Multi-lumen implant

Abstract

The invention relates to a multi-lumen implant for use in human and animal bodies, comprising a substantially tubular element (1) divided into a proximal section (2) and a distal section (3), and at least one stent (8) for fixing the proximal section in a target blood vessel, the tubular element (1) branching in the distal section (3) into at least two lumens (4, 5).

Description

[0001] This application is a divisional application of the PCT International Patent Application No. 201780083208.6, filed on November 14, 2017, having the title “Multi-lumen implant”. TECHNICAL FIELD

[0002] The present invention relates to a multi-lumen implant for application in the vascular system of humans and animals, comprising an essentially tubular element divided into a proximal section and a distal section, and at least one stent for fixing the proximal section in a target blood vessel. BACKGROUND

[0003] An aneurysm is one of the most common pathologies of the human vascular system. An aneurysm is a bulge or protrusion occurring in the wall of a blood vessel. The specific causes can be very different, but it can generally be said that the affected part of the vessel wall is initially weakened and then widens due to the constant blood pressure acting on it.

[0004] Generally, aneurysms can occur in all regions of the body and at all locations of the vascular system. However, due to its vascular anatomy, there are certain locations in the human body that are predestined to form aneurysms alone. This includes, for example, all vascular branch locations, so-called bifurcations.

[0005] There are two aspects relating to the danger of aneurysms to the health of a patient. On the one hand, the aneurysm itself can cause problems if it exerts pressure, for example, on other blood vessels or organs. This can cause pain and / or lead to an insufficient supply of blood to other parts of the body and organs. If the brain is affected, for example, this can lead to more or less severe neurological deficits.

[0006] On the other hand, a rupture of the aneurysm can occur, that is to say, the aneurysm is also prone to tearing. This is particularly dangerous for the patient if the aneurysm is located in the brain or on a large blood vessel that carries or conveys a large amount of blood. A brain hemorrhage can be caused by a burst aneurysm occurring in the brain, which can lead to mild to most severe neurological damage, depending on the size of the blood vessel and the severity of the hemorrhage, and in the worst case, such a brain hemorrhage can even lead to the death of the patient. If the aneurysm tears on a large blood vessel in the patient’s body, a fatal blood loss can occur within a very short time, for example, in the case of a rupture of an abdominal aneurysm or a thoracic aneurysm.

[0007] Until a few years ago, many aneurysms had to be treated with open surgery, but at the same time, there are now various alternative treatment options and medical devices for the minimally invasive and endovascular treatment of aneurysms.

[0008] One of the preferred options for minimally invasive, endovascular aneurysm treatment is the placement of a stent graft. A stent graft comprises a stent frame and a covering, which in combination create a tubular implant. For the treatment of an aneurysm, such a stent graft bridges the area of the aneurysm by connecting healthy parts of the blood vessel via the stent graft, then the blood in the aneurysm area flows through the stent graft. On the one hand, the rupture of the aneurysm is thus prevented, on the other hand, the pressure exerted by the aneurysm on other structures is largely eliminated since the blood is no longer allowed to pass through the aneurysm.

[0009] The placement of such a stent graft in the form of a simple tube is particularly problematic when lateral branches leave the affected blood vessel in the aneurysm area. In this case, the implantation of the stent graft leads to the lateral branches in this area also being cut off from the blood supply, just like the aneurysm itself. Thus, the areas and / or organs to be perfused via the side branches are cut off from the blood supply.

[0010] In order not to cut off the side branches from the blood flow, it is necessary to supply them with blood via stent graft leads. In the prior art, a large number of techniques are known which offer possible solutions. Today, custom-made or modular implants are predominantly recognized, which are tailored to the needs of each individual patient. Both this custom-made product and the modular system are expensive. The production of particularly custom-made products is very time-consuming, since they usually have to be manufactured individually by hand. On the other hand, modular systems are to be assembled by the surgeon in the patient's body during the intervention very often.

