Klappentragendes Conduit

Abstract

The invention provides a valve-bearing conduit for replacing the human heart valve and the ascending aorta.

Description

[0001] The invention provides a vascular prosthesis suitable for replacing the ascending aorta, in particular while preserving the natural aortic valve. In addition, this vascular prosthesis can also be used in combination with a mechanical or biological heart valve to completely replace the human heart valve and the ascending aorta.

[0002] In diseases of the vascular system, it is often necessary to replace the natural blood vessel. Vascular prostheses are typically used for this purpose. These are usually straight or branched tubes that can be made of textile or non-textile materials. Multifilament polyester yarns are particularly suitable for textile vascular prostheses. Such textile vascular prostheses can preferably be knitted or woven. Woven vascular prostheses are preferred for implantation, especially in the region near the heart.

[0003] DE4128611 and EP1534177 describe woven vascular prostheses with a plain weave and floats in the warp and weft directions. EP1389075 describes vascular prostheses with a plain weave and weft threads made entirely of smooth threads and warp threads made of alternating smooth and textured threads. Such woven straight tubes as replacements for the ascending aorta have the disadvantage that they do not reflect the actual anatomical situation, as the ascending aorta has protrusions near the heart, so-called sinuses of Valsalva, which ensure optimal function of the natural heart valve leaflets. EP1253876 and EP1534177 describe tubular vascular prostheses with sewn-on sinuses. EP0955019 discloses prostheses consisting of three sections sewn together, with the middle section being circumferentially bulbous, which, however, also does not correspond to the correct anatomical situation.The woven aortic sinus prostheses described in EP2654618 B1 also have essentially spherical bulbous regions without separate sinuses, but the three sections are seamlessly connected.

[0004] EP1935375 B1 provides an aortic sinus prosthesis that correctly conforms to the anatomical conditions. The woven aortic sinus prosthesis described here is also free of connecting sutures between the various sections and has three individual bulbs in the bulbus area.

[0005] The aortic sinus prostheses described in the prior art are frequently used for valve-preserving aortic root reconstruction. In this case, the patient's own aortic valve is implanted, i.e., sutured, into the aortic sinus prosthesis in an anatomically correct manner. The prosthesis is also sutured to the aortic root near the heart and to the patient's own aorta far from the heart. It is important that such sutures are blood-tight. To prevent blood leakage, additional materials and measures are often required, such as incorporating patch materials into the suture or using hemostatic adhesives, so-called sealants.

[0006] The object of the present invention is to provide an aortic sinus prosthesis which avoids the disadvantages known from the prior art and is in particular designed in such a way that it corresponds to the anatomical conditions, is blood-tight and in particular does not allow puncture channel bleeding.

[0007] Furthermore, it is an object of the present invention to overcome the above-described disadvantages of the prior art and in particular to provide a combination of the aortic sinus prosthesis according to the invention with a biological or mechanical heart valve.

[0008] The vascular prosthesis according to the invention is a vascular prosthesis that has three regions: a first cylindrical region remote from the heart, a second bulbous enlarged region, and a third cylindrical region close to the heart ( Fig. ). These regions are seamlessly connected to one another, i.e. the entire prosthesis is manufactured in a continuous weaving process. The first region, furthest from the heart, can have transverse pleats, as can the third region, close to the heart. The second bulb-shaped region can be unpleated or can also have transverse or longitudinal pleats to increase elasticity in the bulb area. The diameters of the two cylindrical regions can be 22 mm to 40 mm. The diameter of the bulb-shaped region is 1 to 40%, preferably 5 to 10%, larger than that of the cylindrical regions. This bulb area can preferably be formed by two, in particular three separate bulges, so-called sinuses, with straight, non-bulged, triangular surfaces in between.Surprisingly, it has been found that increases in the diameter of the bulbus area of ​​10 to 40%, preferably 15 to 35%, due to the dilatation that is also possible with woven prostheses, can lead to dysfunction of the reimplanted patient's own heart valve under a systolic pressure of 120 to 180 mm Hg, especially if one, two or preferably three separate sinuses are formed in the bulbus-shaped, second prosthesis section (. Fig. ).

