2 polymer coating that provides both an effective seal and good handling properties 14mg / cm 2 Coverage levels exceeding those of standard gelatin-sealed grafts Although the overall stiffness of the handlebars increased beyond that of the original, the increased stiffness and therefore An added amount of polymer coating may be advantageous in some graft applications.

[0521] Tensile elongation force The sample was placed between the jaws of a Lloyd tensile testing machine with jaws spaced 80 mm apart. The machine was zeroed and the jaws were extended by 20% (16 mm) to the maximum measurement. The force was recorded.

[0522] The recorded results are shown below and are for a 20% force-to-extend ) are listed in order from lowest to highest.

[0523] These results demonstrate a strong correlation between handling ratings and extension force, with lower extension forces This corresponds to improved handling characteristics.

[0524] The polymer coating value was examined using the reference sample, as shown by graft sample #15. 40 mg / cm to achieve handling characteristics equivalent to that of Grade 2 2 Up to coating level Bell showed that it was conceivable.

[0525] All grafts that exhibited polymer sealant delamination during the pressure adhesion test were This list shows that low adhesion leads to low elongation and improved The results show that acceptable handling properties can be achieved by This supports the theory that the sealant is due to a lower level of penetration into the bundle. .

[0526] [Table 14]

[0527] conclusion Acceptable handling properties are achieved with a lower level of penetration of the sealant into the yarn bundle. The use of masking agents to limit the amount of polymer penetration into the fabric has been shown to improve It can be used for its handling properties. As evaluated by surgeon users, 40 mg / cm 2 It was found that polymer coating levels up to 100% achieved handling properties comparable to the reference sample. It was proven that:

[0528] Photographs of selected samples from Tables 10-14 are reproduced in Figures 12-19. A description of these figures follows.

[0529] Figures 12 and 13 are SEM photographs of Sample 2 from the table above. Sample 2 is It had the following characteristics: Masking solution: 2% PVP, 0% glycerol in water; Silicone Dispersant: 15% silicone in heptane; Silicone coating: 41 mg / cm 2 ; Silicone penetration rating: 3 (silicone visible); Silicone Adhesion Rating: 0 (Silicone is well adhered to the graft with no signs of failure) not shown); Leakage measured at 120mmHg: 0ml / min; Leakage measured at 600mmHg: 0ml / min; Handling rating: 3 (The graft was judged to be stiffer than the reference, but still had usable properties) had); and Tensile force to stretch the graft by 20%: 1.112N.

[0530] FIG. 12 is an SEM photograph of a cross section of the woven fabric 50 of Sample 2. The outer surface 52 of the woven fabric 50 is The fiber bundle 58A was completely coated with silicone sealant 56. The silicone sealant was applied to the fiber bundle or multifilament. 13, the inner woven surface 54 also has a cross section of the yarn 58. The fiber bundles 58 had a significant amount of silicone sealant 60 .

[0531] Figures 14 and 15 are photographs of Sample 9 from the table above. Sample 9 has the following characteristics: Had the following characteristics: Masking solution: 25% PVP, 0% glycerol in water; Silicone Dispersant: 15% silicone in heptane; Silicone coating: 41 mg / cm2 ; Silicone permeability grading: 0 (silicone visible only on the outer surface of the graft); Silicone adhesion rating: 3 (peeled off, silicone coating is damaged, Bubbles were seen on the surface); Leakage measured at 120 mmHg: exfoliated; Leakage measured at 600mmHg: exfoliated; Handling rating: 1 (the graft was judged to be more flexible than the reference sample); and Tensile force to stretch the graft by 20%: 0.571 N.

[0532] FIG. 14 is a photograph of a cross section of the woven fabric 50 of Sample 9. The outer surface 52 of the woven fabric 50 is made of silicone. The individual fabric bundles 58 were completely coated with silicone sealant 56. However, as indicated by the voids in the peeling, There was peeling of the silicone sealant 56 from the fabric fibers. Additionally, the inner fabric surface 54 and all fiber bundles 58 therein are coated with a significant amount of silicone sealant. It did not contain citronellol 60.

[0533] Figures 16 to 18 are SEM photographs of Sample 7 from the table above. Sample 7 has the following characteristics: It had the following characteristics: Masking solution: 15% PVP, 0% glycerol in water; Silicone Dispersant: 15% silicone in heptane; Silicone coating: 40mg / cm 2 ; Silicone penetration rating: 2 (silicone is visible inside the material) ); Silicone Adhesion Rating: 0 (Silicone is well adhered to the graft with no signs of failure) not shown); Leakage measured at 120mmHg: 4ml / min; Leakage measured at 600mmHg: 14ml / min; Handling rating: 2 (the graft was judged to be equivalent to the reference sample 64B); and Tensile force to stretch the graft by 20%: 0.541 N.

[0534] FIG. 16 shows an SEM photograph of a cross section of the woven fabric 50 of Sample 7. As shown in FIG. The fabric fiber bundles 58 on the outer fabric surface 52 are infiltrated with the silicone sealant 56, The woven fiber bundles 58 on the inner woven surface 54 are impregnated with a silicone sealant 60. As shown in Figures 17 and 18, the silicone sealant 56 did not contain any external The inner fabric surface 54 penetrated and encapsulated the fabric fiber bundles 58. The fiber bundles 58 did not contain silicone sealant 56 .

[0535] Figure 19 is an SEM photograph of Sample 15 from the table above. Sample 15 has the following characteristics: It had the following characteristics: Masking solution: 15% PVP, 5% glycerol in water; Silicone Dispersant: 15% silicone in heptane; Silicone coating: 40mg / cm 2 ; Silicone penetration rating: 2 (silicone is visible inside the material) ); Silicone Adhesion Rating: 1 (The graft reached maximum pressure, but the leak rate was not significant) increased to); Leakage measured at 120mmHg: 3ml / min; Leakage measured at 600mmHg: 22ml / min; Handling rating: 2 (the graft was judged to be equivalent to the reference sample 64B); and Tensile force to stretch the graft by 20%: 0.719 N.

[0536] 19 is an SEM photograph of a cross section of the woven fabric 50 of Sample 15. Silicone sealant 56 encapsulated the outer fibers of the fiber bundles 58 at the outer fabric surface 2. The fiber bundles 58 did not contain any silicone sealant 56 penetration. The sealant (not shown) was visible on the inner surface 54.