[0011] For example, the publication EP 2 749 251 B1 (Cook Medical Technologies LLC) discloses a stretchable stent graft which comprises a base body and rings, which can be modularly adapted to the respective blood vessel anatomy in a certain way. And EP 2 081 515 B1 (Cook Medical Technologies LLC) discloses a special window arrangement in a stent graft in order to be able to connect lateral branches to the implant as universally as possible. In addition, the publication WO2014 / 197774A1 (Aortic Innovations Surena LLC) claims a variable stent graft system, the modular design of which allows the implant to adapt to the blood vessel anatomy of the patient in a predetermined longitudinal path to the turning lateral branches.

[0012] All these systems have disadvantages. Usually, the implantation requires an experienced surgeon, in many cases even a system-specific training in order to correctly construct the modularly designed implant in the patient's body during the intervention.

[0013] Furthermore, the implantation of custom-made, i.e. tailor-made, systems poses a major challenge to the surgeon. The anatomically accurate adaptation of the implant to the main branch and the access to the lateral branch require the surgeon to very precisely fit the implant into the patient's anatomy. What appears to be very simple in a rigid model is in fact very difficult work, because the vessels are not rigid and can change their position relative to each other.

[0014] The consequence of using such complex systems, whether they are fully assembled or modularly designed, is a sometimes lengthy and thus stressful duration of the intervention for the patient and the surgical team, and an increased likelihood of device failure.

[0015] Furthermore, the systems of the prior art usually have to be implanted completely in a single intervention. Stepwise implantation, either planned or in response to a patient's condition, is excluded or at least not without risk, because only a completely implanted system can produce the desired results. Thus, for example, it is difficult for the surgeon during the intervention to respond to a patient's deteriorating condition by postponing part of the steps to a later date. Similarly, it is usually not possible from the outset to perform the plan of the intervention over several days.

[0016] Moreover, the access possibilities of the known systems are usually limited due to their design configuration. Due to their complexity, these systems usually have a considerable diameter even in the folded state, so that insertion is only possible through a correspondingly large introducer sheath. Usually, this prevents the system from being introduced via the arm. Likewise, for design-related reasons, it is usually not possible to perform a retrograde access, for example to connect a lateral branch, with the known systems.

[0017] Another disadvantage of the prior art systems is that they can develop leaks, so-called endoleaks, through migration of the prosthesis, texture damage or development of disease in the upper and lower sealing segments. The relevant remedial measures can be very complex and are usually only possible open surgically.

[0018] Another decisive disadvantage of the prior art systems is that they need to be tailor-made on a case-by-case basis. The systems of the prior art, even if they have a partially modular design, still have to be made to measure in most cases to fit the requirements of a specific case. Usually, this takes several days or even weeks, in exceptional cases several months, until they can be used. It is therefore usually not possible to use such implants for emergency care, which can lead to avoidable deaths of patients during the waiting period for a proper implantation. SUMMARY

[0019] It is therefore an object of the present application to provide a multi-lumen implant which, due to its universal applicability and connection possibilities, is suitable for treating a plurality of patients and various clinical scenarios without the need for pre-interventional customisation or individualisation. Such a system is also suitable for emergency situations and can be stored in hospitals so as to be available at any time.

[0020] It is a further object of the present application to provide a multi-lumen implant which, in the folded state, has a diameter as small as possible, which can accordingly be introduced via a small-diameter introducer sheath, so that in addition to a femoral access, in particular an arm access can also be used as a standard procedure.

[0021] Furthermore, it is an object of the present application to provide a multi-lumen implant which is compatible with conventionally available accessories. In particular, as many of the available prior art covered stents and stent grafts as possible should be usable in order to connect the implant to the continuous vascular system. Similarly, a stepwise intervention should also be possible.

[0022] It is a further object of the present application to provide a system which can be designed in as simple a manner as possible and is very easy to implant. This minimises the costs and failure rate of the system and the duration and risk of the intervention.

[0023] It is also an object of the present application to provide an implant which is suitable for taking remedial action on prior art systems in the event of a defect by providing a seal which is completely independent of the original system and providing its own anchoring method, so that already placed prosthetic components, for example endografts, can remain in the body.