[0009] The cylindrical region of the vascular prosthesis according to the invention, which is distal from the heart and has improved blood impermeability, particularly in the regions of the prosthesis that are connected to the natural aortic tissue or the aortic valve by sutures, can contain additional cylindrical prosthetic branches for connecting and replacing the patient's own blood vessels, such as the carotid arteries, and / or as access for the heart-lung machine. Typically, these additional branches are also textile, preferably woven, vascular prostheses with a diameter of 6 mm to 18 mm, preferably 8 mm to 14 mm. Additionally or alone, the first, distal region can contain a longitudinal suture, resulting in an arched shape. Such a design is particularly suitable for the simultaneous replacement of the aortic arch.

[0010] The basic prosthesis of the aortic sinus prosthesis according to the invention can preferably be woven by a method as described in EP1935375 B1 or EP2654618 B1. For the preferred formation of two or three individual sinuses, the sinus prosthesis produced according to EP1935375 B1 or EP2654618 B1 can be mechanically expanded in the second bulbous region. These individual sinuses can be designed such that they have a drop-shaped form, i.e., their diameter increases continuously from the region remote from the heart to the region close to the heart and then decreases continuously again, with the region of the circumferential increase being longer in the axial direction than the region of the circumferential decrease ( Fig. ). This simulates the anatomically correct situation. Furthermore, the sinuses can vary in length, width, and shape ( Fig. ) The number of individual sinuses can be one to three, preferably two to three. These can be arranged equidistant from one another in the circumferential direction. Between the individual bulbs or sinuses, in the second, bulb-shaped region of the vascular prosthesis according to the invention, there are additional web-like, non-expanded regions, the number of which is also two or three, depending on whether two or three individual sinuses are formed ( Fig. These bridge-like regions between the individual sinuses, which also seamlessly transition into the third region near the heart, occupy 1% to 22%, preferably 3% to 16%, of the circumference at the narrowest point between two individual sinuses, and 1% to 16%, preferably 2% to 10%, in particular 2% to 4%, of the circumference at three individual sinuses. These bridge-like regions widen toward the third region near the heart; in particular, they can be triangular in shape.

[0011] The individual sinuses can also vary in width circumferentially. Consequently, in a prosthesis with three individual bulbs, the longitudinally extending, unexpanded areas between the bulbous sections can be unevenly wide circumferentially.

[0012] To prevent puncture channel bleeding, in a preferred embodiment, the aortic sinus prosthesis can be provided with an additional material. This can be a textile, preferably thin, knitted, warp-knitted, or woven material, or a so-called non-woven material such as a fleece. This material, which encloses the aortic prosthesis in the manner of a cuff, can preferably be attached to the outside of the aortic sinus prosthesis, in particular sewn, glued, sprayed, or welded. In various embodiments, this cuff can encompass the annulus region closest to the heart and / or the bulbus region and / or the first region remote from the heart. In one embodiment, the aortic sinus prosthesis according to the invention is preferably equipped with this cuff in the region of the annulus and the bulbus. In a further preferred embodiment, the sinuses can be partially or completely free of this cuff, i.e.the cuff only partially or not at all covers the part of the aortic sinus prosthesis that has been widened to form the sinus (. Fig. ). For the textile version of this cuff, multifilament yarns made from a polymer from the group consisting of polyesters, polyurethanes, polyamides, polyolefins, as well as blends and copolymers thereof, are suitable. For the non-woven version of this cuff, polymers such as polyethylene, polypropylene, polytetrafluoroethylene (PTFE), particularly expanded polyfluoroethylene (ePTFE), polyesters such as polyethylene terephthalate, nylon, polyurethanes, and blends and copolymers thereof can be selected. In a preferred embodiment, the cuff has elastic properties. In another preferred embodiment, the cuff consists of a coating of the aortic sinus prosthesis in the annulus and bulbus region made of a polymer from the group of polyurethanes. It has been found that, in particular, the polyurethane coating of the aortic sinus prosthesis can prevent puncture channel bleeding when suturing the prosthesis to the aortic stump and / or suturing the patient's own aortic valve.