[0537] Glycerol hydration of masking agents The use of glycerol in different masking agent formulations hydrates the (PVP) masking agent. or plasticizing the yarn structure, coating and filling the yarn structure and preventing the sealant dispersion from penetrating the interior surface. It has been demonstrated in multiple formulations with the aim of improving the performance of

[0538] Masking agent sample preparation The masking agent was prepared using the following method: A target weight of PVP (molecular weight 10,000) was introduced into a plastic beaker on a balance. 100 ml of masking agent solution was added to the target mass of 10 g of PVP (10% concentration). The target volume of deionized water was introduced into a 100 ml plastic measuring cylinder. A target volume of 90 ml was required. Deionized water was added to a plastic beaker. The magnetic stirrer rod was placed in the water and the beaker was placed in a magnetic stirrer. The mixture was placed on a magnetic stirrer. The magnetic stirrer was rotated at a speed of 350-450 RPM. The beaker was rotated and a stirrer was placed in the center of the beaker. Stirring was carried out at room temperature. The PVP solute was visible. Stirring was continued for at least 2 minutes until the masking agent solution could no longer be stirred. After stirring, it was removed from the stirrer and used for control sample preparation.

[0539] An additional step was used for subsequent samples to which glycerol was added. Place the beaker back on the balance, tare it and add the required amount of glycerol to the mass. The target glycerol content was calculated as a percentage by mass in PVP. The target weight of glycerol added at each stage was 1 g, which corresponds to cumulative weights of 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 g. After each addition of the amount of ethanol, each beaker was stirred for at least 2 minutes.

[0540] A summary of the samples prepared is given below.

[0541] [Table 15]

[0542] Dispersion Drop Casting Three individual drops of each maskant formulation were cast onto a dark sheet and allowed to dry. Visual observation was allowed. Drying was accelerated by using a table fan at room temperature.

[0543] The masking agent after drying was evaluated as follows:

[0544] [Table 16]

[0545] conclusion The control maskant formulation (e.g., PVP only) dried completely and became brittle within a few hours. The use of this PVP-only masking agent resulted in a stiff, flaky surface after the mask was applied and dried. The use of 10% glycerol can result in a grafted structure with a PVP masking agent. Helped hydrate the solution, which appeared dry after 12 hours. 20% glycerol The masking agent solution consisting of retained some hydration and was soft / touchable at 12 hours. The amount of glycerol in the range of about 1% to about 30% of the PVP on a weight basis can be , provide suitable ranges for use in the present invention.

[0546] Furthermore, the present invention is not limited to conduit-type vascular prostheses. and masking agents, including medical and non-medical (e.g., non-implantable) textiles. It can be suitably used in other textile products. Other medical products include an auxiliary artificial heart, an artificial heart, etc. Examples include conduits, medical sheets, patches, meshes, etc. Non-medical textiles include limited Although not widely used, it is widely used in clothing, geotextiles, transportation textiles, military and / or Protective textiles, safety and / or protective textiles, sports and / or recreational textiles Furthermore, textiles are not limited to tubular conduits, but may also include, for example: Sheets and / or tapes (e.g., two-dimensional products) or three-dimensional shapes other than duct-shaped products The product may be of any shape including but not limited to:

[0547] Polymeric materials and / or fibers useful for non-medical or non-implantable textiles include, but are not limited to: However, polyethylene terephthalate (PET), polytetrafluoroethylene (P TFE), expanded polytetrafluoroethylene (ePFTE), polyolefin, polyester ester, poly(ether amide), poly(ether ester), poly(ether urethane) , poly(ester urethane), poly(ethylene-styrene / butylene-styrene), and Other block copolymers useful in the non-medical or non-implantable fabrics of the present invention include: Animal fibers include, but are not limited to, wool, alpaca, angora, mohair, llama, and kale. Useful natural fibers include, but are not limited to, linen, cotton, and silk. Examples include tung bamboo, hemp, corn, nettle, and soybean fiber.

[0548] The maskant and / or sealant may be applied by brushing, spray coating, or dipping. or by dipping, etc. However, the present invention is not limited to such techniques. However, other techniques such as chemical deposition, evaporation, chemical vapor deposition, physical vapor deposition, printing, etc. may be suitably used. These techniques are generally suitable for medical textiles. However, non-medical textiles Other techniques may also be used for large-scale commercial fiber production, including, for example, textile sheets. The coating and / or masking material for the substrate is applied by a squeegee type coater. coating, roller coating, knife coating, nip coating, dip coating It may be applied by coating, cast coating, chemical vapor deposition, vapor deposition, etc. , roller printing, stencil printing, screen printing, inkjet printing, risograph printing, 3 Printing techniques such as D-printing are also used in the present invention to apply the masking and / or sealant. Additionally, mechanical devices may be used to apply the masking agent and the tissue to the wall of the graft's textile substrate. For example, in vascular grafts, An inflatable balloon is provided to control the penetration depth of the masking agent into the graft wall. obtain.

[0549] Modifications may be made to the above embodiments within the scope of the present invention.

[0550] The following embodiments or aspects of the invention may be combined in any manner and combination: The following are included within the scope of the present invention:

[0551] Embodiment 1. A method of manufacturing a tubular graft, comprising: The inner surface and the outer surface of the opposite end are disposed between the first open end and the second open end. providing a woven fabric including a tubular wall defining an inner wall portion between one or more The fabric structure includes a woven structure of the above filaments or yarns, and the woven structure itself is permeable to liquids. There is a process and; applying a substantially water-soluble material to at least a portion of the tubular wall; applying a substantially water-insoluble sealant to at least a portion of the exterior surface of the tubular wall. Thus, the substantially water-insoluble sealant is configured to reduce fluid migration through the wall of the conduit. and wherein the water-soluble material is configured to reduce penetration of the sealant into the interior surface of the conduit. ,method.

[0552] Embodiment 2. The step of applying a water-soluble material to at least a portion of the tubular wall comprises applying the water-soluble material to 3. The method of claim 1, further comprising applying the coating to at least a portion of the inner surface of the tubular wall and a portion of the interior. How to post.

[0553] Embodiment 3. The step of applying a water-soluble material to at least a portion of the tubular wall comprises applying the water-soluble material to 3. The method of claim 1 or 2, comprising applying to at least a portion of the outer surface of the tubular wall. .

[0554] Embodiment 4. Any of the preceding embodiments, wherein the water-soluble material is a solution of the water-soluble material and a solvent. The method according to the embodiment.