[0024] The implant proposed by the present application achieves the proposed object in a method which is conceptually significantly different from prior art implants. Prior art implants attempt to reproduce the anatomy of the damaged vascular region and can thus be said to attempt to provide a lining of the region to be repaired. As a result, as described above, these implants must be manufactured and implanted individually as accurately as possible. On the other hand, the implant according to the present application is to be regarded as a distributor implant, which in principle can be connected to the blood vessel to be treated individually by means of a covered stent.

[0025] This object is achieved by a multi-lumen implant having the features described in claim 1. Advantageous embodiments in each case are the subject of the dependent claims. It should be noted that any features and properties included individually in the claims can also be combined with one another in an alternative and technically reasonable manner, so that they disclose further embodiments or methods of the present application.

[0026] In a first embodiment proposed by the present application, the implant comprises a substantially tubular element and at least one stent for fixing the tubular element in the blood vessel.

[0027] The tubular element is structured to form a proximal section and a distal section, the distal section branching into at least two lumens. In the present application, the term distal always denotes the part of the structure pointing in the direction of the blood flow, and accordingly, the term proximal denotes the part facing away from the direction of the blood flow.

[0028] The tubular element can be imagined as a kind of glove and compared therewith. In such a comparison, the proximal section of the tubular element essentially corresponds to the part of the glove surrounding the palm, while the distal section of the tubular element essentially corresponds to the fingers of the glove, wherein the distal branches of the implant corresponding to the fingers open-endedly terminate or are openable at their end.

[0029] In a preferred embodiment, the proximal lumen branches distally into five lumens, one main lumen and four secondary lumens, but other subdivisions are readily conceivable and can be implemented without difficulty. The implant presented by the present application is by no means limited to embodiments of similar proportions, dimensions or other characteristics of a finger glove.

[0030] The tubular element can be fixed in the target blood vessel upstream of the aneurysm by means of at least one stent on the inside or outside of the proximal section of the tubular element. The tubular element can be attached to the stent by further measures, for example by clamping, welding, gluing, sewing or other known techniques. Particularly preferred is a clamp-type connection, as disclosed in the publication WO 2012 / 084202 A2. It is also conceivable to provide embodiments in which the proximal section of the tubular element is located between two stents and, if necessary, is additionally attached to one or both stents as described above.

[0031] In this case, embodiments can be envisaged in which the stent is not only located in the proximal section of the tubular element, but also extends into the distal region or even beyond the end of the distal region. In this way, for example, a first part of the proximal section of the tubular element, which is more or less long, can not be covered by the stent, and therefore this first part can then be folded inwards or outwards around the proximal end of the stent.

[0032] However, preferred embodiments are embodiments in which the proximal section of the tubular element is at least partially folded around the distal section of the tubular element. In particularly preferred embodiments, the stent for fixing the tubular element is then located in the fold or double fold formed between the original outside of the proximal section and the distal section of the tubular element.

[0033] A further preferred embodiment within the meaning already elucidated above is such that the proximal section of the tubular element is folded over the distal section, the length of the folded proximal section exceeding the length of the stent located in the fold thus formed. In this way, the part of the proximal section which protrudes distally beyond the stent can be folded inwards around the distal end of the stent, so that the stent is then wrapped at both ends by the proximal section of the tubular element.

[0034] The distal section of the tubular element branches into at least two lumens, wherein the number of lumens is arbitrary and the number of branches can be chosen, for example, depending on the number of blood vessels to be perfused. However, preferred are embodiments wherein five branches are arranged.

[0035] Particularly preferred embodiments comprise one main lumen with a larger diameter and four secondary lumens with a smaller diameter. However, the diameters are essentially arbitrary and can be chosen to suit the intended use of the implant. When using the implant in the thoracic and abdominal region, the diameter of the proximal section can range between 5 and 45 mm, preferably between 20 and 42 mm, the possible diameter of the main lumen ranges between 3 and 30 mm, preferably between 12 and 25 mm, and for the secondary lumens the following diameters can be used: between 2 and 12 mm, preferably between 4 and 10 mm. When intending to use the implant in the brain region, the diameter of the proximal section can range between 2 and 15 mm, preferably between 2 and 8 mm, the possible diameter of the main lumen ranges between 1 and 5 mm, preferably between 2 and 4 mm, and for the secondary lumens the following diameters can be used: between 1 and 4 mm, preferably between 2 and 3 mm. In case the implant is to be applied in the coronary region, the diameter of the proximal section can range between 2 and 8 mm, preferably between 4 and 6 mm, the possible diameter of the main lumen ranges between 2 and 6 mm, preferably between 3 and 5 mm, and for the secondary lumens the following diameters can be used: between 2 and 5 mm, preferably between 2 and 3 mm.