[0013] In particular, it is advantageous to use a polyurethane that is characterized by high biocompatibility, i.e. a mild tissue reaction after implantation.

[0014] Preferably, the polyurethane is a thermoplastic polyurethane consisting of aliphatic subgroups and whose polymer chains are unbranched, i.e. linear.

[0015] The polyurethane is preferably soluble in an organic solvent. Furthermore, the polyurethane is preferably produced from aliphatic diols and aliphatic diisocyanates, with the macromolecular diols being based on a polycarbonate backbone, such as 1,6-hexanediol polycarbonate. Low-molecular-weight diols that can be selected include, for example, 2,2,4-trimethylenehexanediol, 2,4,4-trimethyldiol, 1,4-butanediol, and combinations thereof. Diisocyanates used can include, for example, hexamethylene diisocyanate, cyclohexyl diisocyanate, and / or dicyclohexylmethyl diisocyanate. Other polycarbonate urethanes and / or polyether urethanes can also be selected. The molecular weight of the polyurethane is typically between 4,000 and 120,000 Daltons, preferably between 15,000 and 45,000 Daltons.

[0016] The polyurethane sleeve or polyurethane coating can preferably be formed on the outside, e.g., as a film or foil, in particular as a cast or sprayed foil. In a further preferred embodiment, the polyurethane coating has a nonwoven structure, in particular a sprayed nonwoven structure.

[0017] The coating accounts for between 0.05 and 10 wt.%, preferably between 0.1 and 5 wt.%, in particular between 0.2 and 2 wt.% of the total weight of the aortic sinus prosthesis. Its layer thickness is between 0.05 and 2 mm, in particular between 0.1 and 1 mm, and preferably between 0.2 and 0.8 mm. The coating preferably comprises fibers with regular and / or irregular fiber thicknesses. The thickness of the fibers can be between 0.01 µm and 10 µm, in particular between 0.1 µm and 5 µm, preferably between 0.5 µm and 3 µm.

[0018] The described structure of the spray-on fleece is particularly suitable for preventing and / or suppressing puncture channel bleeding. It also has the advantage that the patient's own body cells, particularly connective tissue cells (fibroblasts), can migrate into the coating from the outside and, by secreting substances such as collagen and / or elastin, firmly anchor the aortic sinus prosthesis in the patient's body.

[0019] State-of-the-art textile aortic sinus prostheses, in addition to knitted and particularly woven ones, are generally impregnated with, for example, cross-linked gelatin or collagen, or even a synthetically absorbable impregnation to ensure that the prosthesis is blood-tight at the time of implantation. Since this impregnation increases stiffness and needle penetration force, the coating content is reduced to a necessary minimum. This can lead to bleeding, particularly when thicker threads are used to suture the patient's own heart valve. Monofilament threads, e.g. made of polypropylene or other polymers with a strength of USP 4 / 0 and USP 5 / 0, are generally used for this purpose. However, the use of monofilament suture material with a strength of USP 3 / 0 and larger is also common. In this case, puncture channel bleeding is particularly possible with state-of-the-art prostheses.

[0020] According to the invention, these puncture channel bleedings can be prevented by partially increasing the proportion of coating material on the prosthesis due to the fabric construction and the yarns used, without fundamentally altering the handling of the prosthesis. Preferably, the coating content can vary in individual prosthesis regions due to the different construction and / or yarns used. In particular, the fabric construction in the second, bulbous prosthesis section and in the third, cylindrical prosthesis section (annulus region) near the heart can differ from that of the first, distal region.

[0021] In principle, all weave types (basic weaves, derived weaves, and compound weaves) are suitable for manufacturing the aortic sinus prosthesis according to the invention. Plain weave is particularly suitable for this purpose.

[0022] Multifilament yarns are used to create this weave. The yarn count can range from 5 to 250 dtex, and the yarns can be twisted at 10 to 500 turns / m. The repeat can be 8x8.