[0555] Embodiment 5. The solvent is selected from the group consisting of water, a lower alcohol, and combinations thereof. 13. The method of any preceding embodiment, wherein

[0556] Embodiment 6. The solvent is at least partially dissolved prior to applying the substantially water-insoluble sealant. 10. The method of any preceding embodiment, wherein the

[0557] Embodiment 7. Removal of a small amount of water-soluble material by dissolving, abrading, peeling, disintegrating, and combinations thereof. 10. The method of any preceding embodiment, further comprising removing at least a portion of

[0558] Embodiment 8. The water-soluble material is polyvinylpyrrolidone, glycerol, methylcellulose , poly(ethylene glycol), poly(ethylene glycol) hydrogel, polyethylene any preceding embodiment, wherein the aryl group is selected from the group consisting of: The method described below.

[0559] Embodiment 9. The substantially water-insoluble sealant is moisture-curable, light-curable, heat-curable, white an anaerobic curing material selected from the group consisting of a gold catalyst, an anaerobic curing material, or a combination of these curing mechanisms; 13. The method of any preceding embodiment, wherein the polymer is a thermoplastic elastomer material.

[0560] Embodiment 10. The elastomeric material is silicone, polyurethane, polycarbonate, 10. The method of claim 9, wherein the polymer is selected from the group consisting of thermoplastic elastomers, and combinations thereof. How to post.

[0561] Embodiment 11. Substantially water-soluble coating or substantially water-insoluble coating One or more of the components may be selected from the group consisting of colorants, therapeutic agents, dyes, and fluorescent indicators. 10. The method of any preceding embodiment, further comprising:

[0562] Embodiment 12. The water-soluble material has a viscosity of about 6,000 g / mol to about 15,000 g / mol. 10. The method of any preceding embodiment, comprising polyvinylpyrrolidone having a molecular weight .

[0563] Embodiment 13. By applying a water-soluble material, a layer is formed on substantially all of the inner surface of the tubular wall. 10. The method of any preceding embodiment, wherein a

[0564] Embodiment 14. Any of the methods further comprising curing the substantially water-insoluble sealant. 2. The method according to any preceding embodiment.

[0565] Embodiment 15. Curing a substantially water-insoluble sealant; and then applying a water-soluble material.

[0023] The method of any preceding embodiment, further comprising removing at least a portion of the material. method.

[0566] Embodiment 16. The method further comprising removing substantially all of the water-soluble material from the interior surface of the tubular wall. 15. The method of embodiment 14.

[0567] Embodiment 17. Before applying the substantially water-insoluble sealant, at least one of the outer surfaces of the tubular wall is any of the preceding claims further comprising removing at least a portion of the water-soluble material from the 10. The method according to claim 9, wherein

[0568] Embodiment 18. Removing at least a portion of the water-soluble material is carried out at a temperature of about 15°C to about 140°C. 18. The method of any one of embodiments 15 to 17, wherein the temperature is

[0569] Embodiment 19. Removing at least a portion of the water-soluble material comprises applying a solvent thereto. 19. The method of any one of embodiments 15 to 18, further comprising the step of:

[0570] Embodiment 20. The method of embodiment 1, wherein the solvent comprises water, a lower alcohol, and combinations thereof. 9. The method according to claim 9.

[0571] Embodiment 21. The tubular fabric is agitated, rotated, spun, and shaken during removal of the water-soluble material. The method according to any one of embodiments 15 to 20, wherein

[0572] Embodiment 22. The removal of the water-soluble material is carried out by dissolving the water-soluble material, etching, or plasma etching. 22. Any of embodiments 15-21, including grinding, abrading, polishing, and combinations thereof. The method described in one.

[0573] Embodiment 23. The step of applying the water-soluble material comprises spraying the water-soluble material, dipping at least a portion of the tubular wall into a solution of a water-soluble material;

[0023] The method of any preceding embodiment, further comprising:

[0574] Embodiment 24. Any of the preceding embodiments, wherein the substantially water-insoluble sealant is a polymer solution. The method according to any one of the embodiments.

[0575] Embodiment 25. The method of embodiment 24, wherein the polymer solution comprises an organic solvent.

[0576] Embodiment 26. A practical method in which the organic solvent comprises at least one of heptane and xylene. 26. The method of embodiment 25.

[0577] Embodiment 27. A substantially water-insoluble sealant is provided on a substantially water-insoluble sealant. applied by brushing, spraying or roller coating to the The method according to any one of the embodiments.

[0578] Embodiment 28. A tubular wall having substantially different amounts of substantially water-insoluble sealant thereon. and applying a substantially water-insoluble sealant to one of the tubular walls so as to include at least two portions. any preceding embodiment, including one or more steps of selectively applying to one or more portions of the The method described.

[0579] Embodiment 29. A tubular wall having a coating of a substantially water-insoluble sealant, 29. Any one of embodiments 14 to 28, which, after curing, is substantially impermeable to liquids. The method described.

[0580] Embodiment 30. After the substantially water-insoluble sealant has cured, the tubular wall has a H of 120 mm. g pressure: approx. 0.16 ml / min / cm 2 or 0.16 ml / min / c at 120 mm Hg pressure m 2 10. The method of any preceding embodiment, wherein the SiO 2 film has a water permeability of less than 1000 nm.

[0581] Embodiment 31. A woven fabric, The first opening end and the second opening end are disposed between the first opening end and the second opening end opposite the first opening end, and the inner surface and the outer surface opposite the first opening end are disposed between the first opening end and the second opening end opposite the first opening end. the tubular wall comprises a woven structure of one or more filaments or yarns; The woven structure itself is permeable to liquids; a portion of the interior surface including a coating of a substantially water-soluble material thereon; the exterior surface further includes a coating of a substantially water-insoluble sealant disposed thereon; The tubular wall having a coating of substantially water-insoluble sealant thereon, after curing, is A woven fabric that is substantially impermeable to

[0582] Embodiment 32. The water-soluble material is polyvinylpyrrolidone, glycerol, methylcellulose Poly(ethylene glycol), poly(ethylene glycol) hydrogel, polyethylene 32. The fabric of embodiment 31, wherein the fiber is selected from the group consisting of: tetrafluoroethylene, tetrafluoroethylene oxides, tetrafluoroethylene silsesquioxane ... .

[0583] Embodiment 33. The coating of embodiment 31 or 32, wherein the water-soluble material comprises an oleophobic layer. The woven fabric according to claim 1.

[0584] Embodiment 34. The water-soluble material has a viscosity of about 6,000 g / mol to about 15,000 g / mol. 34. The method of any one of embodiments 31 to 33, comprising polyvinylpyrrolidone having a molecular weight of Textile.

[0585] Embodiment 35. An embodiment in which the water-soluble material comprises polyvinylpyrrolidone and glycerol. The woven fabric according to any one of aspects 31 to 34.