[0036] In addition to the embodiments mentioned above, it is also conceivable that embodiments can be provided with more or less than five lumens in total, and furthermore, embodiments can have more than one main lumen and more or less than four secondary lumens.

[0037] If the cross section of the area of the implant after branching is considered, it is preferred to use embodiments with an eccentric distribution of the lumens, in which case in the cross-sectional view the branching with the largest lumen is located on one side while one or more branchings with smaller lumens are arranged on the other side. However, the distribution of the branchings in the distal section of the tubular element is not predetermined and it is also conceivable that embodiments can be used in which, for example, one branching is located in the center area while the other branchings are distributed uniformly or non-uniformly around the central lumen.

[0038] In preferred embodiments, the individual branchings have the same length, but other embodiments are also conceivable in which the branchings are given different lengths. In general, it is preferred if the branchings terminate distally approximately together with the stent used for fixing the implant. However, it is conceivable that distally the stent also reaches beyond the branchings or that the branchings project distally from the stent frame.

[0039] The branches of the implant are connected to the blood vessels located distally of the implant via covered stents (so-called stent-grafts), thereby bridging the aneurysm region in this way and preventing blood flow into the aneurysm and reducing the pressure on the aneurysm. At the same time, the blood vessels located distally are purposefully supplied with blood via the stents.

[0040] In order to better fix the stents connecting the distal branches of the tubular element to each blood vessel to be supplied with blood, the distal branches in the preferred embodiment can taper conically entirely or over a certain length of the respective branch towards their end.

[0041] Other measures for fixing the stents in the distal branches are conceivable, in the form of annular or other reinforcements or stiffeners, especially in the distal region. On the one hand, this ensures a firm fit of the stent-graft, and due to the reinforcement, the risk of tearing the distal branches during implantation of the stent-graft is also reduced.

[0042] The branches in the distal section preferably extend freely from one another, but embodiments are also conceivable in which some or all of the branches are joined together, if it is considered advantageous to group them. The branches can additionally or alternatively be attached to the stents for fixing the implant in place or to the proximal section of the tubular element folded around.

[0043] As material for the tubular element, any physiologically compatible material known from the prior art can be used, primarily ePTFE, which can also be processed by electrospinning.

[0044] For the stent or stents, all materials known from the prior art can be used, which ensure permanent fixation of the tubular element and are not resorbable. Suitable for this purpose are alloys and shape-memory materials, such as nickel-titanium alloys, which enable balloon expansion.

[0045] In general, the implant proposed by the present application is placed proximally of the aneurysm in a still intact blood vessel section. In this case, the implant fulfils the function of a distribution disc or element which allows blood to flow only through the lumen of the distal branches. In order to bridge the aneurysm region, the distal branches of the tubular element are connected to the blood vessels located distally of the implant via covered stents.

[0046] The technology also makes it possible to perform the intervention step by step, since the placement of the implant initially does not prevent blood flow to the blood vessels located distally of the implant. In this way, the implant itself can be placed in position, for example, in a first intervention, where the blood vessels are subsequently connected in one or more further interventions.

[0047] Moreover, a retrograde access can be achieved which is difficult or even impossible with prior art implants in order to connect the branches of the blood vessel and the implant to each other.

[0048] Due to its universal applicability, the multi-lumen implant proposed by the present invention also enables the repair of already placed systems which have developed a leak (so-called endoleaks) due to migration (displacement of the prosthesis), texture damage or the development of disease in the upper and lower sealing segments. The already implanted prosthetic components can remain in the body, since the multi-lumen implant provides a completely independent sealing effect and its own anchoring system.