[0023] The thread density of the warp threads in the cylindrical region is typically 20 to 100 threads / cm of prosthesis circumference, preferably 30 to 90 threads / cm of prosthesis circumference, in particular 40 to 80 threads / cm of prosthesis circumference. The thread density of the weft threads in the cylindrical region can be 10 to 80 threads / cm of prosthesis length, preferably 20 to 40 threads / cm of prosthesis length.

[0024] Overall, the softness of the prosthesis can be adjusted by the weft thread density. The lower the weft thread density, the softer the aortic sinus prosthesis becomes.

[0025] Depending on the anatomical conditions, the first section, far from the heart, and the third section, close to the heart, may have different inner diameters combined with a correspondingly different warp thread spacing.

[0026] The segment closest to the heart preferably has a larger inner diameter than the one farther from the heart. Typically, the inner diameters of vascular prostheses are larger by 2 mm in ascending order of prosthesis size. Thus, the diameter difference between the third and first segments can preferably be 2 mm. Depending on the anatomical conditions, the first segment of the prosthesis far from the heart can also have a larger diameter than the third segment near the heart. A tapered shape between the third and first segments can also be provided.

[0027] The shaping of the bulb section or the individual bulbs within a bulb section can be carried out in various ways, as described, for example, in EP1935375 B1 or EP2654618 B1, whereby the different manufacturing methods can be combined. To increase the warp thread spacing in the bulb area over the entire circumference or, when shaping several individual sinuses over circumferential sections, it is possible to use so-called V-rails. Another option for shaping the bulbs is to stretch the weft threads. This can be achieved by mechanically expanding a tubular blank in the prosthetic area where the bulb is to be shaped.

[0028] Individual bulbs can be shaped in sections by expanding the diameter of the prosthesis. Surprisingly, it has been found that the tendency toward puncture channel bleeding in aortic sinus prostheses can be prevented by the inventive combination of textured and non-textured / smooth threads, in accordance with the state of the art.

[0029] According to the invention, the fabric consists of a combination of smooth and textured threads. Smooth threads are preferably used as warp threads, but textured threads alone can also be used. An alternating sequence of smooth and textured threads is advantageous, such that the ratio of smooth to textured threads is 2:1 and 1:2, in particular approximately 1:1.

[0030] In a further embodiment, the weft threads can be smooth or textured. The weft threads are preferably smooth threads. In another embodiment, smooth and textured threads can be used as weft threads, particularly in alternating sequences. According to the invention, the proportion of textured threads is higher in the bulbus region and / or annulus region than in the first, distal region. This allows a sufficient impregnation content to be achieved to prevent puncture channel bleeding.

[0031] For example, the ratio of smooth to textured threads in the first, cylindrical region far from the heart can be 5:1, but in the bulbus and / or annulus region it can be 1:5.

[0032] If the ratio of smooth to textured threads in the first cylindrical region away from the heart is 4:2, then the ratio in the bulb and / or annulus region can be 3:3, 2:4, or 1:5. If the ratio of smooth to textured threads in the first cylindrical region away from the heart is 3:3, then the ratio in the bulb and / or annulus region can be 2:4 or 1:5. If the ratio of smooth to textured threads in the first cylindrical region away from the heart is 2:4, then the ratio in the bulb and / or annulus region can be 1:5.

[0033] Typically, the weft threads are closer together in the bulbar region than in the first, cylindrical region far from the heart and the third, cylindrical region near the heart.

[0034] Thus, the weft threads in these areas are preferably compacted. In one embodiment, this can be achieved by a stronger beat-up of the weft threads. This can result in the larger spacing of the warp threads in these areas being compensated for by a smaller spacing of the weft threads. This results in the water permeability of the fabric being unchanged compared to the cylindrical sections, i.e., the water permeability is identical between the cylindrical areas and the bulbous area. Typically, the water permeability of the fabric is 0 to 1000 ml / cm 2 / min, especially 0 to 400 ml / cm 2 / min, preferably 180 to 260 ml / cm 2 / min. The method for determining water permeability corresponds to that of Wesolowski at a pressure of 120 ml of mercury column.