[0586] Embodiment 36. The substantially water-insoluble sealant is moisture-curable, light-curable, heat-curable, an enzyme selected from the group consisting of a platinum catalyst, an anaerobic curing material, or a combination of these curing mechanisms; 36. The fabric of any one of embodiments 31-35, which is an elastomer material.

[0587] Embodiment 37. The elastomeric material is silicone, polyurethane, polycarbonate, 37. The composition of claim 36, wherein the polymer is selected from the group consisting of thermoplastic elastomers, and combinations thereof. The fabric described.

[0588] Embodiment 38. Substantially water-soluble coating or substantially water-insoluble coating One or more of the components may be selected from the group consisting of colorants, therapeutic agents, dyes, and fluorescent indicators. 38. The fabric of any one of embodiments 31-37, comprising:

[0589] Embodiment 39. After the substantially water-insoluble sealant has cured, the tubular wall has a H of 120 mm. g pressure: approx. 0.16 ml / min / cm 2 or 0.16 ml / min / c at 120 mm Hg pressure m 2 39. The woven fabric of any one of embodiments 31-38, having a water permeability of less than 1000 .mu.m.

[0590] Embodiment 40. The textile structure is a weave of one or more filaments or yarns, one or more fibers Braiding of filaments or threads, braiding of one or more filaments or threads, and one or more 40. Any of embodiments 31 to 39, wherein the web of filaments or yarns is selected from the group consisting of: A woven fabric according to any one of the preceding items.

[0591] Embodiment 41. The tubular wall is a crimped wall having a series of peaks and valleys. 40. A fabric according to any one of claims 1 to 40.

[0592] Embodiment 42. A substantially water-insoluble sealant is applied to a tubular wall of a 2 Approximately 8m per g or cm of tubular wall area 2 42. The fabric of embodiment 41, wherein the fabric is disposed at more than 8 mg per unit area.

[0593] Embodiment 43. An embodiment in which the tubular wall is a non-crimped wall substantially free of peaks and valleys. 31 to 40. A woven fabric according to any one of claims 31 to 40.

[0594] Embodiment 44. A substantially water-insoluble sealant is applied to a tubular wall of a2 Approximately 4m per g or cm of tubular wall area 2 44. The fabric of embodiment 43, wherein the fabric is disposed at more than 4 mg per unit area.

[0595] Embodiment 45. A substantially water-insoluble sealant is applied to a tubular wall of a 2 Approximately 14 per mg or cm of tubular wall area 2 45. The method of claim 31, wherein the amount of the hydroxybenzoate is less than 14 mg per 1000 mg of the hydroxybenzoate. A woven fabric according to any one of the preceding items.

[0596] Embodiment 46. A portion of the tubular wall is formed so as to provide a first soft and flexible region. having a level of substantially water-insoluble sealant; such that another portion of the tubular wall provides a second region having a higher stiffness than the first region; having a second level substantially water insoluble sealant; The second level of substantially water-insoluble sealant is 46. ​​The fabric of any one of embodiments 31-45, having more than one level.

[0597] Embodiment 47. At least a portion of the coating of the substantially water-insoluble sealant comprises: Any of embodiments 31 to 46, involving at least a portion of one or more filaments or yarns. A woven fabric according to any one of the preceding items.

[0598] Embodiment 48. Any one of embodiments 31 to 47, wherein the fabric is an implantable medical device. The fabric described in (1).

[0599] Embodiment 49. The implantable medical device is a surgical vascular graft, an endovascular graft, a medical a patch, a hernia plug, a vascular wrap, a heart valve, a filter, etc. 49. The fabric of embodiment 48, selected from

[0600] Embodiment 50. Any one of embodiments 31 to 49, wherein the textile is a medical delivery device. The fabric described.

[0601] Embodiment 51. The fabric of embodiment 50, wherein the delivery medical device is a catheter.

[0602] Embodiment 52. A woven structure, a fluid-permeable polymeric fabric layer having opposite first and second surfaces and a length; When cured, the liquid-permeable polymeric fabric layer is substantially impermeable to fluids. a crosslinkable water-insoluble elastomer layer on the first textile surface configured to: a substantially dried water-soluble polymer layer on the second textile surface; The water-soluble polymer layer substantially inhibits migration of the water-insoluble elastomer layer onto the second surface. death; A woven structure wherein the water-soluble polymer layer is substantially removable by exposure to water.

[0603] Embodiment 53. The weight ratio of the crosslinkable water-insoluble elastomeric polymer to the water-soluble polymer is about 53. The woven structure of embodiment 52, wherein the ratio is from 0.1:1 to about 100:1.

[0604] Embodiment 54. The weight ratio of the crosslinkable water-insoluble elastomeric polymer to the water-soluble polymer is about 54. The woven structure of embodiment 53, wherein the ratio is from 1:1 to about 20:1.

[0605] Embodiment 55. A woven structure, a fluid-permeable polymeric fabric layer having opposite first and second surfaces and a length; a crosslinked water-insoluble elastomer on the first fabric surface that forms a substantially fluid-impermeable barrier; a polymer layer, the polymer layer being a cross-linked water-insoluble elastomer that is attached to the first textile surface by elastic contraction; with the storm layer; a water-soluble polymer layer dried on the second textile surface; The weight ratio of the crosslinked water-insoluble elastomeric polymer to the water-soluble polymer is from about 0.1:1 to about 1 00:1, woven structure.

[0606] Embodiment 56. The crosslinked water-insoluble elastomeric polymer to water-soluble polymer weight ratio is about 1. 56. The woven structure of embodiment 55, wherein the ratio of the ratio ...

[0607] Embodiment 57. A graft, The first opening end and the second opening end are disposed between the first opening end and the second opening end opposite the first opening end, and the inner surface and the outer surface opposite the first opening end are disposed between the first opening end and the second opening end opposite the first opening end. a tubular wall having a woven structure of one or more filaments or yarns; the exterior surface including a coating of a substantially water-insoluble sealant disposed thereon; the interior surface being substantially free of the substantially water-insoluble sealant; The tubular wall has a flow rate of approximately 0.16 ml / min / cm at 120 mm Hg pressure. 2 or 120 mm Hg Pressure: 0.16 ml / min / cm 2 The graft has a water permeability of less than 1000 .mu.m.

[0608] Embodiment 58. The textile structure is a weave of one or more filaments or yarns, one or more fibers Braiding of filaments or threads, braiding of one or more filaments or threads, and one or more 58. The web of claim 57, wherein the web is selected from the group consisting of a web of filaments or yarns of raft.