[0049] However, the implants according to the present invention offer various other advantages. They also relate to the manufacturing costs and thus to the cost of the health system, patient safety, improved time planning, availability, product safety and safety of the associated interventions.

[0050] Due to its universal applicability, the implant can be produced in larger quantities with a correspondingly lower unit cost, since it is standardized to five distally arranged lumen, thus being significantly more cost-effective than individualized implants.

[0051] Due to its universal usability because of its flexible connection options, the implant can be stored in the clinic and thus also be available for acute emergencies. Individualized production, which is sometimes associated with long waiting times, thus becomes unnecessary.

[0052] The implant is easy to implant, does not need to be prepared beforehand and does not have to be assembled in the patient's blood vessel system. Basically, the implantation takes place in the same way as the insertion of a normal stent. For the connection of the branches to the blood vessel, no special knowledge is required either, it corresponds to the routine placement of a stent graft.

[0053] The simplicity of the present implant also makes it less susceptible to device malfunctions which can occur during the intervention or are the result of previous manufacturing, handling and preparation activities compared to prior art implants.

[0054] Last but not least, the safety aspect of the actual intervention is expected to be improved, since due to the simplicity of the intervention process - the complex connection of the blood vessel and the assembly of the implant in the patient is eliminated - the intervention time is reduced and thus the risk of surgery-related complications is automatically reduced. BRIEF DESCRIPTION OF DRAWINGS

[0055] The invention and its technical context are described in full detail below with reference to the accompanying drawings. It should be noted that the drawings illustrate particularly preferred embodiments of the invention. However, the invention should not be construed as limited to the illustrated variations. To the extent technically advantageous, the invention particularly includes any alternative combinations of the technical features associated with the invention as described in the claims, description, and related drawings.

[0056] The invention is illustrated in the following figures, wherein... Figure 1 A schematic diagram of a tubular component is shown.

[0057] Figure 2 This is a schematic diagram of the first embodiment of the implant proposed in this invention.

[0058] Figures 3a-3b A schematic diagram showing the proximal segment folded onto the distal segment is provided to better understand a second embodiment of the implant of the present invention.

[0059] Figures 4a-4b This is a schematic diagram showing the proximal segment further folded into the distal segment and the stent position, in order to better understand the second embodiment of the implant of the present invention.

[0060] Figure 5 This is a schematic diagram of the second embodiment of the implant proposed in this invention.

[0061] Figure 6 Transverse section a) and longitudinal section b) are shown through a second embodiment of the implant according to the invention.

[0062] Figure 7 A schematic diagram showing possible allocation options for the distal lumen is presented.

[0063] Figure 8 The diagram illustrates a possible construction of the distal end of the branch, which is used to better secure the stent for delivering blood. Detailed Implementation

[0064] Figure 1 A schematic diagram of a tubular element 1 of an implant according to the invention is shown, the implant being divided into a proximal segment 2 and a distal segment 3. The proximal (p) single-lumen tubular element 1 branches distally (d) into at least two lumens 4, 5, wherein a preferred embodiment includes a main lumen 4 and four secondary lumens 5, or correspondingly, a large branch 6 and four smaller branches 7.

[0065] The relative proportions shown in this diagram are chosen purely for ease of identification of the various parts. Therefore, the ratio of proximal segment 2 to distal segment 3, as well as the ratio of the distal lumens 4 and 5, or the lengths of branches 6 and 7, may differ from those shown in the diagram.

[0066] Figure 2 is shown Figure 1 The tubular element 1 shown in Fig. 1 is shown in Fig. 2, wherein the stent 8 for stabilizing or fixing the tubular element 1 now lies in the tube within the proximal section 2. In this embodiment, the stent 8 reaches the distal section 3. If considered advantageous, the proximal end of the tubular element 1 can protrude beyond the stent 8 and be folded inward on the proximal end of the stent into the lumen of the proximal section 2.

[0067] Figure 3a and 3b is shown the arrangement of the proximal section 2 of the tubular element 1 in the first preferred configuration. In this case, the proximal section 2 is folded onto the distal section 3, so that the distal section 3 is ultimately at least partially surrounded by the proximal section 2.