[0035] So-called shrink yarns are preferably used as weft threads for the cylindrical prosthesis section remote from the heart, and preferably also for the cylindrical section close to the heart. The shrinkability of these threads is at least 20%, preferably at least 30%, preferably at least 40%. Due to the different shrinkage of the weft threads between the cylindrical regions and the bulbar region, a diameter difference can develop between them. Likewise, diameter differences between the cylindrical regions themselves within these sections and within the bulbar region can develop due to different shrinkage of the weft threads.

[0036] In addition to the warp threads of the plain weave, additional float threads may also be arranged parallel to them. These float threads can, in particular, be textured. Suitable ratios and constructions of the float threads running in the warp direction are listed as examples in EP1935375 B1.

[0037] Thus, the floating thread can in particular be a float thread running longitudinally, which runs additionally and in particular parallel to a warp thread in the plain weave. In a preferred embodiment, the float threads are textured. In particular, the fabric of the aortic sinus prosthesis according to the invention can be designed such that the floating threads run both in the warp direction and in the weft direction. Surprisingly, it has now been found that if the float runs over more than 10 threads, the risk of puncture channel bleeding can be largely prevented. It has thus been found that in the weft direction the floats can advantageously run over 12 to 24 threads, in particular over 14 to 22 threads, preferably over 14 to 16 threads.Likewise, in a preferred embodiment, the floatation in the second, bulbous region and / or the third, near-heart region can be different from the floatation in the first, far-heart region in the weft direction. This means that, particularly in the second bulbous region and / or the third near-heart region, in combination with, for example, gelatin or collagen impregnation, the problem of puncture channel bleeding can be eliminated. For example, in the weft direction, the floatation in the first near-heart region can be 5 over 1 and in the bulbous second region 12 over 1. Other combinations are also possible.

[0038] The float is preferably formed on the outside of the prosthesis so that the inside of the prosthesis is advantageously free of floats.

[0039] To ensure blood tightness during implantation, the aortic sinus prosthesis according to the invention can be impregnated with suitable materials such as gelatin, collagen, albumin, or other suitable natural or synthetic, resorbable materials. In this case, it may be advantageous to crosslink the materials chemically or thermally.

[0040] In certain embodiments, the aortic sinus prosthesis according to the invention can be provided with active ingredients such as growth factors, antibiotics, antiseptics and similar active substances.

[0041] The aortic sinus prosthesis according to the invention can be conveniently sterilized using conventional methods and is available in suitable packaging as a sterile, medical implant.

[0042] The following examples provide further characteristics of the invention which are to be regarded only as examples and do not imply any limitations on the invention.

[0043] Advantageously, the three designs of the aortic sinus prosthesis according to the invention can be combined with each other.

[0044] In cases where it is necessary to replace the patient's aortic valve in addition to the diseased part of the ascending aorta, so-called valve-bearing conduits are often used (Bental-De Bono operation).

[0045] The so-called conduits usually consist of a tubular prosthesis, i.e. a straight tube, and a mechanical or biological heart valve. The difficulty with combining a biological heart valve made from bovine or porcine tissue is that these usually have to be stored in a preservation solution. However, since textile aortic prostheses are usually impregnated or coated with gelatin, albumin or collagen or synthetically absorbable polymers for sealing, combining the biological, preserved heart valve with a tubular prosthesis coated in this way is problematic because the preservation solution damages the impregnation or coating, i.e. for example, hardens or decomposes it. The aortic sinus prosthesis according to the invention can, however, be designed in such a way that the conduit can be manufactured and stored with a biological heart valve, since impregnation orCoating of the aortic sinus prosthesis is not necessary.