[0609] Embodiment 59. The coating is disposed within the intermediate portion of the tubular wall between the inner surface and the opposite outer surface. 59. The graft of embodiment 57 or 58, wherein the graft is placed in a graft-like position.

[0610] Embodiment 60. The tubular wall is a crimped wall having a series of peaks and valleys. 59. A graft according to any one of claims 1 to 59.

[0611] Embodiment 61. A substantially water-insoluble sealant is applied to a tubular wall of a 2 Approximately 8m per g or cm of tubular wall area 2 Any of embodiments 57 to 60, wherein the amount of the steroid hormone is more than 8 mg per 100 mg of the active ingredient. or a graft according to one of the preceding paragraphs.

[0612] Embodiment 62. An embodiment in which the tubular wall is a non-crimped wall substantially free of peaks and valleys. 57. A graft according to any one of items 57 to 59.

[0613] Embodiment 63. A substantially water-insoluble sealant is applied to a tubular wall of a 2 Approximately 4m per g or cm of tubular wall area 2 Any of embodiments 57 to 62, wherein the amount of the steroid hormone is more than 4 mg per 100 mg of the active ingredient. or a graft according to one of the preceding paragraphs.

[0614] Embodiment 64. A substantially water-insoluble sealant is applied to a tubular wall of a 2 Approximately 14 per mg or cm of tubular wall area 2 64. The method of claim 57, wherein the amount of the hydroxybenzoate is less than 14 mg per 1000 mg of the hydroxybenzoate. The graft according to any one of the preceding claims.

[0615] Embodiment 65. The substantially water-insoluble sealant is moisture-curable, light-curable, heat-curable, an enzyme selected from the group consisting of a platinum catalyst, an anaerobic curing material, or a combination of these curing mechanisms; 65. The graft of any one of embodiments 57 to 64, which is an elastomer material.

[0616] Embodiment 66. The elastomeric material is silicone, polyurethane, polycarbonate, 66. The composition of claim 65, wherein the thermoplastic elastomer is selected from the group consisting of thermoplastic elastomers, and combinations thereof. The described graft.

[0617] Embodiment 67. Substantially water-soluble coating or substantially water-insoluble coating One or more of the components may be selected from the group consisting of colorants, therapeutic agents, dyes, and fluorescent indicators. 67. A graft according to any one of embodiments 57 to 66, comprising:

[0618] Embodiment 68. The substantially water-insoluble sealant is a silicone, a room temperature curing silicone. , thermoplastic polyurethane, aliphatic polycarbonate, one or more thermoplastic elastomers, Embodiments 57-67, wherein the polymer is selected from the group consisting of polycarbonates, polyisoprene ... A graft according to any one of the preceding claims.

[0619] Embodiment 69. A portion of the tubular wall is formed so as to provide a first soft and flexible region. having a level of substantially water-insoluble sealant; such that another portion of the tubular wall provides a second region having a higher stiffness than the first region; having a second level substantially water insoluble sealant; The second level of substantially water-insoluble sealant is A graft according to any one of embodiments 57 to 69, having more than one level.

[0620] Embodiment 70. An implantable or deliverable medical fabric, comprising: a wall having a woven structure and having a first surface and an opposing second surface; the second surface including a coating of a substantially water-insoluble sealant disposed thereon; fruit; the first surface being substantially free of the substantially water-insoluble sealant; The wall is approximately 0.16 ml / min / cm at 120 mm Hg pressure. 2 or 120 mm Hg pressure at 0.16 ml / min / cm 2 Implantable or deliverable medical fabrics having a water permeability of less than 1000 .mu.m. .

[0621] Embodiment 71. Implantable or deliverable endothelial cell membrane with a selectively applied water-insoluble sealant layer. 1. An assembly for producing a medical textile, comprising: a length, a hollow lumen disposed within a portion of the length, at least one open end, and a wall a mandrel having a plurality of perforations therethrough; a reservoir in fluid communication with the open lumen of the mandrel; a water-soluble polymer disposed within the reservoir.

[0622] Embodiment 72. A tube fixedly positioned over a portion of a mandrel having a plurality of perforations. 72. The assembly of embodiment 71, further comprising a graft.

[0623] Embodiment 73. Embodiment 7 further includes a vacuum source in fluid communication with the hollow lumen of the mandrel. 1 or 72. The assembly according to claim 1 or 72.

[0624] Embodiment 74. Selective flow between the hollow lumen of the mandrel and the reservoir and / or vacuum source. 74. The apparatus of embodiment 73, further comprising a manifold configured to provide fluid communication. Centella asiatica.

[0625] Embodiment 75. An embodiment further comprising a source of pressurized and / or blown air. 75. The assembly according to any one of aspects 71 to 74.

[0626] Embodiment 76. Pressurized and / or blown air flows through the hollow lumen of the mandrel. 76. The assembly of embodiment 75, wherein the body is in communication with the body.

[0627] Embodiment 77. The method of any preceding embodiment, further comprising a support member. Article, graft, device or assembly.

[0628] Embodiment 78. Any of embodiments 1 to 30, wherein the support member is applied to the outer surface of the wall of the conduit. or one of the methods described above.

[0629] Embodiment 79. The method of embodiment 78, wherein the support member is wrapped around the outer surface of the wall of the conduit. method.

[0630] Embodiment 80. The conduit includes a plurality of crimps, and the support member is inserted between the plurality of crimps. 80. The method of embodiment 79, wherein the method is arranged so as to be a receiving element.

[0631] Embodiment 81. The step of adding a support member to the conduit is performed before the step of adding a sealant to the conduit. The method according to any one of embodiments 78 to 80, wherein

[0632] Embodiment 82. The step of applying a sealant to the conduit comprises at least partially applying a sealant to the conduit by means of a support member. 82. The method of any one of embodiments 78 to 81, used to attach materials.

[0633] Embodiment 83. Any of embodiments 78 to 82, wherein the support member is a flexible polymer member. The method according to any one of the following:

[0634] Embodiment 84. The flexible support member is present along part of the length of the graft. 83. The method according to any one of claims 83 to 83.

Claims

1. 1. A method for producing a vascular graft, comprising: (i) providing a conduit comprising a wall, the wall of the conduit comprising an inner surface and an outer surface; at least a portion of the conduit is porous; (ii) applying a masking agent to at least a portion of the porous portion of the conduit; (iii) applying a sealant to at least a portion of the porous portion of the conduit. wherein the sealant is configured to reduce fluid migration through the wall of the conduit. Including process and The masking agent is adapted to reduce the presence of the sealant on the interior surface of the conduit. Consists of a method.