[0068] Figure 4a and 4b are shown two variants of the first preferred embodiment, which are based on the folding of the proximal section 2 as shown in Figure 3a and 3b The variants 4a and 4b shown here differ in the length of the stent 8, which lies in the fold 9 formed by the folded parts, but protrudes to different degrees distally (d) from the fold and thus, on the distal section 3, to a greater degree 4a or a lesser degree 4b.

[0069] Figure 5 is depicted a preferred embodiment, which is based on a folded proximal section 2 as shown in Figure 3a and 3b The proximal section 2 is folded distally (d) up to the ends of the branches 6, 7. The stent 8 is contained in the fold 9 thus formed.

[0070] Figure 6 is shown a cross section 6a and a longitudinal section 6b through the preferred embodiment of the implant shown in Figure 5 The dotted line represents the stent 8, the dashed line represents the distal section 3, and the continuous line represents the proximal section 2 of the tubular element 1.

[0071] Figure 7 is a schematic view through a cross section of the implant, wherein different allocations and arrangements of the distal lumina 4, 5 are shown. The main lumen 4 can be arranged centrally (a, b) or eccentrically (c, d). The secondary lumen 5 can be arranged around the main lumen 4 (a, b) or on one side thereof (c, d). In the cross-sectional view, the main lumen 4 can be circular (a, c) or oval (b, d). Embodiments are also conceivable in which the secondary lumen 5 also has an oval shape. Figure 7 is shown a preferred embodiment.

[0072] Figure 8Various design options for the distal end d of the distal branches 6, 7 are shown, for better fixation of the stent, which connects the distal branches 6, 7 with the respective blood vessel to be perfused. For this purpose and in the preferred embodiment, the distal branches can taper gradually towards their end (a) or taper gradually at the distal tip (d) 12, at which they can have a ring reinforcement 10 or a distally throughout reinforced structure 11 (c).

[0073] The present disclosure also discloses the following embodiments: 1. A multi-lumen implant for the vascular system / body of humans and animals, comprising a substantially tubular element (1) and at least one stent (8), the tubular element (1) being divided into a proximal section (2) and a distal section (3), the at least one stent (8) for fixing the proximal section (2) in a target blood vessel, wherein the tubular element (1) is designed to branch into at least two lumens (4, 5) in the distal section (3).

[0074] 2. The multi-lumen implant according to embodiment 1, wherein the tubular element (1) branches into a main lumen (4) and a plurality of secondary lumens (5) in the distal section (3).

[0075] 3. The multi-lumen implant according to embodiment 2, wherein the secondary lumens (5) have a smaller diameter than the main lumen (4).

[0076] 4. The multi-lumen implant according to any one of embodiments 1 to 3, wherein the stent (8) is arranged inside the proximal section (2) of the tubular element (1).

[0077] 5. The multi-lumen implant according to any one of embodiments 1 to 3, wherein the stent (8) is arranged outside the proximal section (2) of the tubular element (1), wherein a first portion of the proximal section of the tubular element (1) is directed distally outward at least partially around a proximal portion of the stent (8).

[0078] 6. The multi-lumen implant according to embodiment 5, wherein the proximal section (2) of the tubular element (1) is at least partially folded over the distal section (3) and the stent (8) is at least partially arranged within the fold (9).

[0079] 7. The multi-lumen implant according to embodiment 6, wherein the length of the proximal section (2) of the tubular element (1) corresponds to the length of the stent (8).

[0080] 8. The multi-lumen implant according to embodiment 6, wherein the proximal section (2) of the tubular element (1) is longer than the stent (8) and the portion of the proximal section (2) distally (d) protruding beyond the stent (8) is folded inwards over the stent (8).

[0081] 9. The multi-lumen implant according to any of the preceding embodiments, wherein the lumens (4, 5) of the distal section (3) of the tubular element (1) taper (12) in distal direction (d).

[0082] 10. The multi-lumen implant according to any of the preceding embodiments, wherein the branches (6, 7) have a reinforcement (10, 11) distally, in particular ring-shaped.