[0046] The textile vascular prostheses preferably used in the state of the art have a certain porosity measured as water permeability according to the Wesolowski method of approximately > 200 ml / cm 2min at 120 mm of mercury. This porosity is intended to ensure optimal healing of the prosthesis, as it is advantageous that after implantation of the vascular prosthesis, it is integrated into the surrounding body tissue on the outside and that a so-called neointima lines the vascular prosthesis on the side facing the blood. A uniform neointima is particularly advantageous for small-lumen vascular prostheses, such as those used for vascular replacement in the peripheral region of the vascular system, as this reduces the thrombogenicity of the prosthetic material and thus enables long-term patency of the vascular replacement. In the region near the heart, thrombogenicity and the possible deposition of thrombotic material are not a problem due to the large lumen of the prosthesis.In addition, clinical practice has shown that, contrary to the results of animal studies, alloplastic vascular replacements are only slightly colonized by endothelial cells after implantation in humans and thus only a very incomplete neointima is formed.

[0047] In a particular embodiment of the aortic sinus prosthesis according to the invention, the water permeability measured according to Wesolowski is 0-100 mm / cm 2 min, especially 0-50 mm / cm 2 min, preferably 0-10 mm / cm 2 min at 120 mm mercury column, ie the vascular prosthesis is blood-tight.

[0048] This can be achieved by adjusting the weaving parameters known to those skilled in the art, in particular by a suitable weft density and / or warp thread density.

[0049] In conjunction with an artificial, particularly biological, heart valve, the described vascular prosthesis offers several advantages over conventional conduits. For example, the outer surface of the conduit features a high proportion of textured threads and floats, ensuring optimal integration of the conduit into the surrounding natural tissue.

[0050] According to the invention, the aortic sinus prosthesis has single bulbs. This also creates an anatomically correct position for the valve leaflets of the biological or mechanical heart valve, corresponding to their physiological function. This creates optimal conditions for the biological or mechanical heart valve to function properly, offering numerous advantages for the patient, such as favorable hemodynamics due to the natural formation of the systolic vortex, a reduction in stress on the semilunar valves, and thus increased longevity of the biological valve.

[0051] Since impregnation or coating of the basic prosthesis with, for example, cross-linked gelatin to reduce the water permeability or blood impermeability of the prosthesis during implantation is not necessary, the conduit can be kept and stored in a preservative solution so that it is immediately available when needed.

[0052] Conveniently, the valve-bearing conduit according to the invention can be sterilized using common sterilization methods such as gamma rays or electron beam treatment (e-beam treatment) and is available in suitable packaging as a sterile medical implant. Examples for the production of an implant according to the inventionExample 1

[0053] A Jacquard loom is used to produce a prosthesis with a bulb. The bulb is formed using a V-shaped rail. The inner diameter above and below the bulb area of ​​the tubular prosthesis is 28 mm. The bulb has a longitudinal length of approximately 30 mm and a 32 mm wide extension at its widest point. The weaving process can be designed to form an endless tube with regularly spaced repetitions of the bulb area. State-of-the-art shrink yarns with different shrinkages can be used in the bulb and the cylindrical areas, in particular such that the shrink yarn exhibits less shrinkage in the bulb area than in the cylindrical area. This allows additional diameter differences to be created along the prosthesis axis.

[0054] To create the shrinkage, the prosthesis blanks are thermally treated, e.g., in a water bath, then dried. Depending on the design, they are embossed in a transverse direction above and below the bulbus, or only above the bulbus, and then fixed to a round rod. This can be mechanically expanded to create two or three individual bulbs. The resulting structures are then thermally fixed.

[0055] To create a cuff on the outside of the prosthesis in the bulb and / or in the third, cylindrical region closest to the heart, the first, cylindrical region farther from the heart is covered with a suitable sleeve, leaving only the bulb and the cylindrical region closest to the heart freely accessible. When forming two or three individual bulbs, the sleeve can be designed so that, in addition to the third region farther from the heart, the individual sinuses are also covered by the sleeve, leaving the web-like, non-mechanically expanded areas between the individual bulbs free. The sleeve can be rigid or made of a flexible material such as silicone to ensure easier handling.

[0056] The prepared prosthesis is then placed in a spraying device and sprayed with a polyurethane solution, for example, to form a fine-fibrillar fleece. The number of spray cycles required depends on the desired thickness of the fleece, depending on the viscosity of the spray solution and the corresponding polyurethane content in the spray solution.