2. the sealant forms a sealing layer on at least a portion of an outer surface of the wall of the conduit. Item 1. The method according to item 1.

3. wherein the sealant forms a sealing layer on substantially all of the outer surface of the wall of the conduit.

3. The method of claim 1 or claim 2.

4. The masking agent forms a masking agent layer on at least a portion of the inner surface of the wall of the conduit. The method according to any one of claims 1 to 3,

5. The maskant forms a maskant layer on substantially all of the inner surface of the conduit wall. The method according to any one of claims 1 to 4.

6. The method of any one of claims 1 to 5, wherein substantially all of the conduit is porous. 。

7. one or more masking agent removal steps, wherein the or each masking agent removal step comprises: The method of any one of claims 1 to 6, further comprising the step of removing at least a portion of the masking agent from the conduit.

10. The method according to any one of claims 1 to 9.

8. Before applying the sealant to the porous portion of the conduit, 8. The method of claim 7, further comprising removing at least a portion of the masking agent from at least a portion of the substrate. The method described below.

9. After applying the sealant to at least a portion of the porous portion of the conduit, 8. The method of claim 7, further comprising removing at least a portion of the maskant from the interior surface of the wall of the conduit. Or the method according to claim 8.

10. After the step of applying the sealant to at least a portion of the porous portion of the conduit, 10. The method of claim 7, further comprising removing substantially all of the masking agent from the conduit.

1. The method according to claim 1.

11. At least one of the masking agent removal steps is carried out at a temperature of about 15°C to about 140°C. The method according to any one of claims 7 to 10,

12. At least one of the masking agent removal steps is performed by applying a solvent thereto.

12. The method according to claim 7, further comprising the step of removing at least a portion of the masking agent. The method described in paragraph .

13. The method of claim 12 , wherein the solvent comprises water.

14. The conduit is adapted to be agitated, rotated, spun, and / or heated during at least one of the masking agent removal steps. The method according to any one of claims 7 to 13, wherein the method comprises at least one of the steps of: shaking; How to do it.

15. At least one of the masking agent removal steps includes etching the masking agent, 7 to 10, which are carried out by Zuma etching, ablation and / or polishing.

15. The method of any one of claims 14 to 14.

16. the interior surface of the conduit wall is configured to promote growth of biological tissue thereon. Item 16. The method according to any one of Items 1 to 15.

17. The method of any one of claims 1 to 16, wherein the masking agent comprises a polymer.

18. The method of claim 17 , wherein the masking agent comprises a water-soluble polymer.

19. The masking agent may be polyvinylpyrrolidone, glycerol, methylcellulose, poly (ethylene glycol), and poly(ethylene glycol) hydrogel 19. The method of claim 17 or claim 18, further comprising one of:

20. The method of any one of claims 1 to 19, wherein the masking agent is biocompatible. 。

21. The masking agent forms a biocompatible masking agent layer when applied to the conduit. The method according to any one of claims 1 to 20,

22. The maskant is applied from a maskant solution to at least a portion of the porous portion of the conduit. The method according to any one of claims 1 to 21, wherein

23. 23. The method of claim 22, wherein the maskant solution is a polymer solution.

24. The step of applying the masking agent to at least a portion of the porous portion of the conduit comprises: by spraying a solution of scouring agent onto at least a portion of the porous portion of the conduit. The method according to claim 22 or claim 23,

25. The maskant solution applies the maskant to at least a portion of the inner surface of the wall of the conduit.

25. The method of claim 24, wherein the additive is added to the conduit by spraying onto the conduit.

26. The step of applying the masking agent to at least a portion of the porous portion of the conduit comprises: This is done by immersing at least a portion of the porous portion of the tube in the maskant solution. The method according to any one of claims 22 to 25,

27. 27. The method of claim 26, wherein substantially all of the conduit is immersed in the maskant solution. method.

28. The masking agent solution may be from about 5% weight / volume (w / v) of polymer in solution to about 5% weight / volume (w / v) of polymer in solution.

28. The method of any one of claims 22 to 27, comprising about 30% w / v polymer.

29. The step of applying the sealant to at least a portion of the porous portion of the conduit comprises:

29. The method of claim 1, wherein the method does not result in removal of the masking agent from the porous portion of the porous portion.

10. The method according to claim 1.

30. The masking agent is biodegradable when the artificial blood vessel is implanted in the human or animal body.

30. The method of any one of claims 1 to 29, adapted to interpret.

31. A method according to any one of claims 1 to 30, wherein the conduit is a woven fibre polymer conduit. Law.

32. The method of any one of claims 1 to 31, wherein the sealant comprises a polymer.

33. 33. The method of claim 32, wherein the sealant is a water-insoluble polymer.

34. The sealant forms a sealing layer when applied to the conduit, and the sealing layer is The method of any one of claims 1 to 33, wherein the polymer layer is

35. The sealant may be silicone, room temperature curing silicone, thermoplastic polyurethane, or a fatty acid. aliphatic polycarbonates, one or more thermoplastic elastomers, and polycarbonates The method of any one of claims 32 to 34, comprising at least one

36. 36. The method of claim 1, wherein the sealant is applied to the conduit from a sealant solution. The method according to any one of claims 1 to 5.

37. 37. The method of claim 36, wherein the sealant solution is a polymer solution.

38. 38. The method of claim 36 or claim 37, wherein the sealant solution comprises an organic solvent.

39. 10. The method of claim 9, wherein the sealant solution comprises at least one of heptane and xylene.

38. The method according to claim 38.

40. The sealant may be applied by brushing and / or spraying the sealant onto , applied to at least a portion of the porous portion of the conduit. The method described below.

41. wherein the sealant is configured to reduce blood movement through the wall of the conduit. Item 41. The method according to any one of items 1 to 40.

42. 42. The method according to any one of claims 1 to 41, comprising the further step of sterilizing the vascular prosthesis. method.

43. The artificial blood vessel is sterilized by a gamma ray sterilization process, an electron beam sterilization process, and an ethylene oxide sterilization process.

43. The method of claim 42, wherein the container is sterilized by at least one of the following sterilization processes:

44. Any of claims 1 to 43, wherein the conduit is movable between a contracted state and an extended state.

10. The method according to claim 1.

45. applying the masking agent to at least a portion of the porous portion of the conduit includes at least In some cases, the conduit is in the contracted state, the extended state, and / or the 45. The method of claim 44, wherein the method is performed when moving between a contracted state and the extended state.