[0083] 11. The multi-lumen implant according to any of the preceding embodiments, wherein the tubular element (1) is fixed to the stent (8) by clamping, gluing / bonding, suturing or welding.

[0084] 12. The multi-lumen implant according to any of the preceding embodiments, wherein the tubular element (1) is composed of ePTFE.

[0085] 13. The multi-lumen implant according to embodiment 12, wherein the tubular element (1) made of ePTFE is manufactured by electrospinning.

[0086] 14. The multi-lumen implant according to any of the preceding embodiments, wherein the stent (8) is a self-expanding stent.

[0087] 15. The multi-lumen implant according to any of embodiments 1 to 13, wherein the stent (8) is a balloon-expandable stent.

[0088] 16. A kit comprising an implant according to the preceding embodiments and a balloon catheter and / or a catheter for its implantation.

[0089] 17. The kit according to embodiment 16, further comprising a corresponding number of stent grafts for connecting the distal branches (6, 7) of the implant to distal blood vessels.

[0090] Reference Number List 1 tubular element 2 proximal section 3 distal section 4 main lumen 5 secondary lumen 6 main branch 7 secondary branch 8 stent 9 fold 10 annular reinforcement 11 annular reinforcement 12 tapering p proximal d distal

Claims

1. Multi-lumen implant for the vascular system / body of humans and animals, comprising a substantially tubular element (1) which is divided into a proximal section (2) and a distal section (3) and at least one stent (8) for fixing the proximal section (2) in a target vessel, characterized in that the tubular element (1) is designed to branch in the distal section (3) into at least two lumen (4, 5).

2. The multi-lumen implant of claim 1, wherein, the tubular element (1) branches in the distal section (3) into a main lumen (4) and a plurality of secondary lumens (5).

3. The multi-lumen implant of claim 2, wherein, the secondary lumens (5) have a smaller diameter than the main lumen (4).

4. The multi-lumen implant of any of claims 1-3, wherein, the stent (8) is arranged on the inside of the proximal section (2) of the tubular element (1).

5. The multi-lumen implant of any of claims 1-3, wherein, the stent (8) is arranged on the outside of the proximal section (2) of the tubular element (1), wherein a first portion of the proximal section of the tubular element (1) is directed distally outwards at least partially around a proximal portion of the stent (8).

6. The multi-lumen implant of claim 5, wherein, the proximal section (2) of the tubular element (1) is at least partially folded over the distal section (3) and the stent (8) is at least partially arranged within the fold (9).

7. The multi-lumen implant of claim 6, wherein, the length of the proximal section (2) of the tubular element (1) corresponds to the length of the stent (8).

8. The multi-lumen implant of claim 6, wherein, the proximal section (2) of the tubular element (1) is longer than the stent (8) and the portion of the proximal section (2) which protrudes distally (d) beyond the stent (8) is folded inwards over the stent (8).

9. The multi-lumen implant of any of the preceding claims, wherein, the lumens (4, 5) of the distal section (3) of the tubular element (1) taper (12) in the distal direction (d).

10. The multi-lumen implant of any of the preceding claims, wherein, the branches (6, 7) have a, in particular annular, reinforcement (10, 11) distally.

11. The multi-lumen implant of any of the preceding claims, wherein, the tubular element (1) is fixed to the stent (8) by clamping, gluing / bonding, stitching or welding.

12. The multi-lumen implant of any of the preceding claims, wherein, the tubular element (1) consists of ePTFE.

13. The multi-lumen implant of claim 12, wherein, the tubular element (1) made of ePTFE is produced by electrospinning.

14. The multi-lumen implant of any of the preceding claims, wherein, the stent (8) is a self-expanding stent.

15. The multi-lumen implant of any one of claims 1 to 13, wherein, the stent (8) is a balloon-expandable stent.

16. A kit comprising an implant according to the preceding claim and a balloon catheter and / or a catheter for its implantation.

17. The kit according to claim 16, further comprising a corresponding number of stent grafts for connecting the distal branches (6, 7) of the implant to distal vessels.

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