[0057] Typically, the polyurethane is dissolved in chloroform, and the polyurethane solution concentration is 0.1% to 10%. It may be advantageous to treat the prosthesis in a pre-spraying process with a lower concentration of the spray solution than in the main spraying process, and then to spray the still-wet prosthesis with a more concentrated solution. This can increase the adhesive strength of the polyurethane fleece to the outer surface of the prosthesis. By varying the spraying process, particularly by varying the distance between the spray head and the prosthesis blank, a film-like or foil-like cuff can also be formed.

[0058] After drying, the sleeve covering the first area away from the heart is removed and the prosthesis can be impregnated with gelatin, cross-linked and then assembled, packaged and sterilized.

[0059] This embodiment may optionally be combined with those described in Examples 2 and 3. Example 2

[0060] Multifilament yarns are used to manufacture an aortic sinus prosthesis with a different overall ratio of smooth and textured threads in the third region, distal from the heart, and the bulbus region and / or the third region, proximal to the heart. Smooth (100f80Z40) and textured threads (100f80Z240) are used as warp threads. The further construction of the prosthesis can be carried out as described in EP1389075 B1. Smooth and textured threads are used in alternating sequences for the weft threads. For example, if the ratio between smooth and textured threads in the first region, distal from the heart, is 4:2, the ratio in the bulbus and annulus regions is 3:3.

[0061] The prosthesis blanks produced in this way are thermally shrunk on the Jacquard weaving machine as described in Example 1, pleated, and possibly mechanically expanded to form individual bulbs, fixed, and then impregnated with, for example, gelatin. This is followed by cross-linking of the gelatin, assembly, packaging, and sterilization.

[0062] This embodiment may optionally be combined with those described in Examples 1 and 3. Example 3

[0063] To produce an aortic sinus prosthesis with increased floatation compared to the prior art or with floatation that varies along the longitudinal direction of the prosthesis, prosthesis designs as disclosed in EP1389075 B1 are used. Alternatively, in one embodiment, the floatation in the warp and weft direction can extend over more than 10 threads, in particular over 14-16 threads. To produce an aortic sinus prosthesis with varying floatation in the weft along the longitudinal axis, the floatation can be, for example, 5 over 1 in the first region distant from the heart, 12 over 1 in the bulbous, second region, and 12 over 1 in the third region near the heart (annulus region).

[0064] The prosthesis blanks produced in this way are thermally shrunk on the Jacquard weaving machine as described in Example 1, pleated, and possibly mechanically expanded to form individual bulbs, fixed, and then impregnated with, for example, gelatin. This is followed by cross-linking of the gelatin, assembly, packaging, and sterilization.

[0065] This embodiment may optionally be combined with those described in Examples 2 and 3. Example 4

[0066] To simulate possible puncture channel bleeding after implantation in an in vitro test, aortic sinus prostheses with an inner diameter of, for example, 30 mm are manufactured according to the present invention. Matching porcine heart valves are sewn into the prosthesis using the T. David reimplantation method. The test specimens thus manufactured are then subjected to a static water column such that the internal pressure is 200 mm of mercury. The test duration is 30 minutes per aortic sinus prosthesis.

[0067] The following variants of test samples were manufactured and used: 1) Aortic sinus prosthesis according to the invention with three separate single bulbs with sprayed polyurethane fleece on the web-like, non-expanded area between the single bulbs and the third, near-heart area (annulus area); layer thickness of the polyurethane fleece 0.6 mm. 2) Aortic sinus prosthesis according to the invention with three separate single bulbs with a ratio of smooth to textured threads in the first, distal to the heart, cylindrical region of 5:1 and in the bulb and annulus region of 3:3. 3) Aortic sinus prosthesis according to the invention with three separate single bulbs with a float in the weft direction of 5 over 1 in the first, largely cylindrical region remote from the heart and 12 over 1 in the bulb and annulus region.