46. applying the sealant to at least a portion of the porous portion of the conduit comprises at least The conduit may be in the contracted state, the extended state, and / or the contracted state.

46. ​​The method of claim 44 or 45, wherein the method is performed when the device is moved between a contracted state and the extended state. The method described.

47. an amount of masking agent applied to at least a portion of the porous portion of the conduit; and / or or weighing the conduit to at least partially determine the amount of sealant; and and / or one or more steps of measuring the length of the conduit. The method described below.

48. The step of applying the masking agent to at least a portion of the porous portion of the conduit comprises: A method according to any preceding claim, including providing a gas to the tube.

49. 49. The method of claim 48, wherein the gas is directed at an exterior surface of a wall of the conduit.

50. 50. The method of claim 48 or claim 49, wherein the gas is air.

51. A method according to any preceding claim, including adding a support member to the conduit. 。

52. 52. The method of claim 51, wherein the support member is applied to an exterior surface of the wall of the conduit.

53. 53. The method of claim 52, wherein the support member is wrapped around the exterior surface of the wall of the conduit.

54. The conduit includes a plurality of crimps, and the support member is interposed between the plurality of crimps.

54. The method of claim 53, wherein the first and second nodes are arranged to be children.

55. The step of applying the support member to the conduit is performed before the step of applying the sealant to the conduit.

55. The method according to any one of claims 51 to 54, wherein the method is carried out in

56. The step of applying the sealant to the conduit at least partially applies the sealant to the conduit. A method according to any one of claims 51 to 55, used for attaching a member.

57. 57. The method according to claim 51, wherein the support member is a flexible polymer member. How to post.

58. The conduit includes at least two portions having substantially different amounts of sealant thereon. and one or more steps of selectively applying a sealant to one or more portions of the conduit, such as 58. The method of any one of claims 1 to 57.

59. A conduit comprising a wall, the wall of the conduit comprising an inner surface and an outer surface, at least one of the conduit An artificial blood vessel including a conduit, a portion of which is porous; At least a portion of the porous portion is configured to reduce fluid movement through the wall of the conduit. a sealant comprising: The artificial blood vessel, wherein the inner surface of the wall of the conduit is substantially free of the sealant.

60. the sealant forms a sealing layer on at least a portion of an outer surface of the wall of the conduit. Item 60. The artificial blood vessel according to item 59.

61. wherein the sealant forms a sealing layer on substantially all of the outer surface of the wall of the conduit.

61. The artificial blood vessel according to claim 59 or 60.

62. 62. The method of claim 59, wherein substantially all of the conduit is porous. Artificial blood vessels.

63. the interior surface of the conduit wall is configured to promote ingrowth of biological tissue thereon; The artificial blood vessel according to any one of claims 59 to 62.

64. 64. A method according to any one of claims 59 to 63, wherein the conduit is a woven fibre polymer conduit. Artificial blood vessels.

65. 59. The sealant forms a sealing layer, the sealing layer being a polymer layer.

65. An artificial blood vessel according to any one of claims 1 to 64.

66. The sealant may be silicone, room temperature curing silicone, thermoplastic polyurethane, or a fatty acid. aliphatic polycarbonates, one or more thermoplastic elastomers, and polycarbonates The artificial blood vessel according to any one of claims 59 to 65, comprising at least one.

67. wherein the sealant is configured to reduce blood movement through the wall of the conduit. Item 67. The artificial blood vessel according to any one of Items 59 to 66.

68. The artificial blood vessel of any one of claims 59 to 67, wherein the artificial blood vessel is sterilized.

69. The artificial blood vessel is sterilized by a gamma ray sterilization process, an ethylene oxide sterilization process, and an electron beam sterilization process.

69. The vascular prosthesis of claim 68, which is sterilized by at least one of the following sterilization processes: 。

70. 70. Any of claims 59 to 69, wherein the conduit is movable between a contracted state and an extended state.

3. The artificial blood vessel according to claim 1.

71. The artificial blood vessel of any one of claims 59 to 70, wherein the conduit comprises a support member.

72. 72. The method of claim 71, wherein the support member is positioned substantially adjacent an outer surface of the wall of the conduit. Artificial blood vessels.

73. 73. The vascular prosthesis of claim 72, wherein the support member is wrapped around the exterior surface of the wall of the conduit. 。

74. The conduit includes a plurality of crimps, and the support member is interposed between the plurality of crimps.

74. The artificial blood vessel of claim 73, wherein the artificial blood vessel is arranged to be a proximal vessel.

75. The sealant at least partially attaches the support member to the conduit. The artificial blood vessel according to any one of claims 71 to 74, which is deployed.

76. 76. The method according to claim 71, wherein the support member is a flexible polymer member. Artificial blood vessels.

77. The conduit has at least two portions having substantially different amounts of sealant thereon. The artificial blood vessel according to any one of claims 59 to 76, configured to

78. 1. A kit of parts for manufacturing a vascular graft, said kit of parts comprising: (i) a conduit including a wall, the wall of the conduit including an inner surface and an outer surface, a conduit, at least a portion of which is porous; (ii) a masking agent; (iii) a sealant; Including; When applied to at least a portion of the porous portion of the conduit, the masking agent configured to mitigate the presence of the sealant on the interior surface of the conduit; When applied to at least a portion of the porous portion of the conduit, the sealant A kit of parts configured to reduce fluid migration through a tube wall.

79. Addition of the sealant to at least a portion of the porous portion of the conduit 79. The kit of parts of claim 78, wherein a sealing layer is formed on at least a portion of an outer surface of the wall. 。

80. Addition of the masking agent to at least a portion of the porous portion of the conduit 79. A masking agent layer is formed on at least a portion of the inner surface of the wall of claim 78. A kit of parts as described in

81. 81. The pipe of any one of claims 78 to 80, wherein substantially all of the conduit is porous. Sports kit.

82. The kit of parts includes a maskant remover, and the maskant remover is operable to remove an applied masking agent from the conduit.

82. A kit of parts according to any one of claims 1 to 81.

83. 83. The kit of parts of claim 82, wherein the maskant remover comprises a solvent.

84. 84. The kit of parts of claim 83, wherein the solvent comprises water.

85. The maskant remover is applied through the conduit at a temperature of about 15°C to about 140°C.

85. The method of claim 82, operable to remove the masking agent. Kit of parts as described.

86. The kit of parts includes a grinder, the grinder being adapted to grind the mask applied from the conduit. A part according to any one of claims 78 to 85, operable to remove a blocking agent. Tsu kit.

87. the interior surface of the conduit wall is configured to promote ingrowth of biological tissue thereon; 87. A kit of parts according to any one of claims 78 to 86.

88. The part according to any one of claims 78 to 87, wherein the masking agent comprises a polymer. Tsu kit.

89. 90. The kit of parts of claim 88, wherein the masking agent comprises a water soluble polymer.

90. The masking agent applied to the conduit forms a masking agent layer, and the masking agent layer 90. The kit of parts of any one of claims 78 to 89, wherein is a polymer layer.

91. The masking agent comprises polyvinylpyrrolidone, glycerol, methylcellulose, and Claims 88-9, comprising at least one of poly(ethylene glycol) hydrogels.

10. A kit of parts according to any one of claims 0 to 10.

92. 92. The masking agent of any one of claims 78 to 91, wherein the masking agent is biocompatible. Sports kit.

93. 10. The method of claim 1, wherein the maskant applied to the conduit forms a biocompatible maskant layer. 78-92. A kit of parts according to any one of claims 78-92.

94. The kit of parts includes a maskant solution, the maskant solution comprising a masking agent.

94. The method of claim 78, operable to apply a blocking agent to the conduit. Kit of parts listed.

95. 95. The kit of parts of claim 94, wherein the maskant solution is a polymer solution.

96. 96. The method of claim 94 or claim 95, wherein the conduit is immersible in the maskant solution. Kit of parts listed.

97. The masking agent solution may be from about 5% w / v polymer in solution to about 30% w / v polymer in solution.

97. The kit of parts according to any one of claims 94 to 96, comprising a polymer of

98. When the masking agent and the sealant are applied to the conduit, the sealant the addition of the sealant to the conduit removes the applied masking agent from the conduit. The part according to any one of claims 78 to 97, configured not to result in the removal of Tsu kit.

99. The masking agent is adapted to be biodegradable when implanted in the human or animal body.

99. The kit of parts of any one of claims 78 to 98, configured as follows:

100. 99. A method according to claim 78, wherein the conduit is a woven fibre polymer conduit. Kit of parts.

101. Claims 78-100, wherein the sealant comprises a polymer, optionally a water-insoluble polymer.

10. A kit of parts according to any one of claims 1 to 9.

102. The sealant forms a sealing layer when applied to the conduit, and the sealing layer is 102. The kit of parts of any one of claims 78 to 101, which is a polymer layer.

103. The sealant may be silicone, room temperature curing silicone, thermoplastic polyurethane, or a fatty acid. aliphatic polycarbonates, one or more thermoplastic elastomers, and polycarbonates 103. A kit of parts according to claim 101 or claim 102, comprising at least one

104. a kit of parts operable to apply a sealant to the conduit; A kit of parts according to any one of claims 78 to 103, comprising a solution.

105. 105. The kit of parts of claim 104, wherein the sealant solution is a polymer solution.

106. 106. The part of claim 104 or claim 105, wherein the sealant solution comprises an organic solvent. Tsu kit.

107. 10. The method of claim 9, wherein the sealant solution comprises at least one of heptane and xylene.

106. A kit of parts as set forth in claim 106.

108. a sealant applicator operable to apply a sealant to the conduit; and / or includes a maskant applicator operable to apply a maskant to the conduit.

108. A kit of parts according to any one of claims 78 to 107.

109. The sealant applicator is a device for spray coating the sealant.

109. The kit of parts of claim 108, wherein the kit is a device, and / or a brush.

110. The masking agent applicator is a brush, and the masking agent is spray-coated. an apparatus for dipping or immersing the conduit in the masking agent; and / or a device for wiping the conduit with the masking agent.

110. The kit of parts of claim 109.

111. When the sealant is applied to at least a portion of the porous portion of the conduit, 111. Any one of claims 78 to 110, configured to reduce the movement of blood through the wall of a vessel. A kit of parts as described in paragraph .

112. 112. The method of claim 78, wherein the conduit is movable between a contracted state and an extended state.

10. The kit of parts according to claim 1 .

113. A kit of parts according to any one of claims 78 to 112, comprising a further prosthetic device. 。

114. The further prosthesis may be a bioprosthetic heart valve, a synthetic heart valve, a ventricular assist device, or a ventricular assist device.

114. The kit of parts of claim 113, wherein the kit is at least one of:

115. Claims 78 to 114, including a metering device and / or a device for measuring the length of the conduit 10. A kit of parts according to any one of claims 1 to 9.

116. 79. The method of claim 78, further comprising:

116. A kit of parts according to any one of claims 1 to 115.

117. 117. The kit of parts of claim 116, wherein the gas is air.

118. The vascular system, A vascular prosthesis manufactured according to any one of claims 1 to 58; and including a further prosthetic device; The artificial blood vessel may be configured such that fluid can flow between the artificial blood vessel and the further artificial device. a vascular system connected to said further prosthesis so as to be capable of

119. The further prosthesis may be a bioprosthetic heart valve, a synthetic heart valve, a ventricular assist device, or a ventricular assist device. The vascular system of claim 118, which is at least one of the following:

120. A method for implanting an artificial blood vessel, comprising: A method for providing an artificial blood vessel manufactured by the method according to any one of claims 1 to 58. The course; connecting an inlet of the artificial blood vessel to a first blood vessel; connecting the outlet of the artificial blood vessel to a second blood vessel; The artificial blood vessel is configured to allow blood to flow between the first and second blood vessels. The way it is.

121. The first and second blood vessels may be diseased, severed, bisected, or the like. The method of claim 120, wherein the

122. A method for implanting an artificial blood vessel, comprising: Providing a vascular prosthesis according to any one of claims 59 to 77; connecting the artificial blood vessel to a first blood vessel; connecting the artificial blood vessel to a second blood vessel; The artificial blood vessel is configured to allow blood to flow between the first and second blood vessels. The way it is.

123. The first and second blood vessels may be diseased, severed, bisected, or the like. The method of claim 122, wherein the

124. 1. A method of transplanting vasculature, comprising: Providing a vasculature, said vasculature comprising: A vascular prosthesis manufactured according to any one of claims 1 to 58; and including a further prosthetic device; the artificial blood vessel is connectable to the further artificial organ; The artificial blood vessel is connected to the further artificial blood vessel so that blood can flow therebetween. connecting to the government; connecting the end of a blood vessel to the artificial blood vessel; connecting the additional prosthetic device to the heart; allowing blood to flow through the vascular system between the blood vessels and the heart The method.

125. The further prosthesis may be a bioprosthetic heart valve, a synthetic heart valve, a ventricular assist device, or a ventricular assist device.

125. The method of claim 124, wherein the method is at least one of the following:

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