[0068] Medical, monofilament polypropylene threads of size 5 / 0, 4 / 0 and 3 / 0 are used to sew the porcine heart valve into the aortic prosthesis according to the invention.

[0069] Three test samples are tested for each variant of the aortic sinus prosthesis according to the invention.

[0070] In all cases—that is, in all three variants and when using 5 / 0, 4 / 0, and 3 / 0 monofilament threads—the sutures between the natural porcine heart valves and the aortic sinus prostheses according to the invention were watertight under the given test conditions. No leaks occurred. Example 5

[0071] To manufacture the valve-bearing conduit, a blank of the aortic sinus prosthesis is first produced using a loom as described in Example 2. The warp and weft thread density is adjusted so that after boil-shrinkage in a water bath of the shrinkable yarns contained therein, the water permeability according to Wesolowksi is 0 mm / cm 2min at 120 mm of mercury. After mechanically shaping three individual sinuses and creating the pleated, tubular shape, a porcine heart valve suitable for human implantation is sutured in an anatomically correct manner using USP 5 / 0 medical suture material. To verify physiologically correct valve closure without blood backflow, the conduit is subjected to a static water column for 10 minutes, resulting in an internal pressure of 200 mm of mercury. After successful verification of valve closure, the conduit is appropriately packaged and, if necessary, sterilized. Description of the illustrations Fig. Side view of an embodiment of the aortic sinus prosthesis according to the invention Fig. Inventive aortic sinus prosthesis with single bulb and bar-like, non-expanded bulb area Fig. Inventive aortic sinus prosthesis with drop-shaped design of the individual sinus Fig. Other embodiments of the Sinus Fig. Inventive aortic sinus prosthesis with cuff Fig. Inventive valve-bearing conduit consisting of a vascular prosthesis with three single sinuses in the bulbus area and a biological heart valve Reference symbols and their explanation 1 first area, away from the heart, with pleating 2 second, bulbous area 3 third, heart-near area 4 single bulbs (sinus) 5 bridge-like, non-expanded bulbus area 6 drop-shaped design of the individual sinuses 7 Cuff in the web-like, non-expanded area 5 and in the third, near-heart area 3 (annulus area) 8 vessel wall 9 Leaflets of the valve prosthesis 10 Sine 11 Commission 12 suture ring QUOTES CONTAINED IN THE DESCRIPTION

[0000] This list of documents submitted by the applicant was generated automatically and is included solely for the convenience of the reader. This list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions. Cited patent literature

[0000] DE 4128611

[0003] EP 1534177

[0003] EP 1389075

[0003] EP 1253876

[0003] EP 0955019

[0003] EP 2654618 B1 [0003, 0010, 0027] EP 1935375 B1 [0004, 0010, 0027, 0036] EP 1389075 B1 [0060, 0063]

Claims

[1] Valve-bearing conduit for replacing the human heart valve and the ascending aorta characterized by that the textile vascular prosthesis consists of three areas which are seamlessly connected to one another, a substantially cylindrical first area remote from the heart, a second bulb-forming area which adjoins the first area and a third area close to the heart which is also largely cylindrical and adjoins the second area, as well as a heart valve which is attached in the bulb area. [2] Valve-bearing conduit for replacing the human heart valve and the ascending aorta according to claim 1 characterized by that the textile vascular prosthesis is free of floats on the blood-facing side and has an essentially smooth surface. [3] Valve-bearing conduit for replacing the human heart valve and the ascending aorta according to claim 1 characterized bythat the side of the textile prosthesis facing away from the blood has a high proportion of floats. [4] Valve-bearing conduit for replacing the human heart valve and the ascending aorta according to claim 1 characterized by that the textile vascular prosthesis is free of impregnation or coating material. [5] Valve-bearing conduit for replacing the human heart valve and the ascending aorta according to claim 1 characterized by that the second bulbous section has individual bulbs into which a heart valve is sewn in an anatomically correct manner. [6] A method for producing a valve-bearing conduit according to claim 1. [7] A method for producing a valve-bearing conduit according to claim 1, into which a biological heart valve is sewn in an anatomically correct manner.